Autoclave Qualification
Cormica’s Autoclave Qualification Services
We understand that autoclave qualification is critical for maintaining compliance with regulatory standards and ensuring sterility in your processes. With decades of expertise in microbiology and sterility testing, we offer precise, comprehensive autoclave validation services designed to meet global regulatory requirements, including FDA, MDR, and ISO 17025 standards.

Why Autoclave Qualification Is Essential


Autoclaves are pivotal in achieving effective sterilization for medical devices, pharmaceuticals, and lab equipment. Without proper qualification, sterilization cycles may be compromised, leading to contamination risks and regulatory non-compliance.
Our autoclave qualification services ensure:
- Validation of sterilisation processes for efficacy and repeatability.
- Compliance with GMP, GLP, and ISO 17025 standards.
- Risk mitigation through rigorous testing and documentation.
Our Autoclave Qualification Process
We follow a structured approach to ensure your autoclave delivers consistent, reliable sterilization:
- Installation Qualification (IQ): Verifies proper installation and compliance with manufacturer specifications.
- Operational Qualification (OQ): Confirms performance under specified conditions with thermometric studies and biological indicators.
- Performance Qualification (PQ): Validates sterilization effectiveness during real-world use with load mapping and cycle monitoring.
This streamlined process ensures your autoclave meets all regulatory and operational requirements.
What Sets Us Apart?
Expertise Across Global Standards
Our laboratories are accredited to ISO 17025 and follow stringent compliance protocols set by FDA, EMA, and MHRA, ensuring your qualification meets all regulatory requirements.
Comprehensive Testing Facilities
We bring industry-leading testing capabilities across the UK, EU, and US, offering unparalleled service breadth.
Fast Turnaround and Detailed Reporting
We pride ourselves on delivering accurate results efficiently, accompanied by clear, actionable reporting to meet your audit and compliance needs.


Autoclave Qualification FAQ's
Autoclave qualification should be conducted during installation, after repairs, and periodically (annually or as required by regulators) to maintain compliance.
We handle a wide range of autoclaves, including steam sterilizers, vacuum autoclaves, and dry heat sterilizers.
We provide a comprehensive report detailing the qualification process, including test results, calibration data, and validation certificates to support regulatory compliance.