aseptic manufacturing – Pharma GMP

Inspect Cleanroom Garments for Lint Generation to Prevent Contamination

digi — Sun, 06 Jul 2025 18:04:38 +0000

Inspect Cleanroom Garments for Lint Generation to Prevent Contamination Inspect Cleanroom Garments for Lint Shedding in GMP Areas Remember: Cleanroom garments must be regularly inspected for lint generation—particle shedding poses a major contamination risk in GMP environments. Why This Matters in GMP Garments worn in cleanrooms must provide a barrier against human contaminants such as...

Ensure All Filters Are Integrity-Tested Before Use in GMP Operations

digi — Thu, 19 Jun 2025 20:56:05 +0000

Ensure All Filters Are Integrity-Tested Before Use in GMP Operations Integrity-Test Filters Before Every GMP Use Remember: GMP demands that all filters be integrity-tested before use to confirm sterility assurance and prevent microbial contamination. Why This Matters in GMP Filters used in pharmaceutical processes—especially sterile filtration—must function as validated microbial barriers. Whether applied during solution...