Filling aseptically manufactured cytostatic drugs requires high quality standards, especially regarding the protection of staff and substances against contamination. For this purpose, Oncotec Pharma Produktion GmbH is using a complete line from Bosch Packaging Technology for more than five years. The machine concept has stood the test and was approved by the U.S. Food and Drug Administration (FDA) with top marks.
Setting new standards
It was especially important for Oncotec to obtain the entire line from a single source. “Since its installation, the technology from Bosch has stood the test,” says Saskia Killer, responsible person for the syringe filling line at Oncotec Pharma Produktion in Dessau-Rosslau, Germany. The line consists of a compact with 100 percent in-process control and an additional sample check. Further elements include an automatic bag opener ABO, an automatic tub opener ATO, and a tailor-made isolator for all modules.
The FXS 3100 fills the pre-sterilized syringe nests with an output of up to 12.000 syringes per hour. After only one nest row, the filled syringe is closed, thus reducing the opened product’s dwelling time in the isolator to only a few seconds – a key indicator of the FXS platform. For Oncotec, the line has set new standards in the aseptic filling of pre-sterilized syringes.
Since start of production, Oncotec has filled far more than one hundred million syringes on the line. It is currently running at least 45 weeks per year in three-shift operation around the clock from Sunday to Friday. The growing market for cytostatic drugs will probably lead Oncotec to expand its filling lines. “Bosch will of course be shortlisted again,” Killer says.
Read the whole story in our current customer magazine packazine on page 16!
- Get more information about the FXS 3100 on our website.
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