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EN 13824 : 2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
Superseded date

06-01-2011

Published date

01-12-2013

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 (see also Clause 10)
        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

Specifies 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.

Committee
TC 204
DevelopmentNote
Supersedes PREN 13824 (10/2005)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
NF EN 13824 : 2005 Identical
UNE-EN 13824:2005 Identical
BS EN 13824:2004 Identical
PN EN 13824 : 2006 Identical
NBN EN 13824 : 2005 Identical
UNI EN 13824 : 2005 Identical
NEN EN 13824 : 2004 Identical
SN EN 13824 : 2005 Identical
I.S. EN 13824:2005 Identical
NS EN 13824 : 1ED 2005 Identical
DIN EN 13824:2005-02 Identical

02/560165 DC : DRAFT JAN 2002 BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES

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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