Page 60 - CIJ May 2023 Digital Edition

Laundry

garment’s performance within and help to manage garment
the cleanroom and so potentially supply for quality assurance
damage the product being and cost efficiency. In this way,
Workwear that manufactured. we support your contamination
does not create an As a company, we can provide control strategy – a fundamental
adequate barrier to batch process data that proves requirement of your GMP
certification – while also helping
contain contamination that the decontamination and to manage your costs.
sterilisation processes have been
released by an operator correctly adhered to. We have
is an indirect risk of also invested significant time Cost vs benefit
and money to qualify cleanroom
In the Indian market, we do see
contamination within a workwear to determine a a lot of cost sensitivity. However,
cleanroom. maximum garment life, based we have encountered a few
not only on the use cycle that areas where the true costs are
the garment will see within not known. For instance, where
Regulatory standards your cleanroom, but also on cleanroom garments are not
the fundamental garment/fabric
The latest regulatory change testing results which proves that tracked correctly, no-one knows
has been the introduction of the intrinsic garment properties whether the garment achieves its
the revised version of EU are not compromised during the claimed life of say 100 cycles,
GMP Annex 1 covering the processing of the garment over its and so the cost of that garment
Manufacture of Sterile Medicinal expected life. is not really known. This lack of
Products. This guideline is being garment tracking could also affect
adapted throughout the EU and Why outsource? the user’s ability to conform to
by the MHRA in the UK. In the the requirements of Annex 1 or
US, the FDA is not formally All reputable pharma another regulatory framework.
enforcing Annex 1 but is expected manufacturers will recognise the The systems we use give absolute
to enforce similar requirements. need for a cleanroom laundry for clarity on garment performance
The aim of all the regulators is to the supply of cleanroom garments through life and the true costs of
enforce an overall contamination to their operators. Some will opt ownership.
control strategy (CCS). to do this in-house with their own We also allow companies
on-premise laundry and some will
In terms of garments, Annex choose to subcontract to a third- to focus on pharmaceutical
1 states that all cleanroom party specialist supplier like us. manufacturing without having to
divert time, attention and capital
clothing and its quality should
Not only can we supply the
be appropriate for the process garments in a sterile, ready-to- to setting up and then running an
on-premise laundry, with all the
being undertaken, the grade of wear condition but we can also logistics that entails, employing
cleanroom and should always advise on the correct garment additional staff and the capital
protect the product from to use, gowning techniques etc. cost of the laundry equipment.
contamination. For reusable
cleanroom garments, Annex 1
further states that these garments
should undergo qualification
studies. These studies should
determine the life of the garments,
depending on their processing and
use cycles.
Additionally, Annex 1 states
that any garment testing should go
beyond visual inspection, as this
might not detect all the sources
of damage that could affect the
CIJ

MAY 2023•Clean India Journal
60 www.cleanindiajournal.com