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AAMI/ISO 13408-3:2012 (R2015)
Aseptic processing of health care products - Part 3: LyophilizationMore info
Specifies requirements for and offers guidance on equipment, processes, programs 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.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2015-07-13 |
| ICS | 11.080.01 : Sterilization and disinfection in general |
| Replace | ANSI/AAMI/ISO 13408-3 (2006) |
| Year | 2012 |
| Document history | ANSI/AAMI/ISO 13408-3 (2012) |
| Country | USA |
| Keyword | ANSI 13408;ANSI/AAMI/ISO 13408;13408;ANSI/AAMI/ISO 13408-3-2012 (R2015) |