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Batch Processing [BP]
Once they have been process validated by us, irradiate your products for market release. |
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Dose Mapping Study [DMS]
To validate the irradiation process for a specific product in a specific loading pattern, multiple replications of a dosing experiment are carried out to establish a relationship between internal dosimetry and routine monitoring dosimetry. |
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Sterilization Dose Audit [SDA]
Periodic audits of the verification dose must be completed to substantiate a sterilization dose for batch processing. |
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Dose Distribution Study [DDS]
In simple terms, this is a less rigorous Dose Mapping Study. A product sample [or similar] is loaded with dosimeters in order to find high and low dose zones. |
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Research and Development Study [RADS]
Nutek Bravo's structured studies are limited in scope and sometimes clients require additional liberties to solve problems; the Research and Development Study is our answer. Define your requested project's scope, due date, and price with this study type. |
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Maximum Acceptable Dose Study [MADS]
Over-exposure to E-beam radiation may have deleterious effects on products/packaging; therefore, it is important to know where the maximum acceptable dose limit is. Nutek Bravo can incorporate the resulting data from this study into any product-family profile [PFP] in our database. If this value is entered prior to dose mapping, then said upper limit can be accounted for and subsequently headed. |
For Sterilization Validation, email [email protected] or call 510-900-9670.
Fully Managed or Irradiation-only. |
Validation protocol and report. |
Coordinate and manage bioburden recovery and testing. |
Qualification studies per VDmax method. |
Product Irradiation. |