Standard Swedish standard · SS-EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

Status: Valid

Scope
This part of ISO 13408 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

Subjects

Sterilization and disinfection in general (11.080.01) General (11.120.01)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-80777

Edition: 1

Approved: 7/12/2011

No of pages: 28

Replaces: SS-EN 13824:2005