As cytostatic drugs have a toxic effect on human cells, double gloving is recommended when handling these substances – even in the cleanroom.

What are cytostatic drugs?

Cytostatics are substances that inhibit cell growth or cell division. The substances can be of natural or synthetic origin. Cytostatics are classified as toxic due to their effect on cells. In the medical field, cytostatics are administered as growth-inhibiting drugs in cancer treatment, which many people are familiar with through the term chemotherapy.

Since not only malignant tumor cells are attacked by cytostatic drugs, but also healthy cells, chemotherapy sometimes causes very severe side effects. To allow the patient to recover from the cytostatic treatments, chemotherapy is repeatedly interrupted by breaks.

What should be considered when handling cytostatics?

Due to their toxic effect, cytostatic drugs are manufactured in a clean room for health and safety reasons. As cytostatic infusions must be sterile drugs, sterile conditions must prevail in the cleanroom where these cytostatic drugs are produced ready for administration.

Cleanrooms are divided into different classes, whereby there are two different class systems. In the pharmaceutical sector, the so-called GMP system is used, in which there are four cleanroom classes: A, B, C and D. Class A is the class with the highest requirements, i.e. the one that allows the lowest particle concentration in the cleanroom.

When manufacturing cytostatics, a cleanroom class A workbench should be used, which should be located in a class B cleanroom.

When using a so-called isolator, the requirements for the environment are lower.

For emergency situations, an emergency and cleaning kit – a so-called “spill kit” – should also be available to remove contamination from so-called CMR drugs, which also include cytostatic drugs. CMR stands for the English terms “carcinogenic”, “mutagenic” and “reprotoxic”, which means “carcinogenic”, “mutagenic” and “teratogenic or reprotoxic”.

An additional safety measure is the installation of separate airlocks, i.e. an airlock for personnel and an airlock for the material used in the cleanroom.

Processing cytostatics in the clean room

What is double gloving?

To further increase safety when handling cytostatics, double gloving is recommended in some cases, as it cannot be completely ruled out that glove perforations may occur during medical applications. However, the double gloving recommendation also applies to the manufacture and preparation of cytostatics.

The recommendations “Safe handling of medicines in the healthcare sector” issued by Suva (Swiss Accident Insurance Fund) state in the subsection “Protective measures during manufacture and preparation” in the section “Handling cytostatic drugs to be administered parenterally”:

“To eliminate the residual risk (especially with cytostatic drugs with high penetration capacity, such as carmustine, cyclophosphamide or Thio-Tepa), two pairs of gloves made of different materials (e.g. latex and nitrile) should be worn on top of each other (double-gloving).”

Further information on the recommended protective measures when handling cytostatics can be found in the Suva recommendations “Safe handling of medicines in the healthcare sector“.

Which gloves are suitable for double gloving?

When choosing the size of the gloves, you should make sure that the outer glove is not larger than the inner glove to avoid slipping. Either choose two gloves of the same size for the inner and outer glove or choose an inner glove half a size larger than the usual size and the outer glove in the size you would choose if you were only wearing one pair of gloves.

If you choose two pairs of gloves of different colors, you also increase the likelihood of detecting perforations in the outer glove.

Among other things, many of our customers now use the two sterile nitrile gloves PUREZERO HG3 from the manufacturer HALYARD for double gloving. The blue glove is often pulled over the white glove. Both models are readily available at abovo.

Other cyto-compatible products

Our experts can help with any questions

If you would like more information about double gloving or cleanroom products in general, please contact our experts without obligation.

Our specialists in the field of cleanrooms are available by telephone or e-mail for easy contact.

Products from abovo in this article