EU regulation Annex 1 new revision will come into force on 25Aug2023. 

 (any pharmaceuticals selling to EU countries must comply)

With many great improvements to increase product safety comes one new mandatory requirement which is NOT necessary in the majority of pharmaceutical sites all over the world

This is the requirement to introduce facility socks. 

The options to fulfill this requirement are 

a) polymide sock which can be laundered- its lifespan is limited (approx 10-14 cycles reported) due to the high temperatures required to put it through an approved wash cycle (60C) and to remove risk of spread of foot fungus.

b) single use polymide sock

c) attempt to introduce an alternative

option c is not popular or supported as the approved laundering companies want you to buy/rent socks from them. They insist on low particulate cleanroom approved materials. In addition companies are afraid to explore other options for fear of not complying to this new regulation. As the deadline is august for having the socks introduced the POLYMIDE sock (laundered/single use) is the only option for most pharma sites. 

The three biggest issues i have with this new requirement:

1- The majority of sites globally have not seen ANY evidence or encountered ANY problem with operators wearing their own undergarments to date. Processes are robust enough to ensure contamination is not spread from undergarments as they are FULLY covered in cleanroom suitable garb at all times. 

Why can't we procedularise that operators must wear clean socks to work. we trust they shower, we trust they adhere to cleanroom behaviour, we trust they keep their nails trimmed and do not wear perfume/jewellery. why do we not trust they can ensure their socks are basically clean coming to work. 

2. Annex 1 has pushed sites to use risk based approaches to date but now has no trust that a site can manage their own garbing processes in a way that ensures it is kept appropriately clean. Annex 1 revision completely disregards the millions of sample results which indicate our cleanrooms are clean. Without a risk based approach even cleanrooms that are only bioburden reduced and NOT sterile grade A/B environment must introduce the cleanroom socks too- for what reason?

3. Lastly - the biggest issue - there was not one thought given to the environmental cost of this requirement. Its 2023 - in an age of climate change issues ramping up surely the authors of Annex 1 can realise that a one -size-fits-all regulation such has this has MASSIVE environmental implications? why is the environment not even a consideration in 2023??

Please everyone call on the authors of Annex 1 to update this document swiftly to amend this requirement (not within years!!!!) we need action this year before it is too late. 

Pharmaceutical companies are notorious for waste, some is hard to avoid and some is completely senseless. It is time for change.