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Cytostatic Contamination Protection with Tyvek® and Tychem®

 

Any work with cytostatics requires the protection of workers from the dangers of drugs (carcinogenic, mutagenic, reprotoxic impact). At the same time, it is important to protect the product against contamination from people.

Cytostatics are used as drugs in cancer therapy (chemotherapy) to inhibit the multiplication of tumour cells and are also used increasingly to treat other diseases. However, their toxicity affects not only tumour cells but also healthy cells.

To prevent hazards to staff while handling cytostatics, a range of suitable precautions must be taken. What applies to the handling of hazardous substances in general is also true for cytostatics, i.e. the highest priority must be placed on the full use of all technical and organizational measures. For instance, care must be taken to prevent the formation of cytostatic aerosols and dust and to avoid cytostatic contamination during production, preparation, provision, disposal, storage and transportation of such substances. Potential health hazards can be caused even by low-level contact with cytostatic substances. If there is any risk of contact, use of suitable personal protection equipment (PPE) is mandatory to ensure effective full-scale protection. PPE selection is commonly based on the findings and results of risk analysis, in addition to technical and organisational measures.

These protective measures apply to all staff who come into contact with cytostatics, not merely during production and preparation, but also application, disposal, shipping and when being handled by cleaning and maintenance staff.

Both cleanroom clothing and chemical protective clothing need to meet the same basic criteria for use in a cleanroom: the material must be low-linting, the design must be sufficiently tight and the danger of collecting particles on the surface of the garment must be minimised. To be suitable for dealing with cytostatics, such clothing must also be comfortable to wear, it must have good electrostatic discharge efficiency and sterilisation must be possible.

Tyvek® and Tychem® protective suits – a combination of product and personal protection

As well as providing product protection, Tyvek® and Tychem® protective clothing and accessories also meet the PPE requirements for chemical protective clothing in Category III.

Marcelo Milani, Medical & Pharmaceutical Protection Marketing Manager at DuPont, said: “To simplify the selection of suitable clothing, cytostatics can be classified according to their respective barrier requirements: (a) particles, (b) water-soluble and (c) soluble in solvents. Obviously, however, this classification is only suitable as a guideline and cannot replace a risk analysis. The selection of suitable protective clothing always requires a detailed analysis of the hazardous substances and of the working environment. The barrier effect of protective clothing material is substantially influenced by a range of factors, including physical state, concentration, temperature and pressure. As well as looking at protection requirements, criteria such as comfort and impact on the environment should also be considered when choosing protective clothing.”

Tyvek® and Tychem® protective clothing is available in a range of models, e.g. suit with hood or collar, integrated socks, sewn or covered seams, thumbloop, etc. The product range is complemented by accessories such as sleeves, overboots, overshoes, lab coats, aprons and back-fastening gowns.

The cost of waste disposal is not very high for users, as Tyvek® and Tychem® materials do not contain “critical” additives (e.g. additives with halogens) and can therefore be incinerated by local councils. Obviously, if clothing has been contaminated by hazardous substances, then it must be disposed of in the same way as the actual substances. The relevant disposal regulations apply.