Single-Use Pharma Separator Revolutionary Solution for the Biopharmaceutical Industry

Source: Press release

With the new kytero single-use pharma separator, GEA presented a world first for the biopharmaceutical single-use industry. The GEA kytero single-use separator is designed for obtaining fermentation solutions and cell cultures and is equipped with the proven GEA Westfalia Separator disk stack technology for maximum yield, high separation efficiency and gentle product handling.

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GEA presents the kytero Single Use Pharma Separator, a world first for single-use biopharmaceutical processing.
GEA presents the kytero Single Use Pharma Separator, a world first for single-use biopharmaceutical processing.
(Source: GEA)

The single-use separator combines the high performance of larger GEA stainless steel pharmaceutical centrifuges with the features and benefits offered by disposable separation. This type of equipment is in high demand for animal cell and gene therapy processes, as well as for pilot plants, university laboratories, in R&D environments and small-scale production, and by biopharmaceutical manufacturers worldwide, as it relies on centrifugation to significantly reduce filtration dependency.

In centrifugation, unlike filtration, separation of the medium is not achieved by filter media (filter plates and filter cloths), but by utilizing the centrifugal force that occurs in conjunction with the disc pack for increased clarification efficiency. The mobile plug & produce unit also fits into any clean room.

The single-use separator is user-friendly and easy to handle. All elements in contact with the product, such as hoses and containers, are made of recyclable material and are replaced after use. This prevents any cross-contamination and ensures hygienic harvesting of the cells. The change of the single-use parts is very easy due to aseptic connector systems. The design of the aseptic connector system makes the exchange of single-use components fast and very easy, opines the firm.

The small footprint of the GEA kytero for single-use processing makes it highly mobile and minimizes the need for expensive storage or production space. Buffer tanks are not required. The elimination of CIP (clean-in-place) and SIP (sterilize-in-place) also eliminates the cost of chemicals and water, especially water-for-injection (WFI). In addition, the energy and labor required for cleaning and sterilization are eliminated, adds the company.

Set-up and changeover time (only five to ten minutes for preparation) is minimal. No auxiliary equipment such as water, buffers or tanks are required. The noise level is very low at less than 69 dBA. The unavoidable temperature increase of the product during centrifugation is minimal at less than two degrees. In the end, a 500-liter batch of animal cells is processed in about four hours - an excellent result in an excellent time, concludes the firm.