Recent Developments in Materials, Equipment and Services for Med-Tech Packaging
Thermoforming film system
Combining a multilayer coextruded forming film with an uncoated 70 g/m² medical-grade paper, a thermoforming film system engineered for efficient performance produces peelable, fibre-free seals for medical device packages. The Paper Lock system from Perfecseal Ltd
(Londonderry, UK; www.perfecseal.ie
) consists of the grade 36668 hybrid forming film, a direct-sealing film characterised by good mechanical strength and grade 35868 direct-sealing paper, which yields fibre-free seals in the strength range of 300–450 gf/in. and complies with the guidelines in EN and ISO documents pertaining to microbial barrier materials. Heat-seal coatings are unnecessary. The robust hybrid film features a nylon core layer for abrasion resistance and an ionomer layer designed to enhance formability and provide a wide processing window.
The Paper Lock system is suited for applications requiring contoured tooling, such as syringe and pipette packaging. In providing high durability and abrasion resistance, the system compares favourably with ionomer-based coextrusions. Its mechanical strength allows for cost savings through down-gauging.
A full-service manufacturing partner for packaging offers competencies in product analysis, package concept, design and production in quantities ranging from prototypes to production volume. Packaging for medical, biotechnology and life science products is the core expertise of Merrill’s Packaging Inc.
(Burlingame, CA, USA; www.merrillspackaging.com
). The company uses a range of US FDA–approved materials, including PETG, high-density polyethylene, polypropylene, high-impact polystyrene and high-temperature polycarbonate, to produce various types of packaging that can withstand sterilisation by ethylene oxide, gamma irradiation, electron-beam irradiation, dry heat and steam autoclaving. In addition
to packaging, it manufactures components and turnkey products by means of thermoforming, radio-frequency welding, heat-sealing, secondary trimming and assembly.
The service offering begins with design based on transforming the customer’s objectives, specifications and ideas into a final product that will satisfy all contingencies of long-term quality, unit cost and material handling during the production process. Using customer input at each design stage, the company finally generates rapid-prototyped models to test fit, form and function and then builds its own production tooling. Packages are formed in a Class 10 000 cleanroom supported by a quality-management system certified to the standards of ISO 9001:2000. The company provides material certification, lot traceability and statistical process control documentation.
Peelable forming film
A peelable ionomer-based forming film uses a proprietary resin blend to provide seal integrity and clean-peel opening when mated to uncoated Tyvek top web. Available from Amcor Flexibles
(Bristol, UK; www.amcor.com/flexibles
), CP Film is a high-performance multilayer coextruded film that exhibits the good formability and strength associated with ionomer films. Its wide forming range and draw uniformity make the material easy to process on a variety of thermoform-fill-seal machines for many medical device applications. It offers consistent peel strength over a wide seal-temperature window.
The design of the film enables users to realise peelability and absence of fibre tear upon opening for which coated webs are traditionally employed, but offers the lower total package cost of films mated to uncoated web material. Also, because the porosity of uncoated Tyvek is high, ethylene sterilisation cycles can be shorter. The film can also be sterilised via gamma and electron-beam irradiation.
A lightweight yet strong high-density polyethylene material suitable for sterile medical device packaging offers the attractive characteristics of paper, film and fabric in a single material. A speciality of multinational firm DuPont de Nemours
(Contern, Luxembourg; www.medicalpackaging.dupont.com
), porous Tyvek protective material provides a microbial barrier that is vapour permeable, water and chemical resistant, low-linting and clean-peeling and resistant to puncture, tearing and abrasion. It is reportedly as much as eight times stronger than medical-grade papers of equal or greater basis weight. The smooth, opaque material, which consists of tough, continuous interlocked fibres, is available in four styles for use in manufacturing pouches, lidstock, breather patches and headers for medical bags. It is compatible with most commonly used sterilisation methods, including steam, ethylene oxide, gamma and electron-beam irradiation.
A full-service packaging and environmental testing laboratory is equipped to test medical device packages for sterile packaging integrity. To test the sterile barrier system fully, Westpak Inc.
(San Jose, CA, USA; www.westpak.com
) employs package performance testing, accelerated ageing studies, materials evaluation, seal strength testing, altitude testing and several methods of testing package integrity. Depending on customer needs, the service provider can assist in protocol development or provide a company-specific document with a detailed test plan. The company follows guidelines in ANSI/AAMI/ISO 11607, Parts 1 and 2, in providing product and package testing services for first articles and mass-produced devices.
The medical package testing repertoire includes dry penetration testing to detect the possible presence of tiny channels in the heat seals of a pouch or tray, gross leak detection through pouch inflation and submersion in water and burst and peel or seal strength, testing to determine the strength of and consistency within seals in flexible barrier materials.
An engineering company specialising in the production of thermoform packaging machines, tray sealers and conveyor-belt and vacuum-chamber machines can supply customised packaging solutions to manufacturers needing to package and protect sterile products. The machines of Multivac Sepp Haggenmüller GmbH & Co. KG
(Wolfertschwenden, Germany; www.multivac.com
) feature stainless-steel surfaces that are clean
room friendly and easy to clean and can be engineered to comply with GMP and US FDA requirements. High production standards, supported by the validation and calibration of individual machine components to optimise interoperability, ensure performance reproducibility regardless of production volume. The vertically integrated manufacturer offers a complete service that comprises on-site analysis of requirements, development of the packaging line from existing modules or new or modified modules, assembly and installation and training in a corporate training centre or at the customer’s facility.
Thermoform packaging machines that each minute produce and fill as many as 150 packages, which range in length and width dimensions from 20 up to 600 mm, can handle flexible films, rigid films or aluminium compounds. Special-order machines can switch from one packaging format to another at the push of a button and several machines can be linked to produce primary and secondary packaging in one process. Semiautomatic and fully automated tray sealers for packaging trays already filled with product also can operate at rates of 150 packages per minute and also provide quick and simple format changing. Chamber-type machines package anything that fits into a pouch.
The manufacturer is certified to ISO 9001:2000 and ISO 11607.
Multilayer coextruded flexible and rigid thermoforming films are available to packagers of medical devices and other technical products. Wipak Oy Medical
(Nastola, Finland; www.wipak.com
) also offers specialised materials for high- and ultra-high-barrier applications. Its Steriking range of products comprises many different flexible polymer-laminate forming webs, uncoated- and coated-paper lidding webs, laminated-film lidding webs, semirigid webs of laminated polymers and nonforming webs of laminated film for four-side sealing. The forming range includes peelable films for sealing against uncoated Tyvek. Items in this line are sterilisable by ethylene oxide gas, gamma or beta irradiation or steam. Standard and custom medical pouches, non-PVC primary packaging for IV and other administered solutions and overwrap films are among the special options provided. Rounding out a total packaging concept, the supplier offers standard and jumbo reel sizes, special reel and transport packaging and labelling and documentation.
The company supports its product offering with in-house pilot lines and laboratory packaging machinery that are used for pretesting of material and process options. It operates production facilities in seven European and two Asian countries and has sales representation in more than 70 countries. An associated company serves North and South America.
Turnkey packaging systems
Cleanroom blisters, Tyvek or paper lidding material, sealing machines, package design services and validation services are available as a turnkey solution from a company specialising in custom medical packaging. Nelipak bv
(Venray, Netherlands; www.nelipak.com
) has an international network of operations staffed with design teams capable of identifying viable alternative possibilities and then developing a complete packaging system to meet all of a client’s needs. In-house tooling ensures quick turnaround of package prototypes, including custom blisters and medical trays. Blister sealing machines and packaging products are designed and manufactured using vision inspection systems, state-of-the-art robotics and advanced process control and are delivered with seal integrity guaranteed following the performance of sealing studies. Production takes place in a Class 10 000 cleanroom.
A high-barrier, solvent-free overwrap material that was developed using proprietary metallocene-based sealant chemistry is suitable for chemically sensitive pharmaceutical packaging applications. Triad, an extrusion-coated lamination of polyester, aluminium foil and metallocene, has been engineered by Rollprint Packaging Products Inc.
(Addison, IL, USA; www.rollprint.com
) to provide a very strong hermetic weld seal in high-speed packaging processes. The sealant layer bonds to the foil without the use of solvent- or water-based agents. The pharmaceutical-compatible laminate structure does not sacrifice either processing performance or cost-competitiveness; machine processing speed and seal strength are at desirable levels. The chemically clean bonding agents and sealant layer employed in manufacturing this overwrap enable a high moisture and oxygen barrier to be created at sealing speeds in excess of 100 linear feet per minute.
Typical uses for the laminated material include blow-fill-seal unit-dose containers for inhalation therapy and diagnostic kits that require an overwrap to help achieve specified barrier properties. The structure is said to provide an unlimited alternative to adhesive-based, solventless and water-based laminations for a variety of packaging applications in the life sciences.
Sterile packaging materials
A company specialises in the manufacture of medical packaging films and packages for sterile devices. Emphasising flexibility and innovation in its service offer, Südpack Medica AG
(Baar, Switzerland; www.suedpack-medica.com
) provides customised complete solutions developed in close cooperation with the customer. Specifications defining the package shape, size and construction material are prepared jointly following intensive preliminary dialogue between the client and the supplier. Material expertise comes into play as the optimal film for the application is chosen from an extensive range manufactured by the supplier’s parent company. Order volume is not an issue and the delivery service includes a certificate of conformity and a logistical arrangement that ensures short lead times throughout Europe.
The company’s capabilities comprise standard and special products and small, medium and large production runs. A French production facility certified to ISO 9001:2000 and NF EN 13485 standards operates state-of-the-art cleanrooms of ISO Class 100 000 for the manufacture of bags and Class 10 000 cleanroom for the manufacture and printing of blister lids and storage containers. The full product range includes triple-sealed bags, tubular bags, peel pouches, Techpeel-brand pouches and tubes, blister lids for trays, tubular films, patched bags and top- and bottom-web roll products. Materials for packaging medical and pharmaceutical products, medical devices, electronic components and surgical drapes are available.
A full-service provider of medical packaging and logistics assists clients from the product’s conceptual phase through to delivery of the packaged product ready for sale. In collaboration with the customer, Puracon GmbH
(Rosenheim, Germany; www.puracon.com
) develops a package that fulfils safety, functionality and aesthetic requirements. According to contract, it inspects all incoming products, performs product-specific cleaning operations designed to ensure that surface structure and coatings are not affected deleteriously and then assembles the cleaned and inspected components into devices to be packaged. Custom packaging takes place in a GMP class C-certified cleanroom (corresponding to ISO Class 7) with an integrated class A (ISO Class 5) laminar-flow area. Products are packaged in the appropriately functional, precisely fitted, breathable hard blister container or sterile bag by means of automated equipment. The one-stop packaging shop provides label printing, cartoning and, via certified partners, sterilisation through a variety of methods.
Completing the service, the company offers storage and worldwide shipping of packaged products, together with order management and commissioning. The storage facility maintains the conditions of an office environment. Shipping services include customs clearance and selection of a carrier and products are transported to their destinations under conditions that are optimal for the product in question. Inventory is managed so that both parties can review and update it at any time.
Providing many of the benefits of conventional soft PVC, but containing no plasticisers or chlorides, a multilayer polypropylene film system is available in tubular and double-wound flat formats. The Propyflex range from Kobusch-Sengewald GmbH
(Warburg, Germany; www.kobusch-sengewald.com
) features high transparency, flexibility, a water vapour barrier five times greater than a comparable PVC bag and the ability to be sterilised at temperature as high as 121°C. The films are blown on encapsulated extrusion systems with ultraclean internal air to ensure low particle contamination of the material and film rolls are overwrapped in two layers of polyethylene and hermetically closed immediately following extrusion. They are engineered to be easily machinable on the latest bag-making and form-fill-seal equipment. Film thickness is 200 µm.
The tubular film is available in 9 roll widths ranging from 85 to 270 mm, and the flat film comes in six width options between 135 and 250 mm. The material is easy to dispose of, even if incinerated. It can be supplied also in the form of one- and two-tube bags sealed either at top and bottom or on all four sides. The bags can be printed in one colour via a foil stamping process.
A contract services provider packages medical devices such as implants, instruments, biomaterials and diagnostic materials for foreign and domestic companies ranging in size from small start-ups to large multinational conglomerates. An outsourcing partner for more than just packaging, IL-MedTec AG
(Burgdorf, Switzerland; www.ilmedtec.com
) offers a system solution that includes incoming inspection, cleaning and drying of parts to be packaged, Class 10 000 or Class 1000 cleanroom assembly, labelling, final packaging and sterilisation. Its offering includes primary, secondary and tertiary packaging in the appropriate cleanroom and in accordance with relevant EU or US standards. Emphasis is placed on customer service. The general contractor is able to provide microbiology advice and services such as sterilisation validation; monitoring, cleaning and disinfection; cytotoxicity inspection of medical products to ISO 10993; bioburden studies of products and drugs; and shelf-life and integrity testing of complex medical packaging. In addition, it will take responsibility for obtaining and printing packaging media of any sort and for procuring and printing labels. The comprehensive service concludes with sterilisation performed by a qualified partner and logistics capabilities that include component pickup, interim storage and delivery of packaged goods to a specified deadline.
Package components for medical products destined for use in hospitals are available from a supplier that also offers know-how in package design and validation, conformance assessment and training. A variety of Stericlin products, including medical-grade paper, Tyvek, film laminations, paper and aluminium laminations and blister covers, are provided by Vereinigte Papierwarenfabriken GmbH
(Feuchtwangen, Germany; www.vp-group.de
) for four-side-seal, form-fill-seal (FFS) and manual packaging applications. A large range of standardised materials for four-side-seal sterile packaging of thin products is offered; these can be adapted and optimised for product, processing and package-opening requirements. Similarly optimised for application requirements, FFS packaging materials are suitable for packaging thicker products in tray containers with peelable lids. The line of manual packaging components, used primarily for small batches of products, includes prefabricated sterile barrier systems such as three-side-seal pouches, header bags and rigid trays with sealed covers. Product variants are available for sterilisation by gas, irradiation, steam and dry heat. Standard pouches and reels can be supplied printed, including within sealing areas, and process indicator printing is possible.
A specialist developer and contract manufacturer of flexible sterile containment systems for healthcare applications offers expertise particularly in multichamber bags and peelable-seal technology. Medisize
(Hillegom, Netherlands; www.medisize.com
) makes 1-, 2- and 3-chamber bags in a variety of sizes. Although it typically uses multilayer polypropylene-based bag material, the company has experience with various films ranging from the traditional to the innovative. It employs thermal and radio-frequency welding techniques to manufacture bags in ISO Class 7 cleanrooms. In addition to flexible containers, the company develops and produces ports, caps, handles and other bag components by applying its capabilities in moulding. Tools can be designed and manufactured in-house or created with the help of local supplier partners. The complete service package encompasses a range of manual and automated assembly services and in-house sterilisation. The company focuses primarily ion airway management devices and primary packaging for medical devices and pharmaceuticals.
Plastics for OEM device and packaging applications are supplied by a company that specialises in environmentally responsible copolyester and cellulosic resins designed to meet medical performance demands and regulatory requirements. In addition to being free of orthophthalate plasticisers, bisphenol-A and halogens, the plastics compounded by Eastman Chemical bv
(Capelle aan den IJssel, The Netherlands; www.eastman.com
) will not generate polychlorinated pollutants when incinerated. DuraStar and Eastar copolyesters, Eastalloy copolyester-polycarbonate blends, Tenite cellulosics and Tritan copolyester are available for manufacturing a variety of nonimplantable medical devices, and Eastar in sheet form is suitable for rigid thermoformed medical trays. The product line also includes materials from which mono- and multilayer films for flexible packaging can be produced.
The plastics are colour stable; neither their appearance nor their mechanical properties are affected by sterilisation processes, including gamma and electron-beam irradiation. Copolyesters are resistant to lipids, isopropanol and most cleaning solutions, and Tritan is especially tolerant of high temperatures. Medical-grade resins can be supplied with test reports supporting claims of biocompatibility in accordance with ISO 10993 and USP Class VI. Technical data and US drug or device master file authorisation are available for some products.
Tabletop vacuum sealer
Offered by a company that designs, manufactures and supports a full line of tabletop heat-sealers, a medical-packaging vacuum sealer for the tabletop is distinguished by easy removal of the vacuum system and seal bar for simplified cleaning, sterilisation and maintenance. The 8000-series vacuum sealer with quick-release vacuum system, from Accu-Seal Corp.
(San Marcos, CA, USA; www.accu-seal.com
), accommodates pouches with as little as 1 in. (25.4 mm) of header space. It produces seals 8, 11 and 16 in. (203, 279 and 406 mm) long and 1/4 or 3/8 [FRACTIONS] in. (6.35 or 9.5 mm) wide. A linear element tensioner with no exposed electrical connections makes element replacement simple and is designed to ensure element tension under all pressure settings. Designed for use in a Class 100 cleanroom, the vacuum sealer has a built-in non-particle-generating venturi vacuum system and isolated exhaust port.
Completely validatable and calibratable and ISO 11607, CE and RoHS compliant, this robust vacuum sealer occupies a small footprint, has a modular design and features a user-friendly interface, fault alarms, multiple operating modes, recipe storage and upper and lower heating elements. A laser cut and welded seamless stainless-steel case resists harsh antimicrobial sterilising agents. Lockout-protected and alarmed digital process control, activated via the liquid-crystal-display touch screen, ensures that all process parameters are maintained seal to seal.
A packaging film made from sheet produced economically in a roll-to-roll process offers an extremely high water vapour barrier, allowing vapour transmission at a rate of just 10–4 g/m²/day. In addition, X-Barrier film, developed by Mitsubishi Plastics Inc
. (Tokyo; www.x-barrier.com
) and available in Europe, provides a barrier to oxygen and carbon dioxide gases. The customisable film gives users the opportunity to tailor its heat resistance, humidity resistance, climate durability and bending durability. It is suitable for use in medical device and pharmaceutical packaging materials and flat-panel displays.
PVC masterbatches that contain no phthalates are available as a vinyl option for medical devices, packaging and other applications in which stringent requirements of international regulatory standards must be met. OnColor nonphthalate masterbatches from PolyOne Corp.
(Assesse, Belgium; www.polyone.com
), a provider of specialised polymer materials and associated services, are easy to handle and compatible with a variety of processes. Supplied in process-specific versions targeted at injection moulding, extrusion and extrusion blow moulding, they come in custom colours to suit customers’ particular needs. Customer colour requests are analysed at the US-based company’s dedicated colour and additives centre in Belgium so that the product manufacturer can introduce new items into its production operation and then to market as quickly and efficiently as possible. The supplier offers assurance that these masterbatches, like all of its products, are safe, environmentally sound and made only from ingredients that conform to applicable legal and regulatory guidelines.
A system for analysing molecular oxygen (O2
) using optical fluorescence technology is suited for performing nondestructive permeation analysis, headspace and dissolved-oxygen analysis and leak determination in flexible and rigid biopharmaceutical packaging. Mocon Inc.
(Minneapolis, MN, USA; www.mocon.com
) designed the OpTech–O2
Platinum analyser, which employs a long-term-stable, relatively light- and temperature-insensitive platinum fluorescent material, with state-of-the-art electronics so that it would compete favourably with other O2
technologies. The instrumentís platinum chemistry emits light in a measurable quantity that is directly related to the amount of oxygen present. Then, the fluorescence is read optically. The analyser‘s ability to measure amounts of oxygen as small as 10 ppm makes it useful especially for permeation analysis. Its O2
measurement range extends from 0.001 to 30%.
The system uses different techniques for different applications. For permeation analysis, a small platinum-based spot encased in a substrate is inserted into the package headspace or liquid product and a handheld reader is employed to read the change in oxygen over time through the sealed package. The optical reader detects the fluorescence by means of a visible light and offers noncontact readability at distances up to 15 mm. For headspace and dissolved-oxygen analysis, an invasive probe coated with a platinum chemistry is used. The analyser provides an efficient option for in-line process validation.