Maximum Acceptable Dose Study
Usually recommended as the first step in validating a new product for E-Beam sterilization, Max Dose testing helps determine the maximum exposure before product performance is impacted. Product samples are treated with increasing levels of radiation prior to performance testing by the customer.
Dose Mapping and Dose Distribution Studies
Dose mapping establishes the high and low exposure locations within a batch by placing dosimeters within the product. Multiple replicates are performed according to ISO 11137-3 or 11137-4. This PQ is used to support routine batch processing. Dose Distribution studies involve a single replicate of a Dose Map study. This can be helpful to investigate different packaging configurations or understanding product exposure before committing to a Dose Map.
Dose Audit
To comply with ISO 11137, manufacturers must routinely perform a Dose Audit by irradiating product samples with a sublethal dose for further bioburden testing. We can perform the Irradiation component, and if requested, arrange for the bioburden testing to be performed with our Lab partners.
Batch Processing
Once dose mapping is complete, and product is ready for clinical trials or routine production, batch processing is used. This process complies with ISO-13485 and, 21CFR 820 GMP requirements.
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.
Sterilization Validation
We can perform just the irradiation component of sterilization validation, or we can manage the entire process for you, from drafting the protocol to performing the bioburden testing and managing all the samples and reports.
Usually recommended as the first step in validating a new product for E-Beam sterilization, Max Dose testing helps determine the maximum exposure before product performance is impacted. Product samples are treated with increasing levels of radiation prior to performance testing by the customer.
Dose Mapping and Dose Distribution Studies
Dose mapping establishes the high and low exposure locations within a batch by placing dosimeters within the product. Multiple replicates are performed according to ISO 11137-3 or 11137-4. This PQ is used to support routine batch processing. Dose Distribution studies involve a single replicate of a Dose Map study. This can be helpful to investigate different packaging configurations or understanding product exposure before committing to a Dose Map.
Dose Audit
To comply with ISO 11137, manufacturers must routinely perform a Dose Audit by irradiating product samples with a sublethal dose for further bioburden testing. We can perform the Irradiation component, and if requested, arrange for the bioburden testing to be performed with our Lab partners.
Batch Processing
Once dose mapping is complete, and product is ready for clinical trials or routine production, batch processing is used. This process complies with ISO-13485 and, 21CFR 820 GMP requirements.
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.
Sterilization Validation
We can perform just the irradiation component of sterilization validation, or we can manage the entire process for you, from drafting the protocol to performing the bioburden testing and managing all the samples and reports.