Sterilization Validation Consulting
BioVision brings vast experience in sterilization validation and testing to help you define the most efficient, compliant path for this critical processing step.
The right sterilization strategy protects patients, satisfies regulators, and avoids costly delays in production.
Sterilization methods we support
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Ethylene Oxide (EO) - validated to ISO 11135
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Radiation (gamma / E-beam) - validated to ISO 11137
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Moist heat / steam - validated to ISO 17665
How BioVision helps
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Selecting the optimal sterilization method for your device and materials.
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Validation protocol design and execution oversight.
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Sterilization documentation for FDA and MDR submissions.
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Bioburden and sterility assurance level (SAL) strategy.
Frequently Asked Questions
How do I choose a sterilization method?
The choice depends on your device materials, geometry, packaging, and volume. BioVision evaluates these factors to recommend the most efficient compliant method.
Is sterilization validation required for regulatory approval?
Yes. For sterile devices, validated sterilization is a mandatory part of your technical documentation in both the U.S. and EU.