Monday 20 July 2020

Assessing microbiological risks in cleanrooms following pharmaceutical facility shut-downs

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:

Sandle, T. (2020) Assessing microbiological risks in cleanrooms following pharmaceutical facility shut-downs, Clean Air and Containment Review, Issue 41: 10-13

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.

For further details, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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