ISO 13408-1:2008 PDF
Aseptic processing of health care products — Part 1: General requirements
Title (English):
ISO 13408-1:2008
Aseptic processing of health care products — Part 1: General requirements
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 45
- Publication date:
- June 10, 2008
- Edition:
- ISO IS 13408 edition 2 version 1
- ICS:
- 11.080.01
Description (English):
ISO 13408-1:2008 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. ISO 13408-1:2008 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.
Technical details
- Technical committee
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO 13408-1:2008
