More than 99% yield, less filtration and no SIP/CIP
With the kytero 2000 Single-Use Pharma Separator, GEA presents another single-use centrifuge with the proven technology of the large GEA Pharma centrifuges at ACHEMA 2022 in Frankfurt.
The pharmaceutical specialist is thus once again fulfilling the wishes of its renowned global pharmaceutical customers for a single-use machine that excels in terms of high yield, ease of operation and compactness.
The kytero is ready for production in just a few minutes. Filter areas can be saved by up to 75%. The system requires only a conventional power connection; intermediate tanks are a thing of the past. CIP (clean-in-place) and SIP (sterilise-in-place) are eliminated thanks to the simple exchange concept.
Although the kytero 500, which is in high demand worldwide, was a machine for research and development and small-scale production, the kytero 2000 is suitable for pilot-scale and production applications, such as cell harvesting.
The kytero 2000 processes mammalian cell cultures from 150–500 L per hour and E. coli from 30–120 L/h. At just over 99% for mammalian cells, the yield is very high.
With the kytero series, GEA engineers have now succeeded in making single-use separators with disc stack technology available to manufacturers in the single-use process. The proven technology of the large steel separators is characterised by its high efficiency, gentle production process, fast processing and compactness.
In contrast to filtration, centrifugation does not separate the medium by means of filter media (filter plates and filter cloths), but by utilising the centrifugal force that occurs in conjunction with a disk pack for increased clarification efficiency.
The mobile "Plug & Produce" unit kytero with minimal footprint fits easily into any production room and laboratories.
The proven GEA feed system guarantees particularly gentle product treatment. The vitality of shear-sensitive products is preserved. Product runs and scientific investigations at the ZHAW School of Engineering in Zurich have confirmed this.
With the single-use separator, all parts in contact with the product are replaced after use, preventing any cross-contamination without the need for cleaning and sterilisation. The frictionless drive system provides 100% biocontainment by eliminating the need for seals or mechanical bearings.
Set-up and changeover time (5–10 minutes for preparation) is minimal. No utilities such as water, buffers or tanks are required. Changing single-use parts is very easy using aseptic connector systems. The design of the aseptic connector system makes the exchange of single-use components fast and very easy.
The elimination of CIP and SIP processes eliminates not only labour, but also the cost of chemicals, ultrapure water and energy.
GEA engineers have developed an unprecedented drive for kytero: GEA breezeDrive. This frictionless drive system ensures that no contamination of the product can occur, as the system completely dispenses with a conventional drive with spindle, mechanical seal, and mechanical bearing.
The noise level is very low at less than 69 dBA owing to the newly developed breezeDrive drive system.
The unavoidable temperature increase of the product during centrifugation is minimal at less than two degrees.