Best Practices for Cleanroom Gowning Procedures

Source: Lab Supply Network

In industries like pharmaceuticals, biotechnology, and medical devices, contamination control is paramount. Personnel are among the largest sources of contamination in cleanrooms, and proper gowning and de-gowning procedures are critical to maintaining sterility. These processes ensure compliance with stringent regulatory standards, protect product integrity, and maintain a contamination-free environment.

This blog outlines the best practices for cleanroom gowning and de-gowning procedures, emphasizing the importance of designated areas and proper protocols.

Why Gowning and De-Gowning Matter

Personnel introduce particles, microbes, and contaminants into cleanroom environments through clothing, hair, and skin. Proper gowning and de-gowning serve as barriers, minimizing contamination risks.

Key Benefits:

• Ensures compliance with ISO and cGMP standards.

• Protects products and processes from contamination.

• Maintains the overall cleanliness of the cleanroom environment.

• Prevents cross-contamination during exit and entry.

The Importance of Gowning and De-Gowning Areas

Gowning Area

The gowning area acts as a transition zone where personnel don cleanroom garments before entering the controlled environment. Key features include:

• Separation Zones: Clear delineation between “dirty” and “clean” zones to prevent contaminants from entering the cleanroom.

• Storage: Shelves or cabinets for cleanroom-approved garments.

• Sanitization Facilities: Handwashing stations and sanitizing dispensers.

De-Gowning Area

The de-gowning area ensures that contaminants from the cleanroom are not carried into uncontrolled environments. Key features include:

• Trash Receptacles: For disposable garments, gloves, and shoe covers.

• Clear Protocols: Defined steps for removing garments without spreading contaminants.

• Airlocks: Prevent the exchange of air between the cleanroom and external areas during entry and exit.

Tip: Gowning and de-gowning areas should be well-marked and separated to maintain a unidirectional flow of personnel and materials.

Step-by-Step Gowning Procedure

1. Handwashing and Sanitization

   • Wash hands thoroughly with soap and water, focusing on nails and fingertips.

   • Dry hands with lint-free towels or air dryers.

   • Apply an alcohol-based sanitizer.

2. Don Hair and Beard Covers

   • Cover all hair, including facial hair, with a bouffant cap or beard cover.

3. Wear Shoe Covers

   • Place shoe covers over footwear to prevent contaminants from entering the cleanroom.

4. Put on Coveralls

   • Step into cleanroom coveralls, ensuring the suit does not touch the floor.

   • Fasten zippers or snaps securely.

5. Don Gloves

   • Wear sterile gloves, ensuring no skin is exposed between the gloves and coveralls.

   • If double-gloving, wear the first pair under the sleeves and the second pair over the sleeves.

6. Wear Goggles or Face Shields

   • Protect the face and eyes with cleanroom-approved goggles or shields.

7. Final Sanitization

   • Sanitize gloved hands with an approved disinfectant before entering the cleanroom.

Step-by-Step De-Gowning Procedure

1. Exit to the De-Gowning Area

   • Move to the designated de-gowning zone or airlock to prevent contamination spread.

2. Remove Gloves

   • Remove gloves carefully to avoid touching the outer contaminated surface.

3. Take Off Goggles or Face Shields

   • Place goggles or shields in their designated storage or cleaning areas.

4. Remove Coveralls

   • Remove coveralls by unzipping and rolling them downwards, avoiding contact with clean areas.

5. Dispose of Shoe Covers

   • Place shoe covers in a dedicated trash receptacle.

6. Discard or Store Garments

   • Dispose of single-use items appropriately or place reusable garments in designated bins for cleaning.

7. Handwashing and Exit

   • Wash and sanitize hands thoroughly before leaving the de-gowning area.

Best Practices for Gowning and De-Gowning

1. Designate and Maintain Areas

   • Clearly separate gowning and de-gowning zones to prevent cross-contamination.

2. Train Personnel

   • Ensure all personnel are trained in gowning and de-gowning procedures, emphasizing their role in contamination control.

3. Use Cleanroom-Approved Garments

   • Select non-linting, anti-static, and durable materials designed for cleanroom environments.

4. Monitor Compliance

   • Conduct regular audits to ensure personnel adhere to gowning and de-gowning protocols.

5. Maintain Inventory

   • Keep an adequate stock of cleanroom garments and ensure they are stored in contamination-free areas.

Common Mistakes to Avoid

• Skipping Steps: Omitting gowning or de-gowning steps increases contamination risks.

• Improper Handling: Mishandling garments can transfer contaminants.

• Reusing Disposable Items: Always replace single-use gloves, shoe covers, and other items.

• Crossing Zones: Avoid re-entering clean zones after de-gowning without proper re-gowning procedures.

Conclusion

Proper gowning and de-gowning procedures are vital to maintaining a cleanroom’s integrity. By adhering to best practices and using designated gowning and de-gowning areas, businesses can minimize contamination risks, ensure compliance, and protect product quality.

At ReadyStart CleanRooms, our cleanroom facilities have dedicated gowning and de-gowning areas that meet the highest industry standards. In addition, we provide our customers all needed PPE. Contact us today to learn how we can support your operational needs.

About The Author

Darrell Drysen has over 25 years of experience in the Medical Device, Life Science, and Bio-Tech industries. As a technical leader, he holds patents in several fields including Brachytherapy, Electrophysiology, and Neurovascular implants. His outstanding ability to lead projects is evident from the numerous products he has taken from from concept through commercialization for both large companies and starts-ups. He joined ThermoGenesis in 2019 and is currently the Vice President of Operations.

Darrell holds certificates and degrees in Plastics Engineering Technology, Project Management, and Business Administration from California State University Sacramento and Cal Poly Pomona.