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The new generation of separators for pharmaceutical applications with the GEA flexChange concept have been launched.
The bowls of this separator can be quickly and easily interchanged with the standard-model integrated direct drive, without expensive structural alterations.
The new GEA flexChange concept provides a total of three bowl types. These can also be steam sterilised and can be delivered as a skid.
Furthermore, they are specially designed for the production of, for example, insulin, proteins, animal cells and vaccines.
This concept includes two self-cleaning bowls as well as a nozzle bowl type, which was fitted for the first time with the ground-breaking GEA flexicon nozzle technology.
Additional advantages of this new generation of separators for use in the pharmaceutical sector also include an Integrated Directdrive (IDD) as standard for all three bowl types, which will cover nearly all current volumes and meet the highest pharmaceutical hygiene standards as per ASME BPE 2014.
Virtually all pharmaceutical applications are covered.
The GEA flexChange concept of the new line of separators provides for high flexibility, which improves the competitiveness of Contract Manufacturing Organizations (CMO) and of pilot plant operators.
The client can choose the appropriate bowl variant for the particular production line. If the market requirements change, additional bowls can be used in the same machine without complex time-consuming and cost-intensive modifications.
GEA flexicon-nozzle for infinitely variable product adaptation without reconstruction
The new nozzle type separator scores with a newly-designed nozzle, which can be infinitely adjusted from the outside without reconstruction by changing the inlet and outlet pressure during production.
Users may, for example in the application of starter cultures, use just one machine to apply centrifugal force to around 150 different products.
Space and cost saving
An additional advantage of the new generation of separators: the standard-construction Integrated Directdrive, which operates without motor shaft, gearbox, belt, coupling or motor bearings.
This considerably reduces the footprint of the machine, the noise emissions and the power and maintenance costs. The Integrated Directdrive does not allow for particle emissions into the clean room and increases the availability of equipment.
Highest international pharmaceutical hygiene standards (ASME BPE 2014)
In the pharmaceutical industry, aseptic process control combined with optimum equipment cleanability form the basis for the safe economic development and manufacturing of the product.
In this, the new GEA separators in their execution as self-cleaning and nozzel separators offer the user a high operational standard of security, which complies with the highest international pharmaceutical hygiene standard ASME BPE 2014.
All parts product contacting parts have been polished without compound.
Moreover, the steam-sterilised separator design can be sterilised with pure steam under pressure with a temperature of more than 121°C.
New plant for the production of sodium bicarbonate
At the end of 2017, GEA was awarded an order by Ciech Soda Deutschland GmbH & Co, one of the leading manufacturers of soda products, for the development and design, delivery and installation of a plant for the production of sodium bicarbonate.
Together with Chemieanlagenbau Chemnitz, this project is currently in the implementation phase. Commissioning is planned for the first quarter of 2019.
GEA is responsible for process engineering, delivery and commissioning of the main equipment in this project. sodium bicarbonate is responsible for the provision of components, auxiliary units, measurement and control technology (MSR) as well as for the construction of the building including the plant.
The innovative process was developed in intensive test and laboratory phases in close cooperation with Ciech Soda Deutschland GmbH & Co. KG.
By separating several process steps and assigning them to different apparatuses, possibilities were created to control the process more efficiently and to influence the product properties in a targeted manner.
The heat demand required for the new process is provided by exclusively using heat from the soda process. The resulting released cooling tower performance is a positive side effect.
GEA to supply contained tableting lines to top-tier Russian pharmaceutical company
GEA has been chosen by JSC Pharmasyntez, a leading Russian pharmaceutical company, to supply multiple contained tablet manufacturing lines for the production of highly potent hormonal products.
Commenting on the multi-million Euro deal, in cooperation with GEA’s representative in Russia, SolidPharma, Phil Gabb, Head of Solid Dosage Sales Support, GEA, said: “We are extremely pleased to be collaborating with Pharmasyntez and, in particular, with Mr Vikram Punia. He has very ambitious growth plans for his company and has a proven track record in achieving his goals.”
GEA will be working with Pharmasyntez to supply and implement three high containment oral solid dosage (OSD) form production lines for female and other hormonal preparations at the company’s Tyumen plant in Siberia.
With a planned production capacity of more than a billion tablets per annum, the new facility will benefit from state-of-the- art manufacturing technology from GEA’s batch and continuous portfolio, including single-pot processing solutions — with unique features such as microwave drying and swinging bowl functionality to reduce drying times — MODUL contained and wash-off-line rotary tablet presses, materials handling systems and MC BUCK split valve technology.
A specialist in the development and production of antitubercular, antineoplastic, antiretroviral medicines and hospital antibiotics, Pharmasyntez has a product range of 115 products comprising dosage forms such as tablets, capsules, granules, infusion solutions, sterile powders, and injectables.
“After a stringent review of equipment manufacturers around the globe, Pharmasyntez chose GEA to supply three complete lines – from powder handling to tableting – for its state-of-the-art hormone facility in Tyumen (Russia), said Mr. Vikram Punia.
“When it comes to the production of hormonal pharmaceuticals, there are a lot of critical issues to consider, such as operator safety, dosing, cross-contamination, etc. GEA offered us the best quality solutions for all of the above. We understand that reliable solutions require significant investment, but when it comes to pharma, quality is paramount, which is why we chose GEA,” he added.
“Russian pharma has come a long way in the last seven years, since the introduction of the Pharma 2020 program. Almost USD 5 billion has been invested in the pharma industry, more than 30 new manufacturing facilities have been built and, now, more than 80% of the life-saving drugs used in Russia are made in Russia!”
“Today, more than 90% of the hormone drugs used in the country are imported; Pharmasyntez, supported by the Ministry of Trade and Commerce, and the Institute of Endocrinology, decided to change that. As such, Pharmasyntez has invested more than EUR 50 million in the construction of a modern, GMP-compliant hormone facility.”
“Pharmasyntez would like to thank the Ministry of Trade and Commerce, particularly Mr Denis Manturov, Mr Ivan Dedov from the Institute of Endocrinology and, finally, Mr Vladimir Yakushev from the Tyumen government for their kind support, and VTB (bank) of Russia for financial assistance. The new facility will be one of the largest hormone drug production facilities in Europe, and we look forward to collaborating with current and future partners to improve the production and market access of these life-saving drugs,” he concluded.
In summary, Phil added: “As containment experts, we not only offer the largest variety of solutions for contained processing, but also unrivaled experience in identifying the most appropriate solution based on a containment risk analysis. Plus, from powder to coated tablet, no other supplier offers such as comprehensive range of batch-based and continuous tableting technologies, from powder handling to granulating, drying, compression and coating. This partnership with Pharmasyntez is another shining example of how, at GEA, we’re making science work.”
