Page 59 - CIJ May 2023 Digital Edition

Laundry

for parametric release of the
garment against the validated
procedures.

Consequences of
laxity
Workwear that is not
adequately decontaminated
and sterilised is a direct risk
of contamination within a
cleanroom. In addition, workwear
that does not create an adequate
barrier to contain contamination
released by an operator is an
indirect risk of contamination
within a cleanroom.
Garments supplied from
the cleanroom laundry are In some documented cases,
decontaminated and sterilised poor cleanroom workwear
using validated processes to has resulted in unacceptable
achieve a garment that is sterile contamination of pharmaceutical
and has low levels of particulate batches worth millions of
contamination (ASTM F51 Class dollars, which ultimately have
A / IEST RP CC 003 Category 1). had to be destroyed at huge cost
In addition, as a barrier to the pharmaceutical business.
In addition to the direct costs,
cleanroom laundry, each there have also been reputational
garment is tracked (using and consequential damages
an RFID tag sewn into the from either supply shortage in
garment) into a specific the marketplace or having to
processing batch so that we withdraw a product from the
have full traceability of its marketplace.
visual inspection, repairs history
(if allowed by the customer),
thermal disinfection, drying and
sterilisation cycle, which is used

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