Pharmaceutical Machinery Manufacturers in Ahmedabad -Pharma Machinery

Pharmaceutical Machinery Manufacturers in Ahmedabad

Ahmedabad has always been a happening place since Independence.  In western India, it is the largest city in the state of Gujarat.  In terms of providing business there is no other state that can ever compete with Ahmedabad and has always been in the limelight for good reasons.  Today we look at some of the best Pharmaceutical machinery manufacturers in Ahmedabad and throw a light about their product and production unit as well.

Pharmaceutical Machinery Manufacturers in Ahmedabad

  • Prism Pharma Machinery

Prism is one of the most trusted brands in Ahmedabad when we speak about manufactures and exporters of pharmaceutical machinery.  Founded in the year 2003, this company with the advent of time has managed to excel its work activities and have successfully gained good reputation.  They provide a wide range of products that includes High Shear Mixer Granulator- RMG, Mass Mixer, Roto Cone Vacuum Dryer, Tablet Press – PTCMD4, Movable Hoist, Fluid Bed Dryer, Spraying System, Lab Scale Mini Tablet Press, Automatic Liquid Syrup Manufacturing, Inline Homogenizer, Preparation vessel, reactor & Storage and the list is endless.  Today Prism Pharma Machinery stands for its quality and goodwill.

  • Ambica Pharma Machines Private Limited

Ambica Pharma Machines Private Limited is considered to be among the best in manufacturing Pharmaceutical machinery from Ahmedabad.  They have a production unit which is well established in manufacturing wide variety of machinery.  The company boosts its capability in producing different types of machinery that includes vial washing machine, automatic high speed 8 head linear Vial liquid filling, 4 head Linear Vial liquid filling, Automatic high speed 2 head injectable liquid filling, powder and liquid filling combo, dry syrup filling machine, injectable powder filling machine, different types of cap sealing machines for pharmaceuticals, screw cap sealing machine, vial aluminum cap sealing machine and the list is endless.  Since its inception the company till date is growing and today stands as a trusted brand in the business.

  • Spark Tech India – pharmaceutical machinery

Spark technologies have always been in the limelight for providing supreme quality of pharmaceutical machinery that are of world-class quality.  Since its inception in the year 1999, this company has got many acclamation from its clients worldwide and today boots its capabilities of solidifying platform of excellence in business.  They provide quality product which includes different types of liquid filling machinery, heavy automatic high-speed syrup filling machinery, washing machines of different kind which are mostly automatic in nature, different types of cap sealing machines for pharmaceuticals and different other machinery that can really improve the quality of pharmaceutical products and its productivity as well.

Pharmaceutical Machinery Manufacturers in Ahmedabad

  • N K Industries

N K Industries situated in Ahmadabad, Gujarat is a pioneer in the field of pharmaceutical machinery production from a long time and hold a good repute for over 35 years which has simply help them to establish a trust between the client and themselves on the global platform.  Their products are of high quality and impeccable productivity.  Some of their products include tablet pill capsule counting filling machine, Auger powder filling machine, capping machine, Ropp capping machine, washing machine, Injectable dry powder filling machine, screw capping machine and many more which rightly have high demands in today’s market.

On conclusion it can be easily said that these are some of the well trusted brands from Ahmedabad that have gained much popularity through their quality productivity.  There are other names too which are equally best whose activities and productivity are as vibrant as that of the above.  All in all, Ahmedabad truly stands as one of the best pharmaceutical machinery manufacturing production hub.

{PDF} Tablet Evaluation – Pharmaceutics Pharmaceutical Apparatus Material PPT

PDF Tablet Evaluation - Pharmaceutics Pharmaceutical Apparatus Material.JPG

Topic: {PDF} Tablet Evaluation – Pharmaceutics Pharmaceutical Apparatus Material: Tablets are defined as solid unit dosage form of medicaments intended for oral use. They became most popular as they were easy in preparation compared to any other type of dosage forms. But the major drawback exists in its manufacturing. If any minor problem occurs during their manufacturing then the whole batch of the unit should be discarded. It is necessary to avoid any sort of errors during its manufacturing and as a result evaluation of tablets is very important before dispatching of a batch. In the present study, we discussed about the evaluation tests for tablets.

Tablet Evaluation:

Before a tablet is released out into the market it has to pass a few quality checks, which is mandatory. Evaluation of tablet includes the assessment of tablets physical, chemical and biological properties. To studies them the following test are formulated

  •    Appearance,
  • • Size and Shape,
  • • Organoleptic properties,
  • • Uniformity of thickness,
  • • Hardness,
  • • Friability,
  • • Drug Content Uniformity,
  • • Weight Variation Test,
  • • Wetting time,
  • • Water Absorption Ratio,
  • • In vitro Dispersion Time,
  • • In vitro Disintegration Test,
  • • In vitro Dissolution Studies,
  • • Two set of apparatus,

Description:

Appearance:

Appearance is the first most required quality for the acceptance of tablet. General elegance and its identity play a major role for the consumer acceptance. Acceptance of the appearance of batches of the tablet has been done based on the measurement of the following factors like size, color, shape, presence or absence of odor, taste etc. [26-50]. Size and shape

General appearance is the physical appearance of the tablet it has two aspects to address

First one is the patient compliance, if the tablet is appearance is legible and good, it improves the patient compliance.

The second one Is for the manufacturer, it helps him in trouble free manufacturing if there is tablet to tablet, batch to batch and lot to lto uniformity of tablet.

General appearance would include a number of aspects like, size, shape, odor, taste, texture, legibility, identifying marks.

For rapid identification of the tablet and consumer acceptance the tablet are given a specific colour, the colour of the tablet will enable the manufacturer form differentiating the tablet lot.

The uniformity of the colour is important parameter here, the tablet should be free form mottling.

The colour uniformity and gloss of the tablet is evaluated by using reflectance spectrophotometer, tristimulus colorimetric measurement, microreflectance photometer.

Size and shape

Size and shape of a tablet has been determined by its thickness. Size and shape of a tables plays an important role in its patient compliance as the size of the tablet increases it is not much easier for its administration. Micrometer is the devise which is used to determine the thickness of a tablet. It can be acceptable if the batch falls within the ±5% of standard deviation.

Organoleptic properties:

Color should be distributed uniformly without appearance of any signs of mottling. Colour of the tablet should be compared with the standard colour for comparison.

Uniformity of thickness:

To determine the uniformity of thickness random selection of tablets has to be done from each and every batch and need to measure its thickness independently. If the thickness of any single tablet varies then the batch containing that batch will not be dispatched into market

 WEIGHT VARIATION TEST

The weight variation test would be a satisfactory method for determining drug content uniformity of drug distribution. In practice this test is performed by taking 20 tablets, from a batch. 20 tablets are weighed at a time and the average weight is taken. Then the tablet is weighed individually.

 

Average WeightPercentage Difference
130 mg or less10
More than 130 mg through
324 mg
7.5
More than 324 mg5

2) THICKNESS AND DIAMETER (SIZE AND SHAPE)

The thickness of individual tablets is measured with a micrometer, which gives us information about the variation between tablets. Tablet thickness should be within a ±5% variation of a standard value. Any variation in thickness within a particular lot of tablets or between manufacturer’s lots should not be clear to the unaided eye for consumer acceptance of the product. In addition, thickness should be controlled to smooth the progress of packaging.

PDF Tablet Evaluation - Pharmaceutics Pharmaceutical Apparatus Material.JPG

Different shapes and sizes of tablet are available in the market they are manufactured in order to differentiate them based on their purpose of use and quantity of active ingredient, and the age group of the patient who is going to be administered with the drug.

Heart shape tablet signify that they are for the cardiac problems, small toy shape, tablet are manufactured in order to attract children etc.

The shape and size of a tablet would vary based on tooling used in the tablet manufacturing.

The prime consideration here would be the crown size, because if the concavity is very high it many lead to capping, or chipping problem.

The crown size is measured by using micrometer, and sliding caliper scale is used to measure the size of 5 to 10 tablets at a time.

We use Micrometer for tablet thickness

3) UNIQUE IDENTIFICATION MARK:

Pharmaceutical manufacturers in order to differentiate their product from the other manufacturers emboss a special marking g on the tablet. The marking can be an embossing, engraving or printing.

Apart from the company marking there can be imprints which include product code, product name, product potenct,

But care must be taken that the letters that are embossed on the tablet are properly printed without double impression.

5) HARDNESS AND FRIABILITY:

The hardness of the tablet is important for drug products that have bioavailability problem or that are sensitive to altered dissolution release profiles as a function of the compressive force employed. Tablet hardness is the force necessary to break the tablet diametrically. The tablets must be hard enough to withstand mechanical stress during packaging, shipment, and handling by the consumer.

Section <1216> of the USP 24/NF19 outlines a standard tablet friability test applicable to manufactured tablets. Most compounding pharmacy would not have the apparatus specified in Section <1216>. However, there are several hand operated tablet hardness testers that might be useful. Examples of devices are the Strong Cobb, Pfizer, and Stokes hardness testers. The principle of measurement involves subjecting the tablet to an increasing load until the tablet breaks or fractures. The load is applied along the radial axis of the tablet. Oral tablets normally have a hardness of 4 to 8 or 10 kg; however, hypodermic and chewable tablets are much softer (3 kg) and some sustained release tablets are much harder (10-20 kg).

Tablet hardness and strength are the essential to see that the tablet can with the shock and stress during manufacturing packing and transportation, and while handled by the patient.

To test the hardness of the tablet Monsanto tester, Strong-cobb tester, the Pfizer tester, the Erweka tester, the Schleuniger tester are used.

Hardness is sometimes termed the tablet crushing strength. To perform this test the tablets are located between two anvils and force is applied to the anvils, and the strength required to break the tablet is noted. If the tablet is too hard, the disintegration time is long and cannot meet up the dissolution specification, if its too soft, it cannot withstand handling when dealing with processes such as coating or packaging and shipping operations. The force with which the tablet is broken is expressed in kilograms and a hardness of 4Kg is usually well thought-out to be the minimum for satisfactory tablets. Oral tablets have a hardness of 4 to 10kg ; but, hypodermic and chewable tablets  have a hardness of 3 kg  and sustained release tablets have about 10-20 kg.

Pfzier hardness tester was used for measuring the hardness of the formulated Paracetamol tablets. From each batch 3 tablets were taken at random and subjected to test. The mean of these 3 tablets were calculated.

Friability is the tested for a tablet to see weather the tablet is stable to abrasion or not, it is tested by using Roche friabilator. This is made up of a plastic drum fixed with a machine which rotated at 25 rpm for 100 revolutions. And then the twenty tablets which were weighed prior to the test are taken out of the drum and cleaned with a cloth and weighed once again, the weight variation must not be less than 0.5 to 1.0% for an conventional tablet.

6) WEIGHT VARIATION:

Weight variation test is performed to check that the manufactured tablets have an uniform weight.

As per USP twenty tablets are weighed individually and an compendia weight is taken, the average weight is obtained by dividing the compendia weight by 20, now the average weight is compared to the individual weight of the tablet,

For a tablet to pass the test not more than 2 tablets should lie out of the specified percentage and if no tablet differs by more than two times the percentage limit.

Average weight

Maximum percentage difference allowed

WETTING TIME (Gohel et al., 2004)

A circular tissue paper of 10cm diameter were placed in a Petri dish having an internal diameter of 10 cm. 10 ml of water containing methylene blue (10% w/w) was added to the Petri dish. The tablet was carefully placed in the centre of the Petri dish and the time taken for the water to reach the upper surface of the tablets was known as wetting time.

7) DISINTEGRATION:

Disintegration is the first physical change observed for a drug when it enters into the body, thus to see simulate the disintegration of the tablet in the body the disintegration test is performed.

As per USP the disintegration apparatus consist of 6 glass tubes with a 10 number mesh at the bottom, each tube is 3 inch long.

This arrangement of 6 tubes is placed in a medium simulated to the disintegration environment. Which is maintained at 37oc +/- 2oc, in 1 liter vessel.

This system is made to move up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute.

The disintegration time of the tablet is compared with the values in the monograph.

DRUG CONTENT (IP, 2007)

20 tablets were weighed and powdered. A quantity of powder containing 0.15 g of Paracetamol was added to 0.1 M NaOH, diluted with 100 ml of water. It was shaken for 15 minutes and sufficient water was added to produce 200 ml. 10 ml of the filtrate was diluted to 100 ml with water. Then 10 ml of the resulting solution was added to 10 ml of 0.1 M NaOH, finally diluted to 100 ml with water. The absorbance was measured at maximum of 257 nm. Calculate the content of C5H9N02 taking 715 as the value of A (1%, 1cm) at maximum at 257 nm.

8) DISSOLUTION:

Tablet dissolution: Disintegration time determination is a useful tool for production control, but disintegration of a tablet does not imply that the drug has dissolved. A tablet can have a rapid disintegration time yet be biologically unavailable. The dissolution rate of the drug from the primary particles of the tablet is the important factor in drug absorption and for many formulations is the rate-limiting step. Therefore, a dissolution time is more indicative of the availability of a drug from a tablet than the disintegration test. Even though this is an important parameter to measure, most pharmacies do not have the equipment needed to conduct these kinds of tests.

The rate and extent of drug release form the tablet is estimated by dissolution test

Different types of apparatus are used to study the dissolution test of the tablet. As per IP apparatus I (paddle) and apparatus II(basket) are used. called basket dissolution apparatus and paddle dissolution apparatus

But as per USP dissolution apparatus used are

USP 30 classification

i. Rotating Basket (Ph.Eur./BP/JP)

ii. Paddle (Ph.Eur./BP/JP)

iii. Reciprocating Cylinder (Ph.Eur.)

iv. Flow Through Cell (Ph.Eur./BP/JP)

v. Paddle Over Disk (Ph.Eur.)

vi. Rotating Cylinder (Ph.Eur.)

vii. Reciprocating Holder

  1. DISSOLUTION KINETICS (Higuchi WI, 1962)

Method used to compare dissolution data is:

  • Model Dependent Methods (zero order, first order, Higuchi and Korsmeyer’s- Peppas).

Drug release kinetics

Drug release kinetics was studied from the datas obtained from in-vitro drug release studies which were plotted in various kinetics models: Zero order (equation 1) as Cumulative percentage of drug released against Time, First order (equation 2) as Log cumulative percentage of drug unreleased against Time, and Higuchi model (equation 3) as Cumulative percentage of drug released against Square root of time.

C = K0 t                                    (equation 1)

where       K0 indicates zero order rate constant expressed as                            concentration per time and t indicates the time in                                   hours.

A graph of concentration against time gives a straight line with a slope equal to K0 and intercept the origin of the axis.

log C = log C0 – K t/2.303                              (equation 2)

where         C0 be the initial concentration of drug,

K be the first order constant, and t is the time.

Q = K t1/2                                                                        (equation 3)

where        K indicates the constant of the system, t indicates the   time in hours.

Drug release were plotted in Korsmeyer equation (equation 4) as Log cumulative percentage of drug released against Log time, and the exponent was calculated from  the slope of the straight line.

Mt / Mα =  K tn                                                             (equation 4)

where          Mt / Mα is the fraction of solute release, t is the release time,  K is the kinetic constant

The dissolution time and rate is compared to the values mentioned in the monograph.

In vitro disintegration test

Disintegration is defined as the process of breakdown of tablet into small particles. Disintegration time of a tablet is determined by using disintegration test apparatus as per IP specifications. Place each tablet in each 6 tubes of the disintegration apparatus a then add a disc to each tube containing 6.8 pH phosphate buffer. The temperature of the buffer should maintain at 37 ± 2°C and run the apparatus raised and lowered for 30 cycles per minute. Note down the time taken for the complete disintegration of the tablet without any remitants .

References
1. J. S. Swarbrick, Encyclopedia of Pharmaceutical Technology, Third dition – 6 Volume Set,
Taylor & Francis, 2006.

Lachman et al., 1990

 

CMO – How to Set Up Pharmaceutical Contract-Manufacturing-Organization ??

CMO - How to Set Up Pharmaceutical Contract-Manufacturing-Organization

Pharmaceutical-contract-manufacturing organization setup

A contract manufacturing organization (CMO) is a company that serves other companies on a contract basis to provide comprehensive services. In the pharmaceutical industry, the service ranges from drug development to drug manufacturing. Nowadays, it is also termed as contract development and manufacturing organization (CDMO), because of a comprehensive single-source provider from drug development through the commercial manufacturers. It is of help in terms of scalability and allows the major companies to focus on drug discovery and drug marketing instead. Global manufacturers are occupying a monster share of the contract manufacturing market with low-cost. Even the highest ranking service providers target a specific technology or dosage form for the promotion of end-to-end continuity. Therefore, specialization may be an effective hedge against the loss of market share. This reflects their efficiency for the outsourcing clients.

CMOs offer:

  • Pre-formulation
  • Formulation development
  • Stability studies
  • Method development
  • Pre-clinical and Phase I trial materials
  • Late-stage clinical trial materials
  • Formal stability, scale-up, registration batches and commercial production.

CMOs are contract manufacturers but aren’t limited to these services because of their development aspect. For the pharmaceutical market, the outsourcing services providers are used in the form of CMOs and CROs- contract research organizations. In response to the international nature of the pharmaceutical niche, CMOs are called for outsourced services. 

Setup strategy

Putting up a manufacturing unit is a big challenge for a layman not having the technical know-how and idea about the market. Carrying out a good technical and market survey would be beneficial. Moreover, depending upon one’s forte and the market demand the following are considered:

  • The ever-rising competition to be in demand as a constant cost-effective manufacturer
  • Regulatory compliance & Maintenance cost
  • Locations are selected based on Land cost, tax-free zones, accessibility to resources/transportation convenience.
  • Cost factor for faraway places or in government/private industrial zones.

You may choose formulation with a wide market to cover up the cost by having maximum utilization of installed pharmaceutical equipment. For people holding specialization and are sure about its actual application can create a market through the novel product/facility.CMO - How to Set Up Pharmaceutical Contract-Manufacturing-Organization

Notes

  • Regulatory checks are most important as its non-compliance seems untrustworthy.
  • Apply and comply with regulatory bodies country-wise to export products in the Indian Pharmaceutical Association website.
  • For Export registration, enquire the nearest Directorate General of Foreign Trade office.

Line Clearance before Operation of Pharmaceutical Manufacturing Area Friabilator PPT PDF

Line Clearance before Operation of Pharmaceutical Manufacturing Area Friabilator PPT PDF

Here we see Line Clearance before Operation of Pharmaceutical Manufacturing Area Friabilator.

What is Friability Testing?

To determine the physical strength of uncoated tablets on exposure to mechanical pressure, Friability test is done. The test can find out the extent of mechanical stress withstandable by the tablets during their manufacturing, distribution and handling processes. Friability testing is an accepted operation across the pharmaceutical industry, and the instrument used to perform this process is called Friabilator or Friability Tester.

Line Clearance before Operation of Pharmaceutical Manufacturing Area Friabilator PPT PDF

PROCEDURE FOR OPERATION AND CLEANING FRIABILATOR

Tablet friability measures the efficiency of friabilator or indicates the formulation suitability along with routine QC functions or measures “dusting”. For a specified period of time, tablets are rotated in a plastic drum. To quantify the amount of surface material that has worn off, a gravimetric determination is made.

The responsibility and the accountability are generally of the Executive Manufacturing, Executive QA and Assistant Manager QA.

 

CLEANING FRIABILATOR

:

  • By pressing the button to remove the knob on the shaft.
  • Pull the outward drum from the shaft carefully. Similarly, remove the inside drum by pulling it outside.
  • By pulling outside remove the detachable disc from both the drums.
  • Clean both the drums with a clean cloth.
  • Remove both the trays. Clean the trays with a clean cloth.
  • After cleaning, put the drums and trays back on its position.

 Line Clearance before Operation of Pharmaceutical Manufacturing Area Friabilator

CORRECT OPERATION:

  • Check cleanliness of the equipment before switching ON.
  • The drum will initialize itself to the loading position; the display will show START.
  • Record the weight of the tablets.

For each tablet weighing up to 0.650 g, take 20 tablets.

For each tablet weighing above 0.650 g, take 10 tablets.

  • Adjust the counts to 100 by pressing the COUNT Key followed by ‘1’, ‘0’, ‘0’ keys. (Count range 1 to 99999).
  • Confirm the reading by pressing ENTER. To see and confirm the number of counts press COUNT Key. Then press RUN/HALT key to start, check the elapsed count. (Test can be performed by adjusting ‘TIME’ similarly as ‘COUNT’.)
  • The test terminates with an audible beep and displaying END and the drum rotates in reverse direction discharging the tablets in the tray.
  • On removing the trays tablets de- dust and weigh the tablets, note down the weight of the tablets.
  • Calculate the percentage loss in the weight by using the formula

(Percentage Loss =Initial Wt – Final Wt/Initial Wt X 100)

 

Conclusion

On completion of the procedure, the samples are moved, wiped-off dust and weighted again. The difference between the weight before and after the test is the Friability and should not exceed 1 %( ideal percentage). In some cases, where the diameter of tablets is greater than 13mm, such tablets are tested on drums at 10° tilt.

Precautions:

  • Do not hold the drums while rotating.
  • After testing, destroy the tablets.

List of Pharmaceutical Equipment – Instruments Machinery 4 Pharmaceutical Industry PDF

List of Pharmaceutical Equipment - Instruments Machinery 4 Pharmaceutical Industry PDF

List of Pharmaceutical Equipment  used in different Pharma companies Industries. 

 

Pharmaceutical Machinery

The growth in advancement and up-gradation of technology in machinery has lead to manufacture all kinds of Pharmaceutical Machinery in India. As low technology offerings have been faster in the initial stage, the Indian machinery today is considered as one of the value-added engineering’s with the integration of new technologies. More than 350 facilities in India’s pharmaceutical-machine manufacturing industry are present. The Indian pharmaceutical machinery industry is currently catering to the segments of tableting and capsulation, powder processing, material handling, R&D equipment and instrumentation, coating, bulk drug plant installation etc. The SME sector facilitates around 800 pharmaceutical machine manufacturing and allied utility service units. Majority of these units undertake the supply of custom-made machineries using the location advantage of buyers and job works. There is tremendous scope for the machinery manufacturers to exploit the potential in the country provide by serving necessary machinery for existing 17,000 pharmaceutical companies.

 

List of Pharmaceutical Equipment - Instruments Machinery 4 Pharmaceutical Industry PDF

They ensure proper design, ease of user application, simple maintenance and also validation protocol for the new equipment essential for the pharmaceutical companies. The categories varies from pharmaceutical machinery, instrumentation and process control, lab equipment, pharmaceutical research and development (R&D) tools, packaging material and machines, plant design and engineering, pharmaceutical process technology.

 

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List of equipments used in Pharmaceutical industry laboratory pdf

Let’s explore the Pharmaceutical Equipment

  • ADME-Tox Screening System
  • Amino Acid Analysis System / Amino Acid Analysis Instruments
  • Automated Hit Picking Systems
  • Automated Proteomics Workcell
  • Bio molecular Interaction Analysis
  • Automated Bio molecular Interaction Analyzer
  • Dual Polarization Interferometer
  • Quartz Crystal Microbalance (QCM)
  • Surface Plasmon Resonance Imaging (SPR Imaging)
  • Blood Chemistry Analyzer / Blood Analyzers
  • Albumin Analyzers (Albumin Testing)
  • Automated Blood Gas Systems
  • Automatic Biochemistry Analyzer / Automated Biochemical Analyzer
  • Blood Bank Automation System / Automated Blood Bank System
  • Blood Gas Analyzers
  • Blood Lactate Analyzer / Blood Lactate Testing Equipment
  • Chemistry Analyzer / Clinical Chemistry Analyzers
  • External Quality Assessment (EQA)
  • HbA1c Analyzer / Haemoglobin Analyzer
  • Haematology Analyzers
  • Haemostasis Analyzer
  • Immunoassay Analyzer
  • Immunoassay System
  • Immunochemistry Analyzer
  • Laboratory Blood Glucose Analyzers
  • Cell Counters / Colony Counters
  • Automated Cell Counter
  • Bacterial Colony Counters
  • Colony Counting Apparatus
  • Cell Disruptor
  • Cell Harvesting System
  • CO2 Transmitter / Carbon Dioxide Transmitter
  • Colony Picker
  • Disintegration Tester / Disintegration Apparatus
  • Dissolution Apparatus / Dissolution Tester
  • Dissolution Sampler / Dissolution Sampling System
  • Dissolved CO2 Meter / Dissolved Carbon Dioxide Analyzer
  • Electrophoresis Analysis
  • Capillary Electrophoresis Instrument
  • Digital Gel Photography System / Gel Image Capture System
  • Electrophoresis Power Supply
  • Gel Electrophoresis Instrument
  • Off-gel Fractionators/ Off-gel Electrophoresis System
  • UV Trans-illuminator
  • Flow Cytometry
  • Automated Flow Cytometry System
  • Flow Cytometer
  • Friability Tester / Friability Test Apparatus
  • Gas Chromatograph Mass Spectrometer (GC MS Instrument)
  • Gas Chromatography Equipment
  • Gas Chromatograph / GC System (GC Instruments)
  • Gas Chromatograph Mass Spectrometer (GC MS Instrument)
  • GC / GC MS Software
  • GC Auto-sampler / GC Headspace Auto-sampler
  • GC Fraction Collector
  • GC Gas Regulators / High Purity Gas Regulator
  • Multidimensional Gas Chromatography (MDGC / GCxGC)
  • Portable GC MS
  • Glass Bead Autoclave
  • Glass Bead Sterilization / Laboratory Glass Bead Sterilizer
  • Hyper-spectral Image Analysis
  • Chemical Imaging Systems (NIR / Raman)
  • Hyper-spectral Camera / Hyper-spectral Imaging Systems
  • Immuno-blotting Equipment
  • Blot Strip Cutter
  • Inhalation Exposure System / Aerosol Inhalation Chamber
  • Laboratory and Industrial Freezers
  • Cryogenic Refrigerator / Cryofreezer
  • Cryogenic Shippers / Cryoshipper
  • Laboratory Refrigerator Freezer
  • Liquid Nitrogen Canister / Liquid Nitrogen Dewar
  • Liquid Nitrogen Freezer / LN2 Freezers
  • minus 20 freezer (-20C to -40C Freezers)
  • minus 80 Freezer (-86 Freezer)
  • Plasma Freezer / Blood Bank Freezer
  • Tissue Freezer
  • Ultra Low Temperature Freezer (ULT Freezers)
  • Laboratory Animal Monitoring
  • Animal Pulse Oximeters
  • Animal Temperature Probe
  • Animal Ventilator
  • Animal Warmers
  • Blood Pressure Systems / Blood Pressure Monitor
  • Capnograph / Capnography Monitor
  • Lab Animal Exercise / Walking System
  • Laboratory Animal Anaesthesia System
  • Physiological Monitor
  • Laboratory Freeze Dryer
  • Laboratory Hoods
  • Cage Changing Hoods
  • Cell Processing Work Station
  • Forensic Workstation / Forensic Hood
  • Glove Boxes
  • IVF Workstation
  • Laboratory Fume Hoods
  • Laminar Flow Hoods / Biological Safety Cabinets
  • PCR Workstation / PCR Cabinet
  • Reverse Flow Workstations
  • Laboratory Incubators
  • CO2 Incubator / Cell Culture Incubator
  • Dry Bath Incubator / Dry Block Heater
  • Hybridization Incubator
  • Hypoxia Incubator / Hyperoxia Incubators
  • Hypoxic Chamber
  • Incubators and Microbiology Incubators
  • Insect Growth Chamber
  • Laboratory Bioreactor / Cell Culture Bioreactor (Fermentor)
  • Laboratory Test Chambers / Stability Chambers
  • Modular Incubation Chamber (Incubator Chamber)
  • Plant Incubator / Environmental Growth Chambers
  • Radioactivity Containment Incubator
  • Refrigerated Incubator
  • Refrigerated Incubator Shakers
  • Rodent Incubators
  • Roller Bottle Incubator / Roller Bottle Apparatus
  • Shaking Incubator / Incubator Shakers
  • Single Use Bioreactor
  • Vortex Mixer (Incubator)
  • Water Jacketed Incubator
  • Laboratory Pumps
  • Continuous Flow Pump
  • Hazardous Location Pump
  • High Pressure Syringe Pumps
  • Laboratory Liquid Aspiration System
  • Laboratory Peristaltic Pump
  • Laboratory Vacuum Pumps
  • Liquid Pumps
  • Metering Pumps
  • Syringe Infusion Pump / Laboratory Infusion Pump
  • Syringe Pump / Programmable Syringe Pump
  • Laboratory Spray Dryer
  • Laboratory Sterilization Equipment
  • Agar sterilizer / Media Sterilizer
  • Autoclave Sterilizer / Laboratory Autoclaves
  • Cleaning-In-Place (CIP) System / Sterilization-In-Place (SIP) Systems
  • Dry Heat Sterilizer / Dry Heat Oven
  • Laboratory Steam Sterilizer
  • UV Chamber
  • Liquid Chromatography Mass Spectrometer (LC MS Instrument)
  • Liquid Handling Equipment
  • Automated Petri Dish Filler / Agar Plate Pourer
  • Automated Pharmaceutical Formulation Systems
  • Automated Solid Phase Extraction System (SPE System)
  • Automated TLC Spotting System (TLC Spotter)
  • Automated Vial Filling Machine
  • Laboratory Burette / Bottle-top Burettes
  • Laboratory Dispensers / Lab Dispenser
  • Laboratory Liquid Aspiration System
  • Liquid Handling Robotics (Automated Systems)
  • Dispenser / Multichannel Pipetting System (Automated Pipetting)
  • Stacker /  Handler
  • Washer / ELISA Plate Washer
  • Pipettes / Micropipettes
  • Mass Spectrometers
  • Clinical Mass Spectrometry / Clinical Diagnostics Mass Spectrometer
  • Electro-spray Ionization Quadrupole Mass Spectrometer
  • Inductively Coupled Plasma Mass Spectrometer (ICP MS)
  • Maldi TOF Mass Spectrometer (MALDI TOF MS)
  • Mass Spectrometers (by Ion Source)
  • Mass Spectrometers (by Mass Analyzer)
  • Mass Spectrometers (by Systems)
  • Proton Transfer Reaction Mass Spectrometer (PTR-MS)
  • Thermal Evolved Gas Analyzer / Mass Spectrometer (EGA-MS)
  • Mechanical Micro-dissection System / Piezo Power Micro-dissection Systems (PPMD)
  • Microarray Technology / Microarray Imaging
  • Hybridization Station / Microarray Hybridization
  • Microarray Reader / Microarray Scanner
  • Micro-encapsulator
  • Instrumentation
  • Automated Labeler
  • Automated Seal Piercer
  • Automated Sealer
  • Dried Blood Spot (DBS) Processor
  • ELISA System / ELISA Workstation
  • Fluorescent Plate Reader
  • Integrated Multi-Assay Workstation
  • Manual Sealer
  • Capper
  • Centrifuge
  • Dispenser / Multichannel Pipetting System (Automated Pipetting)
  • Incubator Shaker
  • Reader / Micro-titer Plate Reader
  • Micro-plate Reader Gas Control Module
  • Micro-plate Sealing Film
  • Micro-plate Stacker / Micro-plate Handler
  • Micro-plate Thawing Station
  • Micro-plate Transport System / Automated Micro-plate Mover
  • Micro-plate Washer / ELISA Plate Washer
  • Micro-plates / Microtiter Plate
  • Multimode Micro-plate Reader
  • Nephelometer / Micro-plate Nephelometry Reader
  • Plate Luminometer / Luminescence Reader
  • Tube Luminometer
  • Non-Invasive Carbon Dioxide Sensors
  • Non-Invasive pH Sensors
  • Nucleic Acid Sample Preparation
  • DNA Shearing Sonicator
  • Next Gen Sequencing Library Construction / Fragment Library System
  • Nucleic Acid Purification Instruments
  • Organic Synthesizer / Chemical Synthesizer
  • Oxygen Measurement / Oxygen Analysis
  • Dissolved Oxygen Analyzer / Dissolved Oxygen Monitor
  • Non-Invasive Oxygen Sensors
  • Oxygen Transmitter
  • Portable Dissolved Oxygen Meter
  • Shake Flask Monitoring System / Multidisc Monitoring Systems
  • Particle Analysis / Particle Characterization
  • Automatic Titrator / Auto titration (Autotitrator)
  • Chemisorption Analyzer
  • Magnetic Analyzer (Metallic Iron Analyzer)
  • Particle Analysis / Characterization Accessories
  • Particle Counting (Particle Counter)
  • Particle Imaging Systems (Particle Shape Analysis)
  • Particle Size Measurement / Particle Sizing Systems
  • Physisorption Analysis
  • Porisimeter
  • Surface Energy Analyzer (Inverse Gas Chromatograph)
  • Zeta Potential Analyzer
  • PCR Technology / PCR Systems
  • DNA Thermal Cycler / PCR Instrument
  • Gradient PCR Machine
  • PCR Workstation / PCR Cabinet
  • Real Time PCR Machine (qPCR Machine)
  • pH Transmitter
  • Physiology and Neurology Equipment
  • Brain Slice Chamber
  • Electrophysiology Equipment
  • Portable Laboratory Equipment / Field Testing Equipment
  • Hand Held TDS Meter / Portable TDS Meters
  • Leaf Area Meter / Portable Leaf Area Meters
  • Portable Balances
  • Portable Conductivity Meter (EC Meters)
  • Portable Density Meter / Handheld Density Meter
  • Portable Dissolved Oxygen Meter
  • Portable Fume Extractor / Laboratory Fume Extractors
  • Portable Fume Hood
  • Portable GC MS
  • Portable pH Meter / Hand Held pH Meter
  • Portable Photosynthesis System
  • Portable Raman Spectrometer
  • Portable Refractometer / Handheld Refractometers
  • Portable Spectrometer / Handheld Spectrometer
  • Portable TOC Analyzer
  • Portable Turbidity Meter (Portable Turbidimeter)
  • Portable Viscometer
  • Portable XRF Analyzer / Handheld XRF Analyzer
  • Soil Respiration / Soil CO2 Flux Systems
  • Powder Analysis (Powder Analyzer)
  • Powder Flow Tester / Powder Flow Analyzer
  • Powder Handling Equipment / Powder Dispensing Equipment
  • Automated Pharmaceutical Formulation Systems
  • Automated Powder Handling Systems
  • Laboratory Powder Dispenser / Benchtop Powder Dispensers
  • Powder Dispensing System / Semi-Automated Powder Dispensing Systems
  • Powder Flow Tester / Powder Flow Analyzer
  • Powder Pipette
  • Process Analyzer / Process Analysis
  • At-Line NIR Analyzer
  • Chromatography Process Analyzers
  • In Situ Raman Spectrometer
  • NIR Analysis Software
  • Online NIR Analyzers / Inline NIR Analyzer
  • Proton Transfer Reaction Mass Spectrometer (PTR-MS)
  • Refractometer / Brix Refractometers
  • Abbe Refractometer
  • Automatic Refractometer
  • Clinical Refractometer
  • Digital Refractometers
  • Portable Refractometer / Handheld Refractometers
  • TPN Refractometer / Total Parenteral Nutrition Refractometers
  • Rheometers / Viscometers
  • Capillary Rheometer
  • Cone and Plate Rheometer (Cone Plate Rheometers)
  • Cone and Plate Viscometer (Cone Plate Viscometers)
  • Controlled Stress Rheometer
  • Dynamic Shear Rheometer
  • Falling Ball Viscometer / Falling Sphere Viscometers
  • Krebs Viscometer
  • Portable Viscometer
  • Rotational Rheometer
  • Rotational Viscometer / Rotary Viscometers
  • Viscometer / Digital Viscometer
  • Viscometer / Rheometer Accessories
  • Shake Flask Monitoring System / Multidish Monitoring Systems
  • Solid Phase Extraction Equipment (SPE Equipment)
  • Automated Solid Phase Extraction System (SPE System)
  • Extraction System Controller
  • Solvent Recovery System / Bench Top Solvent Recovery Systems
  • SPE Cartridge / Solid Phase Extraction Cartridges
  • SPE HPLC Systems
  • SPE Manifold
  • SPME (Solid Phase Micro-extraction) Syringe
  • Vacuum Evaporator / Vortex Evaporator
  • Transfection Technology
  • Micro-porator / Microporation
  • Ultrasonic Homogenizer / Laboratory Homogenizers (Sonicator)
  • Veterinary Test Kits / Veterinary Diagnostic Kits

List of Pharmaceutical Equipment – Instruments Machinery 4 Pharmaceutical Industry PDF

Present Scenario  of Instruments used in Pharmaceutical industry

Indian pharmaceutical-machine makers and their Western counterparts increasingly are exploring collaborations and partnerships with each other to innovate or share new technology. Together, they are targeting more price conscious products in developing countries. The number of joint ventures between foreign and Indian machinery manufacturers is a testimony of the Indian machinery industry that can produce international quality at affordable prices by understanding the stringent need of pharmaceutical industry. It is significant to note that compared to the US and Europe, India and China are making machinery which is 10-20 times less expensive. However, German made machines are unbeatable in quality, though the prices are undoubtedly more than India and it is difficult for Indian manufacturers to produce such quality machines presently.

In future, we can estimate the pharmaceutical companies waging an all-out war to gain a competitive leverage by slashing their production costs to increase their bottom line with little or no time to efficiently plan and design their manufacturing processes. This would set the machinery industry to make in-roads in the various markets of the world leading a manufacturing revolution just like the IT industry.

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Autoclave Sterilization Principle & Working PDF PPT – Autoclave Validation – Autoclave Diagram

Autoclave Sterilization Principle & Working Diagram

Autoclave Sterilization: Autoclaves provide a physical method for disinfection and sterilization. They work with a combination of steam, pressure and time. Autoclaves operate at high temperature and pressure in order to kill microorganisms and spores.

Autoclave Sterilization

Autoclave Sterilizers are used to decontaminate certain biological waste and sterilize media, instruments and lab ware. Regulated medical waste that might contain bacteria, viruses and other biological material are recommended to be inactivated by autoclaving before disposal.

An autoclave is used to sterilize surgical equipment, laboratory instruments, pharmaceutical items, and other materials. It can sterilize solids, liquids, hollows, and instruments of various shapes and sizes. Autoclaves vary in size, shape and functionality. A very basic autoclave is similar to a pressure cooker; both use the power of steam to kill bacteria, spores and germs resistant to boiling water and powerful detergents.

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Autoclave Sterilizers:

To be effective against spore forming bacteria and viruses, autoclaves need to have steam in direct contact with the material being sterilized (i.e. loading of items is very important).

Create vacuum in order to displace all the air initially present in the autoclave and replacing it with steam.

Implement a well designed control scheme for steam evacuation and cooling so that the load does not perish.

The efficiency of the sterilization process depends on two major factors. One of them is the thermal death time, i.e. the time microbes must be exposed to at a particular temperature before they are all dead. The second factor is the thermal death point or temperature at which all microbes in a sample are killed.

The steam and pressure ensure sufficient heat is transferred into the organism to kill them. A series of negative pressure pulses are used to vacuum all possible air pockets, while steam penetration is maximized by application of a succession of positive pulses

Autoclave Sterilization Principle & Working PDF PPT - Autoclave Validation - Autoclave Diagram

Autoclave Uses & Advantages:

An autoclave chamber sterilizes medical or laboratory instruments by heating them above boiling point. Most clinics have tabletop autoclaves, similar in size to microwave ovens. Hospitals use large autoclaves, also called horizontal autoclaves. They’re usually located in the the Central Sterile Services Department CSSD) and can process numerous surgical instruments in a single sterilization cycle, meeting the ongoing demand for sterile equipment in operating rooms and emergency wards.

They are important in tattoo shops, beauty and barber shops, dentist offices, veterinarians and many other fields.

Autoclave disadvantages:

Autoclave is unsuitable for heat sensitive objects.

Autoclaves Working Principle:

Autoclaves use pressurized steam as their sterilization agent. The basic concept of an autoclave is to have each item sterilized -whether it is a liquid, plastic ware, or glassware- come in direct contact with steam at a specific temperature and pressure for a specific amount of time. Time, steam, temperature, and pressure are the four main parameters required for a successful sterilization using an autoclave.

The amount of time and temperature required for sterilization depends on the type of material being autoclaved. Using higher temperatures for sterilization requires shorter times. The most common temperatures used are 121 C and 132 C. In order for steam to reach these high temperatures, steam has to be pumped into the chamber at a pressure higher than normal atmospheric pressure.

Now that we have covered the basic principle of how autoclaves use pressurized steam to sterilize contaminated materials, we will now go over how autoclaves operate.

Autoclave Design Diagram & Parts

Autoclave Sterilization Principle & Working Diagram

Similar to pressure cookers, steam sterilizer autoclaves work quickly and effectively because of their high temperature. The machine’s temperature and unique shape make it easier to hold the heat inside much longer. The autoclave also does a great job of efficiently penetrating each piece of equipment. The autoclave’s chambers are usually in the shape of a cylinder because cylindrical shapes are more equipped to handle the high pressure that is needed for the sterilization process to work. For safety reasons, there is an outside lock and a safety valve that prevents the autoclave steam sterilizer’s pressure from getting too high.

Once you close the autoclave sterilizer chamber, a vacuum pump removes all the air from inside the device or it is forced out by pumping in steam. If done the first way, the sterilizer is pumped with high pressured steam to quickly raise the internal temperature. On every autoclave there is a thermometer that is waiting for the thermal sweet point, 268-273 degrees Fahrenheit, and then it starts its timer. During the sterilizing process, steam is continuously entering the autoclave to thoroughly kill all dangerous microorganisms. Once the required time of sterilization has the elapsed, the chamber will be exhausted of pressure and steam allowing the door to open for cooling and drying of the contents.

Mode of Action Autoclave Sterilizers:

Moist heat destroys microorganisms by the irreversible coagulation and denaturation of enzymes and structural proteins. In support of this fact, it has been found that the presence of moisture significantly affects the coagulation temperature of proteins and the temperature at which microorganisms are destroyed.

Autoclave Working – Operation:

Place containers in the autoclave.

Check the strainer to see if it is clogged. The strainer is located on the bottom of the chamber near the door. The autoclave will not come up to pressure if the strainer is clogged.

Close door.

               For the SMALL autoclave, rotate the handle clockwise until it is snugly closed.     

                For the LARGE autoclave, rotate the small, inner handle clockwise first until it locks. Then rotate the large outer handle clockwise until it is snug.

Open the glass-faced door in the upper right corner. Set STERILIZE time and, if needed, set DRY time.

Select the SETTING you want by pushing in the colored button that corresponds to:

ON-OFF                FAST EXHAUST  FLUIDS  DRY

GREEN= FAST EXHAUST:  Pressure will decrease rapidly at the end of sterilization. Fluids will bubble over if you use this setting.

YELLOW= Fluids: Pressure decreases more slowly at the end of sterilization.

BLUE=Dry:  Use this setting for paper goods, cotton swabs, etc.

Push in the RED button to turn the autoclave on.

Wait until the temperature reaches 121°C and the RED sterilization light in the glass-faced box turns on before recording the Chamber Pressure on the Log. The chamber pressure should be 16-20 psi once the sterilization cycle starts. Anything below 16 psi should be reported to your lab manager.

At the end of the run, insure the CHAMBER PRESSURE has returned to ZERO before attempting to open the door. The FLUIDS cycle takes much longer than FAST EXHAUST – be patient. If the door cannot be easily opened, WAIT 10 minutes before trying again. If you wrench on the door and  attempt to force it open, the internal metal rod that connects to the door handle will twist from the pressure.

To open the door:

SMALL autoclave: rotate the handle counterclockwise. Be careful, steam burns!  Step to the side and crack open the door. Allow the steam to escape from the chamber then open the door and remove your items.

LARGE autoclave: First rotate the LARGE OUTER handle counterclockwise until it is loose. Next, rotate the SMALL INNER handle counterclockwise until the door opens. Be careful, steam burns!  Step to the side and crack open the door. Allow the steam to escape from the chamber then open the door and remove your items.

As a courtesy to others needing to use the autoclave, promptly remove your items when the cycle is completed and you can easily open the door. Wear protective, heat resistant gloves when removing items.

Autoclaved waste materials are to be taken directly to the dumpster for disposal. Orange autoclave bags must be put into black trash bags before disposing in the dumpster.

Autoclave Cycles

To be effective, the autoclave must reach and maintain a temperature of 121° C for at least 30 minutes by using saturated steam under at least 15 psi of pressure. Increased cycle time may be necessary depending upon the make-up and volume of the load.

The rate of exhaust will depend upon the nature of the load. Dry material can be treated in a fast exhaust cycle, while liquids and biological waste require slow exhaust to prevent boiling over of super-heated liquids.

Liquids cycle

 Liquids rely on the Liquids Cycle to avoid a phenomenon known as “boil-over.” Boil-over is simply a liquid boiling so violently that it spills over the top of its container.  Boil-over will occur if the pressure in your autoclave chamber is released too quickly during the exhaust phase of the cycle.  Significant liquid volume can be lost to boil-over, and this can result in unwanted spills on the bottom of the autoclave chamber that must be cleaned up to avoid clogging the drain lines and the subsequent repair costs to the department.

To help prevent boil-over during the exhaust phase, the chamber pressure must be released slowly.  This process is controlled by the sterilizer’s control system. Controlling the exhaust rate allows the liquid load to cool off as the surrounding chamber pressure is decreased.

The exhaust rate for a Liquids Cycle is different from a standard Gravity or Vacuum Cycle, where the chamber pressure is released quickly. To prevent boil-over, the chamber pressure must decrease slowly to allow the temperature of the load to remain below the boiling point.  If the pressure is exhausted all at once, the temperature of the load will be above its boiling point, resulting in instant and violent boiling.

(Slow Exhaust)

Material Recommended for:

Use with glass containers with vented closures; 2/3 full only

  • Liquid media
  • Nonflammable liquids
  • Aqueous solutions
  • Liquid biological waste

Solids or Dry cycle

(Fast Exhaust)

Material Recommended for:

Glassware: empty and inverted

no tight or impermeable closures

Dry hard items, either unwrapped or in porous wrap

Metal items with porous parts

Other porous materials

Gravity Cycle: Wrapped Goods or Pre vacuum cycle

(Clean: Fast Exhaust

Dirty: Slow Exhaust)

The traditional “Gravity Cycle” is the most common and simplest steam sterilization cycle. During a Gravity Cycle, steam is pumped into a chamber containing ambient air. Because steam has a lower density than air, it rises to the top of the chamber and eventually displaces all the air. As steam fills the chamber, the air is forced out through a drain vent. By pushing the air out, the steam is able to directly contact the load and begin to sterilize it.

At the end of the cycle, the steam is discharged through the drain vent. However, the load can still be hot and possibly wet. To address this issue, gravity autoclaves can be equipped with a post-cycle vacuum feature to assist in drying the load. The sterilizer runs a normal Gravity Cycle and after the load is sterilized, a vacuum pulls steam and condensation through the drain vent. The longer the vacuum system runs during the dry phase, the cooler and dryer the goods will be when removed from the chamber.

Gravity Cycles are commonly used on loads like glassware, bio-hazardous waste (autoclave bag waste), and wrapped and unwrapped instruments.

Material Recommended for:

Glassware that must be sterilized upright and/or can trap air

Wrapped dry items that can trap air

Pipette tip boxes

Sharps decontamination

(in collection containers)

Biohazard waste decontamination, in autoclave bags; can be wet or dry

Autoclave Types & Market

  • Medical autoclaves
  • Dental autoclaves
  • Laboratory autoclaves

Medical autoclaves

Tabletop autoclaves
large horizontal autoclaves
Plasma Sterilizer
Washer Disinfectors
Autoclaves maintain a healthy, clean and sterile environment.
Fast and effective disinfection of surgical instruments in preparation for sterilization is ensured by Autoclaves.
Autoclaves that satisfy the needs of any hospital operating room, central sterile services department or medical clinic.

Dental autoclaves

– ideal sterilizer for dentists

Laboratory autoclaves 

vertical loading autoclaves and fast liquid cooling autoclaves

Life science labs and research institutes need sterilization techniques inevitably

Autoclave Validation

Chemical Indicators

Tape Indicators

Tape indicators are adhesive-backed paper tape with heat sensitive, chemical indicator markings.  Tape indicators change color or display diagonal stripes, the words “sterile” or “autoclaved” when exposed to temperatures of 121°C.  Tape indicators are typically placed on the exterior of the waste load.  If the temperature sensitive tape does not indicate that a temperature of at least 121°C was reached during the sterilization process, the load is not considered decontaminated.   If tape indicators fail on two consecutive loads, notify your Department Safety Manager.

Tape indicators are not designed nor intended to prove that organisms have actually been killed. They indicate that a temperature of 121°C has been achieved within the autoclave.  EHS recommends that you DO NOT use autoclave tape as the only indicator of decontamination or sterilization.

Integrated Chemical Indicator Strips

Integrated chemical indicator strips provide a limited validation of temperature and time by displaying a color change after exposure to  normal autoclave operating temperatures of 121ºC for several minutes.  Chemical color change indicators can be placed within the waste load.  If the chemical indicators fail on two consecutive loads, notify your Department Safety Manager.                            

Biological Indicators

Biological indicator vials contain spores from B. stearothermophilus, a microorganism that is inactivated when exposed to 121.1oC saturated steam for a minimum of 20 minutes. Autoclaves used to treat biological waste will be evaluated with a biological indicator by EHS on a quarterly basis.

Validation Procedure for Autoclave:

EHS will coordinate biological validation testing with laboratory staff.

The indicators will be incubated by EHS for 24 hours at 60°C with a control that has been maintained at room temperature.

Results

If the autoclaved indicator exhibits growth, the validation has failed and will be repeated.

If the second validation indicator fails, EHS will notify the Department Safety Manager and request service on the autoclave.  Autoclave should not be used until service has been conducted and the validation test passes.

Validation tests results are emailed by EHS staff to the appropriate labs and the Department Safety Manager.

EHS maintains documentation of all validation tests.

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[#PDF PPT] Hot Air Oven Working Principle Sterilization Diagram SOP Uses Temperature

hot air oven working pdf

Hot Air Oven Working Principle Sterilization Labelled Diagram Temperature [ #PDF PPT ] is the main theme of this article. Sterilization and aseptic processing are essential practices for healthcare product manufacture and many healthcare services. The execution of these processes in an appropriate manner is essential for patient safety.

A hot air oven is used to sterilize equipment and materials used in the medical field. A hot air oven is a type of dry heat sterilization. Dry heat sterilization is used on equipment that cannot be wet, and on material that will not melt, catch fire, or change form when exposed to high temperatures. Moist heat sterilization uses water to boil items or steam them to sterilize and does not take as long as dry heat sterilization. Examples of items that are not sterilized in a hot air oven are surgical dressings, rubber items, or plastic material. Items that are sterilized in a hot air oven include:

Glassware (petri dishes, flasks, pipettes, and test tubes)
Powders (starch, zinc oxide, and sulfadiazine)
Materials that contain oils
Metal equipment (scalpels, scissors, and blades)
Glass test tubes can be sterilized using a hot air oven
Glass test tubes can be sterilized using a hot air oven
Hot air ovens use extremely high temperatures over several hours to destroy microorganisms and bacterial spores. The ovens use conduction to sterilize items by heating the outside surfaces of the item, which then absorbs the heat and moves it towards the center of the item.

The commonly-used temperatures and time that hot air ovens need to sterilize materials is 170 degrees Celsius for 30 minutes, 160 degrees Celsius for 60 minutes, and 150 degrees Celsius for 150 minutes.

hot air oven images

Principle of HOT AIR OVEN (Dry heat sterilization) 

Sterilizing by dry heat is accomplished by conduction. The heat is absorbed by the outside surface of the item, then passes towards the centre of the item, layer by layer. The entire item will eventually reach the temperature required for sterilization to take place.

Dry heat does most of the damage by oxidizing molecules. The essential cell constituents are destroyed and the organism dies. The temperature is maintained for almost an hour to kill the most difficult of the resistant spores.

The most common time-temperature relationships for sterilization with hot air sterilizers are

170°C (340°F) for 30 minutes,
160°C (320°F) for 60 minutes, and
150°C (300°F) for 150 minutes or longer depending up the volume.

Hot Air Oven ppt working principle uses diagam ppt

Hot Air Oven Working Principle Sterilization Labelled Diagram PDF ppt

Note: Bacillus atrophaeus spores should be used to monitor the sterilization process for dry heat because they are more resistant to dry heat than the spores of Geobacillus stearothermophilus. The primary lethal process is considered to be oxidation of cell constituents.

working principle of hot air oven

Types of HOT AIR OVEN

the static-air type and
the forced-air type.

There are two types of dry-heat sterilizers:

the static-air type and
the forced-air type.
The static-air type is referred to as the oven-type sterilizer as heating coils in the bottom of the unit cause the hot air to rise inside the chamber via gravity convection. This type of dry-heat sterilizer is much slower in heating, requires longer time to reach sterilizing temperature, and is less uniform in temperature control throughout the chamber than is the forced-air type.

The forced-air or mechanical convection sterilizer is equipped with a motor-driven blower that circulates heated air throughout the chamber at a high velocity, permitting a more rapid transfer of energy from the air to the instruments.

Hot Air Oven Labelled Diagram

hot air oven labelled diagram

Uses of HOT AIR OVEN (dry heat sterilization)

A dry heat cabinet is easy to install and has relatively low operating costs;
It penetrates materials
It is nontoxic and does not harm the environment;
And it is noncorrosive for metal and sharp instruments.
Disadvantages for dry heat sterilization

Time consuming method because of slow rate of heat penetration and microbial killing.
High temperatures are not suitable for most materials.

Working Principle of HOT AIR OVEN

Sterilizing by dry heat is accomplished by conduction. The heat is absorbed by the outside surface of the item, then passes towards the centre of the item, layer by layer. The entire item will eventually reach the temperature required for sterilization to take place.

Dry heat does most of the damage by oxidizing molecules. The essential cell constituents are destroyed and the organism dies. The temperature is maintained for almost an hour to kill the most difficult of the resistant spores.

The most common time-temperature relationships for sterilization with hot air sterilizers are

170°C (340°F) for 30 minutes,
160°C (320°F) for 60 minutes, and
150°C (300°F) for 150 minutes or longer depending up the volume.

Different Types of Hot Air Ovens
There are two types of hot air ovens. One is a forced air hot air oven and the other is a static air hot air oven. The forced air hot air oven is more effective than the static air hot air oven.

The forced air hot air oven works by heating the oven and using a fan to move the hot air around. This helps prevent the hot air from rising to the top of the oven and keeping the cooler air at the bottom. The fan keeps the hot air moving around at a consistent temperature throughout the oven.

The static air hot air oven works by using a heating coil at the bottom of the oven. The heat rises throughout the oven and takes a longer time to reach the desired temperature. Since the heat is not circulated as with a forced air hot air oven the temperature is not consistent throughout the oven.

STANDARD OPERATING PROCEDURE of HOT AIR OVEN

Aim:

To lay down the procedure for operation of Hot Air Oven.

Procedure:

1. Connect the power supply.
2. Switch “ON” the main power supply and instrument mains.
Temperature setting
3. Press SET POINT (x/w) key to set the required temperature. press ↑ to
increase the temperature and ↓ to reduce the temperature
4. The temp. Sensor will maintain the set temp which is indicated by the blinking
of set temp on the display screen.
5. The duration of time can also be adjusted using the time adjustment knob
6. After use,SWITCH OFF the power supply.

Safety & Precautions:

=> Maximum Temp. : 350o
C.
=> Ensure that the Exhaust blower is ON before starting the oven.
=> Ensure the GN2 plant is UP.
=> Ensure that temperature does not shoot higher than the set temperature

Cleaning:

# Wipe the surface, walls, top, bottom and trays of the oven with dry lint free
cloth on daily basis so that there will be no dust particles in the oven.
# Wipe all the parts and outer surface of the Oven with wet lint free cloth
soaked in purified water, on weekly basis and fill the weekly cleaning

Note: Bacillus atrophaeus spores should be used to monitor the sterilization process for dry heat because they are more resistant to dry heat than the spores of Geobacillus stearothermophilus. The primary lethal process is considered to be oxidation of cell constituents.

Hot Air Oven Uses ( Advantages) :

Items that are sterilized in a hot air oven include:

Glassware (petri dishes, flasks, pipettes, and test tubes)
Powders (starch, zinc oxide, and sulfadiazine)
Materials that contain oils
Metal equipment (scalpels, scissors, and blades)
Glass test tubes can be sterilized using a hot air oven
Glass test tubes can be sterilized using a hot air oven
Hot air ovens use extremely high temperatures over several hours to destroy microorganisms and bacterial spores. The ovens use conduction to sterilize items by heating the outside surfaces of the item, which then absorbs the heat and moves it towards the center of the item.

Note:Items that are not sterilized in a hot air oven are surgical dressings, rubber items, or plastic material.

Disadvantages for dry heat sterilization

Time consuming method because of slow rate of heat penetration and microbial killing.
High temperatures are not suitable for most materials.

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Tray Dryer Working Principle – Tray Dryers Theory Manufacturer – Best Pharmaceutical Equipment

Tray Dryer Working Principle - Tray Dryers Theory Manufacturer - Best Pharmaceutical Equipment

Tray Dryer is used for the best drying results in conventional process.

Tray Dryer- Pharmaceutical Equipment Introduction :

The most widely used and most general method of tablet preparation is the wet-granulation method. Its popularity is due to the greater probability that the granulation will meet all the physical requirements for the compression of good tablets. Its chief disadvantages are the number of separate steps involved, as well as the time and labor necessary to carry out the procedure, especially on a large scale. The steps in the wet method are weighing, mixing, wet massing, screening the damp mass, drying, dry screening, lubrication, and compression. The equipment involved depends on the quantity or size of the batch and
the percent active ingredient per total weight of the tablets. Wet massing can be performed by:
1. Low Shear mixers/granulators,
2. High Shear mixers/granulators,
3. Fluid-Bed granulators/Tray dryers,
4. Spray Dryers, or
5. Extruders and Spheronizers.
Dryers are used to remove liquids or moisture from bulk solids, powders, parts, continuous sheets or other liquids by evaporation or sublimation. Dryers can be broken up into two main types: direct and indirect. Direct dryers convectively heat a product through direct contact with heated air, gas or a combusted gas product. Indirect dryers conductively heat a product through contact with a heated wall.

Tray Dryer is used for the best drying results in conventional process. It is a double walled cabinet with Single or Two doors. The gap between two walls is filled with high density fibre glass wool insulation material to avoid heat transfer. Doors are provided with gaskets. Stainless steel trays are placed on the movable trolleys. Tray Dryer is provided with control panel board, process timer, Digital temperature controller cum indicator etc. Tray Dryer is available in capacities ranging from 6, 12, 24, 48, 96, 192 trays.

Tray Dryer Manufacture Construction & Specifications Manufacturers

Tray Dryers Theory

A tray Dryer is an enclosed insulated chamber in which trays are placed on top of each other in trolleys. Tray Dryer are used where heating and drying are essential parts of manufacturing process in industries such as Chemicals, Dye stuff, Pharmaceutical, Food Products, Colours etc. The material to be dried either wet or solids are placed in the trays. Heat transfer is by circulation of hot air by electric heaters or steam in radiator coils. Blower fans are installed inside to ensure proper circulation and transfer of heat. A control panel to control the temperature and other parameteres is fixed outside the dryer. These dryers are available in Mild Steel, Stainless Steel or construction. Tray dryer is used for drying of pigments, food, bakery, electrodes, chemical and plastic powders.
The Drying ovens are normally available with choice of heating mode, as electrically heated / steam heated & thermic fluid heated..

In electrically heated model, digital temperature controller provided with digital timer to facilitate working day and night. In steam & thermic fluid heated model, digital temperature indicator is provided with digital timer , but the temperature controller is not supplied with the machine.

Tray Dryer Working Principle - Tray Dryers Theory Manufacturer - Best Pharmaceutical Equipment

A highly effective recirculating air system is provided. The heated air, is recirculated with fresh air in selected proportions for optimum drying. The system is designed so that the materials at the top & the bottom dry simultaneously.

Uniform air circulation, controlled temperature, sturdy construction and large working space are the valuables of the oven which is suitably designed to cover wide temperature range, loading and unloading is faster and simple. In higher capacities trays trolley rolls in and out of the chamber. For continuous operation a spare trolley can be had for loading while the drying cycle is taking place. Digital temperature controller with digital timer are supplied to facilitate working day and night.

Tray Dryer Working Principle

In tray dryer hot air is continuously circulated. Forced convection heating takes place to remove moister from the solids placed in trays.

Simuilaneously the moist air is removed partially.

Wet solid is loaded in to the trays. Trays are placed in the chamber.

Fresh air is introduced through in let, which passes through the heaters and gets heated up.

The hot air is circulated by means of fans at 2 to 5 metre per second.

Turbulent flow lowers the partial vapour pressure in the atmosphere and also reduces the thickness of the air boundary layer.

The water is picked up by the air. As the water evaporates from the surface, the water diffuses from the interior of the solids by the capillary action.

These events occur in a single pass of air. The time of contact is short and amount of water picked up in a single pass is small.

Therfore the discharged air to the tune of 80 to 90 % is circulated back through the fans. Only 10 to 20% of fresh air is introduced.

Moist air is discharged through outlet. Thus constant temperature and uniform air flow over the materials can be maintained for achieving uniform drying.

In case of the wet granules as in tablets and capsules drying is containued until the desired moister content is obtained.

At the end of the drying trays or trucks are pulled out of the chamber and taken to a tray dumping station.

Tray Dryer Diagram:

Tray Dryer Diagram

Tray Dryer Manufacture Construction & Specifications:

The Tray dryer should be of robust construction built on formed angles of 3mm+ thick sheet and suitably reinforced with angles and sections.

The dryers external walls should be manufactured from 1.6mm thick Stainless Steel sheets of 304 quality or more.

 The internal of the dryer is built of 1.6 mm thick quality sheets. The internal structure should be fully TIG welded and all the internals have ground smooth surfaces.

It should be insulated with minimum 50 mm thick glasswool insulation and Cladded with S,S, Polished sheets.

The dryer should be having a fresh air inlet through 20 Micron PP cloth filters and a adjustable air outlet flap and a door at the front. The door is explosion proof and is locked with the help of spring loaded ball latches with suitable pressure. Door lips are having Neoprene rubber Gasket to prevent leakages.

Tray Dryer Working Principle

The design and manufacture of the dryer is of high standard of GMP and has an aesthetic look. It is buffed externally to 150 grit matt finish and internally buffed to 220 grit mirror finish.

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Tray Dryer Working Principle – Tray Dryers Theory Manufacturer pdf Tray Dryer Working Principle – Tray Dryers Theory Manufacturer ppt doc Tray Dryer is used for the best drying results in conventional process ppt

Sources

Remington Pharmaceutics PDF _Essentials_of_Pharmaceutics_-_Felton,_Linda page 589
Mehta RM, Pharmaceutics-I: introduction to the drying process (1996), Page no: 187.
C.v.s subrahmanyam et al., pharmaceutical engineering principles and practices-filtration, 2001, page no. 390 – 392.

The Air inside the Tray Dryer is heated by “U” tube S.S.304 air heaters each of 1 KW.The heaters are fitted on the sides of the dryer to facilitate uniform heating. Maximum temperature attained inside the dryer is 100′ C and will be indicated and controlled by a Digital Temperature indicator cum controller over full range of heating load.

Total heating load for it will be

12 Trays Dryer – 4 KW

24 Trays Dryer – 6 KW

48 Trays Dryer – 12 KW

96 Trays Dryer – 24 KW

The heaters will be inserted inside tubular pipe to prevent it from becoing RED HOT. The terminals of the heaters will be brought outside the dryer to make it more safe for operations for solvent based products.

Racks And Trolleys

Racks are provided for trays insdie the Dryer. They are of fixed type for 12 and 24 Tarys Models. For 48 and 96 Trays Models. Racks are provided with wheels to slide them in and out of the Dryer. An additional S.S, trolley for Racks for outside movement can be provided on request

Drying tests comparing the fluidized bed and a tray dryer for a number of tablet granulations indicated that the former was 15 times faster than the conventional method of tray drying. In

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