Page 70 - MNU-PM502- Pharmaeutical Microbiology Theoritical Book

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

1- Air Samplers (active air sampling)

• Air samplers draw in predetermined volumes of air.

• The air is drawn over a sterile media plate, which is later
incubated to reveal the number of viable organisms per
cubic feet or liter

• correlate microbial contamination with measured air flow.

2- Settling plates (passive air sampling)

sterile growth media are exposed to the environment for a
specific period of time, usually between 30-60 minutes or up
to 4 hours before compromising the integrity of the media
itself.

Only give qualitative results

• A sampling plan describing procedures and identifying sample sites, sampling
numbers and sample frequency should be developed and properly documented in

order to demonstrate that there is a constant level of control over the environment
within the clean room facilities.
• (European Union) EUGGMP 2002 Recommended Limits for Microbial

Contamination

Grade Air sample Settle plates (90mm Contact plates Glove print
(CFU/m3) diameter) (55mm (5 fingers)
(CFU/4hours) diameter) (CFU/glove)
(CFU/plate)
A < 3 < 3 < 3 < 3
B 10 5 5 5
C 100 50 25 -
D 200 100 50 -

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