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Cleaning Validation

PharmEng possesses a group of highly experienced professionals for cleaning validation procedures that are recognized and exceeds the expectations of FDA and Health Canada regulatory bodies. Our consultants will utilize their skills and knowledge to ensure all parameters including worst case scenarios are tested for and validated. We understand the importance of complying with regulatory guidelines for the cleaning of all critical equipment.

We can develop and execute cleaning protocols by challenging the current cleaning procedures in extreme case conditions to ensure the protocol will be effective during any given manufacturing situation. In addition, we will determine the most effective analytical methods and rationalize the appropriate limits for the acceptance criteria.

PharmEng has a proven track record of excellence by developing Cleaning Validation master plans, cleaning validation protocols, and swab recovery studies. We strive to personalize our services to cater to your company standards by working closely with your validation, engineering, quality assurance and regulatory affairs department.