Page 71 - MNU-PM502- Pharmaeutical Microbiology Theoritical Book

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

Monitoring pharmaceutical ingredients, and packaging components

Water

- Water systems should be monitored at points of use, storage tanks.

- Sterile products are manufactured using water for injection (WFI) as ingredient
water

- The USP-recommended specifications are

- as purified <100 CFU/mL

- Highly purified and WFI 10 CFU/100mL

Container Integrity Testing

• Integrity of container/closure system is initially validated by

• Filling container with sterile growth medium
• Then inserting container in broth containing
10 CFU/ml of suitable microorganism

Media Fills Test (Process simulation)

• the performance of an aseptic manufacturing procedure using a sterile
microbiological growth medium in place of the drug solution.
• to test whether the aseptic procedures are adequate to prevent contamination

during actual drug production.
• A media fill is one part of the validation of an aseptic manufacturing process

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