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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 sales@cesltd.uk.com 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 sales@cesltd.uk.com

lternatively, Micronclean offer reusable sterile goggles, launderable cleanroom socks and natural detergent, all compliant with the revised EU GMP Annex 1 recommendations. Contact sales@cesltd.uk.com 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 sales@cesltd.uk.com

SHIELDSKIN XTREME™ STERILE WHITE NITRILE 600 DI+

600 mm / 0.17 mm (ISO 21420:2020)

SHIELDSKIN XTREME™ STERILE WHITE NITRILE 400 DI+

400 mm / 0.15 mm (ISO 21420:2020)

For more information on this or anything else in the blog, please contact sales@cesltd.uk.com

Information on EU GMP Annex 1 is taken from:

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

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