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.
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.
List of Pharmaceutical Equipment’s – Manufacturing Processing Equipment PDF is here. 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. 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.
Let’s explore the Pharmaceutical Equipment’s
ADME-Tox Screening System
Amino Acid Analysis System / Amino Acid Analysis Instruments
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.
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.
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.
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.
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
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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Hardness has long been regarded as an important quality characteristic of tablets. Until recently, only two practical types of tablet hardness testers were available to the pharmaceutical industry. A new addition to this field of testing has just been made. An evaluation of the new instrument includes test comparisons against existing tablet hardness test equipment.Pharmaceutical Equipment Standard operating procedure of Tablet Hardness Tester for performance of tablet Hardness Tester of pfizer stokes monsanto strong cobb for quality control is given below.
Tablet Hardness Tester Standard operating procedure Pfizer Monsanto:
1. Scope:
Applicable to determination of weight, diameter, hardness and thickness of a tablet during in process checking.
2 Objective
This standard operating procedure is intended to provide operating instructions and safety information for the Hardness tester apparatus. This document is intended as a guideline and supplement to proper training that must be provided by qualified personnel before the apparatus is operated. The aim of this document is to ensure that safe work practices have been developed for the apparatus experimental work. This SOP is primarily concerned with the apparatus operating procedure, hazards involved with the apparatus use and safety precautions that must be taken to avoid injuries.
3.RESPONSIBILITIES :
It is the responsibility of designated personnel in Research lab to train staff and students on this procedure and to ensure adherence to this procedure. It is the responsibility of designated personnel (staff or Student) to follow the instructions of this procedure.
4. REFERENCES
Instruction Manual Tablet Hardness Tester Type:
5. DEFINITIONS Nil
6. PRECAUTIONS
During the test, parts of the body like fingers etc. can be squeezed between the movable test jaw and fixed jaw. Please put in the samples by tweezers or a similar tool.
To remove remaining tablet debris use the supplied brush. During breaking the test samples fragments of the samples can spring off. Use only protective glasses
PDF PPT SOP Pharmaceutical Equipment Tablet Hardness Tester Standard operating procedure Pfizer Monsanto:
See the list below for detailed procedures in PDF format. Check all the documents if some thing has misfiled.
The following list shows the relationship between the various units that the hardness tester is capable of measuring in: 1 Kilo Pond = 9.807 Newtons 1 Kilo Pond = 1.4 Strong Cobbs 1 Strong Cobb = 0.714 Kilo Ponds 1 Strong Cobb = 7.005 Newtons 1 Newton = 0.102 Kilo Ponds 1 Newton = 0.143 Strong Cobbs 1 Newton = 2.2048 Lbs. 8.2 RS-232 Serial Port The connector for the RS-232 serial port of the hardness tester is a 25 pin male Sub-D connector.
Interface Baud Rate 2400 Parity Even Data Bits 7 Stop Bits 1 Handshake Hardware RTS/CTS
Pin Assignments Pin Signal Description 1 Protective Ground 2 TXD Transmit Data 3 RXD Receive Data 4 RTS Request to Send 5 CTS Clear to Send 6 DSR Data Set Ready 7 GND Signal Ground 20 DTR Data Terminal Ready
Data Output
All information printed on the built in printer is automatically sent to the serial port. Page 22 Model HT-300/500 Operation Manual Version 3.0
Data Input
The following is a list of commands that can be used to control the hardness tester via the serial port: Command Function S Start Test – same as pressing START key A Stop Test – same as pressing STOP key P Printer On – turn the printer on N Printer Off – turn the printer off
