FDA-Compliant Sterilization Validation
Our sterilization validation services cover autoclaves and SIP systems, ensuring processes meet FDA sterilization requirements and GMP sterilization compliance. We design sterilization cycles tailored to your systems and confirm their effectiveness through rigorous testing.
Cycle Development
We develop customized sterilization cycles for autoclaves and SIP systems that meet FDA sterilization requirements and GMP compliance standards. Each cycle is carefully designed to accommodate varying load configurations, ensuring maximum microbial kill rates and reliable sterilization outcomes.
Physical and Biological Testing for Lethality Verification
Our team conducts rigorous physical testing alongside biological indicator (BI) studies to verify the lethality of the sterilization process. This combination provides comprehensive evidence of microbial inactivation, ensuring robust control and confidence in the validated process.
Comprehensive Process Validation
Through advanced validation techniques, we assess temperature distribution, exposure duration, and system performance under defined operating conditions. These studies demonstrate process consistency, confirm sterilization effectiveness, and support regulatory submissions with complete, audit-ready documentation.
1. Planning & Alignment
We define sterilization requirements, load types, and regulatory expectations, adapting to your SOPs or creating new FDA- and GMP-compliant protocols.
2. Commissioning
Autoclaves and SIP systems are checked for proper installation and baseline functionality.
3. Risk Assessment
Cycle parameters and load configurations are reviewed to identify worst-case conditions for validation.
4. Qualification (IQ/OQ/PQ)
Protocols are executed with thermal mapping, Fo calculations, and biological indicators to verify lethality.
Our Process
FAQS
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