Overview of the Revision of Guidelines for Validation and Application of Isolator Systems for Sterility Test in Chinese Pharmacopoeia 2020 Edition

OBJECTIVE To introduce the new requirements of the Chinese Pharmacopoeia 2020 Edition about validation and application specifications of isolator systems for sterility test. METHODS The new requirements in Chinese Pharmacopoeia 2020 Edition were discussed from the aspects risk management in life cycle, critical performance characteristics, equipment structure and installation requirements, added/revised qualification items and initial qualification system and precautions in application. RESULTS The revised quality standard established a more comprehensive specification based on risk management. CONCLUSION The Chinese Pharmacopoeia 2020 Edition can better promote the standardized application of aseptic isolator systems in pharmaceutical laboratories.