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[PDF PPT DOC] Pharmaceutical FILTER VALIDATION – Sterile Protocol FDA Guide

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Pharmaceutical FILTER VALIDATION PDF DOC PPT- Sterile Protocol FDA Guide

FILTER VALIDATION

Do you know Pharmaceutical Filter validation importance? Pharmaceutical processes are validated processes to assure a reproducible product  within set specifications. Equally important is the validation of the filters used within the process, especially the sterilizing grade filters, which, often enough, are used before filling or the final processing of the drug product. In its Guideline on General Principles of Process Validation, 1985, and Guideline on Sterile Drug Products Produced by Aseptic Processing, 1987, the FDA makes plain that the validation of sterile processes is required by the manufacturers of sterile products. Sterilizing grade filters are determined by the bacteria challenge test. This test is performed under strict parameters and a defined solution (ASTM F 838-83).

In any case, the FDA nowadays also requires evidence that the sterilizing grade filter will create a sterile filtration, no matter the process, fluid or bioburden, found. This means that bacteria challenge tests have to be performed with the actual drug product, bioburden, if different or known to be smaller than B. diminuta and the process parameters. The reason for the requirement of a product bacteria challenge test is threefold. First, the influence of the product and process parameters to the microorganism has to be tested. There may be cases of either shrinkage of organisms due to a higher osmolarity of the product or prolonged processing times. Second, the filter’s compatibility with the product and the parameters has to be tested. The filter should not show any sign of degradation due to the product filtered. Additionally, rest assurance is required that the filter used will withstand the process parameters; e.g., pressure pulses, if happening, should not influence the filter’s performance.

Third, there are two separation mechanisms involved in liquid filtration: sieve retention and retention by adsorptive sequestration. In sieve retention, the smallest particle or organism size is retained by the biggest pore within the membrane structure. The contaminant will be retained, no matter the process parameters. This is the ideal. Retention

by adsorptive sequestration depends on the filtration conditions. Contaminants smaller than the actual pore size penetrate such and may be captured by adsorptive attachment to the pore wall. This effect is enhanced using highly adsorptive filter materials, for example,

Glassfibre as a prefilter or Polyamide as a membrane. Nevertheless, certain liquid properties can minimize the adsorptive effect, which could mean penetration of organisms. Whether the fluid has such properties and will lower the effect of adsorptive sequestration and may eventually cause penetration has to be evaluated in specific product bacteria challenge tests.

[PDF PPT DOC] FILTER VALIDATION - Sterile Protocol FDA Guide

Before performing a product bacteria challenge test, it has to be assured that the liquid product does not have any detrimental, bactericidal or bacteriostatic, effects on the challenge organisms. This is done utilizing viability tests. The organism is inoculated into the product

to be filtered at a certain bioburden level. At specified times, the log value of this bioburden is tested. If the bioburden is reduced due to the fluid properties, a different bacteria challenge test mode becomes applicable. If the reduction is a slow process, the challenge test will

be performed with a higher bioburden, bearing in mind that the challenge level has to reach 107 per square centimeter at the end of the processing time. If the mortality rate is too high, the toxic substance is either removed or product properties are changed. This challenge fluid is called a placebo. Another methodology would circulate the fluid product through the filter at the specific process parameters as long as the actual processing time would be. Afterwards, the filter is flushed extensively with water and the challenge test, as described in ASTM F838-38, performed. Nevertheless, such a challenge test procedure would be more or less a filter compatibility test.

Besides the product bacteria challenge test, tests of extractable substances or  articulate releases have to be performed. Extractable measurements and the resulting data are available from filter manufacturers for the individual filters. Nevertheless, depending

on the process conditions and the solvents used, explicit extractable tests have to be  performed. These tests are commonly done only with the solvent used with the drug product but not with the drug ingredients themselves, because the drug product usually

covers any extractables during measurement. Such tests are conducted by the validation services of the filter manufacturers using sophisticated separation and detection methodologies, as GC-MS, FTIR, and RP-HPLC. These methodologies are required, due to the fact that the individual components possibly released from the filter have to be identified and quantified. Elaborate studies, performed by filter manufacturers, showed that there is neither a release of high quantities of extractables (the range is ppb to max ppm per 10-inch element) nor have toxic substances been found. Particulates are critical in sterile filtration, specifically of injectables. The USP 24 (United States Pharmacopoeia) and BP (British Pharmacopoeia) quote specific limits of particulate level contaminations for defined particle sizes. These limits have to be kept and, therefore, the particulate release of sterilizing

grade filters has to meet these requirements. Filters are routinely tested by evaluating the filtrate with laser particle counters. Such tests are also performed with the actual product under process conditions to prove that the product, but especially process conditions, do

not result in an increased level of particulates within the filtrate.

Additionally, with certain products, loss of yield or product ingredients due to adsorption shall be determined. For example, preservatives, like  benzalkoniumchloride or chlorhexadine, can be adsorbed by specific filter membranes. Such membranes need to be saturated by the preservative to avoid preservative loss within the actual product. This preservative loss e.g., in contact lens solutions, can be detrimental, due

to long-term use of such solutions. Similarly, problematic would be the adsorption of required proteins within a biological solution. To optimize the yield of such proteins within an application, adsorption trials have to be performed to find the optimal membrane

material and filter construction.

Cases that use the actual product as a wetting agent to perform integrity tests require the evaluation of product integrity test limits. The product can have an influence on the measured integrity test values due to surface tension, or solubility. A lower surface tension,

for example, would shift the bubble point value to a lower pressure and could result in a false negative test. The solubility of gas into the product could be reduced, which could result in false positive diffusive flow tests. Therefore, a correlation of the product as a wetting agent to the, water wet values has to be done, according to standards set by the manufacturer of the filter. This correlation is carried out by using a minimum of three filters of three filter lots. Depending on the  product and its variability, one or three product lots are used to perform the correlation. The accuracy of such a correlation is enhanced by automatic integrity test

machines. These test machines measure with highest accuracy and sensitivity and do not rely on human judgement, as with a manual test. Multipoint diffusion testing offers the ability to test the filter’s performance and, especially, to plot the entire diffusive flow graph through the bubble point. The individual graphs for a water-wet integrity test can now be compared to the product wet test and a possible shift evaluated. Furthermore, the multipoint diffusion test enables the establishment of an improved statistical base to determine the product wet versus water-wet limits.

Look out here Pharmaceutical FILTER INTEGRITY TESTING – FDA Guideline on Sterile Drug Products

Pharmaceutical Filter Validation References:

  1. Cooper and Gunn’s. Tutorial Pharmacy by S.J.Carter.
  2. Pharmaceutical engineering; K. Sambamurthy
  3. Pharmaceutical engineering; principles and practices, C.V.S. Subrahmanyam
  4. Encyclopedia of pharmaceutical technology, vol 3, edited by James Swarbrick.
  5. Pikal, M.J.; Lukes, A.L.; Lang, J.E. Thermal decomposition of amorphous beta-lactam antibacterials. J. Pharm. Sci. 1977, 66, 1312–1316.
  6. Pikal, M.J.; Lukes, A.L.; Lang, J.E.; Gaines, K. Quantitative crystallinity determinations of beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 1978, 67, 767–773.
  7. Pikal, M.J.; Dellerman, K.M. Stability testing of pharmaceuticals by high-sensitivity isothermal calorimetry at 25_C: cephalosporins in the solid and aqueous solution states. Int. J. Pharm. 1989, 50, 233–252.
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{PDF PPT DOC} FILTRATION EQUIPMENT – Filtration Mechanism & Types – Adv + Disadvantages

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{PDF PPT DOC} FILTRATION EQUIPMENT – Filtration Mechanism & Types – Adv + Disadvantages deals with details of filtration, filtration equipment,definitions, mechanism of filtration, Classification of filtration equipment, Different types of filtration its advantages & Disadvantages.

FILTRATION Definition:

FILTRATION may be defined as the separation of a solid from a fluid by means of a porous medium that retains the solid but allows the fluid to pass.

The term fluid includes liquids and gases, so that both these may be subjected to filtration.

The suspension of solid and liquid to be filtered is known as the “slurry”. The porous medium used to retain the solids is described as the filter medium; the accumulation of solids on the filter is referred to as the filter cake, while the clear liquid passing through the filter is the filtrate.

2.MECHANISMS OF FILTRATION:

The mechanisms whereby particles are retained by the filter are of significance only in the early stages of liquid filtration, as a rule. Once a preliminary layer of particles has been deposited, the filtration is effected by the filter cake, the filter medium serving only as a support.

STRAINING:

The simplest filtration procedure is “straining”, in which, like sieving, the pores are smaller than the particles, so that the latter are retained on the filter medium.

ENTANGLEMENT:

If the filter medium consists of a cloth with a nap or a porous felt, then particles become entangled in the mass of fibres. Usually the particles are smaller than the pores, so that it is possible that impingement is involved.

ATTRACTIVE FORCES:

In certain circumstances, particles may collect on a filter medium as a result of attractive forces. The ultimate in this method is the electrostatic precipitator, where large potential differences are used to remove the particles from air streams.

In practise, the process may combine the various mechanisms, but the solids removal is effected normally by a straining mechanism once the first complete layers of solids has begun to form the cake on the filter medium.

3.CLASSIFICATION OF THE FILTRATION EQUIPMENT:

Equipment’s are classified based on the application of external force.

  1. Pressure filters: plate and frame filter press and metafilter
  2. Vacuum filters: filter leaf
  3. Centrifugal filters

Classification based on the operation of the filtration

  1. Continuous filtration: discharge and filtrate are separated steadily and uninterrupted
  2. Discontinuous filtration: discharge of filtered solids is intermittent. Filtrate is removed continuously. The operation must be stopped to collect the solids.

Classification based on the nature of filtration

  1. Cake filters: remove large amounts of solids (sludge or crystals)
  2. Clarifying filters: remove small amounts of solids
  3. Cross-flow filters: feed of suspension flows under pressure at a fairly high velocity across the filter medium.

Equipment’s of pharmaceutical interest:

  1. Sand filters:
  2. Filter presses: chamber, plate and frame filters ( non-washing/washing; closed delivery/open delivery)
  3. Leaf filters
  4. Edge filters: stream line and meta filters
  5. Rotary continuous filters
  6. Membrane filters

  1. FILTRATION EQUIPMENT:

  2. {PDF PPT DOC} FILTRATION EQUIPMENT - Filtration Mechanism & Types - Adv + Disadvantages

4.1.SAND FILTERS

 

These are used mainly when relatively small amounts of solid are to be removed from the liquid and when relatively large volumes of liquid must be handled at minimum cost. A standardised pressure sand filter consists of a cylindrical tank at the bottom of which are a number of brass strainers which are either mounted on a false bottom or connected to a manifold embedded in concrete. The strainers have narrow slots sawed in them. Over the strainers is a layer of several inches of moderately coarse gravel on the top of which is a 2 to 4 ft. deep sand layer that forms the actual filter medium. The water to be filtered is introduced at the top on to a baffle which prevents disturbance in the sand by a direct stream. The filtered water is drawn off through the strainers at the bottom. When the precipitate clogs the sand to the extent of retarding the flow of water, it is removed by back washing. This operation consists of introducing water through the strainers, so that it may flow up through the sand bed and-out through the connection that is normally the inlet. This wash water is wasted. These sand filters are applicable only to the separation of precipitates that can be removed from the sand in this manner and that are to be discarded. Gelatinous precipitates or precipitates that coat the sand so that they cannot be removed by back washing or precipitates that are to be recovered cannot be handled in the sand filter.

Capacity is usually 2 to 4 gpm/sq.ft of surface of filtering area.

Fig1: pressure sand filter

For filtering excessively large quantities of very clean water, an open or rapid sand filter is used. It is similar to the pressure sand filter except that the sand is contained in large, open concrete boxes instead of in a closed pressure tank. Sand filter used in this way becomes a gravity filter (also called hydrostatic head filter).

ADVANTAGES:

Gravity filters have advantages of extreme simplicity, needing only simple accessories, low first cost and can be made of almost any material.

DISADVANTAGES:

  • Relatively low rate of filtration.
  • Excessive floor area needed and high labour charges
  • If the amount of particulate matter to be removed is too small or it is finely divided, sand filter will not remove the suspended solids.
  • In processes involving organic materials there may be danger of bacterial infection from an infected process-water supply and the sand filter cannot remove the bacteria as such. In these cases a coagulant like ferrous sulphate or aluminium sulphate is added to the water before filtration. These are hydrolysed by the alkalinity of most normal waters with the formation of a flocculant precipitate of iron or aluminium hydroxide. This precipitate adsorbs finely divided suspended matter and even bacteria, even if added to the water in very small amounts. The resultant flocs, though fine, are removed by the sand filters.

4.2.PLATE AND FRAME FILTER PRESS:

.

Principle : The mechanism is surface filtration. The slurry enters the frame by pressure and flows through the filter medium: The filtrate is collected on the plates and sent to the outlet. A number of frames and plates are used so that surface area increases and consequently large volumes of slurry can be processed simultaneously with or without washing.

Construction .: The construction of a plate and frame filter press is shown in the figure2. The filter press is made of two types of units, plates and frames.

(a) Frame-Maintains the slurry reservoir, inlet (eye) for slurry.

(b) Filter medium.

(c) Plate along with section-supports the filter medium, receiving the filtrate and outlet (eye).. (d) Assemb1y of plate and frame filter press.

These are usually made of aluminium alloy. Sometimes these are also lacquered for protection against corrosive chemicals and made suitable for steam sterilisation.

Frame contains an open space inside wherein the slurry reservoir is maintained for filtration and an inlet to receive the slurry. It is indicated by two dots in the description (Figure ).The plate has a studded or grooved surface to support the filter cloth and an outlet. It is indicated by one dot in the description (Figure ). The filter medium (usually cloth) is interposed between plate and frame.

Frames of different thicknesses are available. It is selected based on the thickness of the cake formed during filtration. Optimum thickness of the frame should be chosen. Plate, filter medium, frame, filter medium and plate are arranged in the sequence and clamped to a supporting structure. It is normally described by dots as 1.2.1.2.1 so on. A number of plates and frames are employed so that filtration area is a large as necessary. In other words, a number of filtration units are operated in parallel. Channels for the slurry inlet and filtrate outlet can be arranged by fitting eyes to the plates and frames, these join together to form a channel. In some types, only one inlet channel is formed, while each plate is having individual outlets controlled by valves.

Working : The working of the frame and plate process can be described in two steps, namely filtration and washing of  the cake (if desirable).

 

Filtration operation : The working of a plate and frame press is shown in Figure. Slurry enters the frame (marked by 2 dots) from the feed channel and passes through the filter medium on to the surface of the plate (marked by I dot). The solids form a filter cake and remain in the frame. The thickness of the cake is half of the frame thickness, because on each side of the frame filtration occur. Thus, two filter cakes are formed, which meet eventually in the centre of the frame. In general, there will be an optimum thickness of filter cake for any slurry, depending on the solid content in the slurry and the resistance -of the

filter cake.

The filtrate drains between the projections on the surface of the plate and escapes from the outlet. As filtration proceeds, the resistance of the cake increase and the filtration rate decreases. At a certain point, is preferable to stop the process rather than continuing at very low flow rates. The press is emptied and the cycle is restarted.

Fig 3: plate and frame filter press

Washing operation: If it is necessary to wash the filter cake, the ordinary plate and frame press is unsatisfactory. Two cakes are built up in the frame meeting eventually in the middle. This means that flow is brought virtually to a stand still. Hence, water wash using the same channels of the filtrate is very inefficient, if not  impossible. A modification of the plate and frame press is used. For this purpose, an additional channel is included (Figure). These wash plates are identified by three dots. In half the wash  plate there is a connection from the wash water channel to the surface of the plate.

The sequence of arrangement of plates and frames can be represented by dQts as 1.2.3.2.1.2.3.2.1.2.3.2.1 so on (between I and 1,2.3.2 must be arranged). Such an arrangement is shown in Figure (a) and (b) for the operations of filtration and water washing, respectively.

The steps are as follows.

(1) Filtration proceeds in the ordinary way until the frames are filled with cake.

(2) To wash the filter cake, the outlets of the washing plates (three dots) are closed.

(3) Wash water is pumped into the washing channel. The water enters through the inlets on to the surface     of the washing (three dots) plates.

(4) Water passes through the filter cloth and enters frame (two dots) which contains the cake. Then water washes the cake, passes through the filter cloth and enters the plate (one dot) down the surface.

(5)Finally washed water escapes through the outlet of that plate.

Fig 4: plate and frame filter press with water wash facility

Thus with the help of special washing plates, it is possible for the wash-water to flow over the entire surface of washing (three dots) plate, so that the flow resistance of the cake is equal to all points. Hence, the entire cake is washed with equal efficiency.

Fig 5: principles of filtration and washing

It should be noted that water- wash is efficient only if the frames are full with filter cake. If the solids do not fill the frame completely, the wash water causes the cake to break (on the washing plate side of the frame) then washing will be less effective. Hence, it is essential to allow the frames become completely filled with the cake. This helps not only in emptying the frames but also helps in washing the cake correctly.

Special provisions:

(I) Any possible contamination can be observed by passing the filtrate through a glass tube or sight glass from the outlet on each plate. This permits the inspection of quality of the filtrate. The filtrate goes through the control valve to an outlet channel.

(2) The filtration process from each plate can be seen. In the event of a broken cloth, the faulty plate can be isolated and filtration can be continued with one plate less.

Uses : Filter sheets composed of asbestos and cellulose are capable of retaining bacteria, so that sterile filtrate can be obtained, provided that the whole filter press and filter medium have been previously sterilized. Usually steam is passed through the assembled unit for sterilization.

Examples include collection of precipitated antitoxin, removal of precipitated proteins from insulin liquors and removal of cell broth from the fermentation medium.

Heating/cooling coils are incorporated in the press so as to make it suitable for the filtration of viscous liquids .

Advantages :

(1) Construction of filter press is very simple and a variety of materials can be used.

– Cast iron for handling common substances.

— Bronze for smaller units.

– Stainless steel is used there by contamination can be avoided.

– Hard rubber or plastics where metal must be avoided.

– Wood for lightness though it must be kept wet.

(2) It provides a large filtering area in a relatively small floor space. It is versatile, the capacity being variable according to the thickness of frames and the number used. Surface area can be increased by employing chambers up to 60.

(3) The sturdy construction permits the use of considerable pressure difference. About 2000 kilopascals can’ be normally used.

(4) Efficient washing of the cake is possible.

(5) Operation and maintenance is straight forward, because there are no moving parts, filter cloths are easily renewable. Since all joints are external, a plate can be disconnected if any leaks are visible. Thus contamination of the filtrate can be avoided.

(6) It produces dry cake in the form of slab.

Disadvantages :

(I)it is a batch filters so there is a good deal of ‘down-time’, which is non-productive.

(2) The filter press is an expensive filter. The emptying time, the labour involved and the wear and tear of the cloth resulting in high costs.

(3)operation is critical, as the frames should be full, otherwise washing is inefficient and the cake is difficult to remove.

(4) The filter press is used for slurries containing less than 5% solids.  So high costs make it  imperative that this filter press is used for expensive materials. Examples include the collection of precipitated antitoxin and removal of precipitated proteins from insulin liquors.

4.3.FILTER LEAF:

The filter leaf is probably the simplest  form, of  filter, consisting of a frame enclosing a drainage screen or grooved  plate, the whole unit being covered with filter cloth. The outlet for the filtrate connects to the inside of the frame. The frame may be of any shape, circular, square or rectangular shapes being used in practice. In use, the filter leaf is

immersed in the slurry’ and a receiver and vacuum system connected to the filtrate outlet. The method has the advantage that the slurry can be filtered from any vessel and the cake can be washed simply by immersing the filter, in a vessel of water. Removal of the cake is facilitated by the use of reverse air flow.

An alternative method is to enclose the filter leaf in a special vessel into which the slurry is pumped under pressure.

This form is commonest in filters where a number of leaves are connected to common outlet, to provide a larger area for filtration. A typical example is “ the Sweetland filters“

Fig 6: filter leaf                                              Fig 7: sweetland filter

The filter leaf is a versatile piece of equipment. Area can be varied by employing a suitable number of units, and the pressure difference may be obtained with vacuum or by using pressures up to order of 8 bars. The leaf filter is most satisfactory if the solids content of slurry is not too high, about 5 per cent being a suitable maximum. A higher proportion, results in excessive non-productive time while the filter being emptied and, provided this is observed. Labour costs for operating the filter are comparatively moderate·

The special feature of the leaf filter is the high efficiency of washing; in fact the cake can be dislodged and refiltred from the wash water if desired.

 

4.4.ROTARY FILTER:

Filters such as the filter leaf and filter press are batch operated and can handle dilute suspensions only, if the process is to be economic. In large scale operation, continuous operation is sometimes desirable and it may be necessary to filter slurries containing a high proportion of solids.

The rotary filter is continuous in operation and has a system for removing the cake that is formed, hence it is suitable for use with concentrated slurries.

The rotary filter consists of a number of filter units (usually 16-20 )  arranged so that the units are passing in continuous succession through the various stages.

One form is the rotary disc filter in which the sectors shaped filter leafs form a disc with the outlet from the each leaf connected to the vacuum system, compressed air, and the appropriate receivers, in the correct sequence, by means of special rotating valve.

fig 8: Rotary drum filter

The commonest form in use in the pharmaceutical industry, however, is the rotary drum filters, a section of which is shown in figure, from which it will be seen that the filter units have the shape of longitudinal segments of the pheriphery of a cylinder. Thus, each filter unit is rectangular in shape with a curved profile so that a number can be joined up to form a drum. Each unit has a perforated metal surface to the outer part of the drum and is covered with filter cloth. Appropriate connections are again made from each unit through a rotating valve at the center of the drum. In operation, the drum rotates at low speed, so that cach unit passes through the various zones shown in figure and listed in table.

Rotary filters may be up to 2m in diameter and 3.5m in length, giving areas of the order of 20m2. Special attachments may be included for special purposes; for example if the cake shrinks and cracks as it dries out, cake compression rollers can be fitted. These compress the cake to a homogenous mass to improve the efficiency of washing as the cake passes through the washing zone, or to aid drainage of wash water as the cake passes to the drying zone.

Where the solids of the slurry are such that the filter cloth becomes blocked with the particles, a pre coat filter may be used. This is variant in which a precoat of filter aid is deposited on the drum prior to the filtration process. The scraper knife then removes the solid filtered from the slurry together with a small amount amount of the precoat, the knife advancing slowly as the precoat is removed.

If the removal of the cake presents the problems, alternative discharge methods can be used. The string discharge rotary filter, for example, is especially useful for certain pharmaceutical applications, particularly for filtering the fermentation liquor in the manufacture of antibiotics where the mould is difficult to filter by ordinary methods because it forms a felt-like cake. The string discharge filter is operated by means of a number of loops of string which pass the drum, and cause the cake to form over the strings as shown in the diagram. The strings are in contact with the surface of the drum up to the cake removal zone, where they leave the surface and pass over additional small rollers before returning to again contact the drum. In operation, the strings lift the filter cake of the filter medium, and the cake is broken by the sharp bend, over the rollers so that it is easily collected while the strings return to the drum.

Advantages:

 

(a) The rotary filter is automatic and is continuous in operation, so that labour costs are very low

(b) the filter has a large capacity, in fact, the area of the filter as represented by A of darcy’s law is infinity.

(c) variation of the speed of rotation enables the cake thickness to be controlled and for solids that form an impermeable cake, the thickness may be limited to less than 5mm. On the other hand, if the solids are coarse, forming a porous cake, the thickness may be 100mm or more.

Table 1: various zones in rotary filter.

Fig 9: string discharge rotary drum filter

Disadvantages:

  • The rotary filter is a complex piece of equipment with many moving parts and is very expensive and in addition to the filter itself, ancillary equipments such as vacuum pumps and vacuum receivers and traps, slurry pumps and agitators are required.
  • The cake tends to crack due to the air drawn through by the vacuum system so that washing and drying are not efficient.
  • Being a vaccum filter the pressure difference is limited to 1 bar and hot filtrates may boil.
  • The rotary filter is suitable only for straight forward slurries,being less satisfactory if the solids formed an impermeable cake or will not separate cleanly from the cloth.

USES OF THE ROTARY FILTERS:

The rotary filter is most suitable for continuous operation on large quantities of slurry, especially if the slurry contains considerable amounts of solids, i.e., in the range 15-30%.

Examples of pharmaceutical applications include the collection of calcium carbonate, magnesium carbonate and starch, and the separation of mycelium from tyhe fermentation liquor in the manufacture of antibiotics.

4.5.MEMBRANE FILTERS:

These are plastic membranes based on cellulose acetate, cellulose nitrate or mixed cellulose esters with pore sizes in the micron or submicron range. They are very thin (about 120 micron thick) and must be handled carefully. They act like a sieve trapping particulate matter on their surface.

Several grades of filters are available with pore sizes ranging from 0.010 ± 0.002

micron to 5.0 ± 1.2 micron. Type codes VF and SM are given by Millipore Filter Corp. for

these two extreme ranges respectively.

Filters with pore sizes from 0.010 to 0.10 micron can remove virus particles from water or air. Filters with pore sizes from 0.30 to 0.65 microns are employed for removing bacteria. Filters with the larger pore sizes, viz. 0.8, 1.2 and 3.0 to 5.0 microns are employed, for example, in aerosol, radio activity and particle sizing applications.

During use membrane filters are supported on a rigid base of perforated metal, plastic or coarse sintered glass as in the case of fibrous pad filters. If the solution to be filtered contains a considerable quantity of suspended matter, preliminary filtration through a suitable depth filter avoids clogging of the membrane filter during sterile filtration. They are brittle when dry and can be stored indefinitely in the dry state but are fairly tough when wet.

ADVANTAGES:

  • No bacterial growth through the filter takes place during prolonged filtration.
  • They are disposable and hence no cross contamination takes place.
  • Adsorption is negligible they yield no fibres or alkali into the filterate. Filtration rate is rapid.

 

DISADVANTAGES:

  • They may clog though rarely.
  • Ordinary types are less resistant to solvents like chloroform

 

4.6.EDGE FILTERS:

A form of filters that differs markedly from those described above is the type known generally as edge filters. Filters such as the leaf or press act by presenting a surface of the filter medium to the slurry. Edge filters use a pack of the filter medium, so that filtration occurs on the edges. Forms using packs of media such as filter paper can be used but in the pharmaceutical industry greatest use is made of the Metafilter.

4.7.METAFILTER:

The metafilter, in its simplest form, consists of a grooved drainage rod on which is packed a series of metal rings. These rings, usually of stainless steel, are about 15mm inside diameter, and 0.8mm in thickness, with a number of semi-circular projections on one surface, as shown in the figure. The height of the projections and the shape of the section of the ring are such as that when the rings are packed together, all the same way up, and tightened on the drainage rod with a nut, channels are formed that taper from about 250µm down to 25µm. One or more of these packs is mounted in a vessel, and the filter may be operated by pumping in the slurry under pressure or, occasionally, by the application of reduced pressure to the outlet side.

In this form, the metafilter can be used as a strainer for coarse particles, but for finer  particles a bed of a suitable material such kieselguhr is first built up. The pack of rings, therefore, serves essentially as a base on which the true filter medium is supported.

Advantages

 

(a) The metafilter possesses considerable strength and high pressures can be used, with no danger of bursting the filter medium.

(b)As there is no filter medium as such, the running costs are low, and it is a very economical

filter.

(c) The metafilter can be made from materials that can provide excellent resistance to corrosion and avoid contamination of the most sensitive product.

(d) by selection of a suitable grade of material to form the bed, it is possible to filter off very fine particles; in fact, it is claimed that some grade will sterilize some liquid by filteration. Equally well it is possible to remove larger particles simply by building up a bed of coarse substances, or even by using the meta filter candle itself if the particles are sufficiently large.

(e) Removal of the cake is effectively carried out by back flushing with water. If further cleaning is required, it is normally necessary to do more than slacken the clamping nut on the end of the drainage rod on which the rings are packed.

Fig:10 (a) surface view ring ,

                                             (b) section through filter

USES OF THE METAFILTER:

 

The small surface of the metafilter restricts the amount of the solids that can be collected. This, together with the ability to separate very fine particles, means that the metafilter is used almost exclusively for clarification purposes.

Furthermore, the strength of the metafilter permits the use of high pressures (15 bars) making the method suitable for viscous liquids. Also, it can be constructed with material appropriate for corrosive materials. Specific examples of pharmaceutical uses include the clarification os syrups, of injection solutions, and of products such as insulin liquors.

CONCLUSION:

Filtration is an unique unit operation. The seperative process of filtration is widely used in the biopharmaceutical industry to remove contaminants from liquids, air, and gases, such as particulate matter, micro organisms. So a thorough knowledge of filtration equipment and their integrity testing is essential.

References:

  1. Cooper and Gunn’s. Tutorial Pharmacy by S.J.Carter.
  2. Pharmaceutical engineering; K. Sambamurthy
  3. Pharmaceutical engineering; principles and practices, C.V.S. Subrahmanyam
  4. Encyclopedia of pharmaceutical technology, vol 3, edited by James Swarbrick.
  5. Pikal, M.J.; Lukes, A.L.; Lang, J.E. Thermal decomposition of amorphous beta-lactam antibacterials. J. Pharm. Sci. 1977, 66, 1312–1316.
  6. Pikal, M.J.; Lukes, A.L.; Lang, J.E.; Gaines, K. Quantitative crystallinity determinations of beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 1978, 67, 767–773.
  7. Pikal, M.J.; Dellerman, K.M. Stability testing of pharmaceuticals by high-sensitivity isothermal calorimetry at 25_C: cephalosporins in the solid and aqueous solution states. Int. J. Pharm. 1989, 50, 233–252
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Filtration equipment pdf

filtration equipment pdf,PDF PPT DOC Pharmaceutical FILTRATION EQUIPMENT – Filtration Mechanism & Types – Adv Disadvantages

[PDF] FILTER INTEGRITY TESTING – FDA Guideline on Sterile Drug Products DOC PPT

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FILTER INTEGRITY TESTING

A filter integrity test is a critical unit operation commonly employed in the Pharma industry. FDA Guideline on Sterile Drug Products @ FILTER INTEGRITY TESTING is given below.

FILTER INTEGRITY TESTING

Sterilizing grade filters require testing to assure the filters are integral and fulfill their purpose. Such filter tests are called integrity tests and are performed before and after the filtration process. Sterilizing grade filtration would not be admitted to a process if the filter would not be integrity tested in the course of the process. This fact is also established in several guidelines, recommending the use of integrity testing, pre- and post-filtration. This is not only valid for liquid but also for air filters.

Examples of such guidelines are :

  1. FDA Guideline on Sterile Drug Products Produced by Aseptic Processing (1987):

Normally, integrity testing of the filter is performed after the filter unit is assembled and prior to use. More importantly however, such testing should be conducted after the filter is used in order to detect any filter leaks or perforations that may have occurred during filtration.

  1. The Guide to Inspections of High Purity Water Systems, Guide to Inspections of Lyophilization of Parenterals, and also the CGMP document 212.721 Filters state the following:
  2. The integrity of all air filters shall be verified upon installation and maintained throughout use. A written testing program adequate to monitor integrity of filters shall be established and followed. Results shall be recorded and maintained as specified in 212.83.
  3. Solution filters shall be sterilized and installed aseptically. The integrity of solution filters shall be verified by an appropriate test, both prior to any large-volume parenteral solution filtering operation and at the conclusion of such operation before the filters are discarded. If the filter assembly fails the test at the conclusion of the filtering operation, all materials filtered through it during that filtering operation should be rejected. Rejected materials may be refiltered using filters whose integrity has been verified provided that the additional time required for refiltration does not result in a total process time that exceeds the limitations specified in 212.111. Results of each test shall be recorded and maintained as required in 212.188(a).
  4. ISO 13408-1 First Edition, 1998-08-1, Aseptic Processing of Health Care Products, Part 1: General requirements: Section 17.11.1 Investigation, m. pre- and post-filter integrity test data, and/or filter housing assembly:
  5. 20.3.1. A validated physical integrity test of a process filter shall be conducted after use without disturbing the filter housing assembly. Filter manufacturer’s testing instructions or recommendations may be used as a basis for a validated method. Physical integrity testing of a process filter should be conducted before use where process conditions permit. ‘‘Diffusive Flow,’’ ‘‘Pressure Hold,’’ and ‘‘Bubble Point’’ are acceptable physical integrity tests.
  6. 20.3.2. The ability of the filter or housing to maintain integrity in response to sterilization and gas or liquid flow (including pressure surges and flow variations) shall be determined.
  7. USP 23, 1995, P. 1979. Guide to Good Pharmaceutical manufacturing Practice (Orange

FDA Guide, U.K., 1983):

  1. PDA (Parenteral Drug Association), Technical Report No. 26, Sterilizing Filtration of Liquids (March 1998):

Integrity tests, such as the diffusive flow, pressure hold, bubble point, or water intrusion tests, are non-destructive tests, which are correlated to the destructive bacteria challenge test with 107/cm2 B. diminuta. Derived from these challenge tests, specific integrity test limits are established, which are described and documented within the filter manufacturers’ literature. The limits are water-based; i.e., the integrity test correlations are performed using water as a wetting medium. If a different wetting fluid, such as a filter or membrane configuration, is used, the integrity test limits may vary. Integrity test measurements depend on the surface area of the filter, the polymer of the membrane, the wetting fluid, the pore size of the membrane, and the gas used to perform the test.

Wetting fluids may have different surface tensions, which can depress or elevate the bubble point pressure. The use of different test gases may elevate the diffusive gas flow. Therefore, appropriate filter validation has to be established to determine the appropriate integrity test limits for the individual process. Bubble Point Test Microporous membranes will fill their pores with wetting fluids by imbibing that fluid in accordance with the laws of capillary rise. The retained fluid can be forced from the filter pores by air pressure applied

from the upstream side. The pressure is increased gradually in increments. At a certain pressure level, liquid will be forced first from the set of largest pores, in keeping with the inverse relationship of the applied air pressure P and the diameter of the pore, d, described in the bubble point equation:

where g is the surface tension of the fluid, y is the wetting angle, P is the upstream pressure at which the largest pore will be freed of liquid, and d is the diameter of the largest pore.

When the wetting fluid is expelled from the largest pore, a bulk gas flow will be detected on the downstream side of the filter system (Fig. 7). The bubble point measurement determines the pore size of the filter membrane, i.e., the larger the pore the lower the bubble point pressure. Therefore, filter manufacturers specify the bubble point limits as the minimum allowable bubble point. During an integrity test, the bubble point test has to exceed the set minimum bubble point.

Manual bubble point test set up

 FILTER INTEGRITY TESTING

 

 

 

1.Diffusion Test

A completely wetted filter membrane provides a liquid layer across which, when a differential pressure is applied, the diffusive airflow occurs in accordance with Fick’s law of diffusion. This pressure is called test pressure and commonly specified at 80% of the bubble point pressure. In an experimental elucidation of the factors involved in the process, Reti simplified the integrated form of Fick’s law to read as follows:

where N is the permeation rate (moles of gas per unit time), D is the diffusivity of the gas in the liquid, H is the solubility coefficient of the gas, L is the thickness of liquid in the membrane (equal to the membrane thickness if the membrane pores are completely filled

with liquid), P (p1 _ p2) is the differential pressure, and r is the void volume of the membrane, its membrane porosity, commonly around 80%. The size of pores only enter indirectly into the equation; in their combination, they comprise L, the thickness of the liquid layer, the membrane being some 80% porous. The critical measurement of a flaw is the thickness of the liquid layer. Therefore, a flaw or an oversized pore would be measured by the thinning of the liquid layer due to the elevated test pressure on the upstream side. The pore or defect may not be large enough that the bubble point comes into effect, but the

test pressure thins the liquid layer enough to result into an elevated gas flow. Therefore, filter manufacturers specify the diffusive flow integrity test limits as maximum allowable diffusion value. The larger the flaw or a combination of flaw, the higher the diffusive flow.

Pressure Hold Test:

The pressure hold test is a variant of the diffusive airflow test. The test set-up is arranged as in the diffusion test except that when the stipulated applied pressure is reached, the pressure source is valved off. The decay of pressure within the holder is then observed as a function of time, using a precision pressure gauge or pressure transducer.

The decrease in pressure can come from two sources:

1) the diffusive loss across the wetted filter. Because the upstream side pressure in the  holder is constant, it decreases progressively as all the while diffusion takes place through the wetted membrane and

2) the source of pressure decay could be a leak of the filter system set-up. An  important influence on the measurement of the pressure hold test is the upstream air volume within the filter system. This volume has to be determined first to specify the maximum allowable pressure drop value. The larger the upstream volume, the lower will the pressure drop be. The smaller the upstream volume, the larger the pressure drop. This also means an increase in the sensitivity of the test, and also an increase of temperature influences, if changes occur. Filter manufacturers specify maximum allowable pressure drop values.

2.Water Intrusion Test:

The water intrusion test is used for hydrophobic ventand air membrane filters only. The upstream side of the hydrophobic filter cartridge housing is flooded with water. The water will not flow through the hydrophobic membrane. Air or nitrogen gas pressure is then applied to the upstream side of the filter housing above the water level to a defined test pressure. This is done by way of an automatic integrity tester. A period of pressure stabilization takes place over time frame, by the filter manufacturer’s recommendation, during which the cartridge pleats adjust their positions under imposed pressures.

After the pressure drop thus occasioned stabilizes, the test time starts, and any further pressure drop in the upstream pressurized gas volume, as measured by the automatic tester, signifies a beginning of water intrusion into the largest (hydrophobic) pores, water being incompressible. The automated integrity tester is sensitive enough to detect the pressure drop. This measured pressure drop is converted into a measured intrusion value, which is compared to a set intrusion limit, which has been correlated to the bacteria challenge test. As with the diffusive flow test, filter manufacturers specify a maximum allowable water intrusion value. Above this value, a hydrophobic membrane filter is classified as non-integral.

References for FILTER INTEGRITY TESTING:

  1. Cooper and Gunn’s. Tutorial Pharmacy by S.J.Carter.
  2. Pharmaceutical engineering; K. Sambamurthy
  3. Pharmaceutical engineering; principles and practices, C.V.S. Subrahmanyam
  4. Encyclopedia of pharmaceutical technology, vol 3, edited by James Swarbrick.
  5. Pikal, M.J.; Lukes, A.L.; Lang, J.E. Thermal decomposition of amorphous beta-lactam antibacterials. J. Pharm. Sci. 1977, 66, 1312–1316.
  6. Pikal, M.J.; Lukes, A.L.; Lang, J.E.; Gaines, K. Quantitative crystallinity determinations of beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 1978, 67, 767–773.

Pikal, M.J.; Dellerman, K.M. Stability testing of pharmaceuticals by high-sensitivity isothermal calorimetry at 25_C: cephalosporins in the solid and aqueous solution states. Int. J. Pharm. 1989, 50, 233–252.

FILTER INTEGRITY TESTING PDF – FDA Guideline on Sterile Drug Products PDF

FILTER INTEGRITY TESTING DOC – FDA Guideline on Sterile Drug Products

FILTER INTEGRITY TESTING PPT

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B.Pharmacy & M. Pharmacy Projects: Titles Project Work Topics {Pharmaceutics}

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B.Pharmacy & M. Pharmacy Projects: Titles Project Work Topics {Pharmaceutics}

Hello Buddies. Here are few topics and title which can be used for B.Pharmacy & M. Pharmacy Projects in the final year. Particularly these are the Titles Project Work Topics for Pharmaceutics specialization. 

PHARMACEUTICS: B.Pharmacy & M. Pharmacy Projects: Topics For Project Work Of Pharmaceutics Students

 

  1. Formulation and evaluation of topical formulations of Bosweellic acids guggulosterones for the treatment of rheumatoid arthritis
  2. Supramolecular: Nanomedicine and nanotechnology pre-concentration, separation and recovery of toxic trace metal
  3. Supercritical fluid technology
  4. Studies on design and development of dissolvable oral drug delivery systems of a poorly water soluble non-steroidal anti-inflammatory drug
  5. Designing of a polyherbal formulation for metabolic disorder
  6. Development of lipidic drug delivery system for bioavailability improvement of the poorly water soluble antihypertensive drug
  7. Formulation, development of rapidly dissolving films containing anti-histaminic drug
  8. Formulation and Evaluation of colon targeted drug delivery systems
  9. Formulation, development and evaluation of controlled drug delivery of analgesics via novel routes
  10. B.Pharmacy & M. Pharmacy Projects: Titles Project Work Topics {Pharmaceutics}

b pharm projects topics and review articles:

  1. Rotary Tableting Press
  2. Finished Goods Quality Assurance.
  3. The Perfect Excipient
  4. Product Composition Affects Material Selection
  5. Fractional Experimental Design. Study of the Incompatibility of Benzocaine in Throat Lozenges
  6. Moisture content of tablet
  7. Stability of the colorant
  8. Changes in tablet hardness. friability. dissolution rate
  9. Formulation and evaluation of colon targeted drug delivery system of mebeverine hydrochloride
  10. Any significant pharmaceutical problem with the drug product related to its formulation, drug delivery and bio-availability.
  11. Methods and types of dosage form which already exsits in the market.
  12. Points you have to study and review for literature purpose:
  13. One should have to study the history of the drug thoroughly.
  14. Early and common problems related to exsisting dosage forms.

M.pharm project topics in pharmaceutics

  1. Drug-induced diseases and Teratogenicity
  2. Drug dependences, Drug abuse, addictive drugs and their treatment, complications.
  3. Introduction to drying processes – Study of Tray Dryers: fluidized Bed Dryer.
  4. Vacuum Dryer and Freeze Dryer.
  5. Viscosity-Imparting Agents in Disperse Systems
  6. Oral Aqueous Suspensions
  7. Topical Suspensions A review
  8. Bio-availability of drugs, including factors affecting it
  9. complete data base of drug available by any source like internet, libraries etc.
  10. Complete physico0chemical parameter of pure drug.
  11. Study of complete drug profile from authenticated sources like pharmacopoeias, FDA online sites etc.
  12. study of depth of the drug and its available formulations and problems related with that available problems.
  13. Development and assessment of Novel In-situ Ocular gels of Ketorolac Tromethamine
  14. Dissolution improvement of weakly soluble drugs using hot melt Extrusion Technology.
  15. Dissolution rate Enhancement of Glimepiride and olanzapine by spray drying technique.
  16. Enhancement of dissolution rate of aceclofenac with meglumin as a novel ternary component
  17. Formulation and estimate of Aceclofenac Topical Emulgels.

B.PHARMACY & M. PHARMACY PROJECTS: TOPICS FOR PROJECT WORK OF PHARMACEUTICS STUDENTS

  • Formulation and estimation of atomoxetine HCL buccal drug delivery system
  • Formulation and assessment of capecitabine tablets for colon specific drug delivery system
  • Formulation and Evaluation of cyclobenzaprine hydrochloride loaded sustained release microspheres.
  • Formulation and evaluation of diclofenac sodium matrix tablets using new natural polymer
  • Formulation and evaluation of duloxetine HCL delayed release enteric coated capsules
  • Formulation and evaluation of fast disintergrating tablets and films for carbinoxamine maleate
  • Formulation and evaluation of frusemide semi solid matrix capsules by liquid filling technology
  • Formulation and Evaluation of Glipizide microemulsion.
  • Formulation and evaluation of implantable drug delivery system for temozolamide
  • Formulation and evaluation of ornidazole topical emulgels
  • Formulation and Evaluation pantoprazole sodium enteric coated tablets using different super disintegrants.
  • Screening, optimization and characterization of polymers for orally dissolving films.

 

PHARMACEUTICS Project Topics: B.Pharmacy

 

Formulation, Evaluation And Validation Of Orally Disintegrating Rizatriptan Benzoate Tablet.

Sustained Release Effervescent Floating Bilayer Tablets A Review Of Novel Approach.

Nanocapsules: Nano Novel Drug Delivery System.

Formulation And Evaluation Of Atomoxetine Hydrochloride Sustained Release Tablets.

Nano-Particles Containing Anticancer Drug.

Solubility Enhancement Of Poorly Water Soluble Drug By Spherical Crystallization Technique.

In-Vitro Antiproliferative Activity Of M. Azedarach.

Impact And Management Tool For Identification And Reduction Of Human Errors In Pharmaceuticals Industry.

Solid Dispersion- A Review.

Validation-In Pharmaceutical Industry : Cleaning Validation – A Brief.

A Review On Gastro-Intestinal Drug Esomeprazole.

Effect Of Ascorbic Acid On Dissolution Stability Of Rifampicin In Market Fixed Dose Combination Products For Tuberculosis.

Prepration And Evaluation Of Nano-Emulsion Formulation By Using Spontaneous Emulsification.

Preparation Method, Properties And Crosslinking Of Hydrogel: A Review.

Formulation Development And In Vitro Evaluation Of Mouth Dissolving Tablets Of Pioglitazone Hydrochloride.

Formulation And Evaluation Of Orodispersible Tablets To Enhance Dissolution Rate Of Lamotrigine By Using Solid Dispersion Technique.

Formulation And Evaluation Of Metformin Hydrochloride Buccal Patch

Recent Pharmaceutics project topics – Current research topics

  1. Lipid Based Solid Self-Emulsifying Delivery System Of Pitavastatin Calcium: Development And Characterization
  2. Design And Characterization Of Paclitaxel Loaded Nanoparticles With Piperine
  3. Development And Characterization Of Topical Microemulsion Of Tranexamic Acid
  4. Exploring Career Advancement Of Pharmacy Support Staff Within Two Queensland Hospitals: A Qualitative Study
  5. Significant Predictors For Topiramate Pharmacokinetics: A Systematic Review Of Population Pharmacokinetic Studies
  6. Nanocapsule Formation By Interfacial Polymer Deposition Following Solvent Displacement
  7. Stability Indicating Reverse Phase High Performance Liquid Chromatography Method For Simultaneous Estimation Of Allantoin, Hydroquinone And Tretenoin In Cream Formulation.
  8. Process Control And End-Point Determination Of A Fluid Bed Granulation By Application Of Near Infra-Red Spectroscopy
  9. Chirality And Its Importance In Pharmaceutical Field-An Overview
  10. Recent Advances In Nanosponges As Drug Delivery System
  11. Fabrication Of Mebendazole Loaded Solid Lipid Nanoparticles: Formulation, Optimization, Characterization, Stabilization, And In-Vitro Evaluation
  12. In Vitro Evaluation And Characterization Of The Nanoparticulate System Of Novel Taxane Derivative
  13. A Comprehensive Review On Solid Lipid Nanoparticles As Delivery Vehicle For Enhanced Pharmacokinetic And Pharmacodynamic Activity Of Poorly Soluble Drugs

The above topics are from the recent work of the scientists and researchers. You can get an idea of the current trend in the Pharmaceutics department. Try to get more information on these type of research work from scholars or research papers and try to do your own way of the topics so that you can get amazing project for your M Pharmacy or B Pharmacy Project topics.

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This article is updated now. M.pharm pharmaceutics project new list 2022

B. Pharmacy First Year Syllabus Subjects 1st Year BPharm

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B pharmacy first year syllabus

  1. B Pharmacy First Year Syllabus

Bachelor of Pharmacy is one of the finest educations at this point in time.  Every year zillions of students are joining B. Pharmacy to study Pharmacy.  It is a degree of three years that is studied semester wise.  It is an under graduation degree that gives the under graduation certification to the students.  It is the next level of education after intermediate.  Students who have studied intermediate with Bi.Pc background will go for under graduation into B. Pharmacy course.  It is a study about art and science.  The candidates of Pharmacy will be eligible to invent new drugs by performing researches in the labs.

Students of Pharmacy will be able to get theoretical knowledge along with practical knowledge as they perform various experiments while preparing new drugs for various diseases.  Pharmacy Council of India (PCI) is responsible to manage Pharmacy graduate level education in the entire country.  It is a statutory body that is governed by the provisions of the Pharmacy Act, 1948 that was passed by the Indian Parliament.

  1. Pharmacy first year

Students from various streams of intermediate like Physics, Chemistry, Maths, or Physics, Chemistry, Biology or Physics, Chemistry, Maths and Biology subjects are eligible to go for B. Pharmacy under graduation for three years.  They need to take entrance test in order to study B. Pharmacy.  B. Pharmacy is a semester wise education where the semester system is different from state to state.  Students will need to take various entrance examinations in order to join B. Pharmacy.  The entrance examinations to enter B. Pharmacy include B Pharma Entrance Exam, GPAT – Graduate Pharmacy Aptitude Test, MHT-CET Maharashtra Common Entrance Test etc.

Candidates can work in various areas of discipline like chemist shops, drug control administration, educational institutes, food and drug administration, health centers, hospitals, medical dispensing store, pharmaceutical firms, research agencies, sales and marketing departments etc.

B pharmacy first year syllabus

  1. Pharmacy First Year Subjects

The subjects in B. Pharmacy first year includes:

  • Remedial Mathematical Biology

  • Advanced Mathematics

  • Anatomy

  • Physiology and Health Education

  • Physical Chemistry

  • Organic Chemistry

  • Physical Pharmacy

  • Basic Electronics and Computer Applications

  • Pharmaceutical Analysis

  • Inorganic Pharmaceutical Chemistry

  • Pharmacognosy

These are the list of subjects that needs to be studied in the first year of B. Pharmacy.       Few state Pharmacy institutes will schedule the B. Pharmacy first year to be held semester wise while few institutes will schedule the B. Pharmacy for an entire year.  The above subjects will be studied in the first year of B. Pharmacy.  Students need to clear all the subjects in order to get promoted to second year of Pharmacy.  Qualified candidates from B. Pharmacy are eligible to take Masters Degree.

  1. B. Pharmacy First Year Syllabus

The Syllabi of Bachelor of Pharmaceutical Sciences includes 11 subjects of total.  It includes both theory and practicals.  The syllabus will be divided into two sections.  The first section of B. Pharmacy includes various topics and contents related to pharma.

Pharmaceutics

Section – I    

  1. Introduction to Pharmaceutics and its scope
    1. Definition of Pharmacy, Pharmaceutics, Area of Pharmaceutics, Physical Pharmacy, Biopharmaceutics, Pharmaceutical Technology, Microbilogy, Dispensing and Pharmacy Practices, Historical background and development of profession of Pharmacy and Pharmaceutical industry in India.
  2. Introduction to pharmacopoeias and other compendia.
  3. Definition of drug, New Drug as per D&C Act 1940, steps for New Drug Development – filing of INDA, clinical research, filing of NDA.
  4. Brief Introduction to Good Manufacturing Practices & Quality Assurance
  5. Introduction to Dosage forms
    1. Classification of the basis of nature, routes of administration, concept of new drug delivery system sustained release and targeted drug delivery system with some examples.
  6. Concept of Pre-formulations and formulation- introductory aspects of physicochemical properties with their application, types of additives with examples.
  7. Concept of Bio-availability, Bioequivalence, Biopharmaceutics, Absorption, and Mechanism of absorption. Concept of drug distribution, Concept of drug metabolism and concept of drug excretion.  Drug efficiency and dose response concept.  Physiological consideration of various routes of administration.
  8. Radiopharmaceuticals: Radioactivity, Production and Quality control of radiopharmaceuticals.
  9. Packaging: Containers, closures, and materials for them, until dose packing.
  10. Alternative systems of medicine: Ayurveda, Homeopathy, Unani and Siddha.

Section –II

  1. Solution – Definition, factors affecting rate of solution, methods used to improve solubility and preformulation studies. Types of ingredients used during formulation.  Manufacturing processes involved in liquid oral preparation.  Evaluation including control on raw materials, in process control and finished Product controls.  Formulation – syrups, elixirs, aromatic water, linctuses, ENT preparations and pains, mouth washes.
  2. Equipments used in manufacturing and packing of oral solution, liquid mixing mechanism of mixing, impeller, propeller mixers, paddle mixer, baffles, prevention of aeration and foam.
  3. Filtration and Clarification.
  4. Size Reducation
  5. Size Separation
  6. Powders
  7. Granule manufacturing as a dosage form

Subjects for 1st year (Semester 1)

Subjects Theory Practical
Hours Marks Hours Marks
HUMAN ANATOMY AND PHYSIOLOGY-I 45 100 4/week 50
PHARMACEUTICAL ANALYSIS 45 100 4/week 50
PHARMACEUTICS- I 45 100 3/week 50
PHARMACEUTICAL INORGANIC CHEMISTRY 45 100 4/week 50
COMMUNICATION SKILLS* 30 50 2/week 25
REMEDIAL BIOLOGY*/ REMEDIAL MATHEMATICS(Only theory)* 30 50 30 25
 
Total marks 675/725 $/750#

#Applicable ONLY for the students who have studied Mathematics / Physics / Chemistry at HSC and appearing for Remedial Biology (RB) course.

$Applicable ONLY for the students who have studied Physics / Chemistry / Botany / Zoology at HSC and appearing for Remedial Mathematics (RM) course.

* Non University Examination (NUE)

Syllabus for 1st Semester

Subjects Syllabus
Theory Practical
 

HUMAN ANATOMY AND PHYSIOLOGY-I

 Unit I(Introduction to human body, Cellular level of organization, Tissue level of organization); Unit II(Integumentary system, Skeletal system, Joints); Unit III(Body fluids and blood, Lymphatic system); Unit IV(Peripheral nervous system, Peripheral nervous system); Unit V (Cardiovascular system) 1. Study of compound microscope. 2. Microscopic study of epithelial and connective tissue 3. Microscopic study of muscular and nervous tissue 4. Identification of axial bones 5. Identification of appendicular bones 6. Introduction to hemocytometry. 7. Enumeration of white blood cell (WBC) count 8. Enumeration of total red blood corpuscles (RBC) counts 9. Determination of bleeding time 10. Determination of clotting time 11. Estimation of hemoglobin content 12. Determination of blood group. 13. Determination of erythrocyte sedimentation rate (ESR). 14. Determination of heart rate and pulse rate. 15. Recording of blood pressure.
 

PHARMACEUTICAL ANALYSIS

 Unit I(Pharmaceutical analysis, Errors, Pharmacopoeia); Unit II(Acid base titration, Non aqueous titration); Unit III(Precipitation titration, Complexometric titration, Gravimetry, Basic Principles,methods and application of diazotisation titration); Unit IV(Redox titrations); Unit V(Electrochemical methods of analysis- Conductometry, Potentiometry, Polarography) Limit Tests- (1) Chloride (2) Sulphate (3) Iron (4) Arsenic; Preparation and standardization of -(1) Sodium hydroxide (2) Sulphuric acid (3) Sodium thiosulfate (4) Potassium permanganate (5) Ceric ammonium sulphate; Assay of the following compounds along with Standardization of Titrant- (1) Ammonium chloride by acid base titration (2) Ferrous sulphate by Cerimetry (3) Copper sulphate by Iodometry (4) Calcium gluconate by complexometry (5) Hydrogen peroxide by Permanganometry (6) Sodium benzoate by non-aqueous titration (7) Sodium Chloride by precipitation titration; Determination of Normality by electro-analytical methods – (1) Conductometric titration of strong acid against strong base (2) Conductometric titration of strong acid and weak acid against strong base (3) Potentiometric titration of strong acid against strong base
 

PHARMACEUTICS- I

 Unit I(Historical background and development of profession of pharmacy, Prescription, Dosage forms, Posology); Unit II(Pharmaceutical calculations, Powders, Liquid dosage forms); Unit III(Monophasic liquids, Biphasic liquids Suspensions, Emulsions); Unit IV(Suppositories, Pharmaceutical incompatibilities); Unit V-Semisolid dosage forms 1. Syrups a) Syrup IP’66 b) Compound syrup of Ferrous Phosphate BPC’68 2. Elixirs a) Piperazine citrate elixir b) Paracetamol pediatric elixir 3.Linctus a) Terpin Hydrate Linctus IP’66 4. Solutions b) Iodine Throat Paint (Mandles Paint) a) Strong solution of ammonium acetate b) Cresol with soap solution c) Lugol’s solution 5. Suspensions a) Calamine lotion b) Magnesium Hydroxide mixture c) Aluminimum Hydroxide gel 6. Emulsions a) Turpentine Liniment b) Liquid paraffin emulsion 7. Powders and Granules a) ORS powder (WHO) b) Effervescent granules c)Dusting powder d)Divded powders 8. Suppositories a) Glycero gelatin suppository b) Coca butter suppository c) Zinc Oxide suppository 8. Semisolids a) Sulphur ointment b) Non staining-iodine ointment with methyl salicylate c) Carbopal gel 9. Gargles and Mouthwashes a) Iodine gargle b) Chlorhexidine mouthwash
 

PHARMACEUTICAL INORGANIC CHEMISTRY

 Unit I(Impurities in pharmaceutical substances, General methods of preparation of compounds); Unit II(Acids, Bases and Buffers, Major extra and intracellular electrolytes, Dental products); Unit III(Gastrointestinal agents, Acidifiers, Antacid, Cathartics, Antimicrobials); Unit IV(Miscellaneous compounds, Expectorants,  Emetics, Haematinics, Poison and Antidote, Astringents); Unit V- Radiopharmaceuticals 1.Limit tests for following ions(Chlorides and Sulphates Modified limit test for Chlorides and Sulphates Limit test for Iron Limit test for Heavy metals Limit test for Lead Limit test for Arsenic) 2. Identification test Magnesium hydroxide Ferrous sulphate Sodium bicarbonate Calcium gluconate Copper sulphate 3.Test for purity Swelling power of Bentonite Neutralizing capacity of aluminum hydroxide gel Determination of potassium iodate and iodine in potassium Iodide 4.Preparation of inorganic pharmaceuticals Boric acid Potash alum Ferrous sulphate
 

COMMUNICATION SKILLS

 Unit I(Communication Skills, Barriers to communication, Perspectives in Communication); Unit II(Elements of Communication, Communication Styles); Unit III(Basic Listening Skills, Effective Written Communication, Writing Effectively); Unit IV(Interview Skills, Giving Presentations); Unit V- Group Discussion Basic communications covering the following topics -Meeting People Asking Questions Making Friends What did you do? Do’s and Don’ts; Pronunciations covering the following topics- Pronunciation (Consonant Sounds) Pronunciation and Nouns Pronunciation (Vowel Sounds); Advanced Learning Listening Comprehension / Direct and Indirect Speech Figures of Speech Effective Communication Writing Skills Effective Writing Interview Handling Skills E-Mail etiquette Presentation Skills
 

REMEDIALBIOLOGY

 Unit I(Living world, Morphology of Flowering plants); Unit II(Body fluids and circulation, Digestion and Absorption, Breathing and respiration); Unit III(Excretory products and their elimination, Neural control and coordination, Chemical coordination and regulation, Human reproduction); Unit IV(Plants and mineral nutrition, Photosynthesis); Unit V(Plant respiration, Plant growth and development, Cell – The unit of life, Tissues 1. Introduction to experiments in biology a) Study of Microscope b) Section cutting techniques c) Mounting and staining d) Permanent slide preparation 2. Study of cell and its inclusions 3. Study of Stem, Root, Leaf, seed, fruit, flower and their modifications 4. Detailed study of frog by using computer models 5. Microscopic study and identification of tissues pertinent to Stem, Root Leaf, seed, fruit and flower 6. Identification of bones 7. Determination of blood group 8. Determination of blood pressure 9. Determination of tidal volume
REMEDIAL MATHEMATICS Unit I(Partial fraction, Logarithms, Function, Limits and continuity); Unit II(Matrices and Determinant); Unit III(Calculus –Differentiation); Unit IV(Analytical Geometry- Introduction, Straight Line, Integration); Unit V(Differential Equations-Application in solving Pharmacokinetic equations, Laplace Transform- Application in solving Chemical kinetics and Pharmacokinetics equations)

 

Subjects for Semester 2

Subjects Theory Practical
Hours Marks Hours Marks
HUMAN ANATOMY AND PHYSIOLOGY-II 45 100 4/week 50
PHARMACEUTICAL ORGANIC CHEMISTRY-I 45 100 4/week 50
BIOCHEMISTRY 45 100 4/week 50
PATHOPHYSIOLOGY 45 100 – –
COMPUTER APPLICATIONS IN PHARMACY* 30 75 – 25
ENVIRONMENTAL SCIENCES* 30 75 – –
 
Total marks 725

* The subject experts at college level shall conduct examinations

 

 

 

 

 

 

Syllabus for Semester 2

Subjects Syllabus
Theory Practical
 

HUMAN ANATOMY AND PHYSIOLOGY-II

 Unit I- Nervous system (Organization of nervous system, neuron, neuroglia, classification and properties of nerve fibre, electrophysiology, action potential, nerve impulse, receptors, synapse, neurotransmitters. Central nervous system: Meninges, ventricles of brain and cerebrospinal fluid, structure and functions of brain (cerebrum, brain stem, cerebellum), spinal cord (gross structure, functions of afferent and efferent nerve tracts, reflex activity) ); Unit II- Digestive system (Anatomy of GI Tract with special reference to anatomy and functions of stomach, Acid production in the stomach, regulation of acid production through parasympathetic nervous system, pepsin role in protein digestion) small intestine 54 and large intestine, anatomy and functions of salivary glands, pancreas and liver, movements of GIT, digestion and absorption of nutrients and disorders of GIT.  Energetics-Formation and role of ATP, Creatinine Phosphate and BMR)  ;Unit III- Respiratory system (Anatomy of respiratory system with special reference to anatomy of lungs, mechanism of respiration, regulation of respiration Lung Volumes and capacities transport of respiratory gases, artificial respiration, and resuscitation methods), Urinary system (Anatomy of urinary tract with special reference to anatomy of kidney and nephrons, functions of kidney and urinary tract, physiology of urine formation, micturition reflex and role of kidneys in acid base balance, role of RAS in kidney and disorders of kidney); Unit IV- Endocrine system (Classification of hormones, mechanism of hormone action, structure and functions of pituitary gland, thyroid gland, parathyroid gland, adrenal gland, pancreas, pineal gland, thymus and their disorders.); Unit V- Reproductive system (Anatomy of male and female reproductive system, Functions of male and female reproductive system, sex hormones, physiology of menstruation, fertilization, spermatogenesis, oogenesis, pregnancy and parturition), Introduction to genetics Chromosomes, genes and DNA, protein synthesis, genetic pattern of inheritance 1. To study the integumentary and special senses using specimen, models, etc., 2. To study the nervous system using specimen, models, etc., 3. To study the endocrine system using specimen, models, etc 4. To demonstrate the general neurological examination 5. To demonstrate the function of olfactory nerve 6. To examine the different types of taste. 7. To demonstrate the visual acuity 8. To demonstrate the reflex activity 9. Recording of body temperature 10. To demonstrate positive and negative feedback mechanism. 11. Determination of tidal volume and vital capacity. 12. Study of digestive, respiratory, cardiovascular systems, urinary and reproductive systems with the help of models, charts and specimens. 13. Recording of basal mass index. 14. Study of family planning devices and pregnancy diagnosis test. 15. Demonstration of total blood count by cell analyser 16. Permanent slides of vital organs and gonads
 

PHARMACEUTICAL ORGANIC CHEMISTRY –I

 Unit I- Classification, nomenclature and isomerism, Classification of Organic Compounds Common and IUPAC systems of nomenclature of organic compounds (up to 10 Carbons open chain and carbocyclic compounds) Structural isomerisms in organic compounds); Unit II- Alkanes*, Alkenes* and Conjugated dienes* (SP3 hybridization in alkanes, Halogenation of alkanes, uses of paraffins. Stabilities of alkenes, SP2 hybridization in alkenes E1 and E2 reactions – kinetics, order of reactivity of alkyl halides, rearrangement of carbocations, Saytzeffs orientation and evidences. E1 verses E2 reactions, Factors affecting E1 and E2 reactions. Ozonolysis, electrophilic addition reactions of alkenes, Markownikoff’s orientation, free radical addition reactions of alkenes, Anti Markownikoff’s orientation. Stability of conjugated dienes, Diel-Alder, electrophilic addition, free radical addition reactions of conjugated dienes, allylic rearrangement); Unit III- Alkyl halides* (SN1 and SN2 reactions – kinetics, order of reactivity of alkyl halides, stereochemistry and rearrangement of carbocations. SN1 versus SN2 reactions, Factors affecting SN1 and SN2 reactions, Structure and uses of ethylchloride, Chloroform, trichloroethylene, tetrachloroethylene, dichloromethane, tetrachloromethane and iodoform), Alcohols*( Qualitative tests, Structure and uses of Ethyl alcohol, Methyl alcohol, chlorobutanol, Cetosteryl alcohol, Benzyl alcohol, Glycerol, Propylene glycol); Unit IV- Carbonyl compounds* (Aldehydes and ketones) Nucleophilic addition, Electromeric effect, aldol condensation, Crossed Aldol condensation, Cannizzaro reaction, Crossed Cannizzaro reaction, Benzoin condensation, Perkin condensation, qualitative tests, Structure and uses of Formaldehyde, Paraldehyde, Acetone, Chloral hydrate, Hexamine, Benzaldehyde, Vanilin, Cinnamaldehyde); Unit V- Carboxylic acids* (Acidity of carboxylic acids, effect of substituents on acidity, inductive effect and qualitative tests for carboxylic acids ,amide and ester Structure and Uses of Acetic acid, Lactic acid, Tartaric acid, Citric acid, Succinic acid. Oxalic acid, Salicylic acid, Benzoic acid, Benzyl benzoate, Dimethyl phthalate, Methyl salicylate and Acetyl salicylic acid), Aliphatic amines* – Basicity, effect of substituent on Basicity. Qualitative test, Structure and uses of Ethanolamine, Ethylenediamine, Amphetamine) I. Systematic qualitative analysis of unknown organic compounds like

1. Preliminary test: Color, odour, aliphatic/aromatic compounds, saturation and unsaturation, etc. 2. Detection of elements like Nitrogen, Sulphur and Halogen by Lassaigne’s test 3. Solubility test 4. Functional group test like Phenols, Amides/ Urea, Carbohydrates, Amines, Carboxylic acids, Aldehydes and Ketones, Alcohols, Esters, Aromatic and Halogenated Hydrocarbons, Nitro compounds and Anilides. 5. Melting point/Boiling point of organic compounds 6. Identification of the unknown compound from the literature using melting point/ boiling point. 7. Preparation of the derivatives and confirmation of the unknown compound by melting point/ boiling point. 8. Minimum 5 unknown organic compounds to be analysed systematically;

II- Preparation of suitable solid derivatives from organic compounds;

III. Construction of molecular models
 

BIOCHEMISTRY

 Unit I– Biomolecules (Introduction, classification, chemical nature and biological role of carbohydrate, lipids, nucleic acids, amino acids and proteins), Bioenergetics (Concept of free energy, endergonic and exergonic reaction, Relationship between free energy, enthalpy and entropy; Redox potential. Energy rich compounds; classification; biological significances of ATP and cyclic AMP) ; Unit II- Carbohydrate metabolism(Glycolysis – Pathway, energetics and significance,Citric acid cycle- Pathway, energetics and significance, HMP shunt and its significance, Glucose-6-Phosphate dehydrogenase (G6PD) deficiency, Glycogen metabolism Pathways and glycogen storage diseases (GSD), Gluconeogenesis- Pathway and its significance, Hormonal regulation of blood glucose level and Diabetes mellitus), Biological oxidation(Electron transport chain (ETC) and its mechanism. Oxidative phosphorylation & its mechanism and substrate phosphorylation, Inhibitors ETC and oxidative phosphorylation/Uncouplers.); Unit III –Lipid metabolism(β-Oxidation of saturated fatty acid (Palmitic acid), Formation and utilization of ketone bodies, ketoacidosis

De novo synthesis of fatty acids (Palmitic acid), Biological significance of cholesterol and conversion of cholesterol into

bile acids, steroid hormone and vitamin D,Disorders of lipid metabolism: Hypercholesterolemia, atherosclerosis, fatty liver and obesity.) Amino acid metabolism

(General reactions of amino acid metabolism: Transamination,

deamination & decarboxylation, urea cycle and its disorders,

Catabolism of phenylalanine and tyrosine and their metabolic disorders(Phenyketonuria, Albinism, alkeptonuria, tyrosinemia), Synthesis and significance of biological substances; 5-HT, melatonin,

dopamine, noradrenaline, adrenaline, Catabolism of heme; hyperbilirubinemia and jaundi); Unit IV- Nucleic acid metabolism and genetic information transfer

(Biosynthesis of purine and pyrimidine nucleotides,

Catabolism of purine nucleotides and Hyperuricemia and Gout disease, Organization of mammalian genome,

Structure of DNA and RNA and their functions, DNA replication (semi conservative model),

Transcription or RNA synthesis

Genetic code, Translation or Protein synthesis and inhibitors); Unit V- Enzymes

(Introduction, properties, nomenclature and IUB classification of enzymes,

Enzyme kinetics (Michaelis plot, Line Weaver Burke plot)

Enzyme inhibitors with examples,

Regulation of enzymes: enzyme induction and repression, allosteric

enzymes regulation, Therapeutic and diagnostic applications of enzymes and isoenzymes, Coenzymes –Structure and biochemical functions)

 1. Qualitative analysis of carbohydrates (Glucose, Fructose, Lactose, Maltose,Sucrose and starch)

2. Identification tests for Proteins (albumin and Casein)

3. Quantitative analysis of reducing sugars (DNSA method) and Proteins (Biuret method)

4. Qualitative analysis of urine for abnormal constituents

5. Determination of blood creatinine

6. Determination of blood sugar

7. Determination of serum total cholesterol

8. Preparation of buffer solution and measurement of pH

9. Study of enzymatic hydrolysis of starch

10. Determination of Salivary amylase activity

11. Study the effect of Temperature on Salivary amylase activity

12. Study the effect of substrate concentration on salivary amylase activity.
PATHOPHYSIOLOGY Unit I – Basic principles of Cell injury and Adaptation:

(Introduction, definitions, Homeostasis, Components and Types of Feedback systems,

Causes of cellular injury, Pathogenesis (Cell membrane damage, Mitochondrial damage,

Ribosome damage, Nuclear damage),Morphology of cell injury – Adaptive changes

(Atrophy, Hypertrophy, hyperplasia, Metaplasia, Dysplasia),Cell swelling, Intra cellular accumulation, Calcification, Enzyme leakage and Cell Death Acidosis & Alkalosis, Electrolyte imbalance), Basic mechanism involved in the process of inflammation and repair:

(Introduction, Clinical signs of inflammation, Different types of Inflammation, Mechanism

of Inflammation – Alteration in vascular permeability and blood flow, migration of

WBC’s, Mediators of inflammation, Basic principles of wound healing in the

skin, Pathophysiology of Atherosclerosis); Unit II– Cardiovascular System:

(Hypertension, congestive heart failure, ischemic heart disease (angina, myocardial infarction, atherosclerosis and arteriosclerosis), Respiratory system: (Asthma, Chronic obstructive airways diseases.), Renal system: (Acute and chronic renal failure.)

Unit III- Haematological Diseases: (Iron deficiency, megaloblastic anemia (Vit B12 and folic acid), sickle cell anemia, thalasemia, hereditary acquired anemia, haemophilia), Endocrine system: (Diabetes, thyroid diseases, disorders of sex hormones.), Nervous system: (Epilepsy, Parkinson’s disease, stroke, psychiatric disorders:

Depression, schizophrenia and Alzheimer’s disease.), Gastrointestinal system: (Peptic Ulcer),

Unit IV– Inflammatory bowel diseases, jaundice, hepatitis (A,B,C,D,E,F) alcoholic liver

Disease, Disease of bones and joints: (Rheumatoid arthritis, osteoporosis and gout), Principles of cancer: (classification, etiology and pathogenesis of cancer), Diseases of bones and joints: (Rheumatoid Arthritis, Osteoporosis, Gout), Principles of Cancer:  (Classification, etiology and pathogenesis of Cancer)

Unit V- Infectious diseases: (Meningitis, Typhoid, Leprosy, Tuberculosis, Urinary tract infections), Sexually transmitted diseases: (AIDS, Syphilis, Gonorrhea)

  

 

 

 

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COMPUTER APPLICATIONS IN PHARMACY Unit IV- Number system: (Binary number system, Decimal number system, Octal

number system, Hexadecimal number systems, conversion decimal to binary, binary to decimal, octal to binary etc, binary addition, binary

subtraction – One’s complement ,Two’s complement method, binary multiplication, binary division.), Concept of Information Systems and Software : (Information gathering, requirement and feasibility analysis, data flow diagrams, process specifications, input/output design, process life cycle, planning and managing the project.); Unit II- Web technologies: (Introduction to HTML, XML,CSS and

Programming languages, introduction to web servers and Server Products, Introduction to databases, MYSQL, MS ACCESS, Pharmacy Drug database.); Unit III- Application of computers in Pharmacy (Drug information storage and

retrieval, Pharmacokinetics, Mathematical model in Drug design, Hospital and Clinical Pharmacy, Electronic Prescribing and discharge (EP) systems, barcode medicine identification and automated dispensing of drugs, mobile technology and adherence monitoring, Diagnostic System, Lab-diagnostic System, Patient Monitoring System, Pharma Information System); Unit IV- Bioinformatics: (Introduction, Objective of Bioinformatics, Bioinformatics Databases, Concept of Bioinformatics, Impact of Bioinformatics in Vaccine Discovery)

Unit-V Computers as data analysis in Preclinical development:

(Chromatographic dada analysis(CDS), Laboratory Information management

System (LIMS) and Text Information Management System(TIMS))

 1. Design a questionnaire using a word processing package to gather information about a particular disease.

2. Create a HTML web page to show personal information.

3. Retrieve the information of a drug and its adverse effects using online tools

4 Creating mailing labels Using Label Wizard , generating label in MS WORD

5. Create a database in MS Access to store the patient information with the required fields Using access

6. Design a form in MS Access to view, add, delete and modify the patient record in the database

7. Generating report and printing the report from patient database

8. Creating invoice table using – MS Access

9. Drug information storage and retrieval using MS Access

10. Creating and working with queries in MS Access

11. Exporting Tables, Queries, Forms and Reports to web pages

12. Exporting Tables, Queries, Forms and Reports to XML pages
ENVIRONMENTAL SCIENCES Unit-I:The Multidisciplinary nature of environmental studies

Natural Resources (Renewable and non-renewable resources: Natural resources and associated problems a) Forest resources; b) Water resources; c) Mineral resources; d) Food resources; e) Energy resources; f) Land resources: Role of an individual inconservation of natural resources.); Unit II:   Ecosystems

§ Concept of an ecosystem.

§ Structure and function of an ecosystem.

§ Introduction, types, characteristic features, structure and function of

the ecosystems: Forest ecosystem; Grassland ecosystem; Desert

ecosystem; Aquatic ecosystems (ponds, streams, lakes, rivers, oceans,

estuaries); Unit- III:

Environmental Pollution: Air pollution; Water pollution; Soil pollution.

  

 

 

 

 

 

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What is Intellectual Property? Intellectual Property Rights & Regulatory Affairs-2

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What is Intellectual Property?

The inventor of a machine, the author of a book, or the writer of music somehow usually ‘own’ their work. From this ownership, certain consequences flow and you probably have been made aware of the fact that we cannot just copy or buy a copy of their works without consideration of their rights. Equally, original industrial designs of furniture, wallpaper and the like seem naturally to be owned by someone or some organization.
Each time we buy such ‘protected’ items, a part of what we pay goes back to the owner as recompense for the time, money, effort and thought they put into the creation of the work. This has resulted over the years in the  development of industries such as the music industry growing worldwide and encouraging new talent to produce more and more original ideas and articles.

What is Intellectual Property? Intellectual Property Rights & Regulatory Affairs-2

The following suggests some of the things that are entitled to protection as intellectual property under national intellectual property laws and / or various international treaties:

Discs

  • Performances
  • Videos
  • Computer games
  • Broadcasts
  • Computer programs

Designs for objects

  • Images
  • Logos
  • Trademarks
  • Integrated circuits
  • Inventions

Geographical indications of origin for certain types of products

  • Chemical formulas
  • Companies’ names
  • Perfumes
  • Industrial processes
  • Materials

The outstanding features that most types of property share are that the owner of the property is free to use it as she/he wishes, provided the use is not against the law, and to exclude others from so using that owned item of property. Now the term “intellectual property” is reserved for types of property that result from creations of the human mind, the intellect. Interestingly, the term intellectual property in the Convention Establishing the World Intellectual Property Organization, or “WIPO”, does not have a more formal definition. 
The States that drafted the Convention chose to offer an inclusive list of the rights as relating to:
“Literary artistic and scientific works; performances of performing artists, phonograms, and broadcasts; inventions in
all fields of human endeavor; scientific discoveries; industrial designs; trademarks, service marks, and commercial names and designations; protection against unfair competition; and “all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields.”

Intellectual property is usually deals with the following:

1) Literary, artistic and scientific works
e.g. books.
Protection of this property is governed by laws concerning Copyright.
2) Performances, broadcasts e.g. concerts.
Protection of this property is governed by laws concerning Copyright’s Related Rights.
3) Inventions
e.g. a new form of jet engine. Protection of inventions is covered by laws concerning Patents.
4) Industrial designs
e.g. the shape of a soft drinks bottle.
Industrial Designs may be protected by its own specialized laws, or those of Industrial Property or Copyright.
5) Trademarks, service marks and commercial names and designations e.g. logos or names for a product with unique geographical origin, such as Champagne.
Protection is normally available under various laws. In this course the laws are covered within the Trademark module.
6) Protection against unfair competition.
e.g. false claims against a competitor or imitating a competitor with a view
to deceive the customer. This is a theme that occurs in many of the modules in this course and is in fact the subject of a separate module.

Principles:

Common to all of the areas are two principles:
• The creators of intellectual property can acquire rights as a result of their work.
• The rights to that work may be assigned or licensed to others.

Importance of Intellectual Property Rights:

Intellectual Property Rights really matter. Do you know why?The first reason is that it is both just and appropriate that the person putting in the work and effort into an intellectual creation has some benefit as a result of this endeavor. The second reason is that by giving protection to intellectual property many such endeavors are encouraged and industries based on such work can grow, as people see that such work brings financial return. Intellectual property rights may also help to extend protection to such things as the unwritten and unrecorded cultural expression of many developing countries, generally known as folklore. With such protection they may be exploited to the benefit of the country and cultures of origin.

The reason for States to enact national legislation, and to join as signatories to either (or both) regional or international treaties governing intellectual property rights include:
• to provide incentive towards various creative endeavors of the mind by offering protections;
• to give such creators official recognition;
• to create repositories of vital information;
• to facilitate the growth of both domestic industry or culture, and international trade, through the treaties offering multi-lateral protection.

Source: World Intellectual Property Organization, or “WIPO“4

INDIAN JOURNALS List to Submit Pharmacy Research Papers – 50* Science

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INDIAN JOURNALS List to Submit Pharmacy Research Papers - Science

Hello Readers. Here is the Indian Journals List to Submit Pharmacy Research Papers. You can submit your original work of your M Pharmacy or PhD on these journals. You know the value of the published papers in your career. So don not neglect write your paper under the guidance of your mentors and publish your research articles. You need to send your abstract then your approval will depend on the norms of the journal you submit. This is a list you can go through and find the best related journal to publish your paper or article.

List Indian Journals List to Submit Pharmacy Research Papers

1. Business India

2. Business Today

3. Business World

4. Chemical Weekly

5. CIMS

6. CSIR News

7. Current Literature on Science of Science

8. Current Science

9. Dataquest Magazine

10. Decision

11. DESIDOC Bulletin of Information Technology

12. Digit

13. Down to Earth

14. Drug One

15. Drugs & Pharmaceuticals-Current R & D Highlights

16. Drugs & Pharmaceuticals-Industry Highlights

17. Drugs Cases

18. Economic & Political Weekly

19. Electronics For You

20. Express Pharma

21. Fortune India

22. IDMA Bulletin

23. India Today

24. Indian Drug Reviews

25. Indian Drugs

26. Indian Journal of Biochemistry & Biophysics

27. Indian Journal of Chemical Technology

28. Indian Journal of Chemistry

29. Indian Journal of Experimental Biology

30. Indian Journal of History of Science

31. Indian Journal of Microbiology

32. Indian Journal of Pharmaceutical Education

33. Indian Journal of Pharmacology

34. Indian Management

35. Industrial Products Finder

36. Journal of Chemical Sciences

37. Journal of Food Science& Technology

38. Journal of Intellectual Property Rights

39. Journal of Marketing & Communication

40. Journal of Medicinal & Aromatic Plant Science

41. Journal of Scientific & Industrial Research

42. Management Review

43. Medicinal and Aromatic Plants Abstracts

44. MIMS India

45. Nandini Chemical Journal

46. Official Journal of the Patent Office

47. Outlook

48. Paradigm

49. Pharma Buz 50. PTI Science Service

51. Punjab University Research Journal

52. Scientific American India

53. Survey

54. Swamy News

55. Udymita Samachar Patra

56. University News

57. Vikalpa

58. Vision

59. Yojana

INDIAN JOURNALS List to Submit Pharmacy Research Papers - Science

This is a list of  Indian Journals List you can go through and find the best related journal to publish your Submit Pharmacy Research paper or article.

Intellectual Property Rights {IPR} & Regulatory Affairs 1 SUPAC

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Intellectual Property Rights {IPR} & Regulatory Affairs 1 SUPAC

SCALE UP & POST APPROVAL CHANGES (SUPAC)

The scale-up process and the changes made after approval in the composition, manufacturing process, manufacturing equipment, and change of site have become known as Scale-Up and post approval Changes, or SUPAC.

Intellectual Property Rights {IPR} & Regulatory Affairs

In the process of developing a new drug product, the batch sizes used in the earliest  human studies are small. As one proceeds through Phase 1 testing (i.e., the first introduction of a new chemical entity to humans), Phase 2 (discovering an indication for use), and Phase 3 (determining dose, side-effect profile, etc.), the size of the batches is grSadually increased. When a New Drug Application (NDA) is approved by the Food and Drug Administration (FDA), the drug product is scaled up to a significantly larger batch size to meet the demands of the anticipated market.

Intellectual Property Rights {IPR} & Regulatory Affairs 1 SUPAC

Similarly, in the development of a generic version of an already approved marketed product, a small batch is produced and tested for, among other things, bioequivalence to the FDA reference listed drug product. When the generic product meets FDA approval criteria, the Abbreviated New Drug Application (ANDA) or generic antibiotic application (AADA) is approved for marketing. It, too, is then scaled up to meet the demands of its anticipated market. Whether a new chemical entity being brought to market for the first time or an approved generic version of previously marketed product, the size of the batch is almost inevitably scaled up to a significantly larger batch. In the process of scaling up, certain changes in the formula (composition) and/or in the manufacturing process and/or in the equipment may be necessary. In addition, the site at which the product will be manufactured may differ from where the smaller (pilot) batches were manufactured. The scale-up process and the changes made after approval in the composition, manufacturing process, manufacturing equipment, and change of site have become known as Scale-Up and post approval Changes, or SUPAC. The FDA has issued various guidance for SUPAC changes designated SUPAC-IR1 (for immediate-release solid oral dosage forms), SUPAC-MR2 (for modified-release solid oral dosage forms), and SUPAC-SS3 (for non-sterile semisolid dosage forms including creams, ointments, gels, and lotions).

SUPAC – Pharmacy Assignments Projects PPT’s

Although scale-up may occur at any point in the lifetime of a product, it most often occurs after the firm has been notified that the drug product is approvable, i.e., it meets all the conditions required by the FDA for marketing. With the submittal of Final Printed Labeling, a showing that the marketed product will meet the conditions for marketing as approved by the FDA (and in the case of generics, production of three consecutive scaled-up batches), and satisfactory completion of a pre-approval inspection by the local FDA district office, the product is formally approved to be manufactured and sold in the United States. At this point, SUPAC begins to exert its effect.

Pharma Assignments Projects PPT’s Power Point Presentation PDF:

Although SUPAC is a means of decreasing regulatory burden by empowering industry to make regulatory decisions, it does not affect any compliance or inspection requirement. It also is limited to scale-up and post-approval changes, even though the underlying science applies to pre-approval changes as well. The major affect of SUPAC is a significant decrease in the time required to implement changes.

Download Intellectual Property Rights IPR & Regulatory Affairs Material SUPAC 1

 

SUPAC:

The premise of the consensus White Papers was that if:
1) The source of the drug substance for the smaller and larger batches was the same;
2) The drug substance particle size (both mean and distribution) was the same;
3) The excipients were the same;
4) The excipient particle size (both mean and distribution) was the same;
5) The order of addition was the same;
6) The equipment was the same;
7) The processing was the same; and, most important,
8) A surrogate test for bioequivalence testing (dissolution) was the same, the two batches were indeed the same. Over the previous 20 years the FDA, Bio-pharmaceutics Program had established that with indefinable limits, dissolution was predictive of in vivo bioequivalence, for the same formulation, processed under the same conditions, on the same equipment. These criteria became the fundamental principle of the SUPAC initiative. (The percutaneous diffusion testis similarly used as a surrogate bioequivalence test for non-sterile, semisolid formulations.)To establish the validity of the approach recommended by the three consensus papers, the FDAcontracted the College of Pharmacy of the University of Maryland to study several drug products chosen on the basis of their solubility and permeability. The data revealed that the workshop recommendations were conservative and could be safely implemented. In fact, the studies showed that even broad differences in in vitro dissolution that resulted from major compositional changes failed to translate into bioavailability differences. Subsequently, the FDA published its SUPAC Guidance for Immediate Release Solid Oral Dosage Forms and followed with guidances for modified-release (controlled-release) and non-sterile semisolid dosage forms. In November 1999 (modified slightly in December 1999), the FDA extended the SUPAC
concept to address changes in analytical methodology, packaging, and Labeling and sterile semi solid dosage forms. This last guidance also updated the previously published guidances on immediate-release, modified-release, and non-sterile,
semisolid dosage forms. In particular, the issue of multiple post approval changes(which had been addressed differently in the previously published guidances) were now the same. The FDA now allowed multiple post approval changes for every solid oral dosage form, using the same requirements a sits SUPAC Semisolid Guidance. The SUPAC Guidances published by the FDA define various levels of change and for each level of change specifies the
1) Recommended chemistry, manufacturing, and control tests;
2) In vitro dissolution testing and/or in vivo bioequivalence tests; and 3) Documentation that the FDA requires to be filed in the NDA, ANDA, or AADA to support the change. These guidances do not affect other compliance or inspection documentation required by the FDA Centre for Drug Evaluation and Research Office of Compliance (CDER-OC) or the FDA field investigation units.

 

 

 

Contract manufacturing organization – Pharma CMO CRO List

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Contract manufacturing organization - Pharma CMO CRO List

Here we present details on Contract manufacturing organization – Pharma CMO CRO for every one related to the pharma sector. Make clear of what it is and what it does. Lets go now in detail of Contract manufacturing organization.

Contract manufacturing organization

What is CMO?

Contract manufacturing organization

What is Pharma CMO?

Contract manufacturing organization related to Pharmaceutical products. It is known as contract development and manufacturing organization (CDMO).

Contract manufacturing organization - Pharma CMO CRO List

How do drug manufacturers select the right contract research organization(CRO)?

I am not certain about the selection standards, but that which I believe is the standing of research business or the departmental heads in search business play significant part in receiving contract.You can add up in the comment section below if you have an idea of selection criteria of contract research organization(CRO)

Invest on a Pharma Company – Business Benefits from other Sectors

What is the pricing structure for a contract manufacturing organization (CMO)?

The pricing structure is not much different than it is for conventional small molecule contract manufaturers. If speaking about API/Drug Substance, then there’s frequently a much longer company order interval and/or capital expenditure financing expectation given the size and timelines related to new capability. In terms of Drug Product/Sterile Filling (all vaccines and biologics are sterile and usually dispensed into vials, syringes, cartridges, bags, etc.), the pricing model again, is pretty similar. The sole reason biologics often command a higher price point is since there’s an increasing requirement there and contract makers presume the margins are greater, so customers would be happy to pay more. Now, regarding vaccines, particularly if using live virus vaccines, not many contract manufacturers will also provide their solutions. This is because a lot of the other customers would have a “restricted compound” clause that prohibits live brokers from being fabricated at exactly the exact same centre without prior written permission. There are a couple of vaccine contract manufacturers that serve this market, but the majority of large CMOs won’t handle vaccines.

How many Contract Manufacturing organizations are there in the USA?

Are contract manufacturing organizations specific/exclusive to the pharmaceutical industry alone or are they used in other industries?

IPhones are made by FoxConn, the largest contract manufacturer in the world.

TONS of electronics, aerospace, medical device manufacturers out there from big corporations to small local outfits.

How do I start a third party contract manufacturer in the pharmaceutical industry?

Third party mfg .
Find out the requirements of the industry for which you want to manufacture the dosage form . Try to keep the budget and expenses in a limit to quote a competitive price .
Find the governing bodies that provides licenses vendor lists and requirements related to get registered and certified. Refer USFDA GUIDELINES. google it
Find a consultancy firm that can help you gain the standards and rectify the errors in the mfg unit .
There is a good deal to be known and done . You’ll require a correct management group which will work on previously stated issues .

Which Countries Offer Best Salaries 4 Pharmacy Graduates? – Pharma Scope

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Which countries offer Best salaries for Pharmacy Graduates? - Pharma Scope

Why do you want to know which countries will offer best salaries for pharmacy graduates? or which one pays you well? Pharmacy is one of the best and popular courses in the field of medicine. Besides the popularity, this course has plethora of opportunities and several career openings. The students who are pretty much interested towards Pharmacy and other medicine related courses, they can simply join in either 4-year Bachelor program or 2 year Diploma program in Pharmacy. Just like the Engineering and Medicine course, the students can pursue a 6 year Post Graduation in the stream of Pharmacy.

Do you know which countries will offer best salaries for pharmacy graduates?

Which countries offer Best salaries for Pharmacy Graduates? - Pharma Scope

Top Country for Pharma- 1

US is indeed the best but you must have a masters in pharmacy to ensure a big paycheck. You will be absorbed by universities or big pharma companies’ R&D which will provide you a great exposure.

Also, since most of these companies are MNCs, they can relocate you to different R&D centers. Try to do a masters first and go for it you are able to secure a seat in a good university in US.

Many people of different department are at big positions in pharma industry now after completing their masters.

Top Country for Pharmacy 2

United Kingdom is the second best country which pays you well if you are a Pharma Grad.

Top Country Pharmaceutical Industry 3

Canada is not only the best place to live with a chilled climatic conditions but it is one of the best place for a pharmacy graduate to take up their job to get paid well.

Many people are very happy with this profession and try to get a challenging job which pays them well. And not only this but it gives an immense satisfaction when you do the work. Let me give a great reason why to take up this wonderful profession. It’s a big secret. It opens a wide golden gate to all the people who want to innovate some thing in their lives with the Research and development department with huge salaries and AID. Choose best country to earn a handsome amount in pharmaceutical department.

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