| NUTEK sets up and delivers a specified
dose to a sample of your packaged devices to determine the effect
of irradiation on the materials and packaging. 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. |
| Depth-Dose Penetration Study
(1-015-84) |
| 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. |
