Clarifiers for Pharma Biotech

GEA clarifiers are especially designed to meet the high requirements in pharma biotech, such as gentle product treatment, efficient recovery of active ingredients, a reliable scale-up but also GMP, optimum cleaning capability and aseptic process management.

Efficient and gentle processing of mammalian cell cultures, hormones, aspetic processes such as vaccines and sera, enzymes and many more. Also available as skid.

GEA clarifiers for the efficient and gentle processing are available with hydrohermetic inlet. This insures a gentle product feed and subsequently a high degree of vitality and protein activity. Changes are minimized. The inlet system prevents shear forces when the product enters the bowl. With the hydrostop system, The ejection system can be adjusted precisely and reproducibly to specific requirements with regards to the concentration of solids. The patented hydrostop system ensures that even small volumes from 1.5 to 2 liters can be ejected reproducibly. This innovative technology allows precise, fast ejection and therefore substantially increased and higher quality yields. According to model ejection with metering pistons is available. The fundamental idea of the control system is to inject a precisely metered volume of opening water with a metering system for partial ejection. Precise ejected quantities can be achieved in this way. The advantage in comparison with the hydrostop system is the low required operating water pressure of just 1.5  bar.

Steam Sterilizing (SIP) and Cleaning Capability (CIP)

In strictly aseptic processes the separator must not only be easy to clean, but is also a part of a sterile, completely closed system. Apart from guaranteeing the agreed performance parameters, GEA also grants a so-called sterile guarantee on the employed sterile separators.

Sterile with steam: SIP (Sterilization-in-place), for example, this applies to our self-cleaning disc separators with hydrohermetic inlets in a special steam-sterilized design. Sterilizing is conducted with the separator in stand still with clean steam under pressure at a temperature of over 121 °C.

Absolutely clean with CIP:Chemical CIP cleaning (CIP = cleaning-in-place) cleans process lines without the need to dismantle or open individual machines. Apart from hot water, 2 percent sodium hydroxide solution at a temperature of up to 80 °C is used as the cleaning liquid. This is circulated until all organic sediments have been dissolved.

Good Manufacturing Practice

The GMP qualification and validation of pharmaceutical machinery have a high priority. Qualification designates the documented proof of the execution and functionality of a machine. Validation refers to the reproducible, reliable setting of the processes. In this, it is particularly important to work with qualification plans and documents approved by the user. Within the machine qualification, GEA can execute the design qualification (DQ), installation qualification (IQ) and operating qualification (OQ) in the course of the FAT. If requested, the OQ can be conducted in the course of the SAT, with support at the first production.GMP Pre-Qualifications are available as an extra.