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:

FDA: New Draft Guidance on Impurity Specifications for Antibiotics

FDA: New Draft Guidance on Impurity Specifications for Antibiotics

The US FDA has issued a new draft guidance (April 2026) on Impurity Specifications for Antibiotics.
Read more
EDQM: Guidance on Traceability of Medicines in Hospitals

EDQM: Guidance on Traceability of Medicines in Hospitals

The EDQM has published new guidance on the traceability of medicines in hospital settings. The aim is to improve traceability up to the point of administration and strengthen patient safety.
Read more
Contamination Control Strategy (CCS) – Not Just an Extended Site Master File

Contamination Control Strategy (CCS) – Not Just an Extended Site Master File

At the GMP-PharmaCongress in Wiesbaden, GMP inspector Frank Sielaff (Regional Authority in Darmstadt, Germany) shared practical insights from recent inspections, high-lighting deficiencies in CCS implementation.

Read more
Which Measures are Crucial for Implementation and Monitoring of Data Integrity?

Which Measures are Crucial for Implementation and Monitoring of Data Integrity?

Here's the answer:
Read more
EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals

EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals

In their „Horizon Scanning Report“, EMA and HMA have recommended updates to the regulatory framework to keep pace with developments in radiopharmaceuticals. Due to their unique characteristics these products require specific regulatory and scientific approaches.
Read more
GMP Meets Radiation Protection – How Do They Fit Together?

GMP Meets Radiation Protection – How Do They Fit Together?

The manufacture of radiopharmaceuticals requires simultaneous compliance with the EU GMP Guide and radiation protection regulations, which can lead to conflicting objectives between product safety and personal protection. Technical solutions such as negative pressure systems and lead-lined cells, as well as early consultation with the authorities, are crucial for implementation that complies with both GMP and radiation protection requirements.
Read more
Previous
Next