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How does Annex 1 affect you?

Annex 1 is specific to the manufacture of medicinal products. This update comes after several years since its last revision and
provides direction to the industry, reflecting best practice. The key changes are highlighted below alongside the products and services that we as a company can provide to help you remain compliant.

It has been re-enforced under section 5.3 that cleaning and disinfection remain prevalent – it is pivotal to the cleanliness of your cleanroom or controlled environment that disinfection must be performed first to remove surface contamination.

 We can source Micronclean’s brand new neutral detergent product range – Delta. Ask us how we can support you with Delta detergent mops, trigger sprays and wipes in addition to their normal rotational cleaning system utilising Alpha and Beta. 

Please see the below link for the product description:

Cleanroom Disinfectant, Cleanroom IPA, Cleaning, IPA Wipes (criticalenvironmentsolutions.co.uk) 

delta trigger 1
Sterile Cleanroom Goggles Bcgs1

Annex 1 also states that garments should be visually checked for cleanliness and integrity prior to entry of the cleanroom or controlled environment. For sterilised garments, it is pivotal that the wearer pays particular attention to whether the clothing or eye covering has been sterilised and the packaging is integral before use.

BioClean Clearview™ Sterile Cleanroom Goggles Single Use Goggles are made 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 unrivalled comfort. See link below for full product description. 

 Cleanroom PPE, Goggles, Eye Protection, Eye Safety (criticalenvironmentsolutions.co.uk)

Annex 1 states that outdoor clothing should not be brought into changing rooms leading to grade B and C cleanrooms. It is recommended that facility suits, i.e. coveralls, overshoes, socks, PPE should be donned before entering the changing area. We recognise that as an additional requirement to Annex 1, that this may need some assistance to put in place. We have disposable socks in our consumable range to help you become compliant with this additional requirement. 

We stock the Berkshire disposable sock which is mid-calf length with an elasticated cuff for a secure fit and extra comfort – please see link below for more details:

Cleanroom Footwear, Shoes, Clogs, Boots (criticalenvironmentsolutions.co.uk)

chsockr1050 choice® cleanroom socks
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