01/121101 DC : DRAFT MAR 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BS EN ISO 14644-7 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE ENCLOSURES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS, MINI-ENVIRONMENTS)
23-11-2012
14-10-2004
1 Scope
2 Normative references
3 Terms and definitions
4 Specification of Requirements
5 Design and Construction
6 Access Devices
7 Transfer Devices
8 Siting and Installating
9 Testing and Approval
Annex A (informative) Separation continuum concept
Annex B (informative) Air handling and gas systems
Annex C (informative) Access devices
Annex D (informative) Transfer device examples
Annex E (informative) Leak testing
Annex F (informative) Design and testing of minienvironments
Annex G (informative) Calculation of maximum permissible
leak rate
Bibliography
BS EN ISO 14644-7
| Committee |
LBI/30
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 |
| 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 |
| 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 |
Access your standards online with a subscription
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.