CYTOSTATIC CONTAMINATION PROTECTION
Personnel working with cytostatics must be provided with effective protection from these drugs, many of which are carcinogenic, mutagenic and reprotoxic. At the same time, it is important to protect the product against contamination by people. Wearing appropriate personal protective equipment is one of the ways of achieving this. DuPont™ Tyvek® and DuPont™ Tychem® garments offer solutions for protective clothing, depending on chemical toxicity and exposure levels, in applications where cytostatic contamination protection is required.
Employers are required to protect their workforce who handle cytostatics by appropriate technical and organisational measures and to provide suitable personal protective equipment (PPE). This includes all employees who may come into contact with cytostatics: during goods receipt and preparation, transport, preparation for application and administration as well as disposal.
The greatest hazards arise during preparation of the cytostatics by: dusts (e.g. in the event of defective injection vials containing dry solids), liquids (e.g. on transfer and dispensing of the dissolved substance), aerosol formation (e.g. when dissolving the dry solids) or when containers containing cytostatics are inadvertently dropped.
The products too, however, must also be protected from contamination by people, e.g. by skin particles, hair, lint or other particles originating from clothing. The German Apothekenbetriebsordnung (ApBetrO, regulation on the operation of pharmacies), which has been in force since June 2012, accordingly for the first time sets out specific hygiene conditions for producing cytostatics. This means that protective clothing must also comply with these requirements. In the event of contamination, clothing must additionally be changed immediately, or at least daily. The requirements may be summarised as follows:
DuPont™ Tyvek® and DuPont™ Tychem® – protection for people and products
Due to its tough and versatile material structure, Tyvek® provides an abrasion resistant barrier. It provides a high level of protection against airborne particles >1μm and against permeation of a range of low concentrated inorganic water-based chemicals.
Tychem® C consists of a Tyvek® substrate with a polymer barrier coating. Tychem® F consists of a barrier film laminated to a Tyvek® substrate. Both materials are 100% particle-tight. They also provide protection against numerous organic and highly concentrated inorganic chemicals and biological hazards (Tychem® F) and a wide range of inorganic chemicals and biological hazards (Tychem® C).
Tyvek® garments are low-linting and have a smooth surface which provides very little foothold for particle adhesion. In addition, protective garments produced from Tyvek® can be easily sterilised using conventional methods.
DuPont protective clothing solutions for handling cytostatics
As limited-use protective clothing, Tyvek® and Tychem® protective garments have the advantage that uncontaminated virgin material with a proven and documented barrier protection is provided for each use. Protective suits made of Tyvek® are suitable for all activities involved in the production of cytostatics. Accessories made of Tyvek®, Tychem® C or Tychem® F, such as sleeves or back-fastening gowns provide additional protection for parts of the body subjected to particularly high levels of exposure.