SFS-EN ISO 13408-1:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.
ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements

4.1 General
4.2 Assignment of responsibilities
4.3 Calibration

5 Aseptic process definition

5.1 General
5.2 Risk management

6 Manufacturing environment

6.1 General
6.2 Manufacturing environment design
6.3 Layout
6.4 Material and personnel flow
6.5 HVAC system
6.6 Cleanroom qualification
6.7 Utility services and ancillary equipment
6.8 Environmental and personnel monitoring programmes

7 Equipment

7.1 Qualification
7.2 Maintenance of equipment

8 Personnel

8.1 General
8.2 Training for APA qualification
8.3 Gowning procedures
8.4 General employee health

9 Manufacture of the product

9.1 Attainment and maintenance of sterility
9.2 Duration of the manufacturing process
9.3 Aseptic manufacturing procedures
9.4 Cleaning and disinfection of facilities
9.5 Cleaning, disinfection and sterilization of equipment

10 Process simulation

10.1 General
10.2 Media selection and growth support
10.3 Simulation procedures
10.4 Incubation and inspection of media filled units
10.5 Initial performance qualification
10.6 Periodic performance requalification
10.7 Repeat of initial performance qualification
10.8 Documentation of process simulations
10.9 Disposition of filled product

11 Test for sterility

11.1 General
11.2 Investigation of positive units from tests for sterility

Annex A Example of a flow chart (informative)
Annex B Typical elements of an aseptic process definition (informative)
Annex C Examples of specific risks (informative)
Annex D Comparison of classification of cleanrooms (informative)
Annex E Specification for water used in the process (informative)
Annex F Aseptic processing area (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements

4.1 General
4.2 Assignment of responsibilities
4.3 Calibration

5 Aseptic process definition

5.1 General
5.2 Risk management

6 Manufacturing environment

6.1 General
6.2 Manufacturing environment design
6.3 Layout
6.4 Material and personnel flow
6.5 HVAC system
6.6 Cleanroom qualification
6.7 Utility services and ancillary equipment
6.8 Environmental and personnel monitoring programmes

7 Equipment

7.1 Qualification
7.2 Maintenance of equipment

8 Personnel

8.1 General
8.2 Training for APA qualification
8.3 Gowning procedures
8.4 General employee health

9 Manufacture of the product

9.1 Attainment and maintenance of sterility
9.2 Duration of the manufacturing process
9.3 Aseptic manufacturing procedures
9.4 Cleaning and disinfection of facilities
9.5 Cleaning, disinfection and sterilization of equipment

10 Process simulation

10.1 General
10.2 Media selection and growth support
10.3 Simulation procedures
10.4 Incubation and inspection of media filled units
10.5 Initial performance qualification
10.6 Periodic performance requalification
10.7 Repeat of initial performance qualification
10.8 Documentation of process simulations
10.9 Disposition of filled product

11 Test for sterility

11.1 General
11.2 Investigation of positive units from tests for sterility

Annex A Example of a flow chart (informative)
Annex B Typical elements of an aseptic process definition (informative)
Annex C Examples of specific risks (informative)
Annex D Comparison of classification of cleanrooms (informative)
Annex E Specification for water used in the process (informative)
Annex F Aseptic processing area (informative)

Bibliography

Tuoteryhmä(t)

11.080.01 Sterilointi ja desinfiointi, yleistä »

Sidokset

Velvoittavat viittaukset

ICH Q 9:2005
ISO 11135-1:2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ICH Q 9:2005
ISO 11135-1:2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
ISO 13408-2:2003 Aseptic processing of health care products -- Part 2: Filtration
ISO 13408-3:2006 Aseptic processing of health care products -- Part 3: Lyophilization
ISO 13408-4:2005 Aseptic processing of health care products -- Part 4: Clean-in-place technologies
ISO 13408-5:2006 Aseptic processing of health care products -- Part 5: Sterilization in place
ISO 13408-6:2005 Aseptic processing of health care products -- Part 6: Isolator systems
ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes
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 14644-1:1999 Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness
ISO 14644-2:2000 Cleanrooms and associated controlled environments -- Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
ISO 14644-3:2005 Cleanrooms and associated controlled environments -- Part 3: Test methods
ISO 14644-4:2001 Cleanrooms and associated controlled environments -- Part 4: Design, construction and start-up
ISO 14644-5:2004 Cleanrooms and associated controlled environments -- Part 5: Operations
ISO 14644-7:2004 Cleanrooms and associated controlled environments -- Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 14698-1:2003 Cleanrooms and associated controlled environments -- Biocontamination control -- Part 1: General principles and methods
ISO 14698-2:2003 Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data
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 14971:2007 Medical devices -- Application of risk management to medical devices
ISO 17665-1:2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 20857:2010 Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices

Tekninen komitea

CEN/TC 204 Sterilization of medical devices »

Direktiivi

90/385/EEC Aktiiviset implantoitavat lääkinnälliset laitteet
93/42/EEC Lääkinnälliset laitteet
98/79/EC In vitro diagnostiset lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

10.08.2015

Julkaisupäivä

28.08.2015

Painos

2

Sivumäärä

53

Julkaisun kieli

englanti