Dec Group, a provider of isolator technology and toxic and sterile component handling systems, has completed a project involving a high containment dispensing and pre-blending system for a Swiss pharmaceutical giant. The company engaged Dec Group on this project as it invested in new production facilities to meet the global demand for dry powder inhalation (DPI) products.
For this project, Dec supplied a series of high containment isolator systems that are used to handle highly active ingredients and excipients.
Specialised containment is required to ensure that both the operators and the environment are protected from exposure to the highly active DPI ingredients. The isolators are therefore suitable for performing operations to a maximum allowable operator exposure limit (OEL) of < 0.4μg/m3 time weighted average (TWA) over an 8 hour operational period.
The high containment systems have been designed to operate at a negative pressure with air on a “once through” basis, meeting cGMP standards. They are also designed to work within an ATEX 2G/1 IIB T4 hazardous process room. The task consists of weighing and pre-blending both high potency active pharmaceutical ingredients (HPAPIs) and excipients, and transfering them into intermediate bulk containers (IBCs).
Dec’s solution was based on a three chamber dispensing and pre-blending isolator that is used for the following distinct process stages in preparation for the final dry powder blending process.
Pre-blending stage
This involves the manual dispensing, sieving and pre-blending of HPAPIs and excipients using an integrated Turbula blender. Once blended, the material is then discharged from the isolator into a blend IBC, which is connected to the isolator using a Split Butterfly Containment Valve. The blend IBC is raised and docked to the ball valve using a lift platform mounted on load cells.
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