White Paper

Simplifying Containment For High Potency API Manufacturing

Source: Chargepoint Technology

Michael G. Avraam, global product manager, containment, ChargePoint Technology

pharm

Powdered constituents, including active pharmaceutical ingredients (APIs) or inert excipients, are vital to drug formulation and manufacturing, whether at R&D, pilot, or full production scale. Both small molecule and biologics manufacturing involve the transfer of powdered constituents at different stages of manufacturing, including at the synthesis, granulating, formulation, tableting, and filling stages.

The APIs and excipients would typically be transferred from drums, bags, or other storage vessels to the required process stages. Without containment, open transfers would generate levels of dust, which would create airborne and surface contamination. Both airborne and surface particles are a risk to health and the environment, and impose a risk for cross-contamination.

High-containment powder transfer provides a way to reduce the risk and make the drug manufacturing process safer and more efficient.