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AMAN MESHRAM PPTX

Quality assurance

Chandrashekhar3
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AMAN MESHRAM PPTX

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  1. TOPIC:- UTILITIES AND MAINTENANCE OF STERILE AREA ,CONTROL OF CONTAMINATION. INSTRITUTE:- CHHATRAPATI SHIVAJI COLLEGE OF PHARMACY DEORI DIST GONDIA (4280) SUB:-PHARMACEUTICAL QUALITY ASSURANCE REPRESENTED BY:- AMAN G. MESHRAM GUIDED BY :- CHANDRASHEKHAR BADWAIK SIR

  2. UTILITES I. All utilities which could impact product quality (e.g., steam, gases, compressed air, heating, ventilation and air conditioning) should be qualified. II. Adequate ventilation, air filtration and exhaust systems should be provided. III. If air is recirculated to production areas, appropriate measures should be taken to control risk of contamination. IV. Pipework should be located to avoid risks of contamination of the intermediate or API. V. Drain should be of adequate size and should be provided with an air brake or a suitable device to prevent back-flow.

  3. MAINTENANCE OF STERILE AREA I. II. For sterile drugs, separate area should be designed and designated. Sterile area should be equipped with air locks for entry and essentially dust free and ventilated with appropriate air supply. III. The air supply shall be filtered through HEPA filters. IV. Routine microbial counts of all sterile area shall be carried out during manufacturing operation. V. Special procedure should be followed for entering and leaving the manufacturing area.

  4. a) Lighting:- ▪There should be appropriate lighting arrangement in the production area for pharmaceuticals. ▪(e.g. Normally, a range of 30-50 foot-candles provides enough light to perform efficiently and effectively for a worker; however, 100 foot- candles is required in some areas, as well as special lighting for some operations, such as inspection of filled vials.) ▪ Once the light levels have been defined, it is necessary that they may be measured periodically, and the results are recorded.

  5. b) Ventilation, Air Filtration, Air Heating and Cooling:- • Adequate ventilation shall be provided in the production area. • Equipment should be provided to maintain adequate control air pressure. • Air-handling systems for the manufacture, processing and packing of penicillin shall completely separate from those for other drug products for human use. c) Plumbing:- • Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air brake or other mechanical device to prevent back-flow.

  6. d) Sewage and refuse:- ➢ Sewage trash, and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary manner. ➢A pharmaceutical plant may consider disposal in several different ways: -Product disposal. -Printing packaging disposal. -General trash and sewage.

  7. e)Washing and Toilet Facilities:- i. ii. For production and materials processing areas. iii. Lavatories and lockers. Eating facilities.

  8. CONTROL OF CONTAMINATION ➢The presence of unwanted materials such as dust and particles during the manufacturingandtransportationtime is called contamination. ➢The term contaminants Includes any unwanted matter that is found in the product. ❖Types of contamination Contaminations are classified in two general types:- 1. Functional Contamination :- Contamination which has a detrimental effect on product or processes. 1. Nuisance Contamination- Contamination which does not have a functional affect on product or processes, but interferes with the orderly management of the cleanroom.

  9. • Sources of contamination:- -particles -chemicals -bacteria -air. Prevention for effective contamination control in pharmaceutical:- i. Safety of patients ii. Minimize the risk of a serious medical hazards .

  10. • Benefits of contamination prevention:- i. Reduced chance of Animal study failure . ii. The animals have a degree of protection which can counter premature death. iii. Less time and reduce in money .

  11. THANK YOU !

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