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Feature Articles : May 1, 2008 ( )
Bioprocess Advances Aim to Streamline Operations
Single-Use Components Take Center Stage at Interphex 2008
Thousands of professionals from the pharmaceutical and biopharmaceutical industries gathered at “Interphex” in Philadelphia on March 26–28. Educational presentations, workshops, and the opportunity for companies to display and demonstrate their latest products, technologies, and service offerings spanned the four major components of Interphex: facilities, outsourcing and contract services, information technology, and manufacturing/processing.
During a press briefing at the meeting, Sartorius Stedim Biotech announced the culmination of a collaborative effort with NewAge Industries to produce a line of single-use bag products with a built-in identification and tracking system. Sartorius has integrated the AdvantaPure GammaTag™ Radio Frequency Identification (RFID) technology into its disposable Flexboy® bioprocess containers to provide traceability and documentation for the lifecycle of the bag.
Sartorius plans to phase in implementation of the RFID biobag tracking system over the next six to eight months and will begin offering the system as an option to customers by the end of this year.
When a bag first comes into a facility it is logged in with its date of manufacture, lot number, part number, and a description all entered onto a microchip embedded in the bag. The end user can read the chip and see that the bag has passed quality control and can then enter his or her name, the date, and the intended use of the bag onto the chip. The bags can be gamma irradiated for sterilization without erasing or damaging the chip.
PreVAS is a prevalidated, preassembled, and presterilized line of disposable, single-use dosing systems from Bosch Pharma designed for the filling markets. Customized systems are clean-room assembled, gamma irradiated, and ISO 11137 validated for sterility. They are scalable to clinical and production quantities and are supplied ready-to-use, requiring only drug compatibility testing. The PreVAS system uses a positive-displacement, rolling-diaphragm pump composed of pharmaceutical-grade plastic fittings, tubing, connectors, and filling needles intended for one-time use.
When ATMI Life Sciences acquired LevTech in January, it added the company’s mixing technology, single-use mixing hardware, and disposable agitators to its line of specialty plastics and single-use processing systems.
Filtration and Chromatography
GE Healthcare showcased its suite of disposable filtration and chromatography products including single-use crossflow devices and prepacked and presanitized chromatography columns containing, for example, Capto Q, MabSelect SuRe, or Capto adhere media.
New Brunswick Scientific featured the new BioFlo 510® fermentor, a sterilize-in-place benchtop or mobile system with a working volume of 19.5 L or 40 L. The vessel headplate and sidewall contain several ports for flexibility in positioning probes, spray balls, valves, or a pressure transducer, for example.
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