In today's dynamic and tightly regulated industries, maintaining the safety of people and integrity of products is paramount. One of the most critical areas of concern is contamination control in controlled and cleanroom environments. Cleanroom classification standards for ISO 7/8, Grade C/D settings require the use of protective clothing in compliance with industry standards to reduce the risk of contamination and protect against chemicals. Industries that commonly require cleanroom coveralls include pharmaceutical manufacturing, medical device production, biotechnology, and laboratory & research.
What are Cleanroom Hazards?
Cleanrooms are controlled environments that are designed to minimize contamination and maintain an aseptic environment for the preparation of sterile products. However, despite the strict controls in place, there are still hazards within the cleanroom, to both the personnel and the products being manufactured, such as:
Chemical exposure, including solvents, acids, and other harmful substances
Airborne particles, from human activity, cleanroom equipment and consumables and air handling systems
Biological hazards, such as bacteria, viruses, and other microorganisms
Safety Measures in Cleanrooms
It is essential for those working in cleanrooms to be aware of these hazards and take steps to minimize their risk of exposure and reduce the risks to the products. To maintain a safe and controlled environment, a contamination control strategy (CCS) should be in place and include:
The wearing of proper cleanroom attire such as low-linting personal protective equipment (PPE), including coveralls, gloves, goggles and face masks
Strict protocols for entering and exiting the cleanroom
Frequent monitoring for contamination and maintaining a clean and sterile environment
Regular maintenance and cleaning of equipment
Disposable vs. Reusable: Making the Right Choice for Cleanroom Coveralls
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 it comes to 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 which 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.
Key Benefits of BioClean™ 2000 Model 111
Our BioClean™ 2000 Model 111 offers numerous advantages, such as:
Advanced Material for Enhanced Protection
The BioClean™ 2000 Model 111 is a sterile disposable coverall constructed from a microporous polyethylene film laminate with SBPP Fabric. This material is lightweight, low-linting, and antistatic, making it an excellent choice for use in controlled and cleanroom environments. The use of microporous polyethylene film laminate provides a barrier to particles and liquids, while still allowing for breathability. This ensures that the wearer stays cool and comfortable, even during long periods of use.
Superior Design for Comfort and Protection
To ensure both comfort and security, the BioClean™ 2000 Model 111 features a 3-piece hood design that fits comfortably and securely around the head, minimizing the risk of contamination. The coverall also includes a front zip with a protective flap to prevent any particle or liquid penetration. Elasticated wrists, ankles, and waist provide a snug fit while ensuring ease of movement, essential for operators performing tasks that require dexterity and precision.
Additionally, the garment features thumb loops to keep the sleeves in place and prevent them from rolling up, further enhancing the contamination protection of the coverall.
Bound seams offer higher liquid chemical repellence and prevent particles from exiting the garment through the seams.
Innovative garment fold technique
All BioClean™ 2000 Model 111 feature Ansell's innovative garment fold technique that enables true aseptic donning, ensuring the coverall remains contamination-free during the donning process, which is crucial in maintaining the integrity of aseptic controlled and cleanroom environments. Learn more about our unique Aseptic fold technique here.
This innovative fold technique ensures compliance with EU GMP Annex 1 guidelines part 7.13 which specifies garments should be packed and folded in such a way as to allow operators to don the gown without contacting the outer surface of the garment and to prevent the garment from touching the floor.
Quality Assurance and Compliance
The BioClean™ 2000 Model 111 cleanroom coverall is fully manufactured and packed in our own state-of-the-art NEBB-certified ISO Class 7 cleanrooms. This includes every stage of production, from material cutting and sewing to the final packaging process. Each coveralls undergo a strict quality assurance process to ensure they meet the highest standards of protection. As part of this, we have committed to extensive quality checks, including Particle Shedding (Helmke Drum Test Cat II) to ensure the air particle count meets required standards.
The coverall is gamma irradiated to ensure sterility, with a Sterility Assurance Level (SAL) of 10⁻⁶, providing assurance of product protection from living microorganisms. For added assurance, our BioClean™ 2000 Model 111 coverall is certified as a CE PPE Category III Type 5 (protection against solid particles) and Type 6 (limited protection against liquid spray/splash), providing additional protection assurance.
Commitment to Packaging Excellence
How PPE is packaged, and the packaging materials used is another critical element for consideration. The BioClean™ 2000 Model 111 sterile coveralls comes vacuum sealed in non-particulating plastic PE packaging, packed in shipper cases with a PE liner to reduce the risk of contamination during the transportation and unpacking of the garment and transfer of the garment to the cleanroom changing room. Sterilization indicators are clearly visible on the packaging to show the PPE has received the specified sterilization process and the Certificate of Irradiation (Gamma) show the min. specification and the dose range received, COIs can be downloaded, per product lot number, via our easy-to-use certificate tool on www.ansell.com/life-sciences/certificates
In line with the EU GMP Annex 1 guidelines part 7.11 which highlights that for sterilised garments (and eye coverings), particular attention should be taken to ensure they have been subject to the sterilisation process, are within their specified hold time and that the packaging is visually inspected to ensure it's integrity before use. The COI proves Ansell sterile PPE has been subjected to the full sterilization process, and all packaging clearly states expiry and manufacturing dates.
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
GRADE A/B QUALITY for GRADE C/D Applications
At Ansell, we are passionate about providing high-quality, reliable products for controlled cleanroom environments. Our BioClean™ 2000 Model 111, sterile ISO Class 7/8 disposable coverall has all the quality features and benefits you’d expect from an ISO Class 4/5 coverall, including lightweight, low-linting antistatic material, secure bound seams for higher particle and liquid chemical repellence, zip with protective flap and elasticated back, cuffs and ankles as well as thumb loops to provide a more secure and comfortable fit. Tailored to the needs of diverse industries like pharmaceutical manufacturing, biotechnology, medical device production, and transportation, it addresses the critical requirement for contamination control, chemical protection, and personal comfort.
Our commitment to quality assurance, compliance, and sustainability in packaging sets us ahead of the curve. With BioClean™ 2000 Model 111, we offer more than just a product; we offer a commitment to outstanding protection and sustainability.
Reduce the contamination risk in your bioburden-controlled/aseptic cleanroom today. Choose BioClean™ 2000 Model 111 and discover the impact of robust protection, innovative design, and an unwavering commitment to quality.
*Packaging recyclability will depend on available disposal options in your country and on the condition of the packaging at the time of disposal.