Originally Published EMDM January 2006
Spotlight
Packaging and Sterilization
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Packaging and sterilization products
A range of semi- and fully automatic packaging equipment includes three- and four-sided-seal pouch machines, blister-tray sealers, and constant-heat pouch sealers. Suitable for cleanroom use, the machinery is validated according to ISO 11607. The company also offers in-house testing, aging trials, and validation services, and supplies sterilization indicators. Medical Engineering Technologies Ltd., Folkestone, Kent, UK.
Radiation cross-linking sterilization
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A company offers precision-controlled radiation cross-linking with accelerated electrons or gamma rays. The procedure can sterilize plastics to regulatory requirements and can enhance their thermal, chemical, and mechanical properties. Specific applications include drip bags, hip-replacement components, and packaged medical devices. Materials suitable for the procedure include polyethylene, polypropylene, polycarbonate, acrylonitrile butadiene styrene, cyclo-olefin copolymers, polyethylene terephthalate, ethylene vinyl acetate, and ultra-high-molecular-weight polyethylene. BGS, Bruchsaal, Germany.
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A one-step electron-beam sterilization process permanently cross-links plastics, increasing their tensile strength and thermal stability. The procedure can be tailored to meet specific sterilization criteria and can improve resistance to solvents, chemicals, and abrasion while increasing oxygen permeability. Applications include tubing, moulded parts, packaged medical devices, and woven and nonwoven materials. E-Beam Services Inc., Cranbury, NJ, USA.
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Radiation sterilization
Radiation sterilization services are offered by a firm equipped with a 10-MeV, 200-kW electron-beam unit and a 4-MCi pallet irradiator that can accommodate 100 × 120 × 195-cm pallets. The services are compliant with ISO 11137 and ISO 13488, EN 552, and CGMPs. The company offers microbiological testing and a range of services including contract packaging, documentation, low-dose verification, and material-selection advice. Studer Hard, Daeniken, Switzerland.
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Automatic case-packaging machine
A horizontal case-packaging machine can insert boxes and other products into shipping cases and close them with either tape or glue. The machine can be adapted to the dimensions of various boxes by means of handwheels with graduated scales and control-panel adjustments. A colour touch screen integrates machine functions. The unit can also be supplied with an industrial PC that uses Windows XP and software conforming to CFR 21 Part 11.
The manufacturer is certified to ISO 9001. MG2 S.r.l., Pianoro, Italy.
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Contract assembly and packaging
Contract assembly and packaging services are offered in Class 100 and Class 10,000 cleanrooms. Additional services can include testing, sourcing, package design, product assembly, and supply-chain management. The facilities operate according to ISO 9001:2000, ISO 13485:2003, and GMP standards. Products typically handled by the company include airway management devices, drainage sets, and orthopaedic instruments. Arrow Medical Ltd., Kington, Herefordshire, UK.
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Sterile bag manufacture
A company has introduced radio-frequency (RF) welding for sterile bag manufacture. RF welding can produce a strong, fluidproof seal in polymer-film bags suitable for use with IV fluids, blood, and urine collection. This service expands on the company’s ultrasonic and thermal-contact welding capabilities. Multiple-chamber bags, peelable-seal technology, and contract manufacture of custom components such as ports and saddles are also available. Medisize, Hillegom, Netherlands.
Packaging services and materials
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Sterile bags, pouches, and films are available in reels. Materials processed include foil, Tyvek, medical-grade paper, polyethylene, polypropylene, and PVC. Material thickness and reel length can be customized. The company is ISO 9001 certified and also offers a range of printing and packaging services. Bolsaplast, Barcelona, Spain.
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