August 17, 2021: Pharmaceutical Interview Questions and Answers

#AsepticAreaGowning #GowningRequalificationFrequency #Endotoxin #InactivationOfEndotoxins

1. Explain the type of gowning required for aseptic area?

  • The gown should provide a barrier between the body and exposed sterilized materials and prevent contamination from particles generated by, and microorganisms shed from, the body.
  • Gowns should be sterile and non-shedding, and cover the skin and hair (face-masks, hoods, beard/ moustache covers, protective goggles, and elastic gloves are examples of common elements of gowns).
  • An adequate barrier should be created by the overlapping of gown components (e.g., gloves overlapping sleeves).
  • If an element of a gown is found to be torn or defective, it should be changed immediately. Gloves should be sanitized frequently.

2. What is the recommended gowning requalification frequency for aseptic area?

Annual requalification is normally sufficient for those automated operations where personnel involvement is minimized and monitoring data indicate environmental control.

For any aseptic processing operation, if adverse conditions occur, additional or more frequent requalification could be indicated.

3. Sanitizing gloves just prior to sampling is acceptable or not acceptable?

Sanitizing gloves just prior to sampling is inappropriate because it can prevent recovery of microorganisms that were present during an aseptic manipulation.

4. What is the recommended solvent for rinse sampling for pre-sterilization preparation of glass containers? What is the acceptance criterion of final rinse water?

High purity water. Final rinse water should meet the specifications of WFI, USP.

5. What is a log reduction criterion for endotoxin after depyrogenation process?

Validation study data should demonstrate that the process reduces the endotoxin content by at least 99.9 percent (3 logs).

6. Is sterilizing-grade filters and moist heat sterilization effective in removing endotoxin?

Sterilizing-grade filters and moist heat sterilization have not been shown to be effective in removing endotoxin.

7. What is an effective way to inactivate endotoxins?

Endotoxin on equipment surfaces can be inactivated by high-temperature dry heat, or removed from equipment surfaces by cleaning procedures.

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

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