Monday 6 December 2021

Risk Considerations for Aging Pharmaceutical Facility Cleanrooms


Pharmaceutical facility cleanrooms are designed to reduce and control particle contamination and to minimize the ingress and retention of microorganisms. Such risks typically are easy to control in well-designed, modern facilities. But risk mitigation is more difficult in older facilities.



Often, older facilities are maintained or even upgraded for commercial and compliance reasons. Plants that predate modern thinking (e.g., quality by design, QbD) might not be able to adapt to future opportunities or threats. Such facilities might be facing risks of microbial contaminations and thus require careful management during shutdown and start-up – hence the need for a risk-based approach.


The article examines the following risk considerations, which take on even greater importance as facilities age:


·         Is the facility suitable for the operations being carried out?

·         Is the facility readily cleanable?

·         Are there proper controls against cross-contamination?

·         Is there adequate ventilation to address sources of contamination?

·         Are there adequate sanitary facilities?

·         Are there separated operational areas to prevent mix-ups and cross-contamination?

·         What is the source of the water supply?

·         Are there adequate systems for the handling and disposal of waste?

·         Is there proper segregation between incoming and released components?

·         Are environmental factors such as temperature and humidity monitored and controlled properly?

·         Is there adequate storage space under the required environmental conditions?

·         Are in-process materials properly stored?

·         Is the facility equipment suitable for its intended use?

·         Is equipment designed to facilitate cleaning?

·         Are there proper filtration systems adequately and properly functioning?

·         Does equipment design prevent contamination from external sources?


To access the article, see:


The reference is:


Sandle, T. (2021) Risk Considerations for Aging Pharmaceutical Facility Cleanrooms, BioProcess International, 19 (5): 10 – 13


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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