Explore Sterile Tyvek® IsoClean®
Navigating how to stay compliant with Annex 1? Consider these questions related to your cleanroom garment systems…
- Why Tyvek® IsoClean®
- Garments & accessories
- Resources
Why Tyvek® IsoClean®?
DuPont understands your need to do everything possible to improve productivity and reduce risk in your controlled environment. The DuPont Controlled Environments (CE) portfolio offers a comprehensive selection of single-use cleanroom apparel and accessories designed for use in various settings that require high standards for particle and microbiological contamination control.
The highest performing garments in our product line are made from Tyvek®, which has been used to make high-quality cleanroom garments for more than 25 years. Tyvek® is made by DuPont with a proprietary flash-spinning process that creates continuous fibers of high-density polyethylene that are randomly distributed and non-directional.
Tyvek® IsoClean® cleanroom garments, designed for single use, offer meaningful advantages in today’s challenging cleanroom environments, including:
- Quality—single-use garments are not subjected to multiple cycles of wearing, laundering, and sterilization, so fabric barrier and strength are consistent and predictable.
- Flexibility—the DuPont single-use apparel program allows you to order only the quantities that you plan to use, which offers flexibility as your needs change.
- Cost control—single-use garments help eliminate budget uncertainties associated with garment repair, damage, and loss, helping you to better predict expenditures.
<b>Sterility assurance</b>
Sterility is achieved by gamma irradiation. Radiation dosage is validated in accorance with ISO 11137 for an SAL of 10-6. A Certificate of Sterility comes with every shipment.
<b>Inherently low linting and protective barrier</b>
Tyvek® is inherently low-linting and provides a consistent barier against dry particles and microorganisms. Clean-processed garments are tested for particle shedding using the Helmke drum (IESTRP-CC003.4) test.
<b>Validated cleanroom packaging</b>
Sleeves are individually packaged by pair and folded to aid in aseptic donning. Case quantity is packaged in a cardboard case with two polyethylene liners.
<b>Quality and traceability you can trust</b>
Tyvek® sterile accessories have lot traceability, from fabric manufacturing to garment conversion.
How do I evaluate the cleanliness of my garments?
Am I prepared for an audit of my cleanroom garment system?
Achieve Annex 1 compliance with DuPont™ Tyvek® IsoClean® Case Study: Explore the benefits of single-use
Garment & Accessories
Protecting operators processes and products with DuPont Personal Protection.
The DuPon Personal Protection portfolio offers a full spectrum of cleanroom and PPE garments and accessories for greater safety, comfort and protection against contamination.
Sterile and non-sterile garments and accessories for GMP A/B/C/D and ISO 4/5 aseptic and ISO 7/8 controlled environments.
Explore Tyvek® IsoClean®
Non-Sterile garments and accessories for GMP C/D, ISO 7/8 and CNC areas.
Explore Tyvek®
Protect workers with chemical barrier fabrics specifically engineered for protection over a range of hazards.
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