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.
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.
The BioClean™ 2000 Model 11 is ideal for use in a variety of cleanroom environments, including:
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.
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:
Or watch our video here that showcases Ansell's innovative garment fold technique that enables true aseptic donning, enhancing your cleanroom safety and efficiency.
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:
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.
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.