Life Science Outsourcing has in-depth expertise selecting and executing medical device sterilization validation services in strict compliance with regulations and ISO standards.
Ensure your medical devices meet the highest regulatory standards with proven sterilization validation. Our expert team streamlines compliance, minimizes risk, and accelerates time-to-market. Discover how we support your validation needs.
The objective of validation is to determine that the sterilization process will consistently achieve sterility and that it won’t have an undesirable effect on the device or its packaging.
All medical device and pharmaceutical manufacturers in the United States are required to validate sterility assurance processes for products marketed as sterile. For reprocessed medical devices, the manufacturer is to validate instructions that render the product fit for use.
Validation elements
Common elements in the validation of any sterilization process include:
Validation protocols
The FDA definition for Validation Protocol:
“A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.”
It is important that the manufacturer prepare a written validation protocol which specifies the procedures and tests to be conducted and the data to be collected. The purpose of the collected data must be clear, it must reflect facts, and it must be accurate. The protocol should specify a sufficient number of replicated process runs to demonstrate consistency in results and measure any process variations between runs. Validation documentation should include evidence of the suitability of materials and the performance and reliability of equipment and systems.
A Validation Protocol typically consists of:
Validation processes for sterilization methods
According to the FDA Process, validation is a requirement of the Current Good Manufacturing Practices Regulations for Finished Pharmaceuticals, 21 CFR Parts 210 and 211, and of the Good Manufacturing Practice Regulations for Medical Devices, 21 CFR Part 820, and therefore, is applicable to the manufacture of pharmaceuticals and medical devices. Sterilization processes are validated to their respective standards (e.g., ISO 11135, ISO 11137, and ISO 17665).
LSO will guide you through the sterilization and validation of single use and reusable products and related documentation based on our extensive experience, knowledge, and industry-leading expertise.
Comprehensive packages for regulatory compliance.
From fractional to full cycles with EtO residual testing.
Secure with 2X qualification.
Tailored to your sterilization needs.
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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