Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2005)
Abstract
ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
DIN EN ISO 13408-6:2013-07 (E)
Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-
6:2005 + Amd 1:2013) (includes Amendment A1:2013)
Contents Page
Introduction …………………………………………………………………………………………………………………………………… 5
1 Scope …………………………………………………………………………………………………………………………….. 6
2 Normative references …………………………………………………………………………………………………….. 6
3 Terms and definitions …………………………………………………………………………………………………….. 6
4 Quality system elements ………………………………………………………………………………………………… 7
4.1 General ………………………………………………………………………………………………………………………….. 7
4.2 Management responsibility …………………………………………………………………………………………….. 7
4.3 Design control ……………………………………………………………………………………………………………….. 8
4.4 Measuring instruments and measuring systems …………………………………………………………….. 8
5 Design of isolator systems …………………………………………………………………………………………….. 8
5.1 General ………………………………………………………………………………………………………………………….. 8
5.2 Types of isolators …………………………………………………………………………………………………………… 8
5.3 Materials of construction ……………………………………………………………………………………………….. 8
5.4 Air-handling system ……………………………………………………………………………………………………….. 9
5.5 Operator interface ………………………………………………………………………………………………………… 10
5.6 Ancillary equipment ……………………………………………………………………………………………………… 10
6 Facility requirements ……………………………………………………………………………………………………. 11
6.1 Surrounding room classification …………………………………………………………………………………… 11
6.2 Process utilities ……………………………………………………………………………………………………………. 11
7 User requirements ………………………………………………………………………………………………………… 11
7.1 Product/process application …………………………………………………………………………………………. 11
7.2 Ergonomics ………………………………………………………………………………………………………………….. 11
7.3 Cleaning ………………………………………………………………………………………………………………………. 12
7.4 Bio-decontamination …………………………………………………………………………………………………….. 12
8 Validation …………………………………………………………………………………………………………………….. 15
8.1 General ………………………………………………………………………………………………………………………… 15
8.2 Design qualification ……………………………………………………………………………………………………… 15
8.3 Installation qualification ……………………………………………………………………………………………….. 15
8.4 Operational qualification ………………………………………………………………………………………………. 16
8.5 Performance qualification …………………………………………………………………………………………….. 17
8.6 Review and approval of validation ………………………………………………………………………………… 18
8.7 Requalification ……………………………………………………………………………………………………………… 19
9 Routine monitoring and control ……………………………………………………………………………………. 19
9.1 Procedures …………………………………………………………………………………………………………………… 19
9.2 System integrity …………………………………………………………………………………………………………… 19
9.3 Bio-decontamination process monitoring ……………………………………………………………………… 19
9.4 Environmental monitoring ……………………………………………………………………………………………. 19
9.5 Change control …………………………………………………………………………………………………………….. 20
9.6 Maintenance and calibration …………………………………………………………………………………………. 20
10 Personnel training ………………………………………………………………………………………………………… 20
Bibliography ……………………………………………………………………………………………………………………………….. 21
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices ………… 22
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices ……………………………………….. 23
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices …………….. 24