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TR 2011/138 Westar RU Gamma Elastomeric Items Sterilization Process Validation Summary

Product classification, facilities, equipment, sterilization process validation, storage considerations, and UBD for Westar RU Gamma.
This document provides a summary of the validation studies that support gamma sterilized, Westar Ready-to-Use (RU) elastomeric closures currently offered by West. The scope of this summary encompasses multiple elastomeric formulations and various closure sizes and configurations.

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