AMPAC Opens cGMP Kilo-Facility

American Pacific Corp.’s subsidiary, AMPAC Fine Chemicals (AFC), opened a new kilogram scale cGMP batch/continuous processing development facility. The new facility can accommodate batch reactors 20 to 50 liters or AFC’s continuous zone reactor technology using as many as seven reactors from 0.25 to 1 liter in volume.

This new facility expands AFC’s scale-up capabilities. According to the company, it will also be useful in demonstrating continuous reaction performance (throughput, yield and purity) using its zone-reactor concept at 0.25 to 1 liter reactors. The facility has two large walk-in hoods, a separate room for solid isolation using two dryers and two remote bays for handling energetic reactions.

Dr. Aslam Malik, president of AMPAC Fine Chemicals LLC, said, “We are excited by the opening of this new facility. 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.”