Pharmaceutical products could be contaminated due to several factors such as cleaning agents, microorganisms, dust and particulates, product residue, etc. The objective of cleaning validation is to provide documented evidence that a specific cleaning process will consistently clean to predetermined limits to prevent contamination that could adversely affect the safety, efficacy, purity and quality of the products. Therefore, implementation and validation of cleaning procedures are essential.

PSC can help you with all aspects for your cleaning validation program, from cleaning procedure feasibility to determining detection limits of analytical methods used for testing. We have extensive experience in developing scientifically defendable acceptance criteria and ensuring the execution is conducted in an orderly manner. We can deliver a complete cleaning validation package from development and execution of protocols to creation of standard cleaning procedures, cleaning logs and training documentation. We select and evaluate effective cleaning methods and processes with complete understanding of regulatory requirements, guidelines and expectations.

If you have a need for Cleaning Validation, please Contact Us.