TABLE 10 SHELF SIZE AND AREA OF DRYING SHELVES IN A TYPICAL LYOPHILIZER
The facility boasts 10 lyophilizers
ranging in capacities from 4 sq.
Currently, control systems follow the architecture of PLC system for actuation of the mechanical components of the lyophilizer
or loading systems, which connects to a PC or HMI," he says.
The production facility utilizes three high-speed filling lines, four lyophilizers
and a clinical fill line.
During fourth-quarter 2004 significant progress was made toward completing the validation process for the Company's second lyophilizer
unit, which should triple existing lyophilization capacity over time.
We have to create the proper environment where vials can be filled and sent to the lyophilizer
and then back out again and crimped in an aseptic environment.
Inside Sterile University OsoBio has set up fully functioning equipment such as a filler and a lyophilizer
to enable new employees to get hands-on experience working with the equipment before they go into the sterile "core" of the manufacturing areas.
On July 28, 2003, Draxis received insurance proceeds of $700 in settlement of physical damage and business interruption losses related to installation problems of its first lyophilizer
unit in 2000.
DRAXIS Pharma commenced commercial production of freeze-dried sterile products during the second quarter 2005 upon the final validation of the recently installed second lyophilizer
Part 19 Delivery lyophilizer
for large volumes - 1 pc.
The specialized facility was originally designed to readily accommodate this second lyophilizer
at a cost significantly less than that of the initial installation with minimal disruption to ongoing production.
The lyophilization line and the specialized facility in which it is housed have been designed to readily accommodate a second lyophilizer
, which will allow DRAXIS to double production capacity at a cost significantly lower than that of the initial installation.