ISO 14644-4-2022 PDF

Full title and description

Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up. This international standard specifies the process and key requirements for translating user requirements into the design, construction and successful start-up of new, refurbished or modified cleanroom and controlled-environment installations. It provides checklists, performance parameters and guidance on energy management, construction practices and initial verification to support lifecycle performance.

Abstract

ISO 14644-4:2022 defines the steps from requirements definition through design, construction and start-up of cleanrooms and associated controlled environments. The document focuses primarily on airborne-particle cleanliness and includes informative annexes and checklists to aid specifiers, designers, builders, suppliers and performance verifiers. It identifies energy-management approaches and highlights considerations for maintenance and continued satisfactory operation over the life cycle.

General information

• Status: Published.
• Publication date: 28 November 2022 (Edition 2).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 13.040.35 — Cleanrooms and associated controlled environments.
• Edition / version: Second edition (2022).
• Number of pages: 57 pages (ISO edition).

Scope

This part of ISO 14644 specifies the process for creating a cleanroom from requirements through design, construction and start-up. It applies to new, refurbished and modified cleanroom installations and is intended for users, specifiers, designers, purchasers, suppliers, builders and performance verifiers. It does not prescribe specific technologies or contractual arrangements and excludes detailed operational activities, fire and safety regulations and routine ongoing operation and cleaning (which are covered by other parts of the ISO 14644 series).

Key topics and requirements

• Translating user requirements into design criteria and performance specifications.
• Design checklists covering layout, airflow concepts, HVAC, filtration and pressure relationships.
• Material, finishes and surface selection to minimise particle generation and support cleanability.
• Energy management approaches and design options for energy-efficient cleanrooms.
• Construction practices, contamination control during build and commissioning requirements.
• Start-up and initial verification procedures, performance testing and acceptance criteria.
• Consideration of maintenance, accessibility and long‑term operation to ensure lifecycle performance.
• Informative annexes providing templates and checklists for requirements, design and start-up activities.

Typical use and users

Used by cleanroom owners and operators, facility planners, architects, HVAC and contamination-control engineers, contractors, suppliers of cleanroom systems, validation and commissioning specialists, and regulatory/compliance teams. Typical sectors include pharmaceuticals and biotech, medical device manufacturing, microelectronics, aerospace, laboratories and any industry requiring controlled airborne-particle environments.

Related standards

ISO 14644-4:2022 is part of the ISO 14644 series and is complemented by related parts such as ISO 14644-1 (classification of air cleanliness), ISO 14644-2 (testing and monitoring), ISO 14644-5 (operations), ISO 14644-7 (separative devices), ISO 14644-8/9/10/12/17 and standards on biocontamination (ISO 14698). National/adopted variants (for example EN/BS adoptions) exist that incorporate this edition.

Keywords

cleanroom; controlled environment; design; construction; start-up; commissioning; airborne particles; HVAC; filtration; energy management; verification; contamination control; ISO 14644.

FAQ

Q: What is this standard?

A: ISO 14644-4:2022 is the second-edition international standard that specifies the process and requirements for the design, construction and start-up of cleanrooms and associated controlled environments.

Q: What does it cover?

A: It covers the full delivery process from requirements definition through design, construction and initial verification/start-up, including checklists, performance parameters, construction guidance and energy-management considerations. It focuses on airborne-particle cleanliness and lifecycle considerations.

Q: Who typically uses it?

A: Owners, designers, specifiers, builders, HVAC and contamination-control engineers, validation and commissioning teams, and suppliers working on cleanroom projects across pharma, biotech, medical devices, microelectronics, aerospace and research laboratories.

Q: Is it current or superseded?

A: Current — ISO 14644-4:2001 (first edition) was withdrawn and replaced by ISO 14644-4:2022 (second edition) published on 28 November 2022. Users should adopt the 2022 edition for new projects.

Q: Is it part of a series?

A: Yes — it is part of the ISO 14644 series on cleanrooms and associated controlled environments; other parts address classification, testing and monitoring, operations, separative devices and related topics (e.g., ISO 14644-1, -2, -5, -7, -8, -9, -10, -12, -17, and ISO 14698 for biocontamination).

Q: What are the key keywords?

A: Cleanroom, controlled environment, design, construction, start-up, commissioning, airborne particles, HVAC, filtration, verification, energy efficiency.