Rapid Sterility Testing Validation Protocol

100

for use with Milliflex^® Rapid Systems.

Rapid Sterility Testing Validation Protocol is designed as a ready to use step by step guide to perform PQ activities of rapid sterility testing using Milliflex^® Rapid system. The PQ protocol will enable the QC/QA Labs to initiate the performance qualification after the IQ andOQ have been completed following the respective separate protocol. The guidelines are GMP compliant and follow EP, USP and JP regulatory guidelines.

Rapid Sterility Testing Validation Protocol is used to validate rapid sterility testing procedures with ease and consistent performance while following regulatory guidelines.

MILLIFLEX is a registered trademark of Merck KGaA, Darmstadt, Germany