The need to re-think the existing standards is becoming more urgent. Emerging technologies in aseptic processing such as advanced isolators, robotics, and increased automation have changed the industry. Modern therapies are proving more difficult to sterilize and handle and require faster speeds to market.
1. Medical & Pharma
The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based WFI systems. This Guide reflects an industry wide collaborative effort by a diverse range of industry experts.