06/21/2017

Safe handling of oncology drugs made easier with Tyvek® single-use cleanroom apparel

Cytostatic drugs thanks to their healing power of destroying cancer cells can
be lifesaving for patients, but may also harm healthy cells of those involved
in their handling. Three protective clothing ranges - Tyvek® IsoClean®, Tyvek®
and Tychem® not only provide confidence for people involved in cancer
treatments, but also protect cytostatic substances from contamination, to
ensure the highest quality of drugs administered to patients.

Without proper protection, cytostatic compounds represent a significant health
risk as they can lead to abnormal formation of cells in healthy organisms,
therefore are carcinogenic, mutagenic and reprotoxic. The greatest hazards
arise by contact with cytostatic dusts, liquids or through aerosol formation.
In the spirit of prevention being the best type of protection, every person
handling cytostatic substances, under law must be provided with appropriate
technical and organisational measures and suitable CE certified personal
protective equipment (PPE). The Quality Standard for the Oncology Pharmacy
Service written by the European Society of Oncological Pharmacy states: "The
directives, regulations and guidelines currently in use stipulate the use of
protective equipment byevery employee of a cytostatic department deriving from
evaluation of the hazard involved. The PPE must carry the CE mark and must be
specified in writing in the hazard evaluation.”

How to choose the right garment for handling oncology drugs?

When considering protective clothing for use with cytostatics it is crucial to
know different fabric technologies as they often exhibit widely varying
performance attributes. For example reusable textiles i.e. polyester garments
are often subjected to multiple cycles of wearing, laundering and sterilization
that can impact negatively barrier properties and durability during the garment
life cycle. Reusable polyester cleanroom clothing is typically not certified as
personal protective equipment according to Directive 89/686/EEC.

On the other hand, Tyvek® material due to its unique versatile structure
provides an abrasion resistant barrier. It provides a high level of protection
against airborne particles >1m and against permeation of a range of low
concentrated inorganic water-based chemicals. Tyvek® garments are low-linting
and have a smooth surface which provides very little foothold for particle
adhesion. Tyvek® material is soft, and supple making garments much more
comfortable to wear than other products.

Evaluation of permeation data as a part of the risk assesment

Hazard evaluation and understanding all requirements associated with a specific
application are essential to determine the most effective personal protective
solution. Apart from protecting people, the products must also be protected
from contamination by people, e.g. by skin particles, hair, lint or other
particles originating from clothing. Product integrity and the relevant aseptic
procedures and GMP guidelines bear the same weight as personal protective
equipment.

PPE must be provided with appropriate technical documentation proving clothing
performance properties e.g. permeation data to cytostatics. In order to provide
appropriate protection against a specific chemical, the chemical permeation
data needs to be consulted as knowing the toxicity or consequences of short- or
long-term exposure to a hazard is essential. A permeation rate indicates the
mass of the chemical in micrograms (g), which can be transferred through one
square centimetre (cm²) of the fabric in one minute (min). For further
information on permeation data of Tyvek® garments please visit
www.safespec.dupont.co.uk.

DuPont protective clothing - solution for every need

Protective suits made of Tyvek® are also suitable for activities involved in
the production of cytostatics and offer different levels of protection
depending on hazard type. Moreover, CE certified Tyvek® coveralls are available
as Cat. III PPE. Accessories made of Tychem® C provide additional protection
from inorganic chemicals for body parts subjected to high levels of exposure.

AplusA-online.de - Source: DuPont Protection Solutions