Residue Removal in Cleanrooms: A Regulatory Overview
With various sources of residue generation within your cleanroom, an effective cleaning and disinfection program is crucial to prevent microbial and other cross-contamination.
2020-01-27
Key Takeaways:
- Residue removal is vital for contamination control and required by global GMP regulations.
- Residues come from products, human shedding, equipment and cleaning agents.
- EU GMP Annex 1 and FDA aseptic guidance stress cleaning to prevent cross-contamination.
- Cleanroom surfaces must be smooth and impervious to facilitate residue removal and disinfection.
- Cleaning programs must be validated to remove both microbial and chemical residues.
