Pharmatek’s Highly-Potent and Cytotoxic (HP/C) Facility Positions it as Industry Leader in Development and Manufacturing of HP/C Compounds
SAN DIEGO, Calif. – April 28, 2009 – Pharmatek Laboratories, Inc. – a premier pharmaceutical chemistry development organization supporting the pharmaceutical industry – has completed comprehensive airborne particulate testing of its new state-of-the-art facility for the development and manufacturing of highly-potent and cytotoxic compounds.
“The testing results of our HP/C facility allows Pharmatek to expand our development and manufacturing services to include highly potent and cytotoxic compounds, and do it in the safest possible way,” says Tim Scott, President of Pharmatek Laboratories. “The results from extensive facility testing exceeded Pharmatek’s expectations for the safe handling of category 4 compounds on a 5 band scheme.”
The monitoring results exceeded the testing goals and demonstrate Pharmatek’s engineering controls and practices are effective at controlling airborne particulates down to 0.1µg/m 3 levels.
“Combined with the facility engineering controls, significantly lower particulate levels are achieved when respiratory protection factors and process specific enclosure systems are taken into account. The specific operator breathing zone results, on an actual time- weighted basis, demonstrate that Pharmatek can safely handle highly-potent and cytotoxic compounds. ” says Kevin Rosenthal, Director of Manufacturing at Pharmatek Laboratories.
The facility was specifically designed for the development and manufacturing of HP/C drug products. The dedicated facility includes 18,000 sq. ft. of analytical, formulation development and manufacturing lab space. In addition to the development space, there are two certified and validated high-containment manufacturing suites designed with soft-wall enclosure systems that give flexibility to meet the demands of each client’s project.Leave a reply →