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

1. 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.

2. 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.

3. Secured seams

   Bound seams offer higher liquid chemical repellence and prevent particles from exiting the garment through the seams.

4. 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.

5. 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 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.

6. 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