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ISO
ISO 13408-3:2006

ISO 13408-3:2006

Aseptic processing of health care products — Part 3: Lyophilization

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General Information

Status : Active

Standard Type : Main

Document No : ISO 13408-3:2006

Document Year : 2006

Pages : 11

Edition : 1

Section Volume : Sterilization of health care products (ISO/TC 198.)

ICS : Sterilization and disinfection in general (11.080.01)

ISO 13408-3:2006 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.