Complete Autoclave Requalification Package
Standard Operating Procedure (SOP)
Purpose: Define procedures for initial and periodic qualification of autoclaves.
Scope: Applies to all steam autoclaves used for sterilization.
Responsibilities:
- QA/Validation: Develop protocol and approve qualification.
- Maintenance: Perform calibration and inspections.
- Operators: Support PQ runs and documentation.
- Safety Officer: Ensure safety compliance.
Definitions:
IQ – Installation Qualification
OQ – Operational Qualification
PQ – Performance Qualification
BI – Biological Indicator
CI – Chemical Indicator
Procedure:
1. Perform IQ → OQ → PQ.
2. Requalify annually or after major repair/relocation.
3. Document all results and deviations.
Installation Qualification (IQ)
Documentation Verification:
- Manuals and wiring diagrams available.
- Serial numbers match purchase docs.
Physical Inspection:
- Chamber, piping, valves, gaskets, electrical panels.
Utilities Verification:
- Steam, water, and electrical supply adequate.
Calibration:
- Temperature/pressure devices calibrated.
Acceptance Criteria:
All installation components meet specification.
Operational Qualification (OQ)
Heat Distribution Test:
- ≥12 thermocouples, 3 consecutive runs.
- Uniformity ±1°C.
Control System Verification:
- Alarms, interlocks, emergency stops.
Leak Test:
- Vacuum leak rate meets spec.
Bowie-Dick Test (if applicable):
- Must show uniform color.
Acceptance Criteria:
Reproducible cycles and stable performance.
Performance Qualification (PQ)
Load Types:
- Wrapped instruments, porous loads, liquids, waste.
Heat Penetration:
- Thermocouples placed in worst-case positions.
- ≥3 successful cycles.
BI Testing:
- Geobacillus stearothermophilus (10⁶ spores).
- No growth.
CI Testing:
- Class 5 or 6 indicators must pass.
Acceptance Criteria:
All BI/CI pass; proper drying; no deviations.
Requalification Requirements
Required:
- Annually.
- After relocation.
- After major repairs or software updates.
Repeats:
- Partial OQ
- Full PQ
Inspection Forms
Daily:
- Chamber clean, gasket intact, cycle success.
Weekly:
- Inspect steam trap, clean chamber.
Monthly:
- Safety valve, door alignment, electrical connections.
Calibration Requirements
Temperature probes: Annually (±1°C)
Pressure transducers: Annually (±1% FS)
Recorders: Annually
Timers: Annually
Qualification Report Template
Header:
- Model, serial number, location, dates.
Summary:
- Overview of IQ/OQ/PQ.
Deviations:
- Root cause, corrective action.
Attachments:
- Calibration certs, mapping data, BI/CI results.
Conclusion:
PASS / FAIL