Meeting Tight OEL Limits in API Milling

According to leading containment isolator manufacturers, it has been estimated that up to 50% of new pharmaceutical products are now being set by the pharmaceutical industry with Operator Exposure Limits (OEL’s) at ≤10μg/m3. A leading European Pharmaceutical company needed to complete various clinical trials with batch sizes of highly dusty materials weighing between 1 - 20kg through a U5 Comil®. The STEL (Short Term Exposure Limit) of the worst case API’s (Active Pharmaceutical Ingredients) that the customer is planning on milling is 40μg/m3. The U5 Comil®is housed within an isolator and the mill’s spindle had to provide containment of API blends to 5μg/m3 when processing.

 

In testing developed by the customer and conducted by the isolator manufacturer, the U5 Comil® was subjected to a pressure of 150 Pa for one minute. The maximum allowable pressure drop in the plastic simulation bag after one minute was 8 Pa. The isolator company tested the U5 head as per the testing protocol and the Comil® achieved a 1 Pa pressure drop over a one minute interval, exceeding the requirements by a large margin. Comils® are designed to the strictest cGMP standards and have proven themselves over the years to provide maximum containment capabilities, making the Comil® the mill of choice for many isolator manufacturers and end-users alike.

 

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