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    I.S. EN 13824:2005

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  05-07-2011

    Language(s):  English

    Published date:  01-01-2005

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality management systems
    5 Personnel
       5.1 Personnel management
       5.2 Training for APA qualification
       5.3 General employee health
       5.4 Monitoring of personnel
       5.5 Gowning
            5.5.1 Gowning training
            5.5.2 Gowning requirements
            5.5.3 Control of gowned personnel
    6 Premises
    7 Process-related media
       7.1 Water
            7.1.1 Potable water
            7.1.2 Treated potable water
            7.1.3 Purified water
            7.1.4 Water for Injections (WFI)
       7.2 Other media
            7.2.1 Vacuum systems
            7.2.2 Gases
            7.2.3 Clean steam
    8 Qualification of equipment and utilities, and process
       validation
       8.1 General
       8.2 Requalification and revalidation
    9 Processes
       9.1 Cleaning and disinfection of the APA
            9.1.1 Disinfectants and cleaning agents
            9.1.2 Validation of disinfection procedures
            9.1.3 Monitoring of cleaning and disinfection
                  effectiveness
       9.2 Bioburden
       9.3 Endotoxins
       9.4 Sterilization, assembly and use of filling equipment and
            utensils
       9.5 Clean in place (CIP)
       9.6 Steam in Place (SIP)
       9.7 Feeding sterilized container components and product to the
            filling line
       9.8 Sterile filtration
            9.8.1 Pore size rating
            9.8.2 Liquid filtration
            9.8.3 Gas filtration
       9.9 Aseptically-produced suspensions
       9.10 Filling process: interventions, rejects
       9.11 Freeze drying
       9.12 Sealing and final packaging
    10 Environmental monitoring and controls
       10.1 Particulate monitoring programme
       10.2 Microbiological monitoring programme
            10.2.1 General
            10.2.2 Alert and action levels
            10.2.3 Review of data
       10.3 Environmental monitoring trend analysis
       10.4 Investigations and reports
            10.4.1 Investigation action plans
            10.4.2 Investigation testing
            10.4.3 Investigation report
    11 Media fills (process simulation tests)
    12 Finished product sterility testing
       12.1 General
       12.2 Investigation of sterility test positives
       12.3 Sampling plans
    13 Product release
    Annex A (normative) Conventional cleanrooms
       A.1 Facility design features
       A.2 Facility design review
       A.3 Material flow
       A.4 Aseptic processing area (APA)
       A.5 Critical processing zones
       A.6 Other processing zones within the APA
       A.7 Support areas outside the APA
       A.8 Environmental air systems and controls
            A.8.1 Temperature and humidity
            A.8.2 Air
            A.8.3 HEPA filter integrity
            A.8.4 Air handling
       A.9 Facility design
       A.10 Preparation areas
    Annex B (normative) Isolator technology
       B.1 Types of isolator
            B.1.1 General
            B.1.2 Transfer devices used with isolators
       B.2 Transfer devices
            B.2.1 General
            B.2.2 Classification system for transfer devices
       B.3 Surrounding area
            B.3.1 General
            B.3.2 Siting of Isolators
       B.4 Gloves, gauntlets, half suits and full suits
            B.4.1 General
            B.4.2 Use of gloves/gauntlets
            B.4.3 Changing gloves/gauntlets
            B.4.4 Use of half suits, full suits
       B.5 Pressure differentials
       B.6 Cleaning of isolators
       B.7 Filtration of air in isolators
       B.8 Pressure differential
       B.9 Air change rate
       B.10 Biodecontamination of isolator internal surfaces by
            microbicidal gas
            B.10.1 Gas contact
            B.10.2 Biodecontaminant residuals
            B.10.3 Isolator biodecontamination: Validation
       B.11 Qualification
       B.12 Monitoring
            B.12.1 Particulate monitoring
            B.12.2 Microbiological monitoring
            B.12.3 HEPA filters
       B.13 Alarms
       B.14 Maintenance and requalification
       B.15 Product release
    Annex C (informative) Aseptically-prepared suspensions
       C.1 General
       C.2 Media fill considerations
    Annex D (normative) Freeze-drying
       D.1 General
       D.2 Validation
       D.3 Gases used during the freeze-drying process
       D.4 Process routing
       D.5 Open containers and stoppers
       D.6 Transport to freeze-dryer
       D.7 Unloading and transport to sealing equipment
       D.8 Cleaning and disinfection of freeze dryer
       D.9 Biodecontamination of the freeze dryer
            D.9.1 Frequency
            D.9.2 Methods
       D.10 Vent filter system
       D.11 Environmental monitoring and controls
       D.12 Media fills for freeze-drying
       D.13 Maintenance
    Annex E (normative) Media fills (process simulation tests)
       E.1 Performance qualification
       E.2 Performance requalification
       E.3 Repeat of performance qualification
       E.4 Media fill
            procedures
       E.5 Media selection and growth support
       E.6 Incubation and inspection of media filled units
       E.7 Acceptance criteria
            E.7.1 General
            E.7.2 Acceptance criteria tables
       E.8 Contamination with media
       E.9 Data required for media fills
       E.10 Media fill runs for which action levels are exceeded
            E.10.1 Investigation
            E.10.2 Further actions
    Annex F (informative) Contamination rate calculations for a
                           given number of media filled units
    Annex ZA (informative) Clauses of this European Standard
                           addressing essential requirements
                           or other provisions of Council
                           Directive 90/385/EEC relating to
                           active implantable medical devices
    Annex ZB (informative) Clauses of this European Standard
                           addressing essential requirements or
                           other provisions of Council Directive
                           93/42/EEC relating to medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements for the design and operation of aseptic processing facilities and the validation and routine control of aseptic processes for the preparation of sterile liquid medical devices.

    Standards Referencing This Book - (Show below) - (Hide below)

    EN ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
    EN ISO 14698-1 : 2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
    EN 1174-3 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES
    ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
    EN 1822-2:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    EN 1174-2 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    EN ISO 14698-2:2003/AC:2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
    EN ISO 14644-5:2004 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    EN ISO 14644-2:2015 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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