Exhibitor News
The CleanFlex product range encompasses flat and tubular films, premanufactured primary and secondary packaging, single- and multiple-ply bags, laminates, and high-barrier packaging. Extrusion, printing, conversion, and all further steps are consolidated and take place under Class 5 cleanroom conditions according to DIN EN ISO 14644-1 at rest and GMPs. STORY CONTINUES BELOW
To meet the needs of high-containment systems, B+K creates tailor-made containment packaging solutions for use in isolators or restricted-access barrier Systems (RABS) together with its partners according to relevant system engineering. Manufactured from flexible materials, these components, as part of a high-containment system, offer significant potential for reducing costs in comparison with traditionally used stainless-steel parts. B+K has extended its capabilities in order to equip packaging materials manufactured from polyethylene, Tyvek, or laminates with individual spouts, valves, or connectors. For other systems, B+K also produces optimal versions of its CleanFlex films through a special sealing-and-cutting process in order to comply with the concept of complete containment.
Isotron utilizes the following technologies in contract sterilization and bioburden reduction:
Many Isotron sites hold pharmaceutical manufacturing licenses. Additional customer support include services from RegiLabs, a cGMP certified pharmaceutical chemical and analytical laboratory; microbiological laboratories and sterilization validation services is also available.
For instance, recent machines for glass syringes automatically feed and position glass barrels and then insert and glue the cannulas. UV curing of the adhesive follows. Optional stations, such as those for pull tests, camera inspection of needle tips, cannula siliconization, flow tests, and other processes ensure correct product assembly. Assembled and tested parts are automatically placed into trays. Camera inspection includes the following procedure: Two backlit cameras situated at an angle of 90 degrees check for needle quality defects. Each needle triggers a light barrier that in turn triggers lighting and cameras simultaneously. Images are then processed by a PC, and if the testing result is NIO (IO = In Order; NIO = Not In Order), the machine will discard the syringe. Up to four needles can be tested during one stroke of the machine. The station comprises two cameras, two backlights, an illumination controller, and a PC. The cameras are connected directly to the PC’s framegrabber connectors. In addition, the PC is equipped with digital I/O lines for communicating with machine controls. R+E adhesive and assembly machines for glass syringes have been in use for more than 20 years. |
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The CleanFlex product line from Bischof + Klein GmbH & Co. KG, exhibiting in Booth A24, conforms to the particular requirements of the pharmaceutical, medical device, and other related industries for flexible cleanroom packaging, including those of high-containment systems. According to the company, the use of CleanFlex packaging helps ensure a high-level of product safety and quality throughout the whole cleanroom chain, from raw material reception, production, and transportation to arrival at customer premises.
At Booth B32, Isotron will share news on its expanding contract sterilization services around the world for pharmaceutical materials and packaging, single-use medical devices, diagnostics and veterinary products. The company maintains a network of 18 sites in 8 countries across Europe, Asia, and Africa, including a new state-of-the-art EtO facility in Venlo, The Netherlands. Further expansion is also underway in China with services from a new facility in Suzhou Industrial Park, near Shanghai.
R+E Automationstechnik GmbH, in Booth B02, designs and manufactures assembly machines for both disposable plastic and glass syringes.