In industries where the manufacture or handling of items such as medical devices and microelectronic products, requires high levels of contamination control and classification of even the smallest particle or airborne molecular contaminant - a pristine cleanroom environment is required.

Cleanrooms are enclosed spaces where the air quality is managed to reduce dust, microbes, and other airborne contaminants to minimal levels. Products and processes that benefit from the control of airborne contamination include pharmaceuticals.

Pharmaceutical manufacturing is always done in clean and controlled environments. Even the supply chain partners like those who supply packaging materials to pharma companies must maintain the highest standards in ensuring that the relevant hygiene, care, cleanliness, and microbe-free environment are present while producing such packaging materials. The three ways in which a cleanroom is clean are:

• The air quality is controlled

• All surfaces and equipment are always cleaned to a certain standard

• It is operated in a specific way — for example, the number of staff is limited

To support the management and control of such environments, BSI has several standards that can help pharmaceutical organizations adopt cleanroom best practices.

To read about clinical laboratories and testing, click here.

Setting the Standard for Cleanroom Best Practices

With pharmaceutical processes constantly evolving, the need for cleanrooms that can keep up with changing needs is crucial.

BS EN ISO 14644-8:2013 Cleanrooms and associated controlled environments. Classification of airborne molecular contamination covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group, or category).  It provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification.

Within this part of BS EN ISO 14644, the presence of airborne molecules is expressed as airborne molecular contamination (AMC). Molecular contamination is a three-step event. The first step is generation due to external sources, process leakage, construction, or human material outgassing. The second step is to transport as AMC in air. The third step is sorption on the sensitive surface, which can be quantified as a surface molecular contamination (SMC).

BS EN ISO 14644-8:2013 is one of a series of standards concerned with cleanrooms and contamination control.  Many factors besides AMC need to be considered in the design, specification, operation, and control of cleanrooms and other controlled environments.  These are covered in some detail in other parts of the standard which include:

• BS EN ISO 14644-1:2015 Cleanrooms and associated controlled environments. Classification of air cleanliness

• BS EN ISO 14644-2:2015 Cleanrooms and associated controlled environments. Specifications for testing and monitoring to prove continued compliance with BS EN ISO 14644-1

• BS EN ISO 14644-3:2019 Cleanrooms and associated controlled environments. Test methods

• BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments. Design, construction, and start-up

• BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments. Operations

• BS EN ISO 14644-6:2007 Cleanrooms and associated controlled environments. Vocabulary

• BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments. Separative devices (clean air hoods, gloveboxes, isolators, and mini environments.

In your compliance-critical industry, ensure you are meeting the cleanroom standards. A BSI Knowledge subscription gives you instant access to the resources you need to effectively protect your products from contamination and build trust throughout your supply chain. Build your own custom collection of standards, or opt for access to one of our pre-built modules and keep up-to-date with any relevant changes to your standards strategy. Request to learn more.

Ensure your cleanrooms and processes are operating to best practices by adding these standards to your collection today.