August 28, 2021: Pharmaceutical Interview Questions and Answers

#MonitoringMicrobiologicalQuality #SurfaceMonitoring #ActiveAirMonitoring #SettlingPlates

1. Which are the acceptable methods for monitoring the microbiological quality of the environment in aseptic area?

Acceptable methods for monitoring the microbiological quality of the environment include:

a. Surface Monitoring

b. Active Air Monitoring

c. Passive Air Monitoring (Settling Plates)

2. Which surfaces monitored during Surface Monitoring?

Environmental monitoring involves sampling various surfaces for microbiological quality. For example, product contact surfaces, floors, walls, and equipment should be tested on a regular basis.

3. What types of techniques shall be used for surface monitoring?

Touch plates, swabs, and contact plates can be used for such tests.

4. What types of device shall be used for Active Air Monitoring?

Assessing microbial quality of air should involve the use of active devices including but not limited to impaction, centrifugal, and membrane (or gelatin) samplers.

5. What should be considered during method validation of Passive Air Monitoring (Settling Plates)?

As part of methods validation, the laboratory should evaluate what media exposure conditions optimize recovery of low levels of environmental isolates. Exposure conditions should preclude desiccation (e.g., caused by lengthy sampling periods and/or high airflows), which inhibits recovery of microorganisms.

Reference: FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice – September 2004

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