December 2008   
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Exhibitor News

Exhibitor MediSeal GmbH in Booth D08 has expanded its company headquarters at Schloss Holte, Germany. Adding 1300 square meters of production space will enable MediSeal meet more-demanding market requirements.

For instance, separate cleanroom areas have been created so that pharmaceutical products can be filled and packaged under climatically sterile conditions. Stephan Plewa, MediSeal’s CEO, explains: “With the cleanroom areas, we can offer our customers extra added-value. These areas are available to our partners in the pharmaceutical industry for the production of small lots and samples, which can then be submitted to the government agencies responsible for licensing new drugs.” Ultramodern equipment is complemented by special safety precautions, such as access control and pressure monitoring.

Assembly areas have also been expanded.

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MediSeal development, designs, and manufactures thermoforming and sachet machines, cartoning machines, and complete packaging lines. MediSeal has also acquired capabilities in dosing and packaging of solids, powders, and other paste products. Sister companies in the KÖRBER MEDIPAK group are Rondo and Dividella.

In Booth B17, Kobusch-Sengewald (Halle/Westfalen, Germany) will share the latest on its new film for sterile barrier systems, Softform. The polyethylene-based film offers deep draws and resists perforation. Suitable for sealing to uncoated paper, Softform is a low-cost alternative for the packaging of simple medical products.

For medical devices with sharp edges, Kobusch-Sengewald provides Formpeel. This deep-drawing film, which is also PA-free, seals to coated paper or coated Tyvek. A special version is available for sealing to uncoated Tyvek: Formpeel-T. Both Softform and Formpeel are virtually shrinkage-free, retaining form even after deep drawing.

A range of PA/PE films are also available, offering high transparency and scuff resistance. On the downside, the high price of the polyamide raw material makes PA/PE films relatively expensive, and they also tend to shrink more.

All deep-drawing films are suitable for EtO or radiation sterilisation and have been test-run by manufacturers of vacuum-moulding machines, such as Multivac.

 

Kistler Instrumente AG, in Booth F07, is currently fitting two 96-cavity molds for the production of insulin pen components with pressure sensors for quality assurance. Each of the 96 cavities and each of the 16 manifolds will be equipped with a sensor, such that each mold will come with a total of 112 sensors. The objective of using mold cavity pressure sensors in injection molding these polypropylene components is to establish 100% automatic quality assurance and zero-defect production. With a front diameter of only 1 mm, the Type 6183A sensors are the smallest used so far for cavity pressure measurement. The mold maker adapts the front ends of the sensors to the contours of the cavity wall, using erosion technology to fit both the sensors and the mold inserts.

Kistler's single-wire technology allows 112 sensors to be integrated into such a compact and complex mold. The cut-and-grip technique permits the sensor cables to be fitted and removed quickly and easily without any additional tooling.

Kistler is a leading manufacturer of pressure and temperature sensors for use in the plastics processing industry. Kistler’s core competence is the development, production, and use of sensors for measuring pressure, force, torque, and acceleration.

 

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.

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.

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.

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