APIs & Excipients
Chemical synthesis and natural extraction of active pharmaceutical ingredients, as well as production of excipients, are subject to expanding regulatory scrutiny. Compliance with current Good Manufacturing Practices (cGMPs) is vital to maintain product integrity and satisfy regulations. Equipment cleaning, maintenance and storage are areas of regulatory focus. Production steps such as synthesis, extraction, isolation, purification, and granulation/milling are critical processes where the use of clean, uncontaminated equipment assuring product integrity is of the utmost importance.
STERIS Barrier Product Solutions has developed product solutions to protect equipment and personnel, eliminate the risk of cross-contamination, and ensure compliance with cGMPs.