GEA Hilge is "the" competence center for hygienic pumps within the globally active GEA Group. The high-quality pumps "Engineered in Germany" ensure reliable processes for pumping demanding products in the pharmaceutical, biopharmaceutical and personal care industries.
In the pharmaceutical industry, pumps and their requirements are subject to a wide range of international laws, regulations and guidelines. The maximum level of microbiological safety must be guaranteed for the entire production process. In this respect, the certified cleanability plays an important role. No less important are the reliable sterilization/sanitation and certification of the properties and origin of metallic and non-metallic materials. The documented surface roughness and ferrite content, as well as extensive welding documentation, can also be part of the standard scope when it comes to the qualification of a pump in a pharmaceutical plant.
Core requirements of operating companies in the pharmaceutical and biopharmaceutical industry: FDA- and GMP-compliant components, high system availability, low maintenance and servicing effort, and maximum cleanability. The focus is always on hygienic, reproducible production, especially for sterile pharmaceuticals. To achieve this, plant designers, equipment manufacturers and component suppliers must take into account a whole range of aspects, beginning with an elaborate production process and ending with machines/components in hygienic design, including sophisticated cleaning processes. The more hygienically the plant is designed, the shorter the CIP and sanitation times.
…that in pharmaceutical production all of the legal regulations, rules and standards listed below must be observed?
…that Philipp Berdelle-Hilge was a pioneer in the field of hygienic pumps? Even during the development of his flagship Hilge HYGIA more than 50 years ago, he attached great importance to good cleanability. He was the first to decide on a pore- and blowhole-free deep-drawn version of the ring housing, while many other manufacturers still use cast housings today.
Fig.1. The first pump of the HYGIA series from 1962
…that complete draining of residual liquid is essential? Ideally, no drain valves are required for this purpose (self-draining design). Even if the surfaces are inclined at an angle of only 3°, the liquid can run off completely, as in the vertical multistage pump series GEA Hilge CONTRA.
Fig.2. Sectional view of the GEA Hilge CONTRA
…that it‘s not enough for the pump itself to be hygienic? The connections must also comply with the Hygienic Design principles. Incidentally, the same applies to the mechanical seal, drain system and O-rings. Only then can a hygienic pump be cleaned in accordance with the EHEDG regulations. All seals must be selected with regard to their durability, CIP/SIP capability and FDA conformity.
Fig.3. Sectional view of the GEA Hilge HYGIA
…that a mechanical seal located in the product chamber provides significant advantages in the cleaning process?
…that the GEA Hilge NOVALOBE rotary lobe pump and the GEA Hilge NOVATWIN twin screw pump handle even the most sensitive products, such as blood plasma, gently and with low pulsation and shear forces? Both can be completely emptied of residues and are fully CIP/SIP-capable, which shortens production downtimes and thus has a positive effect on the operating company’s revenue.
Conclusion: GEA offers single and multistage centrifugal pumps for horizontal or vertical installation as per the requirements of the pharmaceutical, biopharmaceutical, beverage and food industries. The portfolio is supplemented by a rotary lobe pump and a twin screw pump series. Developed and manufactured in accordance with international standards and the Hygienic Design guidelines, all sterile pumps meet the requirements of operating companies with regard to the absence of gaps and dead spaces and the use of high-quality corrosion-resistant Cr-Ni-Mo steels with defined quality and surface roughness levels. In addition to product transfer, the pumps are also designed for use in CIP cleaning and SIP disinfection circuits. GEA pumps are supplied with comprehensive documentation to support the validation and FDA approval of pharmaceutical plants: Factory certificate/acceptance certificate according to 2.2 DIN EN 10204; material certificate according to 3.1 DIN EN 10204; FDA-USP Class VI certificate of conformity for the sealing and other materials used; surface roughness measurement report; ferrite content measurement report. All types are designed in accordance with the EHEDG guidelines.
…that the oversizing of pumps is still very common? And here‘s how it happens: Everyone involved in the ordering process adds “a little extra” to be on the safe side. Such safety margins, even if only 3% per person, can lead to a larger motor or, worse, a larger pump being purchased. But it is a deceptive safety. Cavitation increases during partial load operation, which in turn increases the probability of failure.
Fig.4. Vertical GEA Hilge CONTRA with integrated frequency converter
An electronically controlled pump drive enables infinitely variable speed and power adjustment and the exchange of parameters and process data for central monitoring, control and possible visualization/recording. The keyword is traceability. In addition, frequency converters minimize the negative effect on sensitive media and reduce wear and energy costs. Regular maintenance of wearing parts reduces susceptibility to faults. As a result, the service life is increased. For CIP cleaning, a higher flow rate can be provided.
Sometimes it is necessary to decide between a large and small pump size. In individual cases, it may make sense to select the smaller pump with a larger motor and a frequency converter. In high-frequency mode up to 60 Hz, the higher performance required for, say, CIP operation is achieved, whereas in the more frequent standard operation mode up to 50 Hz, the small pump provides significantly better efficiency. The additional costs of the frequency converter are partly balanced by the lower price of the smaller pump model. The fact that the pump, motor, frequency converter, software and controller all come from a single source ensures well-coordinated and, above all, reliable and safe interaction. Incidentally, the replacement of fixed-speed standard pumps of the same design causes no additional costs, apart from the frequency converter – the new pump only needs to be connected to the power supply and integrated into the piping.
Conclusion: Today, frequency converters are an integral part of sterile pumps. Continuous control via a micro frequency converter integrated in the motor is state-of-the-art. As a decentralized solution, this drive concept is an inexpensive, convenient alternative to external frequency converters, optimized for pump applications.