PRODUCT UPDATE
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PAC Machinery Group
A tabletop band sealer suitable for medical device applications is available from PAC Machinery Group (San Rafael, CA, USA). The unit is equipped with statistical process control for validation of speed, temperature, and pressure. The D666 sealer includes a built-in alphanumeric dot-matrix printer that can be used to print information such as the date, operator name, serial number, and codes directly on the pouch seal at a rate of up to 390 in./min. The unit has a serial port for computer validation. The sealer can be used with a variety of pouch materials including paper/polypropylene and Tyvek. The tabletop unit also features electronic temperature control to 200°C and automatic adjustment of seal pressure.
The company also manufactures standard, modified, and custom thermal-impulse heat sealers, vacuum and gas snorkels, and continuous sealers for medical pouch sealing and related applications. Manual, semiautomatic, and automatic models are available as well as machines with a vacuum and gas flush capability.
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Bischof + Klein
Flexible packaging made from PE and paper is available for medical device applications. A packaging line for medical applications from Bischof + Klein (Lengerich, Germany) includes single-wound and tubular films, open-mouth sealed bags, bottle-shaped liners, and Tyvek/HDPE autoclavable bags. All packaging materials are manufactured in Class 100 cleanroom conditions. The CleanFlex product line of cleanroom packaging encompasses many common packaging types such as flat and tubular film, flat- and side-gusseted bags, double or triple bags, and bottle-shaped bags. Also available are high-barrier laminated bags available on reels or as three-side sealed bags. High-barrier laminated bags enable the optical verification of contents. The company is certified to ISO 9001. Its cleanrooms are certified to ISO 14644-1.
Witt Gasetechnik GmbH
A leak detection system for package testing can be integrated into production lines. Available from Witt Gasetechnik GmbH (Witten, Germany), the Mapmax system can test batches from thermoform or tray-sealing machines. Packages are tested individually, enabling rejected packages to be replaced. This development is the result of an infeed system that consists of two synchronized conveyor belts.
The measurement chamber of the Mapmax is approximately 1800 mm, making retrofitting possible for the majority of production lines. The equipment can carry out automatic quality control of the entire production line at a rate of up to 15 cycles per minute.
The unit uses carbon dioxide as a trace gas for leak detection. Test results are shown on a display; when a leak is detected, an alarm is triggered that switches a volt-free contact.
Analysis software allows the equipment to be operated by remote control and measurement data to be integrated into a quality management system. Data such as date, time, product details, and name of the tester can be transferred to a PC using Ethernet or WLAN connection. The data can then be analyzed in Microsoft Excel.
Command Medical Products Inc.
Focusing on the medical industry, a company offers assembly and packaging services for all types of devices. Command Medical Products Inc. (Ormond Beach, FL, USA) provides on-site packaging integrity testing services such as peel testing and burst testing. Cleanroom packaging and assembly services are offered to the medical device industry from the company’s facilities. Products are packaged in a variety of Tyvek and nylon pouches as well as sealed blister trays, shelf cartons, and shippers. Postpackaging sterilization management, bar coding, and dock-to-stock shipping programs are also offered. The firm is registered with US FDA and certified to ISO 13485. Custom extrusion, RF welding, and assembly services are also available from the company.
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ATEK Medical
A firm provides a range of contract services to the medical device industry including design engineering and product launch support, assembly, supply-chain management, sterilization, and distribution. ATEK Medical (Minneapolis, MN, USA) has extended its range of product and service offerings to the medical device and healthcare communities to include sterile and nonsterile packaging. The firm’s packaging portfolio includes a variety of flexible and rigid packaging materials.
Equipment utilized by the company includes a constant heat sealer, medical tray sealers, and horizontal form-fill-seal machines that are located in Class 10,000 cleanrooms. EtO sterilization services are also provided. The company is certified to ISO 13485:2003.
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Tiromat
A company specializes in the design and production of packaging machines. Concentrating on serving sectors in which hygiene and safety play a major role, Tiromat (Wallau, Germany) offers packaging materials, packaging machines and modules, and consulting services. The firm’s automated packaging systems and stand-alone machines are designed to fulfil the customer’s specific needs. Capabilities include full-factory automated networks, versatile form-fill-seal rollstock packaging machines, and tray sealers. The firm’s Compact and Powerpak machines have a modular design that enables them to be equipped with different heating, forming, and cutting systems. They produce high and uniform sealing pressure that provides hermetically sealed packaging and ensures product sterility using film, coated paper, and Tyvek.
The company also offers a range of integrated printing systems including ink-jet printers for noncontact printing, multicolour rotary printing systems, and thermal printing systems.
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Velfor Plast
Blister packaging suitable for medical device applications is available from Verlfor Plast (St. Pal-en-Chalençon, France). The Velairpack packaging comprises thermoformed “bubbles” and a sealed elastic envelope that conforms to the shape of a device, which floats inside the blister package. A single blister design can be used to package a range of orthopaedic products. There is no risk of abrasion because the device does not touch the blister packaging itself. The packaging can be sterilized using gamma radiation or EtO.
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AL.MA. S.r.l. Packaging and Packaging Machinery
A company founded in 1979 has developed and produced thermoform packaging lines suitable for a wide variety of product types. Packaging machines from AL.MA. S.r.l. Packaging and Packaging Machinery (Cadorago, CO, Italy) are manufactured according to customer requirements. Packaging lines designed for the medical device market make use of features such as centralized compressed-air exhaust and motorized waste-film winders, allowing them to be installed in cleanrooms. The machines can also be customized with thermal-transfer, flexographic, and ink-jet printers, and equipped with sensors. Machines can also be integrated with die-cutting equipment to cut packages with irregular shapes
SteriPack Ltd.
Pouches, header bags, blister lids, rollstock, and other packaging materials are available from a company that is registered with US FDA and certified to ISO 13485:2003 and ISO 9001:2000. Available from SteriPack Ltd. (Clara, Ireland), the packaging is produced in a Class 100,000 cleanroom. Pouches can be customized with the option of four-colour printing and the use of a sterilization indicator ink. The custom manufacturing services are offered with an average 3-week lead time.
A robust alternative to pouches, header bags include a breathable strip of coated Tyvek that enables easy access for bulky products. Header bags are available in a range of materials and in standard and reinforced strengths. Blister lids offer consistent seal strength and a wide sealing window. The firm’s rollstock can be printed in up to four colours.
The firm’s quality management system is fully automated. Contract services available from the manufacturer include new product development, ultrasonic cleaning, logistics management, CE marking, and sterilization management.
