Prevent Contamination and Protect Your Organization with Cleaning Validation Services from Transcat

Cleaning validation is a critical step in preventing cross-contamination – and verifying the efficacy of your cross-contamination strategy. Relying on Transcat to conduct an initial qualification of your manufacturing process and equipment is an ideal starting point.

In pharmaceutical and biomedical applications, cross-contamination between products can compromise patient safety, halt production, cause batch failures, and result in FDA rejection – which can lead to costly fines.  

Components used in the pharmaceutical process, chemical deposits, and microbes are particularly susceptible to cross-contamination, making regularly scheduled cleaning validation essential. 

Our CQV Cleaning Validation Services team will manage your cleaning validation and effectively equip you to prevent contamination by:  

• Clearly defining products 
• API Solubility Matrix / Equipment Train  
• Establishing acceptable limits  
• Providing testing support  
• Performing post-implementation reporting  

Our team will ensure that standard operating procedures (SOPs) are developed for the cleaning processes of utilized equipment; written procedures are created to specify the responsibilities for performing and approving the validation study, as well as the criteria for acceptance and the circumstances under which re-validation will be necessary; documented protocols are created for inspecting each piece of equipment; and reporting is prepared to determine validity of the cleaning process.  

Discover how Transcat can customize a solution for your unique cleaning validation needs.