sterile production based interview questions answer
1. What is sterile production?
Sterile production refers to the manufacturing and packaging of pharmaceutical products in a controlled and sterile environment to ensure their safety and efficacy.
2. What are the different types of sterilization methods used in sterile production? Some common sterilization methods used in sterile production include steam sterilization (autoclaving), dry heat sterilization, ethylene oxide sterilization, gamma irradiation, and filtration.
3. What are the key regulatory requirements for sterile production? The key regulatory requirements for sterile production include compliance with Good Manufacturing Practices (GMP), adherence to guidelines from regulatory bodies such as the FDA and EMA, validation
of sterilization processes, proper documentation and record-keeping, and regular inspections.
4. What are the different cleanroom classifications used in sterile production? Cleanrooms are classified based on the number of particles allowed per cubic meter of air. Common cleanroom classifications include ISO Class 5 (Class 100), ISO Class 7 (Class 10,000), and ISO Class 8 (Class 100,000).
5. What is the purpose of a laminar flow hood in sterile production?
A laminar flow hood is used to provide a sterile working environment by directing filtered air in a unidirectional flow, preventing contaminants from entering the workspace. 6. What is the difference between aseptic and terminal sterilization?
Aseptic processing involves maintaining sterility throughout the manufacturing process, while
terminal sterilization refers to sterilizing the product after its final packaging.
7. How do you ensure the sterility of raw materials used in sterile production? Raw materials used in sterile production should be sourced from reputable suppliers with proper documentation and testing procedures to ensure their sterility. Incoming material testing and validation can also be performed.
8. What is the purpose of a media fill test in sterile production?
A media fill test is conducted to simulate the manufacturing process using a growth medium instead of the actual product. It helps evaluate the effectiveness of aseptic techniques and identify any potential contamination risks.
9. How do you prevent microbial contamination in sterile production? Microbial contamination can be prevented by maintaining strict aseptic techniques, using properly sterilized equipment, ensuring proper cleanroom conditions, implementing effective gowning procedures, and conducting regular environmental monitoring.
10. What is the purpose of environmental monitoring in sterile production? Environmental monitoring involves regularly sampling and testing the air, surfaces, and personnel in the cleanroom to detect any potential sources of microbial contamination and ensure compliance with sterility requirements.
