Latest News

From The CES Blog

Is your Cleanroom complying with the latest EU GMP Annex 1 Revision?

This annex provides general guidance to ensure microbial, particulate and pyrogen contamination is prevented in the final product. The revised guidance in the latest Annex 1 revision advises sterile eye coverings (e.g goggles) should be worn when in the cleanroom.  Cleanroom socks covering the feet should also be worn as outdoor clothing should not be brought into changing rooms. Below are the products that can be provided to help you remain complaint.

BioClean Clearview™ Sterile Cleanroom Goggles – Single Use Goggles are constructed from lightweight and ultra-soft PVC with a silicone rubber latex-free head band, toughened polycarbonate optically correct lens with anti-fog and anti-scratch coating and in-direct ventilation system, offering safety goggles with unrivalled comfort. Contact for a quote or for alternative goggle options.

View Berkshire Cleanroom socks

BCR® Cleanroom socks provide the next level of cleanroom foot health and operator comfort during regular and extended wear. They are engineered with 96% nylon and 4% Lycra microdenier technology. This technology and protection does not diminish with laundering. The micro denier technology provides the sock with superior cool feeling and comfort. Because of the enhanced wicking function, contact discomfort associated with wearing regular cotton or polyester socks is greatly reduced. To request a quote please contact

lternatively, Micronclean offer reusable sterile goggles, launderable cleanroom socks and natural detergent, all compliant with the revised EU GMP Annex 1 recommendations. Contact for further information.

The revision also sets the limit for viable particle contamination in Grade A due to personnel gloves, sleeves and any part of the gown that may directly impact product sterility. One option is a sterile over sleeve but using a longer length glove would be more achievable and effective. Please see below for examples, for more options please contact


600 mm / 0.17 mm (ISO 21420:2020)


400 mm / 0.15 mm (ISO 21420:2020)

For more information on this or anything else in the blog, please contact

Information on EU GMP Annex 1 is taken from:

EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft)

Leave a Comment

Your email address will not be published. Required fields are marked *

Call Us

+44 01793 512 505

2276 Dunbeath Rd, Swindon SN2 8EA

To be the No 1 specialist provider of branded cleanroom consumable products and contamination control supplies to companies manufacturing in critically clean and all controlled manufacturing environments.


Business Hours

Monday to Thursday 08:30 – 17:00
Friday 08:30 – 16:00
Saturday & Sunday Closed

We're an Approved BusinessWe've been approved by approved