BioClean™ 2000 Model 111 FAQs: Sterile Cleanroom Coveralls

What is an ISO Class 7/8 cleanroom coverall?

The primary aim of an ISO Class 7/8 cleanroom coverall is to control contamination and maintain a sterile environment in cleanrooms. The BioClean™ 2000 Model 111, a sterile disposable coverall, is tailored for use in aseptic controlled environments, adhering to ISO 7 and 8 / Grade C & D standards. This coverall, with an integrated hood, offers robust protection against chemicals, aligning well with the fundamental purpose of ISO 7/8 cleanroom coveralls. It's ideal for individuals seeking comprehensive body coverage and reduced contamination risk in bioburden-controlled and aseptic cleanroom settings. Read more about the BioClean™ 2000 Model 111.

What are the features and benefits of BioClean™ 2000 Model 111?

The BioClean™ 2000 Model 111 is designed with advanced material constructed from a microporous polyethylene film laminate with SBPP Fabric, superior design featuring a 3-piece hood design, secured seams, and innovative garment fold technique that enables true aseptic donning ensuring compliance with EU GMP Annex 1 guidelines part 7.13.

It also ensures quality assurance, compliance, and sustainable packaging, making it suitable for various life sciences and industrial applications. This coverall is ideal for aseptic handling, chemical handling, food processing, and more. It's manufactured in NEBB-certified ISO Class 7 cleanrooms, ensuring the highest standards of protection. For further insights, explore the full features and benefits of BioClean™ 2000 Model 111 here.

Who is the target user of the BioClean™ 2000 Model 111?

The BioClean™ 2000 Model 11 is ideal for use in a variety of cleanroom environments, including:

• Pharmaceutical manufacturing
• Biotechnology
• Food and beverage processing
• Electronics manufacturing
• Aerospace manufacturing
• Medical device manufacturing
• Controlled and Critical Environments
• Laboratory Research and Development

What are the compliance standards of the BioClean™ 2000 Model 111?

The BioClean™ 2000 Model 111 is gamma irradiated to ensure sterility with a Sterility Assurance Level (SAL) of 10⁻⁶. It is certified as CE PPE Category III Type 5 and Type 6, providing protection against solid particles and limited protection against liquid spray/splash respectively. The meticulous manufacturing and packaging processes in NEBB-certified ISO Class 7 cleanrooms further attest to its compliance with stringent quality standards. Learn more about its compliance standards.

How to DON the BioClean™ 2000 Model 111?

Ansell's innovative coverall donning method ensures that particulate contamination is prevented before entering cleanroom environments. By rolling up the coveralls to shorten their length, operators provide a better grip for easier donning, and the foot section of the coverall does not touch the floor when operators insert their legs into the pant/trousers part of the coverall. This method and the way Ansell cleanroom coveralls are packed minimize cross-contamination, protecting operators, and maintaining the integrity of products.

The steps to Ansell's aseptic donning method for coveralls are as follows:

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 and is practiced by all pharmaceutical companies. Physical segregation using a bench or bund is often used to clearly separate the two zones.
10. Coverall donning complete.

Or watch our video here that showcases Ansell's innovative garment fold technique that enables true aseptic donning, enhancing your cleanroom safety and efficiency.

Sterile Disposable Cleanroom Coverall vs. Reusable Coverall: Which is the better choice?

People remain the primary source of contamination in cleanrooms so it’s critical that the right protective clothing is worn to maintain the cleanrooms credentials and performance. When selecting cleanroom coveralls, it is important to recognize that while reusable coveralls and disposable coveralls fulfil the same purpose and need, there are fundamental differences that need to be highlighted so you can make an informed choice.

At a glance, both reusable and disposable coveralls serve the same fundamental purpose – providing a barrier against contaminants. However, when delving deeper into their specifics, the disposable coveralls, like those from BioClean™, stand out for several key reasons:

• Post-Processing: Sterilized by gamma irradiation only once, compared to reusable garments which are irradiated (or sterilized by autoclaving) multiple times, which can lead to the breakdown of garment fibres and degrade the fabric.
• Protection: Made from spun-bonded non-woven polypropylene laminated with a film of polyethylene ensuring a solid barrier against contaminants and chemical splash, and are Category III Type 5 & 6 classified PPE, compared to reusable garments made from woven polyester which act like filters and provide little chemical protection.
• No rental contracts: Disposable coveralls can be supplied as and when required and offer flexibility on changes to size demographic and number of coveralls required. No commitment to complex long-term rental contracts pay only for the garments used, and no repair costs.

These features make disposable coveralls ideal for critical applications in pharmaceutical manufacturing, medical device production, and semiconductor fabrication. To understand more about the advantages of using a sterile disposable cleanroom coverall, download the PDF.

How are the BioClean™ 2000 Model 111 coveralls packed?

The BioClean™ 2000 Model 111 coveralls are vacuum sealed in non-particulating plastic PE packaging and packed in shipper cases with a PE liner to minimize contamination risks during transportation and unpacking. The packaging features visible sterilization indicators and provides access to Certificates of Irradiation (Gamma) to verify the sterilization process. COIs can be download, per product lot number, via our easy-to-use certificate tool on www.ansell.com/certificates/life-sciences.

The packaging also adheres to EU GMP Annex 1 guidelines part 7.11, ensuring the coveralls have undergone the sterilization process and are within their specified hold time. Expiry and manufacturing dates are clearly stated on the packaging.
Additionally, aligning with our commitment to Sustainable Packaging Pledge, all packaging component materials used for the BioClean™ 2000 Model 111 are recyclable*. Our aim to reduce our environmental footprint is a priority that goes hand in hand with our dedication to product quality and user safety.

Curious about our use of plastic in packaging? Read our article on the vital role plastic packaging plays in the context of cleanroom consumables.

^{*Packaging recyclability will depend on available disposal options in your country and on the condition of the packaging at the time of disposal.}