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Key Takeaways:
- Indirect surfaces can transfer residues and must be assessed for contamination.
- Regulatory clarity exists for direct surfaces but is lacking for indirect ones.
- Walkthroughs and visual analysis help justify monitoring for indirect surfaces.
- 86% of 35 pharma manufacturers vary monitoring requirements by surface type.
- Monitoring should match surface criticality and proximity to the product stream.
With comprehensive regulatory guidelines around cleaning monitoring requirements for direct product contact surfaces - the industry has seen a gap for indirect product cleaning validation monitoring requirements. This article published in Cleanroom Technology; “Scientific justification for monitoring indirect product contact surfaces” is based on survey findings of pharmaceutical manufacturers.
Read more to learn more about monitoring requirements and approaches for direct and indirect product contact surface, special conditions and case studies.
