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.
Overview of Ansell's Protective Clothing Range
Ansell offers a comprehensive line of protective clothing specifically designed to meet the diverse needs of cleanroom environments. These products are engineered to provide reliable protection, exceptional comfort, and ease of use. All coveralls in the BioClean-D™ series feature an innovative material, making them lightweight and low-linting. The construction of these coveralls includes bound seams with single stitching.
Here is a brief overview of Ansell's BioClean-D™ cleanroom coveralls:
- BioClean-D™ S-BDCCT: This sterile coverall features a high neck collar that needs to be worn with a hood and overboots.
- BioClean-D™ S-BDFC: This sterile coverall with hood features integrated boots with slip-resistant soles for added workplace safety.
- BioClean-D™ S-BDCHT: This sterile coverall is designed with an integrated hood that needs to be worn with overboots.
- BioClean-D™ Drop-down Sterile Garment with Hood S-BDSH: This sterile coverall boasts drop-down design technology, preventing needless external surface contact, and is equipped with quick-release tabs and internal colored tabs, indicating safe touch points that further ensure aseptic donning.
These coveralls are just a few examples of the extensive range of protective clothing offered by Ansell, designed to cater to a variety of needs in the pharmaceutical and medical device industries. By combining their high-quality protective clothing with the aseptic donning method, operators can maintain a sterile environment and ensure the safety and efficacy of pharmaceutical products.
Ansell's Cleanroom Coverall Packaging
Ansell's sterile PPE is double or triple-bagged in durable plastic packaging to reduce contamination, and sterilization indicators show that the PPE has been sterilized to a Sterility Assurance Level (SAL) 10-6. Certificates of Irradiation (Gamma irradiation sterilization) or Certificates of Processing (Ethylene oxide sterilization) per product lot number can be downloaded via Ansell's easy-to-use certificate tool on Ansell's certificate tool page to prove the PPE has undergone the full sterilization process.
Conclusion
Ensuring a sterile environment is critical to prevent contamination and maintain product quality and safety. The EU GMP Annex 1 guideline provides stringent requirements for aseptic processing, including proper gowning guidelines. By following the Annex 1 guidelines and utilizing Ansell's cleanroom coveralls and packaging, operators can maintain a sterile environment and uphold the safety and efficacy of pharmaceutical products. Ansell's aseptic donning method is a recommended approach to minimize contamination during the gowning process, providing several benefits to the industry, including minimizing contamination, being easy to follow, and maintaining product integrity.
Explore our extensive range of disposable cleanroom coveralls, each crafted to support the highest standards of cleanroom performance and worker safety. Discover our innovative and protective clothing solutions at Ansell’s Life Sciences Protective Clothing.
