Cleanroom Qualification & Monitoring Checklist [FREE PDF]
This cleanroom qualification and monitoring checklist ensures cleanrooms meet ISO 14644-1 classification requirements and USP <797>/<800> sterility requirements for pharmaceutical compounding and semiconductor manufacturing. Facility managers and quality directors use this for annual requalification and ongoing environmental monitoring.
- Industry: Laboratory
- Frequency: Quarterly
- Estimated Time: 30-45 minutes
- Role: Facility Manager / Quality Director
- Total Items: 8
- Compliance: ISO 14644-1:2015 (cleanroom classification), ISO 14644-2 (monitoring to demonstrate compliance), USP <797> (pharmaceutical compounding - sterile), FDA 21 CFR Part 211.42 (aseptic processing)
Particle Count & Air Quality
Verify particle count meets ISO classification requirements.
- Airborne particle count within ISO classification limit at all sample points?
- Air changes per hour (ACPH) within specification?
- HEPA filters integrity tested (DOP/PAO test) within certification interval?
- Differential pressure between cleanroom and adjacent areas within spec?
Microbial Monitoring & Gowning
Verify microbial monitoring and gowning compliance.
- Environmental microbial monitoring (settle plates, contact plates, air sampling) current?
- Microbial levels within alert and action limits?
- Personnel gowning procedure followed and documented?
- Cleanroom qualification notes
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Why Use This Cleanroom Qualification & Monitoring Checklist [FREE PDF]?
This cleanroom qualification & monitoring checklist [free pdf] helps laboratory teams maintain compliance and operational excellence. Designed for facility manager / quality director professionals, this checklist covers 8 critical inspection points across 2 sections. Recommended frequency: quarterly.
Ensures compliance with ISO 14644-1:2015 (cleanroom classification), ISO 14644-2 (monitoring to demonstrate compliance), USP <797> (pharmaceutical compounding - sterile), FDA 21 CFR Part 211.42 (aseptic processing). Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Cleanroom Qualification & Monitoring Checklist [FREE PDF] cover?
This checklist covers 8 inspection items across 2 sections: Particle Count & Air Quality, Microbial Monitoring & Gowning. It is designed for laboratory operations and compliance.
How often should this checklist be completed?
This checklist should be completed quarterly. Each completion takes approximately 30-45 minutes.
Who should use this Cleanroom Qualification & Monitoring Checklist [FREE PDF]?
This checklist is designed for Facility Manager / Quality Director professionals in the laboratory industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.