Safe handling of cytostatics: The newly developed perform^® sterile mucasol has proven to be a suitable alkaline cleaning solution in a study

Due to their mechanism of action, the cytostatic drugs used are carcinogenic, mutagenic and/or reprotoxic (CMR: carcinogenic, mutagenic and reprotoxic). Compliance with Good Manufacturing Practices (GMP) or equivalent national guidelines is essential to ensure good product quality and the protection of personnel and the environment. In addition to safe handling techniques, validated cleaning procedures are also required.

• Proper handling of cytostatics is essential to protect product and personnel from toxic substances.
• In addition to compliance with the GMP guidelines, validated cleaning techniques are an essential building block for greater safety.
• An IUTA study ¹ commissioned by schülke confirms the reliable cleaning performance of perform^® sterile mucasol in the cleaning of common cytostatics and monoclonal antibodies.
  

Possible hazards from cytostatic drug residues

In the "MEWIP" research project ², the contamination of the working environment with cytostatic drugs was determined by repeated sampling of selected surfaces. Carry-over and contamination with cytostatic agents was detected on a wide variety of surfaces. They can pose a health risk on keyboards and telephones, in the laboratory, in storage and disposal rooms, in patient toilets, in ward rooms and corridors.

How perform^® sterile mucasol protects against contact with harmful cytostatics

The newly developed perform^® sterile mucasol enables a safe workplace thanks to its proven high effectiveness in cleaning and thus reduces risks when handling cytostatic drugs - especially in sterile areas A and B. The effectiveness of the product has been proven in a study commissioned by schülke from the Institute for Environment & Energy, Technology & Analytics e. V. (IUTA). To determine the cleaning performance, test surfaces were first contaminated with a defined concentration of ten common cytostatics. After the solvent had dried, the surfaces were cleaned with different wipes, cleaning solutions and quantities of cleaning solvent, depending on the study design. The result: perform^® sterile mucasol showed excellent cleaning results even when used once with perform^® sterile mixed dry wipes. In a combined cleaning with perform^® sterile mucasol and subsequent disinfection with perform sterile alcohol IPA, all 10 tested cytostatics were cleaned to 93.6 % - 99.9 %.

Product information perform^® sterile mucasol

Sterile working solution with 2 % perform classic concentrate mucasol^®; alkaline cleaner (pH approx. 11.6); cleaning of common cytostatic drugs, proven by a study with the IUTA¹; available in 500 ml and 1 l bottles, double repackaged for safe introduction into cleanroom zones; with tested bag-in-bottle system for maintaining sterility after opening: Click here for more information.

Sources:
1 Institut für Umwelt & Energie, Technik & Analytik e. V. - IUTA-Report of analysis No. 23/449: cleaning validation study of perform^® sterile mucasol for cytostatic drugs / Institut für Umwelt & Energie, Technik & Analytik e. V. - IUTA-Report of analysis No. 23/449: cleaning validation study of perform^® sterile mucasol for cytostatic drugs / Institut für Umwelt & Energie, Technik & Analytik 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 & Institut für Energie- und Umwelttechnik e. V., 2008