Boehringer Ingelheim Vetmedica, Inc. (BIVI) manufactures aerobic and viral antigen vaccines in its biological production facility (Building B). BIVI has a new successful product called PCV2 that is grown in a fermentation using insect cells. As BIVI sees an immediate worldwide need for this product, it is quickly ramping up production. As part of this production increase, sys-tek has designed an expansion of BIVI’s fermentation capacity, currently under construction.
This PCV2 fermentation expansion includes the installation of a 375L Seed Fermentor, 3200L Production Fermentor and two 2400L Inactivation Vessels. In addition, the process waste, clean-in-place, and bulk gas systems required significant modifications as part of this project. Improvements to the process waste system include replacing a 1200L process waste tank with a 3750L process waste tank, installing a new spiral heat exchanger to accelerate system heating, converting waste flow from a parallel flow to series flow, and making programming modifications to the existing bio kill system. These modifications will increase process waste throughput by about 30 – 40%.
Existing CIP systems are dedicated to specific portions of the building. Improvements to the clean-in-place system will enable the CIP cycle to be broken down into small cycles, and enable CIP systems to be redirected to all parts of the building. This project is being coordinated with the implantation of a separate CIP scheduling system. Together, these projects will double CIP system capacity/availability.
A new 3000 gallon bulk nitrogen gas tank and 1500 gallon bulk oxygen gas tank will be installed in this project. These tanks will provide a constant supply of gaseous nitrogen and oxygen used in the manufacturing process. They will also greatly reduce the number of maintenance hours required to handle and connect much smaller nitrogen and oxygen dewars manually.
This $3 million project has a tight schedule, with each month representing over $5 million in additional sales of BIVI PCV2. The critical path equipment is scheduled to be complete by 2nd Quarter 2008, with remaining construction being complete in 3rd Quarter 2008.
Detailed GMP documentation, such as user requirements specifications and instrumentation lists, were developed by sys-tek in collaboration with BIVI. Working closely with BIVI’s project manager, sys-tek developed process requirements for each aspect of the project, including fermentors, inactivation vessels, transfer paths, gas distribution, waste treatment, clean in place, and water for injection storage & distribution systems. This document included impact assessment for validation and calibration purposes and becomes a permanent record in the project file. Our approach to completing these GMP documents gave BIVI’s Project Manager a high degree of confidence in the design and allowed him to focus on managing the project, instead of teaching the consultant how to do the GMP documents.