The fermenter or bioreactor is a pivotal element in industrial production of vaccines. It is indeed a tank which becomes the ideal environment to support the growth of microorganisms.
Cells are able to optimally play their function only under suitable environmental conditions; that’s why it’s essential to constantly monitor parameters such as temperature, pH, gases (oxygen, nitrogen or carbon dioxide), by using sensors and a finely designed automation system.
To keep oxygen concentration stable in aerobic processes, a gas that is not very soluble in water, adds a further layer of complexity: mechanical handling in continuous stirred tanks must be flawless.
Likewise, sterility of the whole process is indispensable.
The fermenter is designed according to ASME BPE, GEP, cGMP, FDA standards. It consists of a stainless-steel platform; one 1,200 L PED tested fermentation tank; four seed tanks; utilities lines to be connected in the technical area; CIP and condensate discharge lines; one TCM for heating and cooling.
The fermentation tank has a flanged lid with bolted closure and is made of AISI 316, tank-in-tank type. The seed tanks are respectively 3, 4.5, 60, 100 L and feed the fermenter by overpressure, while the containers on scales are used to load the fluid into the fixed tanks by peristaltic pumps.
CIP and SIP modules ensure maximum cleanliness and sterility level at any stage.