HollisterStier Contract Manufacturing Invests $5.7 Million In Customized Lyophilizer And Facility Upgrade
HollisterStier Contract Manufacturing Invests $5.7 Million In Customized Lyophilizer And Facility Upgrade
SPOKANE, Wash.? Hollister-Stier Laboratories LLC has completed installation of a 3.2 million dollar, BOC Edwards 200 ft2 lyophilizer. Approximately $2.5 million was invested in the reconstruction of the Small Volume Parenteral (SVP) area of the Spokane facility to accommodate this new piece of equipment. The new area includes a clean room complex and second floor mezzanine used to house air handling units, mechanical, and refrigeration equipment. In addition, the facility design of this area allows for a second 200 ft2 lyophilizer and loading system that will be installed at a later date. The facility, utilities, and lyophilizer have successfully completed qualification, including three media fill runs.
?Parenteral Contract Manufacturing is potentially a 2 billion dollar industry,? said Anthony Bonanzino, Ph.D., president and CEO. ?The installation of the commercial scale lyophilizer further expands HollisterStier?s ability to service a variety of clients. This is a tremendous accomplishment for our company. Completing a project of this magnitude on time and on budget is another example of the organization?s competency. The installation of the new lyophilizer truly reflects HollisterStier?s commitment to pharmaceutical contract manufacturing.?
HollisterStier?s automatic loading freeze dryer is one of the few lyophilizers world wide, designed to accommodate sensitive pharmaceutical liquid products. These products require loading onto pre-frozen shelves sometimes as low as ?55?C. ?The frost that accumulates on the shelves at these lower temperatures can interfere with the automatic loading of the vials and the heat transfer from the shelf to the vial,? said Jeff Milligan, director of engineering and validation. ?HollisterStier, in collaboration with BOC Edwards Pharmaceutical Systems, has designed a low humidity (down to 5% RH) and low temperature custom environment (10-12?C) in the vial loading area to eliminate concerns with frost.?
The lyophilizer operates using state-of-the-art software allowing the system to be fully automatic. The automatic features include a Clean-in-Place (CIP) system, a Steam-in-Place (SIP) system, integrity testing of dual sterile filters, batch record generation and an automatic load and unload system. Vials are processed and filled using HollisterStier?s existing high speed parenteral manufacturing line. Upon filling and partial stoppering of the vials, they are automatically conveyed to the new clean room complex under ISO5 (class 100) conditions. The automatic loading system on the lyophilizer then loads the vials at speeds up to 200 vials per minute. The vial sizes can range from 2ml to approximately 125ml.
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