Sterile device manufacturers utilize different sterilization methods when it comes to batching and labeling products as sterile. As regulatory guidelines and requirements for microbiology testing on finished products become more stringent, questions related to environmental monitoring expectations, required microbiological testing measures, and finished sterile product testing are on the rise.
To address these questions, industry experts Steve Langille and Melissa Stappen discuss the importance of maintaining a state of control with sound environmental monitoring programs and microbial contamination control within manufacturing facilities. Key topics covered include:
- FDA guidance for medical device manufacturers
- Sterilization process and label claims for terminal sterilization
- Environmental monitoring for terminal sterilization and aseptic processing
- Risk management and GMPs for combination products
- Incoming raw materials testing and finished product testing including sterility, bioburden, and endotoxin
Steve Langille, PhD
Senior Microbiology Consultant
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