Page 67 - MNU-PM502- Pharmaeutical Microbiology Theoritical Book

Pharm D- Clinical Pharmacy Program Third Level Pharmaceutical Microbiology& Antimicrobials (PM 502)

Aseptic process

• The product is prepared under aseptic conditions from previously sterilized

materials

• Aseptic filling is a post sterilization step.

• Strict aseptic conditions are required.

Non-sterile drugs are tested for total aerobic bacteria, yeast, and fungi by the
bioburden or microbial limit test and for the absence of objectionable organisms.

Microbiological quality for sterile drug is assured by

Environmental
monitoring Monitoring
pharmaceutical
ingardients, packaging,
In-process components
Monitoring
Microbial control
(sterile drugs) Sterilization process
monitoring

Sterility testing
Finished produt
testing
Pyrogen test

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