 Minimun Dose Validation Maximum Dose Validation |
Dose Mapping Validation Maintenance |
Validation Maintenance
Validation Maintenance
As long as there are no changes made relative to the processing method, packaging method or configuration, or raw materials utilized for a product, only the minimum dose needs to be re-validated on a regular basis. Methodology for quarterly dose audits is discussed in detail in AAMI/ANSI/ISO 11137, with Method 1 dose auditing covered in section B.3.5.2. Briefly, the Method 1 audit involves delivery of 10 units of product to the testing lab for bioburden analysis and 100 units of product to the sterilizer for processing at the verification dose established during the initial validation process. The 100 units are then delivered to the testing lab for bioburden analysis. If two or fewer positives are obtained, the original sterilization dose is acceptable and no further action is required.
The maximum dose determined by original testing should not need re-evaluation unless product raw materials change.
Product does not need to be re-mapped unless there is a change in packaging method, packaging configuration, and/or raw materials used in normal production.