GEA presented its new kytero Single-Use Pharma Separator at the Single-Use Conference in Leiden, the Netherlands, last month.
The equipment, designed for obtaining fermentation solutions and cell cultures, comprises GEA Westfalia Separator disk stack technology for maximum yield, high separation efficiency and gentle product handling, said the company.
A 500-liter batch of animal cells is processed in about four hours.
“The GEA kytero 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.”
All elements in contact with the product, such as hoses and containers, are made of recyclable material and are replaced after use to ensure no cross-contamination and hygienic harvesting of the cells, said the manufacturer.
The design of the aseptic connector system makes the exchange of single-use components fast and very easy, it continued.
“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 clean-in-place (CIP) and sterilize-in-place (SIP) 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.”
Set-up and changeover time is minimal. No auxiliary equipment such as water, buffers or tanks are required, while the noise level is very low, said GEA.
The unavoidable temperature increase of the product during centrifugation is minimal at less than two degrees, it added.