EaglePicher Pharmaceutical Services adds comercial/ development capacity with new GMP manufacturing suite
EaglePicher Pharmaceutical Services, LLC has added a new Good Manufacturing Practice (GMP) production facility for manufacturing active pharmaceutical ingredients at its Harrisonville, Missouri site. Known as Production Room B, this advanced facility features production equipment that can accommodate bulk or large-scale production, and a state-of-the-art, fully automated process control system.
"Production Room B supports true manufacturing flexibility for exceptional product quality," said Steven Westfall, president of EaglePicher Pharmaceutical Services. "For example, each reactor may be operated independently of the others, and each has its own dedicated condenser."
The new suite has a total reactor train capacity of 700 gallons (two 300-gallon reactors and one 100-gallon reactor). Suite modernization is enhanced through use of glass reactors, Tantalum process condensers, a Hastelloy centrifuge and Teflon-lined process piping.
Production Room B's automated process control system provides tight control of process variables such as temperatures and pressures and enables sophisticated ramping techniques. In addition, the control system provides extensive process history including:
· Trending of process variables
· Tracking of operator intervention
· Alarms.
Armed with this information, users can document best or "golden" batches and devise process improvements.
In addition to exceptional FDA-inspected facilities, EaglePicher Pharmaceutical Services provides:
· A skilled management team with extensive experience in pharmaceutical operations, quality assurance and global regulatory requirements
· A project management group dedicated to meeting customer timelines and budget
· Current Good Manufacturing Practice compliance.
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