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Annex 1 - Cleanroom Goggles

Annex 1 - Cleanroom Goggles BlogCleanroomPPE/Textiles30.03.2023

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 been published and will come into force on August 25th, 2023.

This new version is substantially different to the previous version and includes additional guidance on the requirement for sterile eye coverings or goggles. The purpose of this article is to help Micronclean's customers understand these key changes.

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 the use of Cleanroom Eye Covering or Goggles?

Annex 1 states that every operator entering Grade B or A areas should gown into clean, sterilised protective garments (including eye coverings and masks) of an appropriate size, at each entry. The eye covering should be specially designed cleanroom goggles to form a complete barrier with a face mask and ensure that all facial skin is covered.

Furthermore, Annex 1 states that for sterilised or effectively decontaminated garments and eye coverings, particular attention should be taken to ensure they have been processed, are within their specified hold time and that the packaging is visually inspected to ensure it is integral before use. Reusable garments (including eye coverings) should be replaced if damage is identified, or at a set frequency that is determined during qualification studies.

So, to help with compliance to Annex 1 what should I be looking for in a Cleanroom Goggle?

In essence as a cleanroom operator, requiring a sterile cleanroom goggle you have three options, these being:

  • 1. A Single Use Sterile Cleanroom Goggle
  • 2. A Reusable Cleanroom Google that you must decontaminate, sterilise and inspect
  • 3. A Reusable Cleanroom Goggle that is supplied to you ready to wear where someone else has performed the decontamination, sterilisation and inspection.

In addition, to gain user acceptance your chosen goggle should be lightweight, comfortable to wear, with the ability for the operator to wear glasses comfortably and resistant to fogging.

So, how can Micronclean help with Goggle supply?

In limited circumstances option 1 above might be appropriate but if a significant number are used daily, then the number of goggles required would result in large volumes potentially going to landfill. In order to recycle the goggles, all the various components such as the lens, body of the goggle and the strap would need to be segregated and recycled separately.  All of this would add considerably to your workload and as a result Micronclean would not recommend this as a long-term solution for anything other than occasional use.

If you are located with the UK, Micronclean would recommend that you use our Cleanroom Laundered Reusable Goggle service which is aligned to option 3 above.  The full details of the service are available here but in essence the service offers:

  • Delivery of a lightweight, optically correct goggle, in a sterile ready to wear condition.
  • Full Inspection of the goggle at the start of every decontamination cycle.
  • Decontamination in an ISO Class 4 GMP Grade B facility with the addition of an anti-fogging agent and individually packed into a dedicated shipper.
  • Gamma Irradiation.
  • Full traceability of the decontamination and sterilisation conditions and automatic withdrawal and replacement of end-of-life goggles.

In this way the Micronclean Laundered Goggle Services is fully compliant with Annex 1.

For our International customers, Micronclean offer a reusable goggle that is supplied non-sterile (option 2 above) but is shipped in autoclave ready packaging so that it can be easily processed for its first use.  However, after its first use it is your responsibility to ensure that it is inspected, decontaminated and sterilised. Full product details are available here.

How Micronclean can help you with your overall 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 requirements alongside your cleaning and disinfection needs.

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

S. Yates oval portrait
Stella Yates

Group Product Manager - Cleanroom Textiles