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Validation Services

NUTEK offers three levels of irradiation process verification matched to specific client needs:

1. R&D Verification provides a scientifically sound way of confirming the irradiation dose is correctly matched to the product while minimizing the costs of the required studies.

2. Production Validation affords the Medical Device Client documented experimental data that is matched to their production and regulatory requirements and is designed to meet the demands of 3rd party validation documentation review.

3. Managed Validation services provide turnkey packages for operations that wish to outsource their sterilization validation work. It may include technical consultation services, protocol development, irradiation and testing management, and final reporting.

R&D Verification includes a relatively simple dose distribution study to set a dose specification that provides good assurance that a minimum dose is delivered throughout the product. A radiation tolerance series study provides doses delivered at up to five data points. From this study, you are able to test your products for material compatability to determine the maximum dose that will not degrade the product. We tailor the experiments to your specific needs and provide a written report of the findings with recommended process control limits for your product irradiation processing.

This level of verification service is provided for the client who is using the materials for Research and Development Studies and not for clinical trials. The typical user does not need full validation documentation for regulatory compliance and has a good idea the product is relatively clean microbiologically. It may be useful for returned goods processing verification to confirm that higher levels of contamination can be successfully treated and/or that additional irradiation does not degrade the functionality of the product. It is not intended for products destined for use in clinical trials, Class II or III Medical Devices, drug products or as support for ISO certification.

It includes Radiation Services 1-010-85 Radiation Tolerance Series and 1-010-18 Dose Distribution Study. A written report with interpretation of the results, plus the recommended dose process control limits for your product is provided.

Production Validation provides a package of irradiation services that, when combined with your validation protocols and microbiological testing work, will meet all regulatory requirements for ISO and FDA 3rd party requirements. The basic package assumes materials compatibility and preliminary R&D work is complete and adds Product Dose Mapping per ISO11137, Verification Dose Delivery per Method 1 or AAMI TIR27, and recommends irradiation process controls tailored to your product or family of products. The final report includes information on the packaging configuration, tote configuration, and product weight limits for which the irradiation process is qualified. It also includes a product-specific Process Request Record for ordering routine processing that lists any processing requirements and specific processing controls your require to handle product routinely.

This level of validation services is for clients who are qualifying their product for sale under the EN Medical Device Directive, FDA CDRH, or CDER regulatory requirements, and have in-house regulatory personnel familiar with both sterilization validation and current microbiological testing requirements of the reviewing parties. We will provide supporting information as directed by your protocol design as required.

This service includes Radiation Service 1-010-20 Product Dose Mapping per ISO 11137 and 1-010-22 Verification Dose Audit plus required routine processing specification documents, required reports, a contract agreement to fulfill the requirements of 21 CFR Part 801.150 (e), and review of your protocols and reports by our qualified regulatory personnel if you wish.

Managed Validation services provide all irradiation services routinely performed for production validation, generation of original validation protocols for your approval, handling and management of needed microbiological laboratory services, completion of the validation protocol, and a final comprehensive report appropriate for the level of regulatory review associated with your product.

This level of verification service is provided for the client that wishes to outsource their sterilization validation work and concentrate on their core business of product development and manufacture. We provide the supplier assessments for subcontracted laboratory services, maintain current standards information to support the validation work, and design economical and sound continuing audit programs to maintain the validation that are appropriate to your regulatory requirements.

With its tailored validation services, NUTEK is committed to supplying validation information with exceptional responsiveness to your needs. We want to provide a partnership with you that provides processing and superior business, technical and regulatory support.