Cleaning validation (also known as sterilization validation or GMP validation) provides documented evidence that a cleaning protocol used during the manufacturing process of biologics and therapeutics meets defined regulatory limits to prevent contamination.
Cleaning validation is globally required by all regulatory agencies and affects multiple manufacturing endpoints including:
BioReliance has extensive experience in developing and testing a cleaning validation protocol. BioReliance offers GMP validation covering standard cleaning procedures, training, and documentation with a full understanding of regulatory requirements.
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What products and manufacturing processes are tested during cleaning or sterilization validation?
GMP regulations state that manufacturers of finished pharmaceuticals must clean their facilities and equipment to ensure product safety. The facility should be disinfected regularly using validated sanitizers and sporicides. A contamination control plan should describe the methods for testing and provide a rationale for acceptance of materials to be used in the ongoing program of disinfection.
Laboratory tests are used to evaluate the sanitizers, including the identification of the most resistant microorganisms found in the facility as well as the most difficult to disinfect materials in the facility. Some of the testing in cleaning validation offered by BioReliance includes:
BioReliance is one of the world’s leading CROs, offering multiple cleaning validation assays aimed at enforcing a compliant GMP validation protocol.
Learn more about our cleaning validation services – consult with the BioReliance research team to ensure your validation studies are designed to best suit your project needs. Contact us by clicking here.
How is cleaning validation performed?
All accurate measures of bioburden in a facility are indirectly assayed. Microorganisms are transferred to an agar plate and colony-forming units are counted. These numbers are used to estimate trends over time, assuming the microorganisms can grow on the nutrient agar.
Small scale analysis is used to evaluate the efficacy of sanitizers, sporicides, and disinfectants. The efficacy of the sanitizers and sporicides used in the cleaning validation program must be demonstrated in a study designed to test their cleaning efficiency on the materials of construction and against resident microorganisms found in the facilities.
The protocol involves the following steps:
Coupons are utilized in these studies to represent surfaces within a manufacturing facility and inclusion of the application materials, such as swabs or wipes, also form part of the analysis. These studies allow for regulatory confirmation of disinfectant efficacy.
The validation of sterilization and disinfectants makes up a complete cleaning validation. BioReliance is one of the world’s leading CROs, and can provide individualized cleaning validation, specific for your manufacturing process.
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