The aging facility presents various microbiological contamination risks (and some more recent pharmaceutical product recalls associated with microbial contamination have related to older facilities). These risks include:
Poor facility
management
General
poor upkeep, leading to peeling paint or torn lagging, presents opportunities
for microbial contamination to occur. Risks are more acute for spore forming
organisms, such as Bacillus and related genera and with fungal spores.
Changes to
facility use
Changes
to facility use, in terms of people and equipment, present potential risks. For
example, if a facility was designed for a specific number of personnel and the
operational level increases, this could present new challenges for
contamination control, especially where cleanroom occupancy rates increase
(given that people are the primary contamination source within cleanroom
environments).
Degradation to
fabric
Cracks
in walls, tears to vinyl, and the degradation of construction joints can lead
to microbial contamination events. Here unclean areas can become exposed to
cleanrooms and microorganisms can reside in cracks. Where cracks occur, cleaning
solutions will often not be able to penetrate.
Regular
inspection and a sound repair program can overcome these problems, together
with the fitting of high quality seals such as compressed rubber gaskets.
Building void
spaces
The
voids between adjacent cleanrooms or between cleanrooms and the outside
environment will accumulate dust, and within the dust there will be
spore-forming microorganisms. Such environments will not have any impact unless
they are disturbed. Here contamination will arise when facilities are modified,
such as knocking through a wall in order to expand a cleanroom. Good control
measures should be in place when modifications take place including
partitioning off areas, vacuuming dust and regular cleaning followed by
sporicidal disinfection.
Sandle,
T. (2017) Risk and Microbiological Contamination, PDA Letter, Volime LIII
(7), (July 2017, pp8 at: https://www.pda.org/pda-letter-portal/archives/full-article/pda-summer-reading-for-2017
Posted by Dr. Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources