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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 26-11-2013
Publisher: Association for the Advancement of Medical Instrumentation
Glossary of equivalent standardsCommittee representationBackground of ANSI/AAMI adoption of ISO 13408-6:2005 ForewordIntroduction 1 Scope2 Normative references3 Terms and definitions4 Quality system elements 4.1 General 4.2 Management responsibility 4.3 Design control 4.4 Measuring instruments and measuring systems 5 Design of isolator systems 5.1 General 5.2 Types of isolators 5.3 Materials of construction 5.4 Air-handling system 5.5 Operator interface 5.6 Ancillary equipment6 Facility requirements 6.1 Surrounding room classification 6.2 Process utilities7 User requirements 7.1 Product/process application 7.2 Ergonomics 7.3 Cleaning 7.4 Bio-decontamination 8 Validation 8.1 General 8.2 Design qualification 8.3 Installation qualification 8.4 Operational qualification 8.5 Performance qualification 8.6 Review and approval of validation 8.7 Requalification9 Routine monitoring and control 9.1 Procedures 9.2 System integrity 9.3 Bio-decontamination process monitoring 9.4 Environmental monitoring 9.5 Change control 9.6 Maintenance and calibration10 Personnel trainingBibliography
Describes 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.
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