SOURCING DIGEST
Package leak tester
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A nondestructive leak-testing system for medical devices and nonporous packages features pressure- or vacuum-decay chamber technology. The TME Solution-C test system offered by TM Electronics Inc. (Boylston, Massachusetts, USA; www.tmelectronics.com) in custom configurations produces quantitative test results with medical devices that cannot be accessed through a port for pressurisation, and with sealed flexible medical and pharmaceutical packages. Providing high-resolution leak detection, the system offers the further advantage of not requiring good product or packaging to be wasted. Applications include blister cards, nonporous pouches, liquid-filled bottles and rigid, nonporous medical devices.
Combining the sensitivity of pressure- or vacuum-decay leak testing with the simplicity of sealed fixtures, the test system can detect holes as small as 5 µm. The highly sensitive detection method, based on a proprietary chamber design, finds leaks in product seals and in the walls and seals of packages made from materials such as films, foils and laminations. In addition, it can test induction-welded bottle seals and blister cards. Test fixtures are custom-designed to maximise test sensitivity for a particular product or package. Interchangeable fixture inserts enable each system to accommodate packages of various sizes.
Flexographic printers
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A supplier of on-demand package printing technologies has expanded its series of ultraviolet (UV) flexographic printing machines. Designed for in- or off-line printing of reel-fed pharmaceutical packaging substrates, Hapa AG’s (Volketswil, Switzerland; www.hapa.ch) 200 series has two new units, extending the range of web widths accommodated. The Hapa 210, now the smallest in the range, can print on webs 100 mm wide and on labels; and the Hapa 260 features a web-width capability of 600 mm, twice the width any 200- series machine had previously offered. These machines can print on foils, paper, PVC and laminates, and now make possible just-in-time solvent-free UV printing of small vial labels through to infusion bag materials.
The small printer integrates with labelling machines to partially or fully print precut self-adhesive labels in as many as five colours at speeds to 30 m/min. A sensor monitors label edges to ensure maintenance of accurate registration. Instantaneous UV curing of the ink enables the unit to print on virtually any kind of label stock.
In addition, UV curing prevents migration of the ink through the infusion bag substrate when that material is processed on the large machine. Material handling is a focus of the machine’s design, which prevents mechanical stress on the web.
Blow-fill-seal packager
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A packaging system for blow-moulding containers, filling them with liquid product and sealing the filled containers in one integrated process occupies a plant footprint of 2.01 × 5.16 m and requires a minimum vertical clearance of 3.05 m. The Asep-Tech Model 640 blow-fill-seal system from Weiler Engineering Inc. (Elgin, Illinois, USA; www.weilerengineering.com) can be configured with 10 to 60 cavities for moulding containers with volume capacities of 500 mL down to 0.2 mL. Maximum hourly output ranges from 2000 containers of the largest size to 15000 of the smallest.
The capacity of the machine’s built-in 63.5-mm, 22.4-kW extruder is 109 kg/hr for low-density polyethylene, 91 kg/hr for high-density polyethylene and 81 kg/hr for polypropylene. Dry, oil-free compressed air is supplied to the system at a rate of 24.5 m3/hr at a typical 4.2-bar pressure, vacuum is supplied through airflow of 50 m3/hr at 635 mmHg/min, and sterilising steam, not in use during production, is supplied at a typical 18 kg/hr at 2.7 bar.
Package-testing systems
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A new generation of package testing-systems targeted at medical device manufacturers and quality assurance laboratories is designed for performing a variety of leak and seal-strength tests on flexible, rigid and porous materials. Consisting of the stand-alone Model 4000 and PC-operated benchtop Model 4500, the energy-efficient 4000 series from Paul Lippke Handels-GmbH (Neuwied, Germany; www.lippke.com) uses positive pressure to measure the strength of a package’s seals and material while simultaneously assessing its ability to seal its contents against atmospheric contamination. It conducts tests at three different pressure levels. The testers offer precise, accurate and reproducible test results consistent with ASTM standards F2054, F1140 and F2095 and ISO standard 11607.
The series includes flow booster technology as standard, which ensures that the volume of gas necessary to perform a test is available when needed. Also standard are several features often unavailable or offered on a custom basis on other machines. These include electronic pressure and flow controls for optimising precision and accuracy in leak and burst tests, custom package fixtures, the ability to function in eight test modes, and an advanced leak test option that provides absolute hole size measurement. An array of test method templates, validations, and certified calibration products and services can help medical device manufacturers satisfy regulatory mandates.
Pouching system
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A pouching machine is offered for packaging wound dressings at speeds of up to 150 cycles per minute. The RDM 4SS four-side-sealing machine from Medical Engineering Technologies Ltd (Hythe, UK; www.medical-engineering.co.uk) is suited for operation in an ISO 13485:2003–certified medical production environment. Featuring the Siemens Simotion programmable logic controller that is informative and easy to use, the machine runs at a higher speed and pouch length changes are rapid and efficient. The human–machine interface is a touch screen with intuitive programming. Alarms are displayed clearly and printing integration is simple.
Dressings are fed to the machine via a flighted conveyor, allowing manual or automatic loading. Cutting and folding stations also can be automated. Other products than dressings can be packaged with this equipment, including catheters, diagnostic devices and filters. The product restriction is a height limit of 15 mm. Machine calibration is handled through ports that provide easy access to temperature, pressure and timing signals. Customer support includes ISO 11607:2006–compliant machine qualification performed by the manufacturer.
Ink-jet printer
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An ink-jet printer has been designed by Videojet Technologies UK Ltd (Huntingdon, UK; www.videojet.com) to provide reliable, high-resolution in-line printing of variable data on corrugated shipping containers in applications that require codes as large as 50 mm high to be printed. The Videojet 2320 large-character printer features an automatic self-cleaning and self-maintenance system that keeps the printheads always free of dust and debris. In fact, the noncontact maintenance system obviates the printhead damage that can occur during traditional maintenance servicing. The printer provides an alternative to preprinted shipping cases and to print-and-apply labelling systems.
Automatic printhead maintenance encompasses the recycling of used ink. Also, an air-driven ink system eliminates the downtime required for maintaining pumps, solenoids and other moving parts, and new ink is added during ongoing production by means of inserting sealed nonpressurised containers.
Multiple printers can be operated from a single master unit, and built-in network capability allows remote control of one or more printers from a programmable logic controller, facility information technology system, or other remote computers. An intuitive touch screen interface provides a simple, secure means of changing images in seconds.
Top-loading case packer
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A case packer that can be equipped with a wide range of loading arms adapts to handle various types of pharmaceutical and other products in primary and secondary packaging such as bottles, bags, tubes and regular slotted containers. Cermex (Corcelles les Citeaux, France; www.cermex.fr) has added the compact SD58 to its case-packing machinery range as an alternative that reduces the machine footprint substantially and maximises flexibility. The top-loading case packer performs multiple functions, including product collating, case forming, loading and sealing; for each of which the manufacturer has developed a specialised module. Rethinking series functional design with this model, the machine builder introduces a back-and-forth system to drive the case-holding grippers in the case-extraction and -forming module.
The machine frame supports a variety of loading systems to suit the nature of the product, infeed speed and mass, and loading trajectory envelope. The packer can be equipped with a just-developed three-axis loading arm or can integrate other manufacturers’ multiaxis robotic arms for product gripping and loading. Whatever gripping arm is used, size changeovers affecting other parts of the machine can be completely automated. A vision system can be incorporated to check for good primary and secondary packaging before case packing. This packer can handle payloads to 8 kg and run at speeds to 15 cycles per minute.
Peel performance tester
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A peel tester from Mark-10 Corp. (Copiague, New York, USA; www.mark-10.com) consists of a motorised test stand, digital force gauge and 90° peel fixture. The company designed the new fixture for numerous medical, pharmaceutical and packaging industry applications, including the testing of adhesives, films and packaging. The fixture establishes and preserves a constant 90° angle between the table and the direction of pull in testing, for example, foil seals found on packages and containers. The tester is designed for use on the production floor as well as in research and development (R&D) and quality control laboratories.
The test apparatus’s large flat working table with mounting holes accommodates a range of sample sizes. As the test-stand crosshead moves vertically, the table moves horizontally so that the requisite 90° angle is maintained. The table is connected to the crosshead via a cable. An optional limit switch is available for the motorised stand to prevent cable breakage due to excessive movement.
Form-fill-seal system
Using servomotor technology to achieve high form-fill-seal cycle rates, an automated medical packaging line is available that needs no compressed air, provides great precision of motion, and offers the advantages of mechanical simplicity because of its minimisation of moving parts. The RapidPak RP-55 packaging system from Alkar-RapidPak Inc. (Lodi, Wisconsin, USA; www.rapidpak.com) features a servo-driven plug assist to optimise forming and allow for down-gauging of film thickness with no loss of barrier properties. Other features include an Allen-Bradley ControlLogix system and modem to facilitate maintenance, and construction based on industry-standard off-the-shelf components that are easily sourced. The 371⁄2-ft-long (11.46-m) machine has an overall width of 40 in. (1016 mm) and a custom frame welded and machined to a tolerance of ±0.001 in. (±0.0254 mm) for long-term consistency in performance and minimised component wear.
Servomotors drive all major machine functions, enhanced by continual feedback. Individually driven shape-cutting heads cut only filled packages produced from flexible or rigid film. Formed pockets can have maximum dimensions of 127 mm, and the machine’s indexing capability extends up to 762 mm. A remote electrical panel and NEMA 4 watertight components ensure reliable machine start-up following aggressive cleaning.
Cartoner
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A horizontal clocked cartoner with an output of 140 cartons per minute is an intermittent-motion machine that can attain the performance level of machines that operate continuously. Equipped with a balcony structure, the Promatic P91 S has been designed by Romaco Group (Karlsruhe, Germany; www.romaco.com) to meet the standards of pharmaceutical packaging applications. Finely adjusted handling routines ensure a smooth carton opening and closing sequence, and the machine is driven by low-noise, low-vibration brushless motors. The cartoning process is monitored and controlled via a control panel that employs sensor technology to make operation simple, control flexible, and intervention in the packaging process rapid.
Configuration and installation of this cartoner can be adapted to the customer’s needs. All machine parts are easily accessible, and staff need no special training to adjust the cartoner to different package sizes. Operators can directly perform all necessary changes in format.
Digital ink-jet printer
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A high-resolution ink-jet printing system has been added to an existing range of compact, lightweight printers designed for easy integration into packaging and production lines. The Omega 36 HD, like its predecessors from Atlantic Zeiser GmbH (Emmingen, Germany; www.atlanticzeiser.com), the Omega 36 and 36i, is suitable for web applications. It prints on a variety of substrates, including paper and carton stock and specialised materials such as aluminium, polymer foils and plastics. A resolution of 720 dpi, combined with the manufacturer’s proprietary inks, ensures clear, crisp printing of small characters and a high degree of clarity and readability for bar codes.
Omega printheads are designed to achieve the quality of flexographic printing with the added advantage of being able to print variable data. The versatile system prints these data on all types of packaging and is compatible with sheet-fed as well as web-fed processes. It enables printing service providers to perform short-run jobs cost-efficiently.
Automated assembly and packaging equipment
A worldwide supplier of assembly equipment to the medical device and pharmaceutical industries provides complete system integration and material handling for all system components, from moulding to final assembly and packaging. Kahle Automation Srl (Caravaggio (BG), Italy; www.kahleautomation.com) offers a line of standard and custom-designed and -manufactured automatic loading and transfer systems that facilitate the integration of assembly or processing equipment, packaging machinery, and other elements of a production line. Complementing its offering of high-speed automated production equipment, the company can provide maintenance of the installed machinery at the customer’s manufacturing facility.
Phthalate-free TPE
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A speciality line of thermoplastic elastomers (TPEs) includes a phthalate-free option. GLS Corp. (McHenry, Illinois, USA; www.glscorporation.com) has added CL E95 to its Versaflex family of high-performance TPEs to address regulations limiting the use of phthalate-based plasticisers in certain applications and market demands for low-extractable TPEs. The new elastomer offers water-like clarity and stability under conditions of gamma irradiation and autoclave sterilisation. It is suitable for use in durable packaging applications, tubing and films as well as blow-moulded bags.
The phthalate-free TPE has a low hardness of 95 Shore A and a specific gravity of 0.90, and exhibits typical tensile strength of 17.2 MPa at break, elongation of 575% at break, 300% modulus of 11.7 MPa and tear strength of 4.8 MPa. materials also offer good flexibility at low temperatures.
