Steam sterilization is a common method used in medical device manufacturing to ensure products are completely free from harmful microorganisms. It's like a highly controlled dishwasher that uses very hot steam under pressure to clean medical devices. Companies use this process because it's reliable, cost-effective, and meets strict healthcare safety standards. You might also see it called "autoclave sterilization" or "moist heat sterilization." This is one of the most important skills for workers in medical device production because it directly impacts patient safety.
Managed Steam Sterilization processes for Class III medical devices
Validated Autoclave Sterilization cycles for surgical instruments
Led team responsible for Moist Heat Sterilization operations in clean room environment
Typical job title: "Sterilization Technicians"
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Q: How would you handle a failed sterilization cycle in production?
Expected Answer: A senior candidate should describe a systematic approach: investigating root cause, documenting the incident, quarantining affected products, implementing corrective actions, and updating procedures to prevent recurrence. They should mention regulatory reporting requirements if applicable.
Q: What experience do you have with sterilization validation?
Expected Answer: Should explain how they ensure sterilization processes are consistent and effective, including establishing parameters, conducting testing, and maintaining documentation for regulatory compliance.
Q: What parameters do you monitor during a steam sterilization cycle?
Expected Answer: Should mention temperature, pressure, time, and steam quality as key factors. Should understand normal ranges and why each is important.
Q: How do you ensure proper loading patterns in an autoclave?
Expected Answer: Should explain the importance of proper spacing, not overloading, allowing steam circulation, and following validated loading patterns.
Q: What safety precautions do you take when operating an autoclave?
Expected Answer: Should mention personal protective equipment, checking door seals, waiting for pressure to decrease before opening, and following standard operating procedures.
Q: How do you verify a successful sterilization cycle?
Expected Answer: Should describe basic indicators like chemical and biological indicators, checking cycle printouts, and proper documentation procedures.