Well-designed
cleanrooms when operating as intended are invariably in a state of control. There are, however,
circumstances that can impact this state
of control. Cleanrooms are subject
to a greater level of particulate and microbiological risk when they
undergo maintenance or where there is a facility shutdown. Such risks are
potentially greater with aging facilities. This article considers the controls
required to minimise the risks to cleanrooms during shutdowns, including a
particular focus on aseptic processing areas, and examines the level of testing
required to bring a facility back into
use, including the application of sporicidal disinfectants and risk-based
environmental monitoring.
In
relation to this, Tim Sandle has written an article. The reference is:
Here
is an extract:
Regular
maintenance is essential in order to ensure that all equipment and processes
continue to operate in their validated state and within their defined critical
operating parameters. Preventive maintenance includes activities such as pre-planned inspections, lubrication,
intensive non-routine cleaning, adjustments,
or verification of the proper operation of equipment and utilities. It can also include restoring/ upgrading the
condition of the facility. As well as maintenance, shut-downs also allow for
room modifications to be made. Each
activity can present a microbial risk, such as when building works lead to dust
generation, when surfaces are exposed, when water is used or when unsanitary items are
introduced into the cleanroom. Microbial risks also arise when air handling
units are deactivated, resulting in increases to particle levels and the
inability of a room to ‘clean-up’ through operating with adequate ventilation.
This
article considers some of the microbiological risk factors as cleanrooms
undergo works and are then reinstated.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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