Camille Flores-Kilfoyle reports on a laboratory high containment filtration and drying facility
Active ingredients and pharmaceutical compounds developed in laboratories and R&D centres have increasing potency and require additional protection for the operators and environment. When developing new drugs, the risks at early stages are not always fully understood and a conservative approach should be preferred.
Occupational exposure levels (OELs) set by scientific committees and institutes are increasingly strenuous and containment performance can go as low as 10ng/m3, eight-hour time weighted average (TWA). Traditional restricted access barrier system (RABS), laminar flow cabinet or fume hood do not provide such a strict controlled environment, but high containment technologies do.
Containment technologies such as isolator and glovebox fulfil the above requirement at any scale. ISPE defines containment technology as a “leak-tight enclosure designed to protect operators from hazardous/potent processes or protect processes from people or detrimental external environments or both.”
To provide a safe and ergonomics solution to its laboratory nutsche filter dryer, the GFD, Powder Systems Ltd, a pioneer of high containment technologies, developed the GFD FilterBox (Fig. 1). The FilterBox consists of a small agitated nutsche filter dryer (GFD) being completely integrated within a PSL isolator, providing high containment when handling highly potent APIs and other highly active or cytotoxic powder.
The FilterBox achieves containment to nanogram levels protecting both the product and the operator during operations including charging, sampling, filtration, drying and discharging. The cleaning procedure can be performed safely and thoroughly as the vessel base and the removable filtration basket can be easily accessed in a contained environment. Interconnecting nozzles and pipes can be dismantled without any containment breach for a contained cleaning and maintenance.
The FilterBox provides a more compact design than traditional separate agitated nutsche filter dryer and containment products, reducing floor space requirement and impact on plant design. The solution is easily scalable for laboratory to industrial production.
The system can comprise 0.002m² to 0.05m² filter dryers as part of the GFD range (Fig. 2). The GFD technology combines filtration, cake washing and drying all in one step and product is fully recovered through the filtration basket. This miniature version of a PSL production size filter dryer allows process development during early stages. Due to its direct scale-up abilities, this vacuum lab filtration and drying unit is ideal for feasibility studies and trials before investing in a large-scale agitated nutsche filter dryer.
The GFD FilterBox shown in Fig. 1 includes a Maxi Lab GFD for the API manufacturing of an oncology drug, which is done in Turkey. The containment performance was tested by a third-party industrial hygienist, Vega Environmental Consultants. The personal sampling results obtained from the surrogate containment testing to measure airborne levels of lactose during the use of the PSL GFD FilterBox indicated that the target OEL of less 0.1 μg.m-3, 8h TWA, was likely to be met (see Table 1).
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Camille Flores-Kilfoyle is with Powder Systems Limited (PSL).