2 Introduction

INTRODUCTION

DUPONT™ TYVEK® GARMENT MATERIAL

DUPONT QUALITY SYSTEMS FOR CLEANROOM GARMENTS

Th e highest performing garments in our product line are made from DuPont™ Tyvek®, which has been used to make high- quality cleanroom garments for more than 20 years. Tyvek® is made by DuPont with a proprietary fl ash-spinning process that creates continuous fi bers of high-density polyethylene that are randomly distributed and non-directional.

 Tyvek® is tough, yet lightweight and soft.  Tyvek® offers an ideal balance of protection, durability,

comfort and contamination control.  Tyvek® acts as a breathable barrier against particles

and bacteria.  Tyvek® repels aqueous liquids and liquid aerosols.  Tyvek® is inherently low linting and abrasion resistant.

DuPont single-use garments for controlled environments off er the following standards of quality:

✓ Th e DuPont Controlled Environments quality management system is ISO 9001:2008 registered.

✓ DuPont™ Tyvek® IsoClean® sterile garments have a sterility assurance level (SAL) of 10-6 . Radiation doses are validated in accordance with ANSI/AAMI/ISO 11137 through bio burden and dose verifi cation testing.

✓ DuPont™ Tyvek® IsoClean® sterile garments are gamma irradiated in a facility that is registered by ISO 13485 quality standard and adheres to the requirements of ANSI/AAMI/ISO 11137.

✓ A Certifi cate of Sterility and a Certifi cate of Compliance come with every shipment of sterile Tyvek® IsoClean® single-use garments.

✓ Dose audits are conducted quarterly to maintain dose validation.

✓ Customers are invited to audit our manufacturing and sterilization facilities.

✓ Quality documentation is readily available and accurate when requested to help meet customer requirements.

✓ Lot traceability is maintained through garment manufacturing, processing and sterilization.

✓ All DuPont™ Tyvek® IsoClean®  sterile products are packed in validated cleanroom sealed bags. Certain models are available packed in a dual barrier validated packaging system, consisting of an inner and outer easy tear, validated, cleanroom bag. Th e system serves both as an additional sterility risk management component and is a key element for contamination risk reduction when transferring apparel into clean areas.

200x magnifi cation Source: DuPont

Picture 1: DuPont™ Tyvek® structure.