Annex 1, Blog

Gearing up for Annex 1

Annex 1 Cleanroom socks - Integrity

The newly revised EU GMP Annex 1 is expected to place a much greater emphasis on the importance of minimizing microbiological contamination to ensure the quality of sterile products that are manufactured. A clear understanding, and the subsequent control, of potential routes of contamination will be a requirement for all companies manufacturing sterile products.

It is well documented that personnel are the primary source of contamination and so a focus on apparel and gowning procedures as part of a contamination control strategy is vital. For example, when entering a cleanroom, it has been found that workers infrequently change their socks when gowning which raises issues with contamination control as regular socks may house hair, carpet and other fibres along with bacteria. Therefore, it is expected that the revised Annex 1 will require cleanroom workers operating at a level of ISO3 and upwards to change their regular socks for dedicated cleanroom socks.

Our Principle white, sterile cleanroom socks are manufactured from a 100% polyamide knit making them lightweight, breathable and strong. Free from chemicals that fall within the scope of regulation (EC) 1907/2006 (registration, evaluation, authorisation and restriction of Chemicals (REACH)), Principle cleanroom socks are Gamma irradiated at a minimum of 25kGy.

For more information or to request a sample please contact us.

At Integrity Cleanroom we constantly monitor the quality and assess the range of apparel we offer to meet the most stringent ISO requirements. You can see our full range here.