August 23, 2021: Pharmaceutical Interview Questions and Answers
#InterpretationOfMediaFillResults #InvestigationOfMediaFillFailure #FiltrationEfficacyStudy
1. How to interpret test results of media fill?
Recommended criteria for assessing state of aseptic line control are as follows:
i. When filling fewer than 5000 units, no contaminated units should be detected.
One (1) contaminated unit is considered cause for revalidation, following an investigation.
ii. When filling from 5,000 to 10,000 units
One (1) contaminated unit should result in an investigation, including consideration of a repeat media fill.
Two (2) contaminated units are considered cause for revalidation, following investigation.
iii. When filling more than 10,000 units
One (1) contaminated unit should result in an investigation.
Two (2) contaminated units are considered cause for revalidation, following investigation.
2. What should be considered when performing investigation of media fill failure?
The microorganisms should be identified to species level.
The investigation should survey the possible causes of contamination. In addition, any failure investigation should assess the impact on commercial drugs produced on the line since the last media fill.
3. To carryout Filtration Efficacy study, which microorganism should be considered for challenge? Why?
The microorganism, Brevundimonas diminuta (ATCC 19146) when properly grown, harvested and used, is a common challenge microorganism for 0.2 μm rated filters because of its small size (0.3 μm mean diameter).
4. What concentration of organism should be considered for Filtration Efficacy study?
A challenge concentration of at least 107 organisms per cm2 of effective filtration area should generally be used, resulting in no passage of the challenge microorganism. The challenge concentration used for validation is intended to provide a margin of safety well beyond what would be expected in production.
Reference: FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice – September 2004
