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Quality Control
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Sara Quality Control |
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Major Instruments used in Quality Control Laboratory
- Spectrometer
- Polarimeter
- Single Pan Balance
- Muffle Furnace
- Melting Point Apparatus
- pH Meter
- Potentiometer
- Karl-Fisher Titrator
- Microscope
- POD Incubator
- Incubator
- Autoclave
- Hot Air Oven
- Hot Plate
- Water Bath
- Heating Mantle
- Bacterial Endotoxin Test Apparatus
- Vortex Mixer
- Heating Block
- Sterlity Chamber with Laminar Flow
- Membrane Holder
- Syringe Box with Foreceps
- Vaccum Pump
- Refrigerator
- Electric Bunsen
- Air Conditioner
- Flame Photometer
- Magnetic Stirrer
Validation and Calibration
Critical equipment like scales are calibrated daily before that start of production activities. The laboratory equipments are calibrated/revalidated on a regular basis from time to time as per standard procedures and records maintained. If found incorrect they are replaced.
Process validation is done for every product for the first three batches by analyzing the bulk solution by thorough mixing or as the case may be.This is repeated for at least one batch every month for a product and also if there is any change in the machinery or after the service of machine.
Cleaning and Sanitation procedure of manufacturing areas and equipments.
Standard cleaning procedures for equipment and areas are written and displayed.
Three types of disinfecting agents for floors and walls are used alternatively every week.
The method of evaluating the effectiveness of cleaning is by microbial evaluation.
Microbiological methods like swab testing are carried out to monitor the efficiency of cleaning methods in critical areas like dispensing(thrice a week),processing areas(twice a week).
Cleaning method for the water supply system: Overhead tank storing raw water is cleaned with disinfectants once a month. Cartridge is cleaned by back wash method and pipe line are fully dismantled and cleaned using steam. This is done once in a month.
Cleaning method of Air Handling System
The filters are removed and sprayed with 1% detergent solution after wetting and then washed with a jet of water. The filters are then absolutely dries and then refitted
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