ASEPTIC DONNING IN CLEANROOMS: BEST PRACTICES & COMPLIANCE

Every step in cleanroom gowning matters. A single mistake can introduce contaminants, putting products, processes, and patient safety at risk.

With the updated EU GMP Annex 1 guidelines now in effect (August 25, 2023), ensuring proper aseptic donning is no longer just best practice, it’s a regulatory requirement. But what are the common challenges? And how can operators minimize contamination risks while improving efficiency?

In this article, we’ll explore:

• Why aseptic donning is critical for compliance.
• Ansell’s innovative donning methods designed for Annex 1.
• Step-by-step donning techniques with video resources.

Why Aseptic Donning is Essential for Cleanroom Compliance

Aseptic donning is the backbone of contamination control in cleanroom environments. This process ensures cleanroom personal protective equipment (PPE) is donned correctly, preventing microbial and particulate contamination. Annex 1 guidelines emphasize:

• Validated Protocols: Operators must follow step-by-step, documented procedures to maintain sterility.
• Minimized Contamination Risks: Proper gowning techniques protect cleanroom environments and products from harmful particles and microbes.
• Operator Training: Continuous education is crucial to reinforcing correct aseptic techniques and sustaining compliance.

Key challenges in cleanroom operations include:

• 30% of entire gowning process time is spent on donning coveralls*.
• One-third of operators are unsure of their garment’s sterility due to appearance of its packaging*.
• 50% of operators report garments ripping or billowing due to poor fit*.

Properly donning disposable cleanroom coveralls, gloves, face masks, and goggles is essential to preventing contamination and maintaining the integrity of both the products and the environment. By embedding these principles into daily operations, pharmaceutical manufacturers can significantly reduce contamination risks and remain compliant with Annex 1.

Ansell’s Unique Folding Technique: Designed for Success

Ansell’s unique coverall folding technique and packaging enables true aseptic donning and has been specifically designed to minimize contamination risks and ensure compliance with EU GMP Annex 1.

The unique folding technique on the legs of the coveralls shortens their length, ensuring that the legs of the coverall do not touch the floor when operators insert their legs into the pant/trousers section. By focusing on proper handling and gowning techniques, this method maintains sterility throughout the process.

Step-by-Step Guide to Donning Disposable Cleanroom Coveralls

1. Remove the coverall from the package. The coverall is unzipped, and the chest inverted around the sleeves and legs which have been folded in a specific way to ensure they do not unfold and touch the floor whilst donning
2. Hold the coverall at the waist, which will be the interior, hold in front of you to prepare for donning
3. Optionally, roll the coverall at the waist slightly to shorten the length and provide a better grip for easier donning
4. While holding the interior at the waist, carefully insert each leg into the pant/trousers one at a time
5. Once legs are fully donned, insert the hand carefully into one sleeve while the other hand maintains grip at the waist. Once one arm is donned insert the other hand into the other sleeve
6. Once both hands are inserted into the sleeves, raise both hands up above your head to fully stretch out the garment
7. To don the hood, reach behind your head with palms facing each other, insert hands inside the hood, and bring the hood up and over the head
8. Cross your legs, hold the zipper, and pull upwards until the coverall is fully zipped up
9. After zipping up the coverall, it is important to transfer the leg to the cleaner part of the changing room (white zone) after putting on the overboot. In the industry, a "grey zone" is typically used to denote the preparation area, which is not as clean as the "white zone." This is a crucial step in maintaining a sterile environment, a physical segregation using a bench or bund is often used to clearly separate the two zones.
10. Coverall donning complete.

Ansell’s Protective Solutions and Training Resources

To simplify compliance with Annex 1, Ansell offers a range of BioClean-D™ & Kimtech™ disposable cleanroom coveralls paired with updated donning video demonstrations.

Explore BioClean-D™ & Kimtech™ disposable cleanroom coveralls: