The facility will be used to manufacture nearly 40 bacterin and viral products that can be mixed to create hundreds of finished products for worldwide distribution.
The facility includes state-of-the-art fermentation processes with a number of fermenters of various sizes, roller-bottle cell culture areas, various downstream harvesting and purification processes and a central service area for media preparation, tank cleaning, staging and offices. Process utility systems include clean in place systems, steam in place systems, Water for Injection, sterile compressed air and others.
The design also included environmentally controlled isolators for aseptic seed propagation. The isolators were designed to Class 100 conditions for protection of the product, and utilized isolation flanges and doors for the transfer from glass mixing flasks to stainless steel seed canisters. Isolation technology helped to maintain viability of the seed stock by eliminating steam lock assemblies, thus reducing transfer time from the isolators to the seed fermentors. A breathing air regulating system was design for connection to workers' local breathing apparatus. The production processes and facility were designed and qualified to meet the regulatory requirements of the proposed European Community standards.
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