Aseptic processing of health care products – Part 3: Lyophilization (ISO 13408-3:2006)
Abstract
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.
DIN EN ISO 13408-3:2011-09 (E)
Aseptic processing of health care products – Part 3: Lyophilization (ISO 13408-
3:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 Quality system elements …………………………………………………………………………………………………5
4.1 General …………………………………………………………………………………………………………………………..5
4.2 Management responsibility ……………………………………………………………………………………………..6
4.3 Design control ………………………………………………………………………………………………………………..6
4.4 Measuring instruments and/or measuring systems ………………………………………………………….6
5 Product definition ……………………………………………………………………………………………………………6
6 Process definitions …………………………………………………………………………………………………………6
7 User requirements …………………………………………………………………………………………………………..7
7.1 General …………………………………………………………………………………………………………………………..7
7.2 Equipment characterization ………………………………………………………………………………………………
7.3 Product handling …………………………………………………………………………………………………………….8
7.4 Microbiological and particulate environmental monitoring ……………………………………………….8
7.5 Cleaning and sterilization ………………………………………………………………………………………………..8
7.6 Vent filter system ……………………………………………………………………………………………………………9
7.7 Lyophilizer leak test ………………………………………………………………………………………………………..9
8 Validation ……………………………………………………………………………………………………………………….9
8.1 General …………………………………………………………………………………………………………………………..9
8.2 Design qualification ………………………………………………………………………………………………………10
8.3 Installation qualification ………………………………………………………………………………………………..10
8.4 Operational qualification ……………………………………………………………………………………………….10
8.5 Performance qualification ……………………………………………………………………………………………..12
8.6 Process validation …………………………………………………………………………………………………………12
8.7 Review and approval of validation …………………………………………………………………………………13
9 Routine monitoring and control …………………………………………………………………………………….13
9.1 General …………………………………………………………………………………………………………………………13
9.2 Operator training …………………………………………………………………………………………………………..13
9.3 Standard operating procedures ……………………………………………………………………………………..13
9.4 Requalification ………………………………………………………………………………………………………………14
9.5 Maintenance of equipment …………………………………………………………………………………………….14
9.6 Change control ……………………………………………………………………………………………………………..14
Bibliography …………………………………………………………………………………………………………………………………18
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices ………….15
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices ……………………………………….. 16
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices …………….. 17