Life Science Outsourcing (LSO) provides medical device sterilization validation engineering and testing services in FDA-registered, ISO 13485-certified facilities. Services include validation of ethylene oxide (EO), radiation (gamma and eBeam), and steam sterilization processes in accordance with FDA regulations and ISO standards.
LSO provides end-to-end sterilization validation services, including:
These services support regulatory compliance, product release, and ongoing manufacturing.
Medical device sterilization validation is the documented demonstration that a sterilization process consistently achieves sterility assurance without adversely affecting the medical device or its packaging. Validation confirms that defined process parameters reliably produce acceptable results under routine manufacturing conditions.
Sterilization validation is required for:
FDA regulations, including 21 CFR Parts 210, 211, and 820, require manufacturers to validate sterilization processes as part of current Good Manufacturing Practices (cGMP).
Sterilization validation is performed using documented protocols and objective evidence generated through qualification studies.
Common Validation Steps
Common elements in the validation of any sterilization process include:
The FDA defines a validation protocol as a written plan describing how validation will be conducted, including test parameters, product characteristics, production equipment, and acceptance criteria.
A sterilization validation protocol typically includes:
Validation documentation provides evidence that a sterilization process consistently produces a product meeting predefined specifications and quality attributes.
Validation reports typically include:
Ethylene Oxide (EO) Sterilization Validation
Radiation Sterilization Validation (Gamma and eBeam)
Steam Sterilization Validation
LSO’s sterilization validation services support compliance with:
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