Overview: The purpose of a cleanroom is to minimize risk of contamination to critical operations. Thus it is imperative to thoroughly investigate and remediate the situation when the cleanroom has been compromised. This is not only essential for compliance, but also to maintain an environment that is safe for the critical operations. A series of case studies are presented to demonstrate recommendations for evaluating the risk of environmental monitoring excursions, as well as show effective investigation strategies. The case studies use real life examples of excursions including vegetative organisms, fungal spores and bacterial spores. The importance of an effective investigation is strengthened by providing regulatory references, as well as example 483 observations and warning letters. Lastly, tips on how to recover from a worst case contamination event are presented.
Key Points:
- Contamination Risk Assessment
- Excursion Investigation Guidance
- Case Study: Vegetative Organisms
- Case Study: Fungal Spores
- Case Study: Bacterial Spores
- Recovery from a Worst Case Event