HiPo API facility
Dishman Pharmaceuticals commissioned its first high-containment active pharmaceutical ingredients (API) facility in India in January 2010. Located in Bavla, Ahmedabad, the facility will develop a range of oncology APIs and other associated highly potent (HiPo) products. Phase one of the facility became fully operational by the end of the second quarter of 2010.
The second and third phases of the facility are currently under construction. As of 2010, the company had already invested INR1.20bn. The facility is expected to be fully operational by the end of 2011.
The facility is owned and operated by Carbogen Amcis, a Dishman group company. Constructed at an estimated cost of $20m, the facility follows the same conceptual design and standards as Carbogen Amcis’ Switzerland-based HiPo API facilities.
Ahmedabad API facility
The Ahmedabad facility is fully cGMP-compliant and has 4,300m² of operational floor space. Designed to manufacture HiPo APIs of less than 1μg/m³, the facility can accommodate up to four independent HiPo handling cells with capacity for three reactors.
There are two independent manufacturing cells in the facility. Housed on the second floor of the facility, each cell accommodates 600l, 1,000l and 1,600l reactor vessels and has an annual capacity of 5t.
There are a total of three floors in the facility. Arranged on the basis of flow of gravity, the ground floor is equipped with self-contained filter dryers. The 1m² filters are enclosed within a milling glove box that has the capacity for batches up to 200 at a particle size between 1μm and 1,000μm.
The production area also includes an analytical laboratory that characterises raw materials, vital intermediates and final products. An energy centre equipped with back-up power, HVAC system and a warehouse is also set up on the facility’s campus. There is an incinerator that ensures waste is disposed with respect to local and national requirements and in accordance with safety and ecological regulations.
The facility is fully equipped to handle products with the required containment at all stages. Clean rooms have pressurised airlocks. To allow loading and unloading operations with complete containment, the facility has also been installed with split butterfly valves and La Calhene-make transfer ports.
Construction of HiPo API facility
The facility is being constructed in a phased manner. Phase one of the three-phased construction programme is complete, and became fully operational in the second quarter of 2010. In the second phase, two additional manufacturing cells with three reactors of 2,500l capacity will be added.
The final phase will create a custom cell with up to 8,000l reactors to accommodate certain products.
The facility can produce up to 195kg per hour with particle size ranging between 200μm and 1,000μm. With particle size ranging between 10μm and 100μm, the productivity rate reaches 75kg/hour. It is 18kg/hour when particle size is between 1μm and 10μm.
Process technology at Dishman site
The facility will adopt milling technology that granulates and classifies materials to micron and sub-micron sizes in a single operation and in a single grinding chamber.
The grinding system adopted by the facility delivers particle-on-particle impact. Hard wall barrier isolation technology provides several levels of engineering containment to the process.
The glove box functions at below negative pressure and under inert nitrogen atmosphere to avoid any kind of contamination. HiPo products and substances are increased in weight, charged in the dispensing glove box, sealed and shifted by means of rapid transfer ports in the reactor glove box.
All the analytical samples are recorded by a laboratory information management system that allows data to be accessed by project chemists located at the Swiss site.
The categorisation of intermediates and the final product is evaluated by the toxicology and operational health group of Carbogen Amcis. The group performs a toxicology assessment based on the occupational exposure level or the performance-based exposure limit according to information provided by the customer.
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