Annex 1 - Cleanroom Reusable Textiles

What is EU GMP Annex 1?

Annex 1 of EU GMP provides specific guidance on the manufacture of sterile medicinal products. The latest version of the guidance has recently been published and will come into force on August 25th, 2023.

This new version is substantially different from 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 the key changes with respect to the qualification of cleanroom garments.

This article forms part of a series of posts from Micronclean that will look at the key parts of EU GMP Annex 1, explain the key requirements to remain compliant with Annex 1 and then suggest how Micronclean’s products and services could help you remain compliant, and follow best practice.

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 100% visual inspection of the garments as standard. They should also be able to provide batch process data that proves that the decontamination and sterilisation process have been correctly adhered to.

The supplier should work with you to qualify the garment by determining a sensible garment life, based not only on the use cycle that the garment will see within your cleanroom, but also on the fundamental garment/fabric testing results which proves that the intrinsic garment properties are not compromised during the processing of the garment over its expected life.

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 cleanroom fabrics. Micronclean has qualified its cleanroom garments to prove how the properties of the fabric, and the garment as a whole, are affected by the numerous decontamination and sterilisation cycles.

The Micronclean Garment study is available to every Micronclean customer, and potential customer (just ask your BDM), and describes how we tested a variety of cleanroom fabrics to assess the effect of both decontamination and sterilisation cycles (covering both irradiation and autoclave process) on several fundamental properties including particle filtration, durability, tensile strength and abrasion resistance. In this way we have established a unique knowledge about the right fabrics to use and the performance of our garment systems made from these fabrics.

As a result, when you are looking to qualify your garments in use, Micronclean can advise you on the use/life cycle of your garments, using a vast amount of research data, cutting your own qualification process considerably.

Micronclean has also published some of its cleanroom fabric/garment research in a respected peer reviewed scientific journal and this paper can be found here.

Consequently, 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.

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 cleaning and disinfection needs.

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

Author
Stella Yates
Group Product Manager - Cleanroom Textiles