Page 69 - MNU-PM502- Pharmaeutical Microbiology Theoritical Book

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

It includes:

A- Viable monitoring refers to testing for the detection and enumeration of
bacteria, yeast and mold.
B- Non-viable environmental monitoring which is a reference for particle

counts measured by a laser counter

Viable monitoring

The areas that are sampled in a manufacturer’s clean room include:

1- Personnel
• The contact plates monitor areas of the body that may
interact with the sterile field or product
exposure areas.

• These may include gloved hands, forearms,
or other locations on gown

2- Surfaces

o Contact Plates o Surface Swabs

used for flat surfaces - used for irregular surfaces, areas of machinery

- sample area of 25 cm hard to reach
2
2
- Area approx 25cm is swabbed
- medium protrudes above sides

- Swabbing is more qualitative than quantitative

2- Air

56