August 16, 2021: Pharmaceutical Interview Questions and Answers
#DrinsInClassifiedArea #TrainingForAsepticArea #PracticeOfPersonnelInAspeticArea #ImportanceOfunidirectionalAirflow
1. Drains are preferably not allowed in which area classification zones?
Drains are considered inappropriate for classified areas of the aseptic processing facility other than Class 100,000 (ISO 8) areas.
2. Types of training required to be conducted before an individual is permitted to enter the aseptic manufacturing area?
Fundamental training topics should include aseptic technique, cleanroom behavior, microbiology, hygiene, gowning, patient safety hazards posed by a non-sterile drug product, and the specific written procedures covering aseptic manufacturing area operations.
3. What measures required to be followed by personnel in aseptic area to maintain sterility of sterile items and surafaces?
- Measures required to be followed by personnel in aseptic area are:
- Contact sterile materials only with sterile instruments.
- After initial gowning, sterile gloves should be regularly sanitized or changed, as appropriate, to minimize the risk of contamination.
- Personnel should not directly contact sterile products, containers, closures, or critical surfaces with any part of their gown or gloves.
- Move slowly and deliberately.
- Keep the entire body out of the path of unidirectional airflow.
- Approach a necessary manipulation in a manner that does not compromise sterility of the product.
- Maintain Proper Gown Control – Prior to and throughout aseptic operations, an operator should not engage in any activity that poses an unreasonable contamination risk to the gown.
4. What is the impact of rapid movements in Aspetic area?
Rapid movements can create unacceptable turbulence in a critical area. Such movements disrupt the unidirectional airflow, presenting a challenge beyond intended cleanroom design and control parameters. The principle of slow, careful movement should be followed throughout the cleanroom.
5. What is the potential impact if body parts interrupt the path of unidirectional airflow?
Disruption of the path of unidirectional flow air in the critical area can pose a risk to product sterility because, the purpose of unidirectional airflow design is to protect sterile equipment surfaces, container-closures, and product.
Reference: FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice – September 2004