Skip to main content Skip to search Skip to main navigation

New cleanroom standard for particle sampling

A new part of the ISO 14644 cleanroom series has been published: ISO/TR 14644-21:2023 Cleanrooms and associated controlled environments — Part 21: Airborne particle sampling techniques.

This document discusses the physical limitations of probe and particle counter placement, and any tubing that connects the two, particularly in providing representative samples where particles 5 micrometres and greater are of interest.

The document further identifies the key factors of sampling performance when classifying and monitoring, and good practice to determine and maintain an acceptable compromise between attainable accuracy in counting and feasibility of counting in real-life situations.

This document includes a decision tree, used to identify key considerations when sampling airborne particles, and whether the system requires further assessment. There are also examples provided to illustrate typical application challenges and show how the decision tree can be used.

It is assumed that this document is read in conjunction with ISO 14644-1 and ISO 14644-2. This document is not a manual, but an explanatory document. It does not describe measurement methods, which is handled in ISO 14644-1 and ISO 14644-2, but provides information to help make effective choices of sampling configuration, when evaluating a new or existing system.


Source:

ISO Online Browsing Platform (OBP): ISO/TR 14644-21:2023(en)

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

How is First Air Verified and Monitored During Aseptic Process Qualification?

How is First Air Verified and Monitored During Aseptic Process Qualification?

Here's the answer:
Read more
Outsourced Activities in the GDP Environment Part I: Supplier Management

Outsourced Activities in the GDP Environment Part I: Supplier Management

Supplier management is the systematic management of a company´s relationship with its suppliers. It encompasses supplier qualification and customer audits as described in the following excerpt from GMP:KnowHow Pharmalogistics (GDP).

Read more
FDA: Draft Guidance on Assessing Container Closure Systems for Drugs and Biologics

FDA: Draft Guidance on Assessing Container Closure Systems for Drugs and Biologics

On 14 August 2026, the US Food and Drug Administration (FDA) announced the publication of a new draft guidance document entitled ‘Container Closure Systems for Human Drugs and Biological Products’.

Read more
FDA: New FDA Commissioner Dr. Heidi Overton

FDA: New FDA Commissioner Dr. Heidi Overton

President Donald Trump has named White House aide Heidi Overton to lead the US Food and Drug Administration (FDA). Overton will fill the position previously held by Marty Makary, who left the agency in May. This announcement was made on Trump's Truth Social account on 19 August. Her nomination is subject to confirmation by the Senate.

Read more
IPEC: Stability Guide for Excipients has been Updated

IPEC: Stability Guide for Excipients has been Updated

The IPEC Stability Guide for Pharmaceutical Excipients has been updated and is now available as version 3 (2026), as announced on the IPEC (International Pharmaceutical Excipients Council) website.

Read more
EU: “Forever Chemicals” in a Conflict of Interests

EU: “Forever Chemicals” in a Conflict of Interests

On 14 July 2026, the European Parliamentary Research Service (EPRS) published a comprehensive briefing on PFAS (per- and polyfluoroalkyl substances), also known as ‘forever chemicals’. The document is intended to serve as a technical basis for MEPs in their upcoming political decisions on PFAS regulation and summarises the current state of scientific knowledge, regulation and procedures.

Read more
Previous
Next