Pharma Process Vessels

GEA is a single source supply of preparation and pressure vessels, fermenters & bioreactors to meet the needs of any pharmaceutical, microbial or cell fermentation process.

The processing of sterile and non-sterile liquids, such as blood plasma have specific purity requirements that can only be achieved with great technical skill and experience. Preparation and pressure vessels from GEA set new performance standards and ensure that our customers 'central process components' have competitive advantages. The surfaces of our preparation and pressure vessels are ground and polished, and as required, electro-polished. All welds are smoothed to the current GMP-/ FDA-standards and exclude even the smallest cleaning dead spaces.

Preparation & Pressure Vessels

GEA manufactures its vessels using only high-alloy stainless steels. These materials require the most exacting welding and grinding techniques to ensure the integrity, long life and reliability of the vessels.

TIG welding (Tungsten Inert Gas) is preferred as it offers the best guarantee of perfect welded seams, however MAG (Metal Active Gas) and orbital welding are also suitable in some applications. GEA welders are experienced in all techniques and always achieve thorough penetration, a high quality finish and reproducible quality. All welds are checked using the latest techniques to provide continuous monitoring of results.

Functional specifications:

Volume: 2 to 20,000 liters nominal capacity
Material: stainless steel 316L, 316Ti, 904L
Surface finish: ≤ 0.2 µm
Surface polishing: mechanical and/or electro-chemical
Pressure: pressureless / -1/10 bar (g)
Temperature: -20 °C to 200 °C
Cleaning options: CIP / SIP
Design: Single, double and triple wall design, heatable, insulated

Examples:

preparation vessel for production of highly sterile products
buffer preparation vessel for blood plasma fractionation
media preparation for pharmaceutical fermentation processes

All vessels can be supplied as stand-alone equipment (stationery or mobile) or as automated process units delivered as fully-functional modules installed on-site that include: agitators; homogenizers; metering and regulating technology; control units; valves and pipe connections. Options for hazardous environments are also available.

Mixing, Heating & Cooling

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.

Storage & Transportation Vessels for Liquid Products

GEA provides high quality storage and transportation vessels made of stainless steel. Each vessel is designed to customer´s requirements.

Cleaning

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.

Quality Control & Testing

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.