Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN ISO 13408-1:2015
• Năm ban hành / Publication date: 2015
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
• Phạm vi áp dụng / Scope of standard: This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. 1.2 This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.