Microbiology is the crucial section of Sterile Pharmaceutical products also it is very Important in Non- Sterile Products. Microbiology sections can be divide in following sections;
- Antimicrobial Effectiveness Testing.(USP <51>)(Ph. Eur. general texts 5.1.3)
- Microbial Examination of Non-Sterile Products.( USP <61>,<62>)(Ph. Eur. method 2.6.13./2.6.12)
- Sterility Testing.(USP <71>),(Ph. Eur. method 2.6.1)
- Bacterial Endotoxin Testing.( USP <85>)
- Particulate Matter.(USP <789>)
- Antibiotic Potency Testing.( USP <81> )
- Bio-burden Estimation for Medical Devices.(ISO 11737-1)
- Environmental Monitoring.(ORA.007 CHAPTER 9)
- Rapid Screening Methods.(ORA.007 CHAPTER 10)
- Methods of Sterilization.(Ph. Eur. general texts 5.1.1).
1) SOP on ENTRY, EXIT & GOWNING PROCEDURE IN MICROBIOLOGY TESTING AREA( Non- Sterile ).
2) SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites.
3) SOP For Good Microbiological Laboratory Practice.
5) SOP ON OPERATION AND CALIBRATION OF pH METER.
6) SOP ON BIO-BURDEN OF PACKING MATERIAL.
7) SOP on Plate Exposure to see Efficacy of Fumigation.
8) SOP on Microbial Testing of Drain Water.
9) SOP On Cleaning Of Incubators.
10) SOP ON OPERATION AND CALIBRATION OF COLONY COUNTER.
11) What is the Meaning of Sterility Test?
12) SOP on Maintenance and Preparation of Anaerobic Culture Suspension.
13)SOP on cleaning, operation and calibration of Antibiotic Zone Reader.
All these test can be found in USP & EP/BP And other regulatory & semi regulatory pharmacopoeias.