The Importance of Cleanrooms in the Life Sciences industry

The role of cleanrooms in life sciences

Pharmaceuticals

A key field in the life sciences sector is pharmaceuticals, the development of medicinal drugs to diagnose, treat, or prevent diseases. Cleanrooms play a vital role throughout the entire pharmaceutical lifecycle, from research all the way to packaging and storage.

Due to the nature of application of pharmaceutical products, control of particulates, microorganisms, and impurities is critical, and therefore require controlled environments with strict parameters during production. This includes, but not limited to, filtered airflow via HEPA or ULPA fan filters, regulated temperature and humidity controls, and personnel protocols to maintain product integrity and quality.

Whilst the classification may vary depending on the stage and sterility of the application, manufacturing pharmaceutical products typically require a GMP-compliant facility, demonstrating effective contamination control, protocols, and cleanliness for the production of safe and compliant products.

Cell and gene therapy

Cell and gene therapy include advanced treatments that use living cells or genetic materials to treat or cure diseases. Gene therapy involves altering a patient’s DNA to treat a genetic issue, with cell therapy using living cells to provide treatment, like a blood transfusion.

Across the cell and gene therapy field, cleanrooms are vital. For facilities conducting applications for research purposes only, a lower-level cleanroom (e.g., ISO class 7) or laboratory setting may be suitable. However, once cells are being derived, cultured, and stored for potential human application, this must take place in a regulated, controlled environment with effective contamination control measures.

Due to the nature of the products, cell and gene therapy manufacturing cleanrooms typically need to meet high-grade GMP requirements to minimise microbiological and particulate contamination during production. The use of grade A equipment located in the cleanroom environment to provide additional product protection is prevalent within the cell and gene therapy field.

Medical devices

Not only does life sciences involve the research and production of medicinal vaccines and treatments, it also includes the development of electronics and technologies used to diagnose, monitor, and treat illnesses. Medical devices can include tools like walking sticks or wheelchairs to more complex machinery, including pacemakers or X-rays.

For the most part, cleanrooms are essential during research and development of medical devices as they provide the environmental requirements needed to prototype, assemble, and test products without introducing contaminants that could compromise their safety, function, or quality.

Cleanroom classification for medical device production varies depending on the type and risk level. Many early-stage activities are conducted within an ISO class 7 cleanroom, which provide controlled particulate levels suitable for most device assembly and handling operations. More contamination-sensitive products, especially those that are used for surgical purposes or implantation in the body, will require a higher classification cleanroom, such as ISO class 5. Most cleanrooms intended for the manufacture of medical devices are regulated by the Medical Devices Regulation (MDR) 2002 that classify the device based on its risk level:

• Class I: Generally regarded as low risk
• Class IIa: Generally regarded as medium risk
• Class IIb: Generally regarded as medium risk
• Class III: Generally regarded as high risk

Biotechnology

Another aspect of life sciences includes biotechnology that, like the name suggests, combines biology and technology to create products including medicines, food items, and cleaner energy solutions.

Like other areas of life sciences, the production of biotechnology requires a controlled environment to prevent contamination, ensure product quality, protect researchers and operators against potentially biohazardous substances, and provide appropriate production conditions including temperature and humidity controls.

Cleanrooms play a vital role throughout the entire lifecycle of biotechnologies, from research and development, to manufacturing, production, packaging, and storage. Cleanroom classification will vary depending on application and production stage, ranging from a GMP facility to ISO class 7, however, across all stages of biotechnology production, cleanrooms provide the tightly regulated environments required to maintain sterility (if needed) and maintain biological integrity.