17.01.2024
Cytostatics and monoclonal antibodies are central pillars in tumor treatment. The basic substances are produced by the pharmaceutical industry, while the patient-specific preparation or dosage is carried out in specialized pharmacies or hospitals. Due to their formular, 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 product quality and the protection of staffand the environment. In addition to safe handling techniques, validated cleaning procedures are required.
Possible hazards from cytostatic drug residues
In the "MEWIP"2 research project, the contamination of the working environment with cytostatic drugs was examined by repeated sampling of selected surfaces. Carry-over and contamination with cytostatic drugs 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 cytostatic drugs
The newly developed perform® sterile mucasol ensures a safe workplace due to its proven high effectiveness in cleaning. Thus reduces risks when handling cytostatics - 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. When perform® sterile mucasol and subsequent desinfection was combined 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 11.6); cleaning of common cytostatic drugs, proven by a study with the IUTA1; available in 500 ml and 1 l bottles, double-packed for safe introduction into cleanroom zones; with tested bag-in-bottle system for maintaining sterility after opening: Click here for more information.
Quellen:
1 Institut für Umwelt & Energie, Technik & Analytik e. V. - IUTA-Report of analysis No. 23/449: cleaning validation study of perform® sterile mucasol for cytotatic 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-Effekt-Studie für Wischproben in Apotheken, BGW & Institut für Energie- und Umwelttechnik e. V., 2008
Schülke & Mayr GmbH (schülke)
Schülke & Mayr GmbH, with its headquarters in Norderstedt near Hamburg, has been a global leader in infection prevention and control for almost 135 years. Infectious germs know no borders - this has always been the case and is even more common in today's globalized world. Committed to the mission "We protect lives worldwide", the strategic business areas of schülke Healthcare, Over the Counter (OTC), Life Sciences and Direct Patient Care actively contribute to the safety and health protection of people. With strong brands such as octenisept®, kodan®, desderman® or microshield®, schülke is one of the international market leaders in the field of wound and mucous membrane antisepsis as well as hand and surface disinfection in German hospitals. People in more than 80 countries around the world rely on schülke products every day. With its wide range of high-quality and innovative products, expert advice and reliable service, schülke offers holistic concepts for infection treatment and control in professional healthcare, for end users and the pharmaceutical sector. Schülke consists of more than 1,100 dedicated employees, over 20 subsidiaries and three production sites in Germany (schülke), France (Bioxal) and Brazil (Vic Pharma). In 2022, schülke contributed to protecting patients and health care professionals in hospitals from infections with nearly three billion product applications.
You can find more information about schülke here: www.schuelke.com