Sterile manufacturing: Cleanroom gowning process


Cleanroom gowning involves wearing specialized clothing to enter and work in an environment that has been specially designed to minimize the presence of airborne particles and other contaminants. This is particularly important in sensitive industries such as semiconductor manufacturing, pharmaceuticals, and medical device production, where even the slightest impurity can compromise the quality and integrity of the products being made. As such, gowning is a crucial aspect of maintaining the cleanliness of these environments and ensuring that these high-tech products meet the necessary standards of quality and safety.

Here are the general steps involved in cleanroom gowning:


Before entering the gowning area, individuals should remove any personal items and change into facility-provided undergarments. This helps minimize the introduction of contaminants from outside.

Initial Cleaning:

Workers often go through an initial cleaning step, which may involve washing hands and sometimes even taking a shower, depending on the cleanliness requirements of the cleanroom.

Gowning Up:

Gowning typically includes wearing cleanroom garments, such as coveralls, hoods, gloves, and sometimes masks or face shields. The specific gowning requirements can vary based on the cleanroom class and industry standards.

Proper Sequence:

There is usually a specific sequence to follow when putting on cleanroom garments to minimize the risk of contamination. For example, putting on a hood before coveralls and gloves ensures that any particles shed during the gowning process do not reach critical surfaces.

Controlled Entry:

Cleanrooms often have an air shower or an airlock entry system. This is designed to remove loose particles from the surface of the garments before entering the cleanroom properly.

Continuous Monitoring:

Once inside the cleanroom, individuals may be required to follow certain protocols to minimize contamination, such as moving in a controlled manner, avoiding unnecessary movements, and using specified pathways.

Regular Inspections:

Cleanroom garments may be subject to regular inspections to ensure they remain free of particles and contaminants. If a garment becomes compromised, it may need to be replaced to maintain the cleanliness of the environment.

Cleanroom gowning procedures are often detailed and specific to the requirements of the cleanroom in question. The level of cleanliness required is often defined by industry standards, such as ISO 14644 for cleanrooms and associated controlled environments. Adhering to proper gowning procedures is essential for maintaining the integrity of cleanroom processes.

Contact Us:

If you’re struggling with Cleanroom behaviour-related issues or need help setting up Cleanroom areas, don’t hesitate to contact GxP Cellators. Our highly trained SMEs are experts in designing best practices and documents for contamination-free operations. Trust us to provide you with the support you need to ensure a safe and efficient Cleanroom environment. Feel free to contact

by admin

I am a seasoned GxP expert and the founder and CEO of GxP Cellators, a consulting firm that provides GxP advisory and auditing services to clients across the globe. My mission is to help clients achieve excellence in quality, compliance, and remediation, and to foster a robust quality culture in their organizations.

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