BS EN ISO 13408-1:2015 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.

This part of ISO 13408 includes requirements and guidance relative to the overall topic of a septic 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.

NOTE This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regional jurisdictions.


Cross References:
ISO 11135-1
ISO 11137-1
ISO 11137-2
ISO 13408-2
ISO 13408-3
ISO 13408-4
ISO 13408-5
ISO 13408-6
ISO 13485
ISO 14160
ISO 14644-1:1999
ISO 14644-2
ISO 14644-3
ISO 14644-4
ISO 14644-5
ISO 14644-7
ISO 14698-1
ISO 14698-2
ISO 14937
ISO 14971
ISO 17665-1
ISO 20857
ISO 9000:2005
ISO 9001
ISO 9004
ISO 11137-3
ISO/TS 11139
ISO/TR 14969
ISO 15223
ANSI/AAMI ST67:2003
IEC 60812
EN 556-2
EN 1822-1
90/385/EEC
93/42/EEC
98/79/EC


All current amendments available at time of purchase are included with the purchase of this document.