Autoclaves in life sciences facilities should typically be validated or qualified annually, as recommended by industry standards like ISPE and OEM manuals.
However, the frequency may vary based on usage, risk level, and regulatory requirements (e.g., GMP, FDA). For high-use autoclaves in pharmaceutical or biotech settings, more frequent validation—such as semi-annually—may be necessary.
We help clients assess their specific needs by reviewing historical data, process criticality, and manufacturer guidelines to establish the right service interval for your equipment.
Our services support a range of life sciences industries, including pharmaceutical, biotech, medical device, hospitals, and pharmacies. For example, pharmaceutical companies rely on GMP-compliant autoclave validation for drug manufacturing, while hospitals use our services to ensure sterilization for patient safety. Biotech firms benefit from validation to maintain research integrity, and medical device manufacturers need FDA-compliant sterilization for product safety.
At Quantus, the on-site qualification phase—covering Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)—typically takes 3–5 days, depending on the number of autoclaves and facility complexity. This includes setup, empty chamber testing, and initial loaded chamber runs to verify performance.
The broader validation process encompasses more extensive testing, such as multiple cycle runs, various load patterns, cycle development, and supporting utilities like clean steam qualification. Depending on the rigor of testing and any issues like failed runs, validation can take 2–4 weeks. For example, clean steam testing, as per ISPE guidelines and EN 285 standards, may require additional time for sampling and analysis to ensure steam quality. Once testing is complete, biological indicators are analyzed in our microbiology lab in Blue Bell, Pennsylvania, where we address any deviations with customer approval.
After all testing, data QA review, and final signatures are completed, Quantus delivers the final report—a comprehensive binder with the completed protocol and all related data—within 2 weeks, ensuring your facility meets GMP and FDA compliance with minimal downtime.
Our services are designed to meet stringent life sciences regulations, including GMP (Good Manufacturing Practices), FDA (Food and Drug Administration), and USDA APHIS (Animal and Plant Health Inspection Service). We also align with industry standards like ISPE (International Society for Pharmaceutical Engineering) and ASTM (American Society for Testing and Materials), ensuring your autoclaves are fully compliant and audit-ready.
Yes, Quantus offers nationwide autoclave validation and qualification services across the United States, including the mid-Atlantic region. Whether you have a single lab or multiple facilities, our experienced engineers can coordinate and execute validation at all your locations, ensuring consistency and compliance across your operations.
If an autoclave fails validation, our team provides a detailed report identifying the issues, such as temperature inconsistencies or equipment malfunctions. We’ll work with you to recommend corrective actions, which may include recalibration, maintenance, or adjustments to operating procedures. Once resolved, we can retest the autoclave to confirm compliance. Our goal is to get your equipment back to GMP and FDA standards as quickly as possible.
Getting started is easy. Contact Quantus to discuss your facility’s needs, or request a free quote online. We’ll schedule a consultation to assess your autoclaves, review your regulatory requirements, and provide a tailored validation plan. With reports delivered in as little as 2 weeks, you’ll be on your way to compliance in no time.
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