Introduction
A Factory Acceptance Test (FAT) is a vital pre-shipment process to verify that an autoclave sterilizer meets technical specifications, performs reliably, and complies with standards before leaving the manufacturer’s facility. Essential for high-value, custom, or critical autoclaves in healthcare, pharmaceuticals, and laboratories, an FAT minimizes risks and ensures seamless installation. This guide explores the importance of an FAT, its components, and best practices, aligning with standards like EN 285, ISO 17665, and AAMI ST79.
What Is a Factory Acceptance Test (FAT)?
An FAT is a formal evaluation conducted at the manufacturer’s site to confirm that an autoclave:
- Meets contractual and technical specifications.
- Performs sterilization cycles (e.g., gravity, pre-vacuum, liquid) correctly.
- Operates safely with all components functioning as intended.
It includes visual inspections, functional and performance tests, and documentation review, often observed by the buyer or a third-party inspector.
Components of an FAT
- Documentation Review: Verifies drawings (e.g., P&ID, electrical), material certificates, and compliance with EN 285 or ISO 17665.
- Visual Inspection: Checks build quality, welds, finishes, and labeling.
- Functional Testing: Tests valves, pumps, sensors, control systems, alarms, and software (e.g., HMI, data logging).
- Performance Testing: Runs cycles to confirm temperature, pressure, and vacuum performance for various loads (e.g., solids, hollow items).
- Punch List: Documents deviations for correction before shipment.
Why Request a Factory Acceptance Test?
An FAT ensures autoclave reliability and compliance, offering key benefits:
1. Verifies Performance Before Delivery
Confirms the autoclave achieves sterilization parameters (e.g., 121–134°C, 15–30 psi) for specific cycles, ensuring efficacy for diverse loads (see Autoclave Validation).
2. Detects Issues Early
Identifies defects at the factory, where corrections are easier and less costly, reducing downtime during installation.
3. Ensures Compliance with Standards
Verifies adherence to EN 285 (large sterilizers), EN 13060 (small sterilizers), ISO 17665, and AAMI ST79, critical for regulated industries.
4. Validates Custom Configurations
Ensures tailored features (e.g., double doors, custom cycles for liquids or prions) meet user needs (see Qualification of Autoclave).
5. Streamlines On-Site Commissioning
Reduces issues during Site Acceptance Testing (SAT), Installation Qualification (IQ), and Operational Qualification (OQ), minimizing delays.
6. Provides Documentation for Audits
Generates test reports, calibration certificates, and validation data for regulatory compliance and GMP audits.
7. Facilitates Collaboration and Training
Allows buyers to engage with engineers and train staff on autoclave features, enhancing operational readiness.
8. Mitigates Financial and Operational Risks
Confirms performance before shipment, avoiding costly repairs or delays, especially for international orders.
When Is a Factory Acceptance Test Applicable?
An FAT is recommended or required for:
- Large or Complex Autoclaves: Hospital-grade or CSSD sterilizers with high complexity.
- Custom Configurations: Specialized features like pass-through designs or custom cycles.
- Regulated Industries: Pharmaceuticals, biotechnology, or biosafety labs requiring GMP compliance.
- High-Value Investments: Significant capital expenditures needing performance assurance.
- International Shipments: To address issues before long-distance transport.
- Critical Applications: Where failure impacts patient safety or production (e.g., surgical instruments, pharmaceutical products).
- New Suppliers or Technologies: To validate unproven vendors or innovative designs.
- Project Timelines: To maintain schedules for facility upgrades.
For standard tabletop autoclaves, FATs may be optional, as quality control tests often suffice (see # Autoclave and sterilizer qualification).
How Does a Factory Acceptance Test Work?
The FAT process includes:
- Protocol Development: Buyer and manufacturer agree on a detailed protocol, specifying tests and acceptance criteria.
- Testing Execution:
- Visual inspection of build quality and components.
- Functional tests of valves, sensors, and controls.
- Performance tests of sterilization cycles for various loads.
- Software verification for cycle programming and data logging.
- Witnessing: Buyer or inspector observes for transparency.
- Documentation: Records results, including charts, calibration data, and punch lists.
- Resolution: Manufacturer corrects non-conformities before shipment.
- Sign-Off: Buyer approves, confirming requirements are met.
Best Practices for Requesting an FAT
- Include in Contract: Specify FAT requirements, tests, and standards in the purchase agreement.
- Define Clear Criteria: Outline tests (e.g., vacuum leak, cycle performance) aligned with EN 285 or ISO 17665.
- Involve Key Personnel: Send qualified staff or inspectors to witness the FAT.
- Document Thoroughly: Ensure reports and certificates support audits and SAT/IQ/OQ.
- Plan for Corrections: Allow time for issue resolution.
- Train Staff: Use the FAT to familiarize operators with autoclave features (see Qualification of Autoclave).
FAQ: Factory Acceptance Test for Autoclave Sterilizers
Why is an FAT important for autoclaves?
It verifies performance, ensures compliance, and reduces installation risks.
When should an FAT be requested?
For large, custom, or critical autoclaves in regulated industries or high-value purchases.
What tests are part of an autoclave FAT?
Visual inspections, functional checks, cycle performance, and software verification.
How does an FAT differ from an SAT?
FAT occurs pre-shipment at the factory; SAT verifies performance post-installation at the site.
How does an FAT support compliance?
It provides documentation for regulatory audits, aligning with EN 285 and AAMI ST79.
Can an FAT reduce operational risks?
Yes, by detecting issues early, ensuring reliable sterilization for various loads.
Conclusion
A Factory Acceptance Test (FAT) is critical for ensuring autoclave performance, compliance, and reliability before delivery. By verifying specifications, detecting issues, and supporting validation for diverse load types, an FAT minimizes risks and ensures seamless commissioning. Aligned with EN 285, ISO 17665, and AAMI ST79, FATs are essential for safe, effective sterilization in regulated settings.