Annex 1 - Cleanroom Reusable Textiles

The current version is substantially different to the previous version and includes additional guidance on the qualification of cleanroom garments. The purpose of this article is to help Micronclean’s customers understand these changes with respect to the qualification of cleanroom garments.

This article is part of a series from Micronclean that will explore the essential aspects of EU GMP Annex 1, outlining the key compliance requirements and demonstrating how Micronclean's products and services can support your compliance efforts and help you follow best practices.

So, what does Annex 1 say about reusable cleanroom garments?

Fundamentally Annex 1 states that all clothing and its quality should be appropriate for the process being undertaken, the grade of cleanroom and should always protect the product from contamination.

For reusable cleanroom garments, Annex 1 further states that these garments should undergo qualification studies. These studies should determine the life of the garments, dependant on their processing and use cycles.

Additionally, Annex 1 states that any garment testing should go beyond visual inspection, as this might not detect all the sources of damage that could affect the garments performance within the cleanroom and so potentially damage the product being manufactured.

So, to help with compliance to Annex 1 what should I be looking for from a cleanroom garment supplier for garment qualification?

Within the UK all suppliers of reusable cleanroom clothing should offer at the very least 100% visual inspection of the garments as standard although this on its own does not meet the requirements of Annex 1.

As a result, the supplier should work with you to qualify the garment by establishing a sensible garment lifespan. This should be based not only on the expected use cycle within your cleanroom but also on fundamental garment and fabric testing results, ensuring that the intrinsic properties of the garment are not compromised throughout its processing over its intended lifespan.

Finally, the supplier should also be able to provide batch process data that proves that the decontamination and sterilisation process have been correctly adhered to.

So, how can Micronclean help with garment qualification?

As the UKs leading supplier of reusable cleanroom garments, we have a vast experience to draw on, having been supplying garments into the UK cleanroom marketplace since the mid 1980’s.

In addition, within the UK, Micronclean is unique in that it has committed a large amount of resource to undertake fundamental research into its entire range of cleanroom fabrics and supplied garments. As a result, we now have results covering the fabrics used for:

• Sterile Outer Garments
• Non-Sterile Outer Garments and
• Non-Sterile Undergarments.

In these studies, Micronclean has qualified its entire range of cleanroom garments to prove how the properties of the fabric, and the garment, are affected by numerous decontamination and sterilisation cycles (if these are applicable). In addition, for potentially the most critical case (Sterile Outer Garments) these results have been qualified by being published in a respected peer reviewed external journal.

The Micronclean garment studies are on our website (links at the end of this blog) and describe how we tested the relevant cleanroom fabrics to assess the effect of both decontamination and sterilisation cycles. Several fundamental properties were tested, including particle filtration, durability and tensile strength. In this way, we have established unique knowledge about the right fabrics to use and the performance of our garment systems made from these fabrics.

As a result, when qualifying your garments, Micronclean can provide expert guidance on their use and lifecycle, leveraging extensive research data to significantly streamline the process.

In addition, you can be absolutely assured that if you have a garment contract with Micronclean you are not only complying with Annex 1 but that the garments will remain absolutely fit for purpose during the agreed life.

Micronclean Technical Garment Studies

Micronclean UK: TECHNICAL OVERVIEW - CLEANROOM GARMENTS

Micronclean UK: TECHNICAL OVERVIEW - NON-STERILE GARMENTS - WF55 FABRIC LIFE STUDY

Micronclean UK: TECHNICAL OVERVIEW - NON-STERILE UNDERGARMENT FABRIC LIFE STUDY

Peer Reviewed Technical Papers

Performance of Cleanroom Garment Fabrics When Processed in an Industrial Laundry, Comparing Irradiation and Autoclave Sterilisation, EJPPS 264 (2021): https://www.ejpps.online/post/vol24-6-performance-of-cleanroom-garment-fabrics-when-processed-in-an-industrial-laundry

How Micronclean can help you with your compliance to Annex 1?

Micronclean is unique in the UK Cleanroom market in that we have an in-house R&D team which includes Microbiologists who can assist you with your garment, cleaning and disinfection needs.

For more information about how we can help you please contact us.

Author
Marta Underwood
Group Product Manager - Cleanroom Textiles