GB/T 25915.7-2010 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)
1 Scope
This part of GB/T 25915 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 GB/T 25915.4 and GB/T 25915.5.
The application of this part of GB/T 25915 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 25915.1-2010 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999, IDT)
GB/T 25915.2-2010 Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with GB/T 25915.1 (ISO 14644-2:2000, IDT)
GB/T 25915.3-2010 Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005, IDT)
GB/T 25915.4-2010 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001, IDT)
GB/T 25916.1 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (GB/T 25916.1-2010, ISO 14698-1: 2003, IDT)
GB/T 25916.2 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (GB/T 25916.2-2010, ISO 14698-2: 2003, IDT)
ISO 10648-2:1994 Containment enclosures - Part 2: Classification according to leak tightness and associated checking methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 25915.1-2010, GB/T 25915.2-2010 and GB/T 25915.4-2010 and the following apply.
3.1
access device
device for manipulation of processes, tools or products within the separative device
3.2
action level (general)
level set by the user in the context of controlled environments, which, when exceeded, requires immediate intervention, including the investigation of cause, and corrective action
3.3
alert level (general)
level set by the user in the context of controlled environments, giving early warning of a drift from normal conditions, which, when exceeded, shall result in increased attention to the process
3.4
barrier
means employed to provide separation
3.5
breach velocity
velocity through an aperture sufficient to prevent movement of matter in the direction opposite to the flow
3.6
containment
state achieved by separative devices with high degree of separation between operator and operation
3.7
decontamination
reduction of unwanted matter to a defined level
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Design and construction
6 Access devices
7 Transfer devices
8 Siting and installing
9 Testing and approval
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
