Retrofit for high potency

摘要

When an unnamed contract manufacturing organisation that provides outsourced services to the global pharmaceutical industry faced the task of re-equipping its operations to handle a highly potent API, it selected ChargePoint Technology for the equipment and refit. The need arose when feedback from a customer programme of toxicity testing resulted in a reduced Occupational Exposure Limit (OEL) for an API manufactured at the plant from 20μg/m~3 to 0.5pg/m~3. As a result of the API being reclassified as a PB-ECL category 5 product, manufacturing was immediately halted to assess the impact of change.