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
- 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
- Hold the coverall at the waist, which will be the interior, hold in front of you to prepare for donning
- Optionally, roll the coverall at the waist slightly to shorten the length and provide a better grip for easier donning
- While holding the interior at the waist, carefully insert each leg into the pant/trousers one at a time
- 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
- Once both hands are inserted into the sleeves, raise both hands up above your head to fully stretch out the garment
- 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
- Cross your legs, hold the zipper, and pull upwards until the coverall is fully zipped up
- 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.
- 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:
This sterile coverall features a high neck collar that needs to be worn with a hood and Overboots. Watch the donning video here or download the donning guide.
This sterile coverall with hood features integrated boots with slip-resistant soles, for added workplace safety. Watch the donning video here or download the donning guide.
This sterile coverall is designed with an integrated hood that needs to be worn with overboots. Watch the donning video here or download the donning guide.
This sterile coverall boasts drop-down design technology, preventing needless external surface contact, and is equipped with quick-release tabs and internal colored tabs, indicating safe touch points that further ensure aseptic donning. Watch the donning video here or download the donning guide.
Kimtech™ A5 Sterile Cleanroom Coverall
Featuring Clean-Don™ Technology, this coverall incorporates snap technology, an inside-out fold pattern, and thumb loops to simplify aseptic donning and minimize contamination risks. Watch the donning video here.
These resources ensure operators can confidently follow best practices, reducing errors and maintaining a sterile environment.
Why Choose Ansell’s Solutions?
Ansell’s unique folding technique combined with high-performance and quality disposable cleanroom coveralls, addresses some of the most pressing challenges in cleanroom contamination control.
Key Benefits:
- Minimizing Contamination: Cleanroom operators dispose of 10% of sterile garments every week due to exterior contamination during gowning*. Ansell’s apparel presentation ensures operators handle only the interior surface of the coverall, reducing cross-contamination risks.
- Easy to Follow: With clear step-by-step guides in both video formats and donning guide, operators can quickly adopt correct aseptic techniques. This is crucial, as new operators require an average of 30 hours of training in cGMP donning procedures before they are allowed inside a cleanroom*.
- Maintaining Product Integrity: The folding and packaging minimize cross-contamination, protecting the integrity of products manufactured in aseptic environments.
Disposable cleanroom coveralls provide an added layer of protection by eliminating the risk of residual contamination from previous use, making them a reliable choice for sterile environments.
Learn more about the benefits of disposable cleanroom coveralls here.
Sterile Packaging for Added Assurance
One-third of cleanroom operators report being unsure of their garment’s sterility due to the appearance of its packaging. Ansell solves this concern with its double or triple-bagged sterile PPE, designed to minimize contamination risks during transfer into cleanroom environments.
Each package includes sterilization indicators that confirm the PPE has been sterilized to a Sterility Assurance Level (SAL) of 10⁻⁶, ensuring the highest level of protection and compliance with cleanroom requirements.
Additionally, Certificates of Irradiation (Gamma irradiation sterilization) or Certificates of Processing (Ethylene oxide sterilization) are available for every product lot and can be downloaded via Ansell's Certificate Tool to verify the complete sterilization process.
Conclusion: Empower Your Contamination Control Strategy
Maintaining compliance with EU GMP Annex 1 starts with precision, validated methods, and trusted solutions. Ansell’s BioClean-D™ and & Kimtech™ disposable cleanroom coveralls and aseptic donning resources empower operators to maintain sterility, reduce contamination risks, and protect product integrity.
Ready to elevate your contamination control? Explore Ansell’s range of protective clothing and training resources today.
*Kimtech™ have spent 2 years interviewing cleanroom operators, visiting them in their workplaces and evaluating the features and functions of traditional sterile cleanroom gowns to identify areas in which there was potential room for improvement.