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BS EN ISO 14644-7:2004

Current
Current

The latest, up-to-date edition.

Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-14-2004

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.

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.

  • User requirements are as agreed by customer and supplier.

  • Application-specific requirements are not addressed.

  • Specific processes to be accommodated in the separative-device installation are not specified.

  • 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.

Committee
LBI/30
DevelopmentNote
Supersedes 01/121101 DC (11/2004)
DocumentType
Standard
Pages
64
PublisherName
British Standards Institution
Status
Current
Supersedes

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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