Standard Swedish standard · SS-EN ISO 13408-1:2015

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

Status: Valid

Scope
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.

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.

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.

Subjects

Sterilization and disinfection in general (11.080.01) Disinfectants and antiseptics (11.080.20) General (11.120.01)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-8014812

Edition: 2

Approved: 7/6/2015

No of pages: 72

Replaces: SS-EN ISO 13408-1:2011 , SS-EN ISO 13408-1:2011/A1:2013