Design of Analytical Method Validation Protocol Evaluating Environmental Monitoring of AND Contamination on Surfaces Based on Cleaning Validation Procedures: A Multi Component RP-UHPLC Method.

Environmental monitoring of anti-neoplastic drug (AND) residues in workplaces is crucial to limit exposure to workers who handle with them. Although wipe sampling is the most appropriate methodology to evaluate the risk, conflicting results are also reported due to the lack of standardized and validated procedures. In this study, procedures for surface contamination of ANDs in workplaces are presented, with a focus on sampling, sample preparation and instrumentation.

Exposure assessment of pharmaceutical powders based on an environmental monitoring method: a pilot study.

Background: About 8 million healthcare workers in the USA are potentially exposed to hazardous drugs or their toxic metabolites over a long period of time despite the fact that both the Occupational Safety and Health Administration and the European Parliament recommend the monitoring of exposure among workers dealing with substances which have carcinogenic, mutagenic or toxic effects on the reproductive system. The objective of this study is to determine exposure to active pharmaceutical ingredients (APIs) among pharmaceutical industry workers, and to develop a methodology which promotes the accurate monitoring, evaluation and control of exposure to active pharmaceutical ingredients, also in compliance with good manufacturing practice.

Material And Methods: The pilot study was designed in accordance with "Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice," issued by the U.