Need: Pharmaceutical and Biopharmaceutical facilities currently lose productivity and waste resources because equipment has not been optimized for easy, rapid and robust CIP cleaning. The result is long and stressful cleaning validations which hinder future optimizations - often with the easy excuse of regulatory pressure. Use: By pharmaceutical & biopharmaceutical manufacturers as a guide to specify cleanability and OPEX requirements on URS documentation for new equipment and facilities. By equipment manufacturers and regulators as a guide to good practice. Users: Pharmaceutical & biopharmaceutical manufacturers. Project Engineering companies. Equipment manufacturers. Regulatory bodies.
The title and scope are in draft form and are under development within this ASTM Committee.