Once completed, Tergene would have a manufacturing facility as
per US FDA specifications.
The suite will have up to 1000 L of fermentation capacity besides
state of the art down stream equipments and purifications
systems. The suite will have the necessary support areas.
A formulation and fill-finish facility for liquid and lyophilized
vials. A syringe filling unit (PFS) is also considered as part of
this suite. Separate packaging area is attached to this suite.
Centralized ware housing facility for raw materials and finished
goods with prescribed level of segregations. Separate sampling
and dispensing booths for sterile and non sterile materials.
Centralized quality control laboratory with adequate
instrumentation support for raw material and finished products
testing. Dedicated sterility testing areas for liquid and
Common ETP facility for liquid waste disposal and an incinerator
for solid waste disposal will be built as per central pollution
control department. All bio waste generated in the process will
be thermally inactivated prior to treatment.