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Key Takeaways:
- A risk-based approach links rinse analysis and visual checks to surface cleanliness.
- The FDA’s validation model ensures structured cleaning process design and verification.
- Controlled studies define residue limits using light intensity, angle and variability.
- TOC and conductivity testing confirm surface cleanliness and cleaning effectiveness.
- Continuous monitoring reduces testing while ensuring compliance and product safety.
Cleanrooms provide a contamination-free environment for biotechnology and pharmaceutical testing and manufacturing. However, maintaining a controlled environment is challenging.
The transfer of materials into a cleanroom is one of the primary sources of cleanroom contamination. Keeping the product clean during transfer has several challenges:
- Not everything going into the cleanroom is sterile
- Not everything can be steam sterilized for entry
- Sterilized materials may still need to be cleaned to reduce contamination on packaging
That’s why a material transfer process is key. Setting a cleaning protocol for surfaces, packaging, products, and trolleys during transfer helps control cleanroom contamination.
Just as important as cleanroom cleaning procedures is using the right cleanroom solutions.
Here are several products from STERIS Life Sciences that are proven to be effective solutions in a contamination control strategy for material transfer into cleanroom environments.
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Download 7 Cleanroom Solutions for Transferring Materials to Controlled Environments for more information about maintaining a controlled environment from STERIS Life Sciences.
