August 29, 2021: Pharmaceutical Interview Questions and Answers

#MicrobiologicalIdentification #LesserControlledAreasMicrobiologicalIdentification #GenotypicMethods #BiochemicalAndPhenotypicTechniques #IncubationConditionForEnvironmental Monitoring

1. How microbiological identification is useful in sterile product manufacturing facility environmental monitoring program?

Characterization of recovered microorganisms provides vital information for the environmental monitoring program. Environmental isolates often correlate with the contaminants found in a media fill or product sterility testing failure, and the overall environmental picture provides valuable information for an investigation. Monitoring critical and immediately surrounding clean areas as well as personnel should include routine identification of microorganisms to the species (or, where appropriate, genus) level.

2. How uncontrolled area or lesser controlled areas microbiological identification is useful in sterile product manufacturing facility environmental monitoring program?

In some cases, environmental trending data have revealed migration of microorganisms into the aseptic processing room from either uncontrolled or lesser controlled areas. Establishing an adequate program for differentiating microorganisms in the lesser-controlled environments, such as Class 100,000 (ISO 8), can often be instrumental in detecting such trends.

At minimum, the program should require species (or, where appropriate, genus) identification of microorganisms in these ancillary environments at frequent intervals to establish a valid, current database of contaminants present in the facility during processing (and to demonstrate that cleaning and sanitization procedures continue to be effective).

3. Which method of microbial identification is more accurate?

Genotypic methods have been shown to be more accurate and precise than traditional biochemical and phenotypic techniques. These methods are especially valuable for investigations into failures (e.g., sterility test; media fill contamination). However, appropriate biochemical and phenotypic methods can be used for the routine identification of isolates.

4. What is the goal of microbiological monitoring?

The goal of microbiological monitoring is to reproducibly detect microorganisms for purposes of monitoring the state of environmental control.

5. What should be the capability microbiological culture media used for aseptic area environmental monitoring program?

The microbiological culture media used in environmental monitoring should be validated as capable of detecting fungi (i.e., yeasts and molds) as well as bacteria and incubated at appropriate conditions of time and temperature.

6. What should be incubation condition for environmental monitoring media plates and what should be the duration?

Total aerobic bacterial count can be obtained by incubating at 30 to 35°C for 48 to 72 hours. Total combined yeast and mold count can generally be obtained by incubating at 20 to 25°C for 5 to 7 days.

7. How to ensure that the incoming lots of environmental monitoring media is able to reliably recover microorganisms?

Incoming lots of environmental monitoring media should be tested for their ability to reliably recover microorganisms. Growth promotion testing should be performed on all lots of prepared media. Where appropriate, inactivating agents should be used to prevent inhibition of growth by cleanroom disinfectants or product residuals (e.g., antibiotics).  

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

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