ข่าว บริษัท เกี่ยวกับ Modular Cleanroom Documentation: Organizing Compliance Records for Audits and Inspections

To ensure audit compliance, modular cleanroom documentation must include comprehensive records covering design, installation, operation, and maintenance. Critical documents include:

1. Design and Installation Documentation
   • Cleanroom classification certificates (ISO 14644-1)
   • As-built drawings showing HVAC layouts and pressure differentials
   • Material compatibility reports for walls, floors, and surfaces
   • HEPA/ULPA filter certification (IEST-RP-CC034.3)
   • Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) reports
2. Operational Records
   • Daily environmental monitoring logs (particle counts, temperature, humidity)
   • Pressure differential trend charts with alarm thresholds
   • Equipment calibration certificates (airflow meters, particle counters)
   • Gowning procedures and personnel training records
3. Maintenance and Change Control
   • Filter replacement logs with DOP/PAO test results
   • Cleaning and disinfection protocols with microbial monitoring data
   • Change control documentation for any system modifications
   • Preventive maintenance schedules with service reports
4. Regulatory Compliance Files
   • FDA 21 CFR Part 11 compliant electronic records (where applicable)
   • EU GMP Annex 1 (2022) compliance statements
   • Risk assessment documents for critical processes
   • Validation protocols (IQ/OQ/PQ) for automated systems