The market for toxic medications has grown rapidly in the past few years as a result of both the increasing prevalence of cancers around the world and the emergence of targeted, patient specific therapies.
As a result, manufacturers and active pharmaceutical ingredient (API) suppliers operating in the sector have had to develop new ways of handling hazardous materials to ensure both employee and patient safety.
This is particularly critical when weighing quantities of toxic drug ingredients as even small inaccuracies at this stage of manufacture can produce potentially lethal medications.
Mike Savill, pharmaceutical technology group manager at Capsugel, said that the firm had developed the containment unit in response to this growing customer demand, particularly from clients seeking capsule filling capability for occupational exposure band (OEB) 4 class drug compounds.
Savill commented that drugmakers attempting to use ‘generic’ or standard flow hoods with such substances had encountered considerable difficulties, explaining that: “Such hoods often produced vibration feedback which interfered with weighing, causing dosing inaccuracies.”
Enhanced operator safety
The Xcelohood system, which will be officially launched at next month’s Technopharm exhibition in Germany, is compatible with Capsugel’s Xcelotable support stand technology, which minimises vibration during dose weighing operations.
A second key feature of the unit is the fact that its continuous extraction fans are not attached to any of its weighing mechanisms. This prevents movement or vibration during the lamina air flow circulation reducing the accuracy of weighing steps.
Capsugel added that because the fans maintain a constant air flow when one or both of the unit’s horizontal doors are opened, there is no risk of hazardous APIs escaping from the system during, often highly complex, manufacturing operations.
The hood can be combined with the Capsugel’s Xcelodose microdosing system, which automates capsule filling steps, operator handling of hazardous and toxic drug ingredients during industrial production is minimized.
Capsugel also believes that the system’s use of dual pre-filters, high efficiency particulate air (HEPA) filter and “bag-in, bag-out” changeover capacity provides an additional degree of operator safety and further minimises the risk of clean room contamination.