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GB/T 25915.14-2022Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (English PDF)

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

December 30, 2022

Implementation date

July 1, 2023

Scope

GB/T 25915.14-2022 (Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration) is available as an English-translated PDF.

GB/T 25915.14-2022 — This document applies to the assessment of the suitability of equipment (e.g., machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments. As specified in GB/T 25915.1, airborne particle sizes range from 0.1 µm to equal to or larger than 5 µm. The following items are not covered by this document: -- assessment of suitability with respect to biocontamination; -- testing for suitability of decontamination agents and techniques; -- cleanability of equipment and materials; -- requirements on design of equipment and selection of materials; -- physical properties of materials (e.g., electrostatic, thermal properties); -- optimizing performance of equipment for specific process applications; -- selection and use of statistical methods for testing; -- protocols and requirements for local safety regulations.

Document preview — GB/T 25915.14-2022

National Standard of the People's Republic of China

Issued by: SAMR; SAC

Contents

  • Foreword...3
  • Introduction...5
  • 1 Scope...7
  • 2 Normative references...7
  • 3 Terms and definitions...8
  • 4 General outline of the assessment...9
  • 5 Visual examination...10
  • 6 Assessment of suitability by airborne particle concentration measurements...11
  • 7 Record...18
  • 8 Statement on cleanroom suitability...21
  • Annex A (Informative) Example for data processing deriving from measurements ..22
  • Annex B (Informative) Additional optional tests...26
  • Bibliography...29

Foreword

This document was drafted in accordance with the rules provided in GB/T 1.1-2020

Directives for Standardization - Part 1: Rules for the Structure and Drafting of

Standardizing Documents.

This document is Part 14 of GB/T 25915 Cleanrooms and associated controlled

environments. The following parts have been issued for GB/T 25915:

-- Part 1: Classification of air cleanliness by particle concentration;

-- Part 2: Monitoring to provide evidence of cleanroom performance related to air

cleanliness by particle concentration;

-- Part 3: Test methods;

-- Part 4: Design, construction and start-up;

-- Part 5: Operations;

-- Part 6: Vocabulary;

-- Part 7: Separative devices (clean air hoods, gloveboxes, isolators and

minienvironments);

-- Part 8: Classification of air cleanliness by chemical concentration (ACC);

-- Part 9: Classification of surface cleanliness by particle concentration;

-- Part 10: Classification of surface cleanliness by chemical concentration;

-- Part 12: Specifications for monitoring of air cleanliness by nanoscale particle

concentration;

-- Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of

particle and chemical classifications;

-- Part 14: Assessment of suitability for use of equipment by airborne particle

concentration;

-- Part 15: Assessment of suitability for use of equipment and materials by airborne

chemical concentration.

This document is identical to ISO 14644-14:2016 Cleanrooms and associated

controlled environments - Part 14: Assessment of suitability for use of equipment by

airborne particle concentration.

Cleanrooms and associated controlled environments - Part

14: Assessment of suitability for use of equipment by

airborne particle concentration

1 Scope

This document applies to the assessment of the suitability of equipment (e.g., machinery,

measuring equipment, process equipment, components and tools) for use in cleanrooms

and associated controlled environments. As specified in GB/T 25915.1, airborne

particle sizes range from 0.1 µm to equal to or larger than 5 µm.

The following items are not covered by this document:

-- assessment of suitability with respect to biocontamination;

-- testing for suitability of decontamination agents and techniques;

-- cleanability of equipment and materials;

-- requirements on design of equipment and selection of materials;

-- physical properties of materials (e.g., electrostatic, thermal properties);

-- optimizing performance of equipment for specific process applications;

-- selection and use of statistical methods for testing;

-- protocols and requirements for local safety regulations.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this

document and are indispensable to its application. For dated references, only the version

corresponding to that date is applicable to this document; for undated references, the

latest version (including all amendments) is applicable to this document.

GB/T 25915.1-2021, Cleanrooms and associated controlled environments - Part 1:

Classification of air cleanliness by particle concentration (ISO 14644-1:2015, MOD)

Note: There is no technical difference between the referenced content of GB/T

25915.1-2021 and the referenced content of ISO 14644-1:2015.

Note: Testing of equipment for ISO Class 1 suitability is accomplished in an ISO Class

1 environment.

The test environment shall not contain any other particle sources than the equipment to

be assessed to avoid influencing the measurement results. This can be achieved using

unidirectional airflow.

6.2.6 Approximate identification of HPC location(s)

For equipment with moving elements/components, there is frequently a significant

variation in the concentration of particles generated between different zones of the

equipment.

The intention of the cleanroom suitability methodology is to include those zones that

contain HPC(s) within the suitability assessment measurements. It is essential that

moving elements/components, utilities, interfaces, etc., are included in this assessment.

Note: The number of moving elements/components can influence the number of

approximate HPC locations.

Although safe sampling can impose sampling position limitations, the objective is to

vary the distance and/or position of the sampling probe in order to identify the HPC

location(s).

The approximate identification shall be performed using a systematic scan of the

equipment with a light scattering discrete airborne particle counter (LSAPC). The entire

system including product spaces of the equipment should be scanned by the sampling

probe. While the equipment is scanned using a sampling probe of the LSAPC, a

correlation between its position and the HPC is acquired. Depending on the make/model

of the LSAPC used, the feedback required to establish this correlation can use visual

and/or acoustic means. The sample acquisition time shall be chosen to ensure that the

location of the HPC(s) can be identified appropriately.

Previously identified contamination sources (output of any pre-tests) should be

included in this part of the assessment.

The conclusions of the measurements undertaken for the approximate identification of

particle sources are qualitative in nature.

6.2.7 Precise determination of HPC location(s)

Following the approximate identification, a precise determination of HPC location(s)

is carried out using a LSAPC assessing at least 28.3 L/min of air with a probe having

an openness limited to 20 cm2. During this measurement stage, the geometrical position

of the LSAPC sampling probe is adjusted to achieve the optimum sampling of the HPC

location. Probe position shall be set and recorded. This is repeated for each HPC

location identified under 6.2.6.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — all pages — is available in the English PDF.

Referenced standards

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