Temperature control and agitation during the process are key to achieving a successful and repeatable outcome. GEA ensures that the temperature of products within fermenters and vessels can be controlled within narrow limits ( /- 0.5 °C) to achieve the highest growth and product formation rates and avoid product variation during production.

This high degree of temperature control throughout the heating, production and cooling processes, and product homogeneity is achieved using the latest heat exchanger technology and careful agitation. Precise instrumentation measures all the key parameters of pH, p02, temperature, agitator speed and weight, throughout processing.

The cleaning characteristics of pharma vessels and fermenters are key right from the start of the design process. It is essential to eliminate dead-leg areas and ensure that Clean-in-Place (CIP) and Sterilize-in-Place (SIP) systems are effective.

GEA uses the latest computer-aided simulation of theoretical spray patterns during the design phase to ensure cleaning in accordance with every customer’s requirements. Cleaning systems are designed to minimize the use of cleaning media thereby reducing running costs. This cleaning capability is then verified in practice, using a Riboflavin test, for every vessel supplied. The cleaning of the exterior of the vessel is important too and all GEA vessels are designed with appearance and practicality in mind. Exterior features, designed for easy cleaning and to ensure a safe working environment for operators include:

• Round edges and corners
• Homogeneous surface finish (with certificate if required)
• No indentations or pits
• Gap-free components and accessories.

Throughout the manufacturing process all vessels and fermenters are subject to stringent quality checks. An overall test forms part of the FAT (Factory Acceptance Tests) procedures and the relevant documentation forms part of the FAT protocols.

Customer-specific factory acceptance tests (FAT) include:

• riboflavin test
• heating/cooling test
• surface roughness measurement
• delta ferrite determination
• electrical testing as per VDE (e.g. agitator test, control cabinet test etc.) 

Material traceability of vessel parts and components 
Our quality management system ensures the full traceability of all materials used including the provision of certificates.