Peter
Schofield recently composed a white paper on a recent project that was
delivered to a Pharmaceutical customer. The paper is entitled "Integration
of Tray Dryers and Nutsche Filter in a Containment Isolator System". A
short description follows.
Walker Barrier Systems
was tasked with providing a system to contain potent and toxic active
pharmaceutical compounds to 0.5µg/m³ exposure level (TWA over operation
duration), for an existing Lab space. The unit was designed for product
filtration, drying in vacuum heat oven, hand sieving and discharging and final
dispensing for further processing, using a Hicoflex system, for an existing
Laboratory. The isolator was to be multi-purpose, and therefore, not only is
the aspect of containment considered in the design, but also cleanability to
prevent cross-contamination. The chamber had to operate in an inert atmosphere
using nitrogen, so the isolator was equipped with an oxygen sensing system,
which would maintain an atmosphere within the enclosure to £ 2% oxygen using customer supplied nitrogen. All
components inside the chamber were to be rated for a Class 1 Div 1 environment
and controlled using PLC controls.
The whitepaper in its entirety will be posted on our website soon. Other white papers covering topics from downflow booth containment screens to validating a sterility test isolator can be found here as well.
