Powder Systems Limited (PSL) supplied a full suite of contained filtration and drying solutions to India’s leading drug manufacturer for their new oncology plant in Bangalore. The new plant includes several production lines and PSL has provided a suite of filter dryers for both small and large-scale production of potent APIs. The suite provided incorporates contained discharge to achieve a proven OEL (occupational exposure limit) of less than 1µg.m-³ during the sampling period.
The high containment filtration and drying suite consists of four filter dryers with integrated high containment discharge isolators for assured operator and product protection. One of the small scale agitated nutsche filter dryers for Kilo Lab production is in PSL’s revolutionary GFD FilterBox. This stainless steel isolator comprises a glass filter dryer, both designed and integrated by PSL. The number one Indian pharma company opted for a full high containment scale-up solution to repeat their process while handling small to large quantities of highly potent compounds. The contained product offloading can be done either inside the filter box or through the discharge isolators mounted on the side of the 0.125m², 0.3m² or 0.6m² filter dryers.
Scale-up from chemical development in small-scale batches to industrial volume is a complex and time intensive process requiring considered technology risks, equipment design and process constraints. The commercial application of a technology developed at an early stage requires scalability of the equipment used throughout the whole process.
“The new oncology plant needed to transfer from the kilo-lab scale for oncologic chemical development to obtain larger volumes of highly potent APIs. The contained filtration suite provided by PSL is an ideal solution. The highly active batch production will be carried over to the scaled-up industrial yield and they will obtain kilograms of dry and homogeneous HAPIs in a shorter time-to-commercialisation,” explains Rémy Wattiaux, Managing Director, PSL.
Before starting the manufacturing of the 15 different anti-cancer products, the manufacturer and PSL proceeded to the SAT (Site Acceptance Test) last month at the oncology plant based in Bangalore. It is primordial that all the containment systems complied with the targeted OEL level prior commencing production. Independent OEL tests were carried out during surrogate (lactose) handling trials in the PSL’s Filter Dryer Discharge Isolators and the Kilo-Lab GFD FilterBox. The target containment limits for personal exposures of less than 1 µg.m-³ averaged over the task duration and less than 0.3 µg.m-³ as an eight-hour time weighted average (8h TWA) were achieved. It was also desirable to prove control personal exposures to less than 25 per cent of these values i.e. < 0.25µg.m-³, over the task duration and < 0.075 µg.m-³, 8h TWA.
PSL has been established for 23 years and is an original pioneer of high containment systems such as isolators and glove boxes. We have significant experience designing and engineering advanced containment processes for highly potent and valuable products including sterile, oncology, hormone and many other pharmaceutical compounds. PSL provides a full range of filtration, drying and contained isolator products for small scale production to full process systems.
EP News Bureau – Mumbai
