BS EN ISO 14644-7:2004
Current
The latest, up-to-date edition.
Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Hardcopy , PDF
English
14-10-2004
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Design and construction
6 Access devices
6.1 Use
6.2 Manual operation
6.3 Robotic handling
7 Transfer devices
7.1 Use
7.2 Selection
7.3 Fail-safe design
8 Siting and installing
9 Testing and approval
9.1 General
9.2 Glove breach test
9.3 Operating differential pressure
9.4 Leak testing
9.5 Periodic testing
Annex A (informative) Separation continuum concept
Annex B (informative) Air-handling systems and gas systems
Annex C (informative) Access devices
Annex D (informative) Examples of transfer devices
Annex E (informative) Leak testing
Annex F (informative) Parjo leak test method
Bibliography
Describes the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5.
Committee |
LBI/30
|
DevelopmentNote |
Supersedes 01/121101 DC (11/2004)
|
DocumentType |
Standard
|
Pages |
64
|
PublisherName |
British Standards Institution
|
Status |
Current
|
Supersedes |
This part of ISO14644 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO14644-4 and 14644-5.
The application of this part of ISO14644 takes into account the following limitations.
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User requirements are as agreed by customer and supplier.
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Application-specific requirements are not addressed.
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Specific processes to be accommodated in the separative-device installation are not specified.
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Fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply.
This part of ISO14644 is not applicable to full-suits.
Standards | Relationship |
UNE-EN ISO 14644-7:2005 | Identical |
SN EN ISO 14644-7 : 2005 | Identical |
EN ISO 14644-7:2004 | Identical |
NEN EN ISO 14644-7 : 2004 | Identical |
ISO 14644-7:2004 | Identical |
I.S. EN ISO 14644-7:2004 | Identical |
NF EN ISO 14644-7 : 2004 | Identical |
NS EN ISO 14644-7 : 1ED 2005 | Identical |
NBN EN ISO 14644-7 : 2004 | Identical |
UNI EN ISO 14644-7 : 2005 | Identical |
DIN EN ISO 14644-7:2005-01 | Identical |
12/30240811 DC : 0 | BS 8568 - CLEANROOM ENERGY - CODE OF PRACTICE FOR IMPROVING ENERGY EFFICIENCY IN CLEANROOMS AND CLEAN AIR DEVICES |
PD 6609:2007 | Environmental cleanliness in enclosed spaces. Guide to in situ high efficiency filter leak testing |
BS 8568:2013 | Cleanroom energy. Code of practice for improving energy efficiency in cleanrooms and clean air devices |
EN 12298:1998 | Biotechnology - Equipment - Guidance on testing procedures for leaktightness |
ISO 10648-1:1997 | Containment enclosures — Part 1: Design principles |
ISO 14698-2:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data |
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 |
EN 12307:1997 | Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel |
ISO 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
BS 3636:1963 | Methods for proving the gas tightness of vacuum or pressurized plant |
NFC 01 371 : 85 AMD 1 1999 | ELECTROTECHNICAL VOCABULARY - CHAPTER 371: TELECONTROL |
ISO 14698-1:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
ISO 14644-3:2005 | Cleanrooms and associated controlled environments Part 3: Test methods |
ENV 1631 : 1996 | CLEANROOM TECHNOLOGY - DESIGN, CONSTRUCTION AND OPERATION OF CLEANROOMS AND CLEAR AIR DEVICES |
ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
EN 12296:1998 | Biotechnology - Equipment - Guidance on testing procedures for cleanability |
ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
ISO 10648-2:1994 | Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods |
EN 12469:2000 | Biotechnology - Performance criteria for microbiological safety cabinets |
ISO 13408-6:2005 | Aseptic processing of health care products Part 6: Isolator systems |
ISO 13408-5:2006 | Aseptic processing of health care products Part 5: Sterilization in place |
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