SOURCING DIGEST
Med-tech packaging services
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An outsource packaging services company has invested in the medical technology side of its business to the extent that it has created a dedicated new business entity for this sector. IL-MedTec AG (Burgdorf, Switzerland; www.ilmedtec.com), a unit of Ivers-Lee AG, offers packaging and supplementary services on a partnership basis for medical devices, high-grade pharmaceutical products and clinical-trial-sample logistics. Its new facility contains a reportedly state-of-the-art cleanroom with ISO Class 8, Class 7 and Class 6 zones (Class 100,000, Class 10,000, and Class 1000), as well as the infrastructure and logistics necessary for properly packaging med-tech products. Certified to ISO 9001:2000 and ISO 13485:2003, the company packs a range of medical devices, including dental implants, orthopaedic implants, traumatology products and surgical instruments.
The assembly and packaging process comprises testing, washing, final rinsing, assembly and contamination-free packaging, followed by product sterilisation. Specific services performed include goods-in checks, washing and pure-water rinsing in a Class 100,000 room, assembly in Class 10,000 or Class 1000 areas, packaging under Class 10,000 conditions, labelling, final packaging for dispatch, final sterilisation and logistical services. The company is equipped with Hagmann-type blister packaging systems and a Kallfass shrink-wrapping system.
Materials for sterile packages
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A service provider to medical device manufacturers specialises in offering a full set of services in the areas of product cleaning, assembly, sterilisation and packaging. Inpac Medizintechnik GmbH (Birkenfeld, Germany; www.inpac-medizintechnik.de) employs modern equipment to perform these operations and in the production of packages in ISO Class 7 and Class 8 cleanrooms. The company also supplies high-quality packaging materials for sterile packages to customers that intend to do their own packaging in-house.
Packaged products are fabricated from biocompatible materials that have undergone extensive testing to verify biocompatibility and maintenance of sterility. The company uses computer-aided design (CAD) software to design the package for a product so that subsequent tool construction can be based directly on the CAD model. Attention is given to aesthetics as well as functional and application requirements. All the requirements of sterile packaging are taken into consideration in the design and in material selection.
The company manufactures blister packages to specification. It designs the tools for producing the blister and the sealing materials and has trusted partners produce them. The company will produce a complete package for the customer to use in-house, if requested, and it will provide advice on packaging and sterilisation validation, or perform those processes itself. In addition, it can supply a range of standard peel pouches with tested long-term internal sterility or, alternatively, will develop and manufacture pouches tailored to customer requirements. Flexibility in producing tools for the purpose ensures short lead times, it says.
Pouching machine
A pouching machine that can relieve operators of the risk of repetitive motion injury opens, fills and seals large premade Tyvek-strip header bags and foil and barrier pouches that are used to package bulky medical devices and trays. The Maverick Poucher from About Packaging Robotics Inc. (Thornton, CO, USA; www.aboutpackagingrobot ics.com) comes with one of the manufacturer’s automatic bar seal (ABS) systems, and a second ABS system can be integrated if higher production rates are required. The machine can include a system for embossing codes, and can provide modified-atmosphere or controlled-atmosphere packaging via a diving snorkel system. Bar code readers and print-and-apply label applicators can also be added.
Product loading takes place on a 30° incline to help ensure gentle handling. Products can be loaded manually or automatically. Pouch size changeover is reportedly quick and requires minimal operator training. The pouching machine’s programmable logic control system includes self-diagnostics, calibration firmware and alarmed limit checks to ensure reliable sealing and processing. It provides continuous control of the intermittent motion of both the pouch and product throughout the cycle.
Header bag
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A specialised sterile header bag is offered for the packaging of large or bulky items such as surgical kits and drapes. The Steribag from SteriPack Medical Ltd (Clara, Co. Offaly, Ireland; www.steripack.ie), is similar to a conventional header bag except that it combines Tyvek and linear low-density polyethylene (LLDPE) film in the header strip to produce a high-performance peel system with good breathability. The bag can be sterilised by EtO and gamma irradiation. The use of clear LLDPE film enables the enclosed product to be fully visible. This bag, like all products manufactured by the company, is produced in a Class 100,000 cleanroom. Customised versions of the package can be manufactured to supplied specifications.
Cleanroom services
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A specialist company injection-moulds medical device components from thermoplastic and liquid silicone rubber materials and provides related packaging services. Top Clean Injection (Peschadoires, France; www.tcinjection.com) offers silicone overmoulding and precision moulding of products using polypropylene, polycarbonate, ABS, SEBS, PBT, cyclo-olefins, PEI, PPSU, liquid-crystal polymer and PEEK in ISO Class 7 and Class 8 cleanrooms. Pad printing and packaging services can also be provided in a Class 7 environment. Plasma-based sterilisation is available, and an ISO Class 5 laminar airflow is maintained over the all-electric injection moulding machines. Quick response to customer needs is ensured by an in-house toolmaking shop, and the company’s model-making shop uses advanced Pro/Engineer CAD tools.
Needle packaging
A range of packaging for syringes, needles and vascular access devices offers a choice of features and performance capabilities that accommodate the demanding application requirements of this family of products. A specialist in flexible packaging for healthcare applications, Amcor Flexibles (Bristol, UK; www.amcor.com) provides films for this purpose whose abrasion resistance has been enhanced and includes options for sealing to fully peelable and direct-seal top webs.
Given the requirements of this class of product, the company uses base webs that offer good thermoforming characteristics and minimum tendency to revert; films and papers that run fast and efficiently on packaging lines; abrasion- and puncture-resistant materials that will not develop pinholes during transport and storage; and where EtO sterilisation will be employed, a porous top web. It recommends nylon-based coextruded films for the base web in syringe packaging, buried-nylon base films when cost reduction is a factor, and all-olefin films of polypropylene and direct-seal polyethylene as a cost-effective option for sealing to uncoated-paper top webs when the circumstances allow.
The four basic base-web film formulations come in gauges ranging from 60–275 g/m2 for the tough nylon polyethylene film designed for sealing to peelable top webs. Available top web materials are the high-performance-peeling paper grid lacquer laminate, uncoated paper, peelable film laminate of PET and peelable polyethylene, and peelable film coextruded of high-density and peelable polyethylene. Films and coated Tyvek are offered to customers wishing to flow-wrap or ribbon-pack syringes.
Custom thermoforming
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A thermoforming company with manufacturing facilities in the United States and Asia and a sister company in Europe provides custom thermoforming services to customers worldwide. Prent Corp. (Janesville, WI, USA; www.prent.com) specialises in plastic thermoformed trays, clamshells, totes and package components, and offers cleanroom manufacturing, seamless tool transfer, and short tool and part lead times. Its capabilities include custom design in virtual 3-D, in-house prototyping, engineering, precision in-house tool building, and in-house design and construction of matched pressure-forming equipment.
The company has facilities for extrusion of the plastic sheet from which package components are thermoformed. It can perform secondary operations such as cutting, sealing, assembly and final decoration and labelling. Processes are uniform and governed by real-time statistical process control. Complete process and material traceability are ensured and six-sigma quality and on-time delivery are its watchwords, says the company.
Packaging material
As part of the recent harmonisation of medical packaging standards, EN 868-1 has been replaced by ISO 11607, which is now mandatory in Europe and other parts of the world. DuPont Medical Packaging (Contern, Luxembourg; http://medical packaging.dupont.com), which produces Tyvek for medical packaging applications, has compiled documentation that demonstrates the product’s compliance with the standard to satisfy Medical Device Directive requirements.
The ISO 11607 standard is divided into parts that cover the areas of materials and design (Part 1) and processes (Part 2). Part 2 introduces requirements for forming, sealing and assembling terminally sterilised packaging, and thus represents a new validation stage. Users of Tyvek can be certain that they are in compliance with Part 1 of ISO 11607, which allows them to then concentrate on package production and final package validation portions of the standard.
Tyvek complies with the standard because of its strength, microbial barrier property, moisture resistance, inertness to most chemicals, air permeability and clean-peeling seals. These attributes enable the material to be utilised in the manufacture of high-value terminally sterilised medical device packaging that can be sterilised by a variety of methods.
Thermoforming
Films for medical device, pharmaceutical, electronics, food, and general-purpose packages produced by thermoforming are the specialty of a multinational plastics company that operates advanced calendering, extrusion, coating, laminating, stretching and printing lines. Klöckner Pentaplast (Montabaur, Germany; www.kpfilms.com) says it invests in state-of-the-art production technology to ensure that its products perform consistently and always meet precise specifications for colour, surface quality, thickness and formulation. Its high-technology manufacturing processes result in the highest level of gauge control, which means high yields and minimised costs for customers. A state-of-the-art R&D laboratory provides technical support together with new product development.
Monolayer film and sheet are produced in Barex, expanded polypropylene, expanded polystyrene, high-impact polystyrene, polypropylene, polyester, polylactide acid, vinyl (PVC) and vinyl/ABS. Multilayer films have structures based on vinyl, polyester, polyamide (nylon), polystyrene, and polypropylene and employ materials such as Aclar, aluminium, cycloolefin copolymer, polycarbonate, polyvinylidene chloride (PVDC), Surlyn, polyethylene and polypropylene with or without EVOH, and biaxially oriented polypropylene, polyester, and polyamide. The manufacturer processes these films in a controlled environment to CGMP and BRC/IoP standards and maintains absolute traceability of raw materials and products.
Films for medical device and diagnostics packaging are available in several brands. Pentapharm films for pharmaceutical blister packaging come in a variety of mono- and multilayer formulations to suit numerous applications, including versions compounded with PVDC and with Aclar that combine good barrier properties with attributes that ensure good packaging line performance for high productivity.
Validatable pouch sealer
A completely validatable continuous dual-heat band sealer for difficult-to-seal materials is recommended by its manufacturer for the sealing of medical devices in pouches. Available in a vertical or horizontal sealing position, the Model VBS-DH-3/8-10-V continuous band sealer from All Packaging Machinery Corp. (Ronkonkoma, NY, USA; www.allpackagingmachinery.com) allows validation of temperature, speed and sealing and cooling bar pressure. Its extra sealing capacity enables the machine to accommodate processing speeds up to 60 ft/min. It is designed to seal Tyvek/Mylar, nylon, polyethylene, polypropylene, laminates, kraft/polyethylene and foil. Tyvek pouches can be sealed at reported rates of up to 40 ft/min.
A self-contained compressed-air source is sufficient for performing pressure validation. Instant pressure release on bands placed in an open position reportedly makes changeover and cleaning of the heavy-duty, wear-resistant laminated Teflon bands quick and easy. Uniform pressure on all sealing and cooling surfaces creates consistent seals whose quality can be validated. These secure seals may be 1⁄4 or 3⁄8 in. wide. All gauges are highly visible and easy to read.
Digital temperature controls maintain consistent heat to ensure high quality hermetic seals. Heat up to 500 °F ±2 °F is generated from front and rear heaters. The quad controls allow regulation of individual heating assemblies. The sealer comes equipped with a 10-in. heating zone and 10-in. cooling zone.
High-performance polymers
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A range of high-performance polymers and compounds for medical device manufacturing applications includes a formulation that is suitable for packaging. The transparent, reportedly easy-to-process plastics from Degussa AG (Darmstadt, Germany; www.degussa.com) are the impact-modified, acrylic-based XT Polymer and Cyrolite multipolymer compounds and the pure-PMMA Plexiglas 6N. According to the company, XT Polymer, whose main properties include good chemical resistance, a high heat deflection temperature, and good impact strength and processability, serves as an alternative to PETG in medical packaging applications. The material stands up to body fluids and tolerates plasticisers among other chemicals.
This compound bonds well and consistently to PVC tubing and other compatible plastics, and is amenable to solvent and thermal bonding. The material can also be welded by means of high-frequency, ultrasonic, vibration, spin and hot-plate techniques. It offers a high level of light transmission with little haze, and can be easily pigmented or dyed. XT Polymer is suitable for EtO sterilisation. Although thick-walled parts moulded from the compound exhibit a colour shift when exposed to gamma or beta radiation, the films made from it are resistant to both of these sterilisation methods.
Package testing equipment
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The comprehensive range of services provided by a manufacturer and supplier of semiautomatic and fully automated packaging systems includes specialised package testing equipment and an in-house package testing, ageing and validation service. Medical Engineering Technologies Ltd (Hythe, UK; www.met.uk.com) can deliver an integrated system by including with its packaging equipment, in-line testers for sealed packages and burst testers for gas-permeable packs. It has adapted techniques used in the food industry that allow impermeable packages sealed in a carbon dioxide–rich atmosphere to be tested in-line at reported rates of six packs per minute.
The company’s range of robust, cost-effective, user-friendly packaging equipment includes three- and four-side-sealing pouch-making machines, blister tray sealers, and a constant-heat pouch sealer. The machines are designed for operation in a cleanroom, can be expected to provide reliable and consistent performance, and are easy to validate against ISO 11607. Equipment is available to meet requirements for trial runs, low package volumes, or large-scale production.
In-line flexographic printer
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A small flexographic printer is designed to use minimal space on a medical device or pharmaceutical packaging machine and thereby leave room for robotic loading equipment or other peripheral machinery. The FlexPrint mini operates like other FlexPrint-series printers from Bell-Mark Corp. (Pine Brook, NJ, USA; www.bell-mark.com), but is approximately half the size and weight. At 200 lb, the in-line printer claims an 11.5 × 11.5 in. (292 × 292 mm) footprint on the machine, yet provides the same functionality and features as the company’s larger systems. The printer offers a print width of up to 600 mm and can reportedly print at speeds of up to 50 cycles per minute. It uses odourless ammonia-free inks. Other features include a self-contained inking system and an ink tray with a nonstick coating to facilitate ink changeover.
Protective packaging
A company that specialises in protective packaging solutions for products in transit offers an associated audit service to help companies determine whether their current packaging systems are appropriate and cost-effective. Using materials ranging from advanced protective foams to simple corrugated cardboard and composites, Interactive Packaging Solutions Ltd (Wrexham, UK; www.ips-uk.co.uk) designs, develops and manufactures protective packaging for customers in many industries. The company applies expertise gathered through its wide-ranging experience when it conducts its packaging audits.
Each audit looks at the effectiveness of the client’s current packaging activities and considers how they could be improved. This can involve reconciliation of the protective and promotional aspects of the packaging, assessment of the suitability of current materials in terms of cost, weight and aesthetics, and resolution of design issues in favour of revisions that enable tooling and setup costs to be reduced and lead time shortened. Also, the company will devise a manufacturing and distribution process that is environmentally friendly and focuses on the recyclability and reusability of packaging materials and potential bottom-line advantages.
