Over the course of the manufacturing process, products may become contaminated. This can be due to many different factors such as cleaning agents, microorganisms, dust, particulates, residue, etc. The objective of cleaning validation is to provide documented evidence that a specific process works as intended. Failure to consistently clean to predetermined limits will result in contamination that could adversely affect the safety, efficacy, purity and quality of the product, as well as the reputation of the company. Therefore, the implementation and validation of cleaning procedures are essential.
How can PSC Biotech help with cleaning validation?
We can help you with all aspects of your cleaning validation program, from procedure feasibility to determining detection limits of analytical methods used for testing. We have extensive experience in developing scientifically supportable acceptance criteria and ensuring that execution is conducted in an orderly manner. We can deliver a complete process validation package – from the development and execution of protocols to the creation of standard operating procedures, cleaning logs and training documentation. We select and evaluate effective cleaning methods and processes with complete understanding of both regulatory requirements, and industry guidelines and expectations.
If you would like more information, get in contact with us directly here.