Nowadays new drug development focuses mainly on biopharmaceuticals rather than fine chemicals, which means that the end product has to be an injectable fluid instead of solids. Also the new drugs are designed and developed for specific populations, which means that the batch sizes are smaller.
Therefore it is necessary to reduce cost, to minimize risk – including cross contaminations between batches- and to increase efficiency. Additionally there is need for a reduction in time involved in validation procedures; for example, paperwork and man-hours. All these factors lead to one optimal solution; Levitronix pumps with single use pump heads and/or peristaltic pumps with single use tubing or tubing assemblies used in almost all bio-pharmaceutical fill & finish applications.
ESI Technologies BV offers sterile single use (molded) filling assemblies with Advantapure.
These standardized single use solutions support the change to single use processing to
save time and reduce the risk of cross contamination while increasing productivity between
batches. These assemblies will be delivered sterile with sterility assurance level SAL 10-6
.
Compared to the traditional systems used in (bio)pharmaceutical processing the single use
assemblies can be quickly installed and be operational in a fraction of time.
The assemblies are made with Advantasil pt cured silicone tubing and molded components,
or weldable and sealable Advantaflex TPE biopharmaceutical tubing and components.
The assemblies are custom made with bags, filters, sterile connectors, filling needles
depending on end user’s choice. Furthermore, the choice of molded pieces (straight, Ypiece, T-piece) will be an advantage for continuous flow and especially to reduce the leak
and entrapment issues associated with barbed fittings. AdvantaPure also has a special
pump grade tubing range available for a longer pumping life in peristaltic pump applications.
