Autoclaves are critical for sterilization of equipment, garments, media, components, and products in pharmaceutical and healthcare operations. PrimeGMP offers comprehensive Autoclave Qualification services to ensure your sterilization processes consistently achieve the required sterility assurance level (SAL) and comply with global regulatory guidelines.

Our Autoclave Qualification Scope

1. Design Qualification (DQ)

• Review of URS, P&ID, data sheets, and OEM documentation
• Verification of chamber design, loading capability, control systems
• Assessment of critical components (valves, sensors, steam piping)
• Compliance check with ISO 17665, WHO, EU Annex 1

2. Installation Qualification (IQ)

• Verification of equipment installation against approved design
• Calibration of pressure gauges, temperature sensors, and controllers
• Utility checks (clean steam, power supply, drain system)
• Verification of safety devices, alarms, interlocks
• Documentation review (manuals, certificates, FAT/SAT)

3. Operational Qualification (OQ)

• Empty chamber heat distribution studies
• Control system testing (alarms, cycles, fail-safes)
• Vacuum leak tests
• Bowie-Dick test for pre-vacuum autoclaves
• Steam penetration verification
• Cycle reproducibility checks

4. Performance Qualification (PQ)

• Loaded heat penetration studies using thermocouples
• Placement mapping as per worst-case locations
• Biological Indicators (BI) challenge tests
• Determination of Sterility Assurance Level (SAL ≤ 10⁻⁶)
• Qualification of sterilization loads (garments, glassware, media, components)
• Cycle optimization and validation summary

Documentation Provided

• URS, DQ, IQ, OQ & PQ Protocols
• Cycle Development Studies
• Heat Distribution & Heat Penetration Reports
• Biological Indicator Test Reports
• Calibration Certificates
• Alarm Challenge & Safety Testing Reports
• Final Qualification Summary Report
• SOPs for routine operation, loading patterns & maintenance

Standards & Guidelines Followed

• ISO 17665–1 & 2 (Steam Sterilization)
• WHO TRS 961 / TRS 1019
• EU GMP Annex 1 & Annex 15
• USFDA 21 CFR Parts 210/211
• ISPE Baseline Guide – Sterilization Principles
• EN 285 (for large steam sterilizers)

Why Choose PrimeGMP for Autoclave Qualification?

• Expertise in all types: pre-vacuum, gravity, HPHV, DHS, component sterilizers
• Calibrated, traceable instruments for accurate measurements
• Deep understanding of sterile manufacturing requirements
• Quick execution with audit-ready documentation
• Support for requalification and cycle revalidation
• Hands-on troubleshooting during qualification