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Microbiology.

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;

  1.  Antimicrobial Effectiveness Testing.(USP <51>)(Ph. Eur. general texts 5.1.3) 
  2. Microbial Examination of Non-Sterile Products.( USP <61>,<62>)(Ph. Eur. method 2.6.13./2.6.12)
  3. Sterility Testing.(USP <71>),(Ph. Eur. method 2.6.1)
  4. Bacterial Endotoxin Testing.( USP <85>)
  5. Particulate Matter.(USP <789>)
  6. Evaluation.
  7. Antibiotic Potency Testing.( USP <81> )
  8. Bio-burden Estimation for Medical Devices.(ISO 11737-1)
  9. Environmental Monitoring.(ORA.007 CHAPTER 9)
  10. Rapid Screening Methods.(ORA.007 CHAPTER 10)
  11. Methods of Sterilization.(Ph. Eur. general texts 5.1.1).
  12. SOPs.

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