Ensuring a sterile environment is crucial in various industries such as pharmaceuticals, biotechnology, and medical device manufacturing. Ansell’s range of cleanroom coveralls plays a vital role in maintaining these sterile conditions. This blog post will explore the differences between disposable and reusable cleanroom coveralls, the importance of aseptic donning, and the benefits of Ansell’s high-quality disposable coveralls.

Disposable vs. Reusable Cleanroom Coveralls

People are the biggest cause of contamination in cleanrooms. Therefore, it’s critical to wear the right coveralls to maintain cleanroom standards. When selecting cleanroom coveralls for life sciences applications, it’s important to recognize the fundamental differences between reusable and disposable coveralls to make an informed choice.

By selecting the appropriate garment for the application, employers can protect their valuable products and processes from harmful particles and ions. This improves product integrity and minimizes risk while protecting their workforce with appropriate PPE.

The Difference Between Disposable and Reusable Cleanroom Coveralls

	Material and Post-Processing: Disposable Coveralls: Typically feature a polyethylene film outer layer and a non-woven polypropylene inner layer, sterilized once by gamma irradiation without water usage in post-processing. This method maintains the integrity of the garment. Reusable Coveralls: Generally made of woven polyester, sterilized multiple times by gamma irradiation or autoclaving, and washed in deionized water. Repeated irradiation cycles can lead to the breakdown of garment fibers and degrade the fabric, causing it to relax and the pore size to become larger.
	Bacterial Filtration Efficiency: Disposable Coveralls: Due to the laminated nature of the material, testing for bacterial filtration efficiency is not applicable. Reusable Coveralls: Initially show a bacterial filtration efficiency of less than 70%, which can drop to below 40% after several washes.
	Chemical and Particle Protection: Disposable Coveralls: Offer TYPE 6 limited protection against liquid spray and splash, ensuring a barrier against chemical splashes. They also provide TYPE 5 protection against solid particulates. The design allows for comfort and flexibility during use while creating a solid barrier against skin particles, hair, lint, and other particles escaping from the garment. Reusable Coveralls: Do not offer effective protection against chemicals, as these substances can easily penetrate the garment, leading to contamination of the wearer.
	Repairs and Rental Agreements: Disposable Coveralls: Require no repairs or rental agreements, offering a one-off payment system. Reusable Coveralls: Necessitate repairs for even minor damage and involve long-term rental contracts with fixed weekly costs, irrespective of garment usage.

Benefits of Disposable Cleanroom Coveralls

Disposable cleanroom coveralls are crucial for minimizing cross-contamination and offering superior chemical protection. Classified as Class III PPE, they provide a flexible, no-commitment solution for adjusting quantities and sizes. They also come with consistent performance, physical characteristics, and recycling options, depending on your business or location.

Understanding EU GMP Annex 1

The EU GMP Annex 1 guideline, updated on 25th August 2022, emphasizes quality risk management and contamination control in aseptic processing. It provides comprehensive guidance on maintaining sterility in medicinal product manufacturing.

The Importance of Aseptic Donning

Aseptic donning is crucial for maintaining sterility. Using Personal Protective Equipment (PPE) properly minimizes contamination risks during gowning. Adhering to specific protocols ensures the integrity and safety of both products and cleanroom environments.

Ansell's Aseptic Donning Method

Ansell's aseptic donning method for cleanroom coveralls is a recommended approach to minimize contamination during the gowning process. Ansell's donning guides, available in static and video formats, show how to don cleanroom coveralls according to strict guidelines stipulated in Annex 1. Operators are only allowed to touch the inner surface of the cleanroom coverall when donning.

Watch our video guide for the BioClean-D™ Coverall with Collar (S-BDCCT) to understand the steps involved in maintaining a sterile environment during the donning process.

Our video showcases Ansell's innovative garment fold technique that enables true aseptic donning, enhancing your cleanroom safety and efficiency. For more detailed guides, check out our other donning videos: BioClean-D™ Coverall with Hood and Integrated Boots S-BDFC and BioClean-D™ Sterile Coverall with Hood S-BDCHT.

Benefits of Ansell's Aseptic Donning Method

Ansell's aseptic donning method offers several advantages to the pharmaceutical industry, including:

	Minimizing Contamination: The method ensures that operators only touch the interior surface of the cleanroom coverall during the donning process, minimizing cross-contamination risks.
	Easy to Follow: The method is straightforward, with clear instructions provided in static and video formats, ensuring operators are properly trained to don the coveralls aseptically.
	Maintaining Product Integrity: The method and Ansell's cleanroom coverall packaging minimize cross-contamination, protecting the integrity of products manufactured in aseptic environments.