ISO 14644-1:2015 PDF

Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration

Open preview (PDF)

Title (English):

ISO 14644-1:2015

Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 37
Publication date:: December 9, 2015
Edition:: ISO IS 14644 edition 2 version 1
ICS:: 13.040.35

Delivery type:

Full version25 €Read online 24h10 €Read online 72h15 €

Document language:

enru

Delivery time:Immediate download

Price:25 €

Description (English):

ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644‑7. Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm are considered for classification purposes. The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations. ISO 14644-1:2015 does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1 µm) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 µm). ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.

Technical details

Technical committee: ISO/TC 209 - Cleanrooms and associated controlled environments
SKU: ISO 14644-1:2015

Abstract

Overview

ISO 14644-1:2015 - "Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration" defines how to classify cleanrooms, clean zones and separative devices according to the concentration of airborne particles. The standard covers particle-size thresholds from 0.1 µm to 5 µm, uses light scattering (discrete) airborne particle counters (LSAPC) as the basis for measurement, and retains an M descriptor (Annex C) to quantify macroparticles (>5 µm). ISO 14644-1:2015 specifies the classification method, the reference testing approach (Annex A) and requirements for sampling locations and reporting - but it does not characterize particle chemistry, viability or ultrafine (nano-scale) particles (<0.1 µm).

Key technical topics and requirements

Particle size range: Classification applies to cumulative particle thresholds between 0.1 µm and 5 µm. Nano-scale particles are outside this part and handled separately.
Measurement method: Use of LSAPC instruments for counting particles ≥ specified sizes (see Annex F for instrument guidance).
ISO Classes: Defines integer and intermediate decimal cleanliness classes (tables provide maximum particle concentrations for each class and size).
Sampling strategy: Statistical approach based on an adapted hypergeometric sampling model; minimum sampling locations referenced in Table A.1. The model provides at least 95% confidence that 90% of the area will meet class limits.
Designation and reporting: Rules for class number, particle sizes, occupancy states and required test reporting (see Clause 5 and Annex A).
Macroparticles: Annex C describes counting/sizing of particles >5 µm and use of an M descriptor for regulatory adaptation (e.g., sterile product guidance).

Practical applications

ISO 14644-1:2015 is essential for organizations that design, validate, operate or regulate contamination-controlled environments, including:

Pharmaceuticals and sterile manufacturing (cleanroom classification and sterile product annex adaptations)
Medical devices and healthcare facilities
Microelectronics and semiconductor fabrication
Aerospace and precision engineering
Food processing where particulate control is required It is used to establish an ISO Class target, select monitoring and test protocols, validate HVAC and filtration performance, and produce compliance test reports for audits and regulatory inspections.

Who should use this standard

Cleanroom designers and engineers
Validation and quality assurance specialists
Facilities and operations managers
Test laboratories and auditors
Regulatory and compliance personnel

Related standards

ISO 14644‑2 (monitoring to provide evidence of performance)
ISO 14644‑3 (test methods)
ISO 14644‑7 (separative devices: hoods, gloveboxes, isolators)
Other parts of ISO 14644 (Parts 4, 5, 8–10) and ISO 14698 (biocontamination control)

Keywords: ISO 14644-1:2015, cleanrooms, air cleanliness, particle concentration, LSAPC, ISO class, sampling locations, macroparticles, clean zones.

Related standards

Standards mentioned in the description

Abstract

Overview

Key technical topics and requirements

Particle size range: Classification applies to cumulative particle thresholds between 0.1 µm and 5 µm. Nano-scale particles are outside this part and handled separately.
Measurement method: Use of LSAPC instruments for counting particles ≥ specified sizes (see Annex F for instrument guidance).
ISO Classes: Defines integer and intermediate decimal cleanliness classes (tables provide maximum particle concentrations for each class and size).
Sampling strategy: Statistical approach based on an adapted hypergeometric sampling model; minimum sampling locations referenced in Table A.1. The model provides at least 95% confidence that 90% of the area will meet class limits.
Designation and reporting: Rules for class number, particle sizes, occupancy states and required test reporting (see Clause 5 and Annex A).
Macroparticles: Annex C describes counting/sizing of particles >5 µm and use of an M descriptor for regulatory adaptation (e.g., sterile product guidance).

Practical applications

ISO 14644-1:2015 is essential for organizations that design, validate, operate or regulate contamination-controlled environments, including:

Pharmaceuticals and sterile manufacturing (cleanroom classification and sterile product annex adaptations)
Medical devices and healthcare facilities
Microelectronics and semiconductor fabrication
Aerospace and precision engineering
Food processing where particulate control is required It is used to establish an ISO Class target, select monitoring and test protocols, validate HVAC and filtration performance, and produce compliance test reports for audits and regulatory inspections.

Who should use this standard

Cleanroom designers and engineers
Validation and quality assurance specialists
Facilities and operations managers
Test laboratories and auditors
Regulatory and compliance personnel

Related standards

ISO 14644‑2 (monitoring to provide evidence of performance)
ISO 14644‑3 (test methods)
ISO 14644‑7 (separative devices: hoods, gloveboxes, isolators)
Other parts of ISO 14644 (Parts 4, 5, 8–10) and ISO 14698 (biocontamination control)

Keywords: ISO 14644-1:2015, cleanrooms, air cleanliness, particle concentration, LSAPC, ISO class, sampling locations, macroparticles, clean zones.

ISO 14644-1:2015 PDF

Technical details

Abstract

Overview

Key technical topics and requirements

Practical applications

Who should use this standard

Related standards

Related standards

Abstract

Overview

Key technical topics and requirements

Practical applications

Who should use this standard

Related standards

Related standards

Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom perfo…

Cleanrooms and associated controlled environments. Test methods.

Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes,…

Cleanrooms and associated controlled environments. Biocontamination control - General principles and methods