California-based AMPAC Fine Chemicals, the wholly owned subsidiary of American Pacific Corporation, has recently inaugurated a new kilogram scale cGMP batch/continuous processing development facility.
The new facility can accommodate either batch reactors (20 to 50 litres) or AFC's continuous "zone reactor" technology using up to seven reactors from 0.25 to 1 litre in volume. It comprises two large walk-in hoods, a separate room for solid isolation using two dryers and two remote bays for handling energetic reactions.
The facility not only allows AFC to expand its scale-up capabilities, but will also be very useful in the demonstration of continuous reaction performance (throughput, yield and purity) using the company's "zone reactor" technology at significant scale.
"We are excited by the opening of this new facility," said Dr Aslam Malik, president of AMPAC Fine Chemicals. "Through our history of handling energetic chemistry and highly potent compounds, AFC has developed an extensive knowledge and expertise in continuous processing. Smaller reactor volumes, smaller quantities of reactants, better yield and cleaner impurity profiles make the process safer, more reliable, and more economical than the traditional batch process.
"In an industry that has been traditionally batch, implementing continuous processing is not easy. However, due to the recent push by the FDA for Quality by Design and use of Process Analytical Technology, continuous processing is achieving greater acceptance in the pharmaceutical industry."