Cytostatic Contamination Protection

Personnel working with cytostatic drugs; most of which are carcinogenic, mutagenic and reproductive toxic agents – must be effectively protected. At the same time, the product itself must be protected against contamination that could be caused by humans. One way to achieve this is to wear appropriate personal protective equipment. DuPont™ Tyvek® and DuPont™ Tychem® coveralls provide solutions for protective clothing in applications where cytostatic contamination protection is required, depending on chemical toxicity and exposure levels.

Worker Protection

Employers must protect workers using cytostatatics with appropriate technical and organizational measures and provide suitable personal protective equipment (PPE). This includes all workers who may come into contact with cytostatatics: during receipt and preparation of materials, transportation and disposal, as well as during preparation for application and administration. The greatest hazard occurs during the preparation of cytostatatics: through contact with dusts (for example, when defective injection vials containing dry solids are involved), liquids (for example, during transport and distribution of dissolved substances), aerosol formation (for example, when dry solids are dissolved) or when containers with cytostatatics are accidentally dropped [1].

Product Protection

However, products must also be protected against human-caused contamination. These can result, for example, from skin particles, hair, fibers or other particles from clothing. In this regard, the German Pharmacy Regulations [2], which have been in force since June 2012, established for the first time special hygiene conditions for the production of cytostatatics. This means that protective clothing must also comply with these requirements. If contamination occurs, the garment must be changed immediately or at least daily. [1]: German employer liability insurance association for health and social services: "Cytostatatics in the healthcare sector – safe handling of cytostatatics", 07/2009 [2]: German regulations concerning the operation of pharmacies, revision - 26.9.1995 I 1195, latest amendment - 5.6.2012 I 1254

DuPont™ Tyvek® and DuPont™ Tychem® – Protection for People and Products

Thanks to its durable and versatile material structure, Tyvek® has excellent barrier properties against wear. It provides a high level of protection against airborne particles larger than 1 μm and against penetration by a range of low-concentration aqueous inorganic chemicals. Tychem® C consists of a protective polymer coating together with a Tyvek® backing layer. Tychem® F contains a protective film laminated to a Tyvek® backing layer. Both materials provide 100% particle protection. At the same time, they provide protection against many organic and high-concentration inorganic chemicals and biological hazards (Tychem® F) and against many inorganic chemicals and biological hazards (Tychem® C). Tyvek® coveralls have very low fibrillation levels and have a smooth surface to prevent particle adhesion. In addition, protective clothing made from Tyvek® material can be easily sterilized using conventional methods.

DuPont Protective Clothing Solutions for Use When Working with Cytostatatics

Limited-use Tyvek® and Tychem® protective garments have the advantage of providing proven and documented barrier protection with each use when not contaminated. Protective garments made from Tyvek® are suitable for all activities involved in cytostatic production. Accessories made from Tyvek®, Tychem® C or Tychem® F materials (sleeves, aprons, gowns, etc.) provide additional protection for body areas that are particularly more exposed to contamination. The following table summarizes the results of permeation tests conducted on Tyvek®, Tychem® C and Tychem® F fabrics with typical cytostatic solutions: Breakthrough time 0.1 = breakthrough time normalized to 0.1 μg/cm²/minute; BT 1.0 = breakthrough time normalized to 1.0 μg/cm²/minute; EN Class = classification according to EN 14325. Figen Ersezer DuPont Chemical and Thermal Protective Clothing Turkey and Israel Sales and Marketing Manager DuPont Turkey