Aphex undertook an extensive body of work for a pharmaceutical client including the development of a cleaning validation strategy for the client’s new manufacturing process. A validation plan which ensured compliance with regulatory guidelines was implemented; this plan included the latest updates to Annex 15. As this site was a multi-product facility a matrix rational document detailing worst case product was created. The equipment design was analysed to ensure dead legs were minimised & eliminated, Riboflavin coverage testing was completed and flush times, flow rates, drain times were determined as part of cycle development. Acceptance criteria was also developed to factor in product carry over and toxicology data.
Aphex provided assistance with analytical method development and subsequent method qualification & validation in accordance with USP guidelines. Monitoring locations were minimised by taking a risk based approach, which was possible because a robust cycle development strategy was followed, while engineering runs and subsequent cleaning validation runs were executed in a timely and compliant fashion to meet the client’s requirements.
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