Retrofit for high potency – case study
When toxicity testing resulted in a reduced Occupational Exposure Limit (OEL) for an API from 20µg/m3 to 0.5µg/m3, the contract manufacturing organisation had to re-engineer its facility to provide contained powder handling and processing. ChargePoint Technology was chosen for the equipment and refit.
Figure 1: The ChargePoint valve powder transfer system
All drug materials entail differing degrees of safe handling, dependent on potency. When a recent reclassification occurred due to new information, ChargePoint Technology was able to step in and retrofit a facility for high containment operation.
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/m3 to 0.5µg/m3. 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.
The conclusion to this assessment was that the containment in the current facility needed to be re-engineered as the design was no longer considered suitable for the protection of staff. The impact of cleaning requirements and cross-contamination risk management were also factored into the solutions.
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