Pressemitteilung BoxID: 589405 (GEA Tuchenhagen GmbH)
  • GEA Tuchenhagen GmbH
  • Am Industriepark 2-10
  • 21514 Büchen
  • Ansprechpartner
  • Jürgen Henke
  • +49 (4155) 49-2242

TechnoPharm 2013: GEA Niro Soavi Homogenization as a turnkey solution for pharmaceutical and biotech applications

(PresseBox) (Büchen, ) GEA Niro Soavi is presenting a live-example of homogenization technology. It will be a great occasion to see and touch the result of homogenizing process presenting a complete stand-alone pilot plant laboratory homogenizer.

See the features in detail of the pilot plant homogenizer Panther NS3006L which will be shown in action during the exhibition:

PantherNS3006L in his standard configuration is an easy-to-use and compact homogenization unit with a feeding hopper. This movable unit can be configured in two variants. Panther 1000: 120 l/h at 1.000 bar working pressure and Panther 1500: 50 l/h at 1.500 bar working pressure. The laboratory skid shown during the exhibition will be composed of: PantherNS3006L with integrated feeding hopper, feed pump and piping for sampling and electrical power board .

Our Pilot unit Homogenizer Panther NS3006L is ready for Plug & Play tests at pilot scale with recording of all relevant homogenization test parameters. It is an example of high customization obtained with a close cooperation and partnership with our customers. This unit is suitable for realization of batch and continuous flow processes, which are often used for emulsions, dispersions and liposomes in pharmaceutical, cosmetic and food and beverage applications. Optionally it can be equipped with a tubular heat exchanger after homogenization in order to cool down the product back to the inlet temperature value. Panther can be cleaned (CIP) and sterilized (SIP) in place. It guarantees an effective particle size reduction and maximum yield with excellent results pharmaceutical drugs, biotechnology cell rupture, nanoparticles and nano emulsions & dispersions.

High Customization

GEA presents a highly customized pilot plant homogenizer with the following extra features:

- Adjustable variable capacity between 60 l/h and 120 l/h at 1.000 bar for different batch sizes
- Product cooler after homogenizing valve to recover the temperature increase by homogenization
- Temperature measurement at inlet, outlet of the homogenizer and outlet of the cooler.
- Digital data recording of process data (nominal capacity, pressure and temperatures) suitable also for validated processes under cGMP regulations.

These features allow a wide range of application and make the presented unit to a universal and modern homogenization unit. The homogenization valve is configured by GEA Niro Soavi to meet the best performance for dedicated application. The special design of RNSTM and Re+ valve are the results of Research and Development studies that were carried out using fluid-dynamic analysis. Experimental studies showed tangible advantages on the processed products. The selected homogenizing valve realizes a repeatable, uniform particle size, or the highest yield of enzymes of the disrupted cells with guaranteed scale-up from R&D to full production.

From laboratory size productions to industrial scale - The evolution of pharma skid

The great success of Laboratory plug and play skid brings GEA Niro Soavi to carry on a new project direct to develop the PLUG & PLAY PHARMACEUTICAL SKIDS not only for laboratory units, but extended also for industrial homogenizers. Today, pharmaceutical, food and even chemical manufacturers are demanding safe and ultra clean plug and play solutions able to work in aseptic condition and fully compliant with all pharmaceutical requirements and regulations. The equipment must be capable of operating at very high temperatures, withstand fatigue stress, operate with a high safety level, and be comprised of reliable and long-lasting components.

GEA Niro Soavi developed full skid homogenizers able to meet all these fundamental requirements of hygienic design and quality. The long experience in pharmaceutical application enables a technical support in the preparation of a full documentation package for cGMP certification and in the selection of the right components materials (FDA approved gasket and 3A certified materials) .

Skids are available for small and medium size homogenizers from Ariete range. In their standard configuration are composed of feed pump, homogenizer, electrical power board and heat exchanger, but they have a long list of available options to easy-fit for any customer's needs.

Our Skids are able to achieve effective particle size reduction with maximum efficiency and optimal yield in cell rupture, nanoparticles and nanoemulsions production with energy saving.

The Skid plant homogenizers are available also for the processing of pharmaceutical formulations under qualified conditions and cGMP guidelines. For these applications, GEA Niro Soavi supplies the full documentation package and support for qualification (IQ/OQ) on site. The collaboration and direct interaction with customers is the long-standing hallmark of our company's mission and remains one of our core values in which we continue to invest.

From the initial feasibility study and throughout the entire life cycle of the machine our customer was flanked by our skilled personnel, offering customized solutions, product tests (FAT-SAT) on the machine, and the documentation required to secure the most stringent certifications (cGMP).

GEA Niro Soavi supported customers with its in-house laboratory and Innovation Centre, equipped with complete pilot plants. The facility guaranteed the possibility of advance evaluation of the effect of the homogenization process, with consequent customization of process parameters able to optimise production efficiency and suitable for replication on an industrial scale.

A widely distributed aftermarket support network and scheduled maintenance programmes will accompany the customer throughout the working life of the machine.

GEA Niro Soavi at TechnoPharm: Hall 6, Stand 229