Reduction of External Contamination in Highly Potent Pharmaceuticals (RedAk)

Description:

Cytostatic drugs are used in cancer treatment, but pose a significant risk to healthcare personnel due to their carcinogenic and mutagenic properties.

Errors in the manufacturing or preparation process, for example, can lead to contamination of these highly potent substances. Against this backdrop, wipe samples are regularly analyzed to identify potential hazards and implement appropriate countermeasures. While the contamination of flat surfaces in pharmaceutical environments is regularly assessed as part of cleaning validations, standardized methods for sampling cytostatic drug residues on non-flat surfaces, such as medication vials, have been lacking until now. This study presents the development and evaluation of a robust method for nonplanar surfaces. Various strategies for application and extraction are compared to optimize recovery rates for different cytostatic drugs. Based on this study, contamination in the pharmaceutical industry can be assessed. Furthermore, cleaning validations can be performed on medication bottles to permanently improve the protection of manufacturing staff, pharmacy staff, nursing staff, and patients.