Safe handling of cytostatics

– Proper handling of cytostatics is essential to protect product and personnel from toxic substances.
– In addition to complying with the GMP guidelines, validated cleaning techniques are an essential component for increased safety.
– A study commissioned by Schülke from the IUTA1 confirms the reliable cleaning performance of perform® sterile mucasol when cleaning common cytostatics and monoclonal antibodies.

Cytostatics and monoclonal antibodies are central pillars in tumor treatment. The active substances are produced by the pharmaceutical industry, while patient-specific preparation or dosing is carried out in specialized pharmacies or hospitals. Due to their mechanism of action, the used cytostatics are carcinogenic, mutagenic, and/or reproductive toxic (CMR: carcinogenic, mutagenic, and reprotoxic). Compliance with Good Manufacturing Practices (GMP) or equivalent national guidelines is indispensable to ensure good product quality and protect personnel and the environment. In addition to safe handling techniques, validated cleaning procedures are also required.

Possible hazards from residues of cytostatics

In the research project "MEWIP"2, the contamination of the working environment with cytostatics was determined through repeated sampling of selected surfaces. Cross-contamination and contamination with cytostatics could be detected on various surfaces. Among others, on keyboards and telephones, in laboratories, storage and disposal rooms, on patient toilets, in station rooms, and hallways, they can pose health risks.

How perform® sterile mucasol protects against contact with hazardous cytostatics

The newly developed perform® sterile mucasol enables a safe workplace through its proven high efficacy in cleaning and thus reduces risks when handling cytostatics – especially in Sterile Area A and B. The effectiveness of the product is confirmed by a study commissioned by Schülke from the Institute for Environment & Energy, Technology & Analytics e. V. (IUTA). To determine the cleaning performance, test surfaces were initially contaminated with a defined concentration of ten common cytostatics. After the solvent dried, the surfaces were cleaned with different cloths, cleaning solutions, and amounts of cleaning solution depending on the study design. The result: perform® sterile mucasol already showed excellent cleaning results with a single application using perform® sterile mixed dry wipes. When combined cleaning with perform® sterile mucasol and subsequent disinfection with perform sterile alcohol IPA, all 10 tested cytostatics were removed by 93.6% – 99.9%.

Product information perform® sterile mucasol

Sterile ready-to-use solution with 2% perform classic concentrate mucasol®; alkaline cleaner (pH approx. 11.6); effective against common cytostatics, confirmed by a study with IUTA1; available in 500 ml and 1 l bottles, double-packaged for safe entry into cleanroom zones; with tested Bag-in-Bottle system to maintain sterility after opening.

Sources:

1 Institute for Environment & Energy, Technology & Analytics e. V. - IUTA-Report of analysis No. 23/449: cleaning validation study of perform® sterile mucasol for cytostatic drugs / Institute for Environment & Energy, Technology & Analytics e. V. - IUTA-Report of analysis No. 23/718: cleaning validation study of perform® sterile mucasol for monoclonal antibodies
2 Monitoring effect study for wipe samples in pharmacies, BGW & Institute for Energy and Environmental Technology e. V., 2008