Steven Cumper

October 17, 2023

3 Min Read

The global biotechnology industry has undergone a significant period of growth over the past three to four years. The COVID-19 pandemic accelerated the size and importance of an already growing sector, compounding the responsibility that falls on developers and manufacturers to deliver products that are uncontaminated and safe. Ensuring compliance with industry regulations is essential to safety, and professional attire for laboratories and cleanrooms is an integral part of adhering to standards.

Biomanufacturing businesses often handle living cells, cell components, live viruses, and other potentially sensitive or harmful substances. Such work involves adhering to strict safety and cleanliness standards. Because of the potential hazards of bioprocessing, the industry is heavily regulated. Depending on the nature of their work, companies may be subject to rules imposed by the US Department of Agriculture (USDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Food and Drug Administration (FDA). Agency guidelines must comply with the US Coordinated Framework for the Regulation of Biotechnology.

Guidelines for Appropriate Professional Attire
Bioprocessing industry guidelines are far-reaching and include specifications for professional attire. Appropriate clothing differs depending on the work of the person in question. For example, a senior executive might wear a business suit, whereas employees doing hands-on laboratory work will have to meet different expectations. In most laboratories, hard-wearing scrubs are the best choice of garment. Medical scrubs have roots in the early 20th century when medical professionals learned more about and emphasized the importance of hygiene.

However, in some bioprocessing environments, scrubs offer inadequate protection. Cleanrooms require an even higher level of control to preserve the integrity of processes and products. Such environments are common in the bioprocessing and pharmaceutical industries. Cleanroom attire may resemble a hazmat suit, including a full-body gown, shoe covers, a face mask, and gloves. Such attire enables wearers to remove their suits without compromising their own clothing or skin.

Cleanrooms are regulated by the International Organization for Standardization (ISO). ISO 14664 defines 10 classes of cleanrooms, each category specifying a type of protective clothing (1). Class 1 refers to the strictest of cleanrooms, with professional attire that resembles the hazmat suits mentioned above. The remaining nine levels are somewhat less stringent in their requirements.

The Benefits of Following Guidelines
Professional attire guidelines benefit employers and employees alike. Employees benefit from increased workplace safety because the guidelines are designed to keep workers in laboratories and similar locations safe. That protection also extends to their families once employees leave their places of work. And just as professional attire keeps workers safe, it also protects manufactured products.

Industry leaders have recognized that employee health and well-being are closely tied to company growth and profitability. Providing a safe workplace is an integral part of corporate social responsibility. Complying with legal requirements helps companies mitigate risk and limits liability in cases of unexpected incidents and accidents.

By following regulations imposed by organizations such as OSHA and ISO, employers can mitigate employee exposure to risks arising from the nature of their business. Professional attire in bioprocessing keeps employees and their families as safe as possible by preventing cross-contamination of cleanroom products with external substances. The same is true for potentially harmful substances that might be removed accidentally from laboratories and contaminate home environments.

Maintaining regulatory compliance in bioprocessing attire starts by understanding current guidelines for specific environments and ensuring that a company’s procedures and protocols are up to date. Businesses need to understand that different areas of each company will be subject to different regulations. Although financial concerns are understandable, leadership teams must recognize the importance of workplace safety in bioprocessing. Initial cost, disposability, and sterilization requirements are all important considerations, but none is more critical than employee safety.

1 ISO 14644-1:2015: Cleanrooms and Associated Controlled Environments — Part 1: Classification of Air Cleanliness by Particle Concentration. International Organization for Standards: Geneva, Switzerland, 2015;

Steven Cumper is founder and director of Medshop Australia and Scrubs IQ; [email protected];;

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