August 20, 2021: Pharmaceutical Interview Questions and Answers
#MachineSpeedDuringMediaFill #GrowthMediumForMediaFill #GrowthPromotionTestForMediaFill #IncubationDurationForMediaFill
1. Why high machine speed and low speed should be challenged during media fill runs?
Hgh line speed is often most appropriate in the evaluation of manufacturing processes characterized by frequent interventions or a significant degree of manual manipulation. Use of slow line speed is generally appropriate for evaluating manufacturing processes with prolonged exposure of the sterile drug product and containers/closures in the aseptic area.
2. What types of growth medium should be used during media fill runs?
A microbiological growth medium, such as soybean casein digest medium, should be used.
Use of anaerobic growth media (e.g., fluid thioglycollate medium) should be considered in special circumstances.
3. Which should be characteristic of microbiological growth medium to be used during media fill?
The media selected should be demonstrated to promote growth of gram-positive and gram-negative bacteria, and yeast and mold (e.g., USP indicator organisms).
Environmental monitoring and sterility test isolates can be substituted (as appropriate) or added to the growth promotion challenge.
4. What should be the concentration of organism while testing of Growth promotion units?
Growth promotion units should be inoculated with a <100 CFU challenge.
5. What action should be done if growth promotion test fails?
If the growth promotion testing fails, the origin of any contamination found during the simulation should nonetheless be investigated and the media fill promptly repeated.
6. What should be the incubation duration and temperature for media filled units?
• Incubation temperature should be suitable for recovery of bioburden and environmental isolates and should at no time be outside the range of 20-35 °C. Incubation temperature should be maintained within +2.5 °C of the target temperature.
• Incubation time should not be less than 14 days. If two temperatures are used for the incubation of the media filled units, the units should be incubated for at least 7 days at each temperature (starting with the lower temperature).
Reference: FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice – September 2004