Irradiation Services
Radiation Tolerance Study (1-015-84)
NUTEK sets up and delivers up to five specified doses to the specified sets of samples of your packaged devices to determine the effect of irradiation on the materials and packaging at various dose levels. The resultant samples are analyzed by the client or test laboratories to determine the physical effects of radiation. This test is frequently paired with a Depth-Dose Penetration study to determine if there are adverse physical effects at the highest dose expected in routine irradiation. It may also be used to determine the effect of re-sterilization on a returned device, or to establish the upper limit for dose in a radiation-sensitive device.
Precise Dose Delivery - Internal (1-015-83)
NUTEK will target a specific area of your device within a box at a narrow dose range. This experiment will enable you to examine the effects of a precise dose delivered to a particular part of your device.
Dose Distribution Study (1-010-18)
NUTEK uses multiple dosimeters to monitor high and low density areas of a specific product/package configuration to detect the high and low doses that will be experienced by a product undergoing routine irradiation. This information allows NUTEK to set a specific surface dose specification that will be adequate to deliver a minimum dose throughout the product/package. When combined with the Materials Compatibility Study (1-015-83), a basic "R & D Verification" report will be created for the client with discussion and interpretation of the results and suggested process control limits for routine processing.
Product Dose Mapping Per ISO 11137 (1-010-20)
This testing provides a three dimensional map of the dose received throughout the product/package during irradiation. Not less than 12 dosimeters are located in areas where the lowest and highest doses are likely to occur. Additional surface dosimeters are attached to provide the reference for production runs. Three test runs are made to determine the reproducibility and uniformity of the dose delivery. Part of the process is to work with the customer to determine the optimum packaging to minimize variability and processing costs. A report includes raw data with the internal dose levels referenced to the external target data. The report also recommends a target surface dose and process limits. NUTEK documentation is created to assure that the intended dose is delivered in routine production. Product dose mapping is requirement for irradiation validation in ISO 11137.
Verification Dose Audit Per ISO 11137 (1-010-22)
Good quality practices (and ISO 11137) dictate that the response of a medical device's existing bioburden be checked during both initial process validation and periodically thereafter. Samples are irradiated at a dose that is a fraction of the production dose and the samples are then checked for sterility. A successful verification dose experiment therefore assures a safety factor in routine sterilization. NUTEK will deliver a dose within 10% of the target or within 0.5 kGy, whichever is larger, to comply with the current regulatory requirements.
More Information
NUTEK Corporation
1001 Whipple Road
Hayward, California 94544
510.429.2900 FAX 510.441.9209
