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).
All these test can be found in USP & EP/BP And other regulatory & semi regulatory pharmacopoeias.