Inspections
quality
Cleanroom Daily Audit
ISO 14644-aligned daily cleanroom audit — particle counts, gowning, environmental monitoring, material flow.
Built for:
Pharmaceutical
Medical Device
Semiconductor
Biotech
What's inside this template
Environmental Conditions
- Temperature within spec (e.g. 68-72°F)
- Humidity within spec (e.g. 30-60%RH)
- Differential pressure positive vs adjacent areas
- HEPA filter pre-filter not loaded; manometer reading normal
Particle Monitoring
- Daily particle count taken at all monitoring locations
- Counts within ISO class limits
- Particle counter calibration current
Gowning Compliance
- All personnel wearing required gowning per zone
- No exposed skin or hair
- No cosmetics or jewelry visible
- Gowning room: bench, sticky mat, mirror, signage all in order
Material & Personnel Flow
- Pass-through used for material entry; no direct corridor entry
- Materials wiped down with IPA before entry
- Daily cleaning log signed and current
- No unauthorized materials (cardboard, wood, paper) in cleanroom
Common use cases
Daily cleanroom QA
GMP compliance
ISO 14644 verification
Frequently asked questions
Is this audit a GMP requirement?
For FDA-regulated GMP environments — yes, daily verification of environmental conditions is required by 21 CFR 211. ISO 14644 sets the technical limits for particle count by class.
What ISO class does this template target?
ISO 7/8 (formerly Class 10,000 / 100,000) — the most common pharma manufacturing classes. Tighter classes (ISO 5/6) need more frequent monitoring and tighter gowning requirements.
Related templates
Ready to use this template?
Get started with MangoApps and use Cleanroom Daily Audit with your team — pricing built for small business.
