IMS Detection And Quantification Of Active Pharmaceutical Ingredients For Personal Air Monitoring

Introduction
As new and more potentially active pharmaceutical ingredients (APIs) enter the processing pipeline, protecting workers from hazardous compounds is becoming an increasing concern in the pharmaceutical manufacturing industry. Typically between 5 and 10 percent of commercial available drugs are in the high potency catagory. This number is expected to increase to about 25 percent as more patented small-molecule APIs, currently the fastest growing segment of pharmaceutical research, reach the market.

In response, a new generation of particle-size select occupational exposure limits (OELs) are emerging for aerosols. The American Conference of Governmental Industrial Hygienists (ACGIH), the International Organization for Standardization (ISO), and the European Standardization Organization (ESO) have all adopted particle size selective methods for inhalable, thoracic and respirable aerosols.2 These methods make it possible to predict how much of the API has been deposited into the lungs after inhalation, which in turn can be matched to health effects based on a particulate exposure assessment.

Small, lightweight samplers are used for personal air monitoring. Workers typically wear these samplers as they go about their duties. Air is drawn through a filter with a battery-powered personal air sampling pump. After the samples have been collected on the filter, the next step is to quantify the amount of API in the filter and determine the worker's exposure. The current standard method is to use high performance liquid chromatography (HPLC) to analyze samples collected by the cassette. Technicians prepare the mobile phase and diluents and set up the instrument. The next step is sample preparation which can take between 60 and 90 minutes.