WHAT IS CLEAN?

How clean is your manufacturing equipment? Are there residuals of any therapeutically active drug substances or detergents, and can you ensure that there is no carryover of drug to the next batch of product?  FDA wants to know.

What is the definition of clean, are current cleaning procedures adequate and can they be validated?  Let us design a cleaning validation program for you that will answer these questions. Our cleaning validation service includes design and writing of the cleaning validation protocol, swabbing of surfaces and collection of rinsates, arranging for analytical testing (and validation if necessary), evaluation of data and production of the final cleaning validation report.