GB/T 25915.4-2010 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
1 Scope
This part of GB/T 25915 specifies requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements. It is intended for use by purchasers, suppliers and designers of cleanroom installations and provides a checklist of important parameters of performance. Construction guidance is provided, including requirements for start-up and verification. Basic elements of design and construction needed to ensure continued satisfactory operation are identified through the consideration of relevant aspects of operation and maintenance.
Note: Further guidance in respect of the above requirements is given in Annexes A to H. Other parts of GB/T 25915 may provide complementary information.
Application of this part of GB/T 25915 is restricted in the following:
——user requirements are represented by purchaser or specifier;
——specific processes to be accommodated in the cleanroom installation are not specified;
——fire and safety regulations are not considered specifically; the appropriate national and local requirements shall be respected;
——process media and utility services are only considered with respect to their routing between and in the different zones of cleanliness;
——regarding initial operation and maintenance, only cleanroom construction-specific requirements are considered.
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 of the referenced document (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 25916.1-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1: 2003, IDT)
GB/T 25916.2-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2: 2003, IDT)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 25915.1-2010 and the following apply.
3.1
changing room
room where people using a cleanroom may change into, or out of, cleanroom apparel
3.2
clean air device
stand-alone equipment for treating and distributing clean air to achieve defined environmental conditions
3.3
cleanliness
condition of a product, surface, device, gas, fluid, etc. with a defined level of contamination
Note: Contamination may be particulate, non-particulate, biological, molecular or of other consistency.
3.4
commissioning
planned and documented series of inspections, adjustments and tests carried out systematically to set the installation into correct technical operation as specified
3.5
contaminant
any particulate, molecular, non- particulate and biological entity that can adversely affect the product or process
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Planning and design
6 Construction and start-up
7 Testing and approval
8 Documentation
Annex A (informative) Control and segregation concepts
Annex B (Informative) Classification examples
Annex C (Informative) Approval of an installation
Annex D (Informative) Layout of an installation
Annex E (Informative) Construction and materials
Annex F (informative) Environmental control of cleanrooms
Annex G (informative) Control of air cleanliness
Annex H (informative) Additional specification of requirements to be agreed upon between purchaser/user and designer/supplier
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