|By Marketwired .||
|December 18, 2012 11:16 AM EST||
CHICAGO, IL -- (Marketwire) -- 12/18/12 -- Abbott Laboratories continues to advance its contract pharmaceutical manufacturing capabilities to meet the life science industry's expanding need for more efficient services for solid-dose potent and cytotoxic products.
To address this robust market demand, Abbott recently installed a state-of-the-art dry granulation roller compactor, providing customers with the flexibility and efficiency needed to advance their potent drug product needs. The new compactor is housed in a dedicated, manufacturing suite in Abbott's multi-product potent facility in Sligo, Ireland.
The new roller compactor offers precise process control, measuring all product quality relevant parameters (e.g., force, gap and roll speed) online for a well controlled, documented manufacturing process. All parameters are calibrated and validated. The compactor has a floating gap for consistent compaction force. The gap and torque adjustments are automatic, ensuring consistent output with minimal property fluctuations in the granules. The fully contained compactor features a glove box for dispensing materials, bin blenders, and a Comil® for uniform size reduction, deagglomeration, and optimal particle size dispersion, which improves mixing process efficiency and product consistency.
"With the substantial growth today of oncology and other high potency drugs, Abbott continues to upgrade our potent facilities and equipment to better serve the industry," said Timothy O'Sullivan, Technical Operations Manager of Abbott's Sligo, Ireland facility. "Our new roller compactor contributes greater efficiency, flexibility and quality to potent drug manufacturing and development, offering customers distinct advantages."
The output of Abbott's new roller compactor is small, uniform particles for tablets or capsules, and more reliable results, minimizing output uncertainty. The equipment provides excellent control of bulk density and flow properties, very high throughput for rapid processing, energy-efficient production, and reduces uncertainty in development and scale-up to commercial levels, particularly compared with wet granulation. These efficiencies save customers considerable production time and costs.
Abbott's additional high potency suite with the new roller compaction unit is located off the existing airlocked production corridor. The facility uses the latest design concepts for handling potent compounds to containment levels up to OEB 5 ( < 1mcg/m3), and both the facility and each room are designed for high containment.
Operating for almost a decade, Abbott's 110,000-square-foot Sligo facility has the capability of manufacturing a wide range of potent pharmaceuticals, from active pharmaceutical ingredients to finished goods. The facility offers high-shear wet granulation with single-pot processors, milling and blending, encapsulation, coating and tableting processes for potent compounds, in addition to the new granulation capabilities. All unit operations are designed for high containment, with processing housed in dedicated manufacturing suites. The high potency site meets FDA, ICH and EU requirements. Abbott also offers potent manufacturing services at its Wyandotte, Michigan site, producing high potency intermediates and active pharmaceutical ingredients.
"Handling potent products is more complex, requiring additional safety precautions to avoid exposure," says O'Sullivan. "Abbott has broad experience and expertise in the development and scale-up through commercialization of high potency products for small through large-scale production, and the most advanced infrastructure. Customers count on us for the highest quality, most efficient production of potent products."