Pharma - answering special demands

It is undeniable that pharmaceutical packaging places unique demands on packaging. Concepts of traceability, tamper-evidence, anti-counterfeiting and childproof closures that facilitate easy opening for adults are of extreme importance. This leaves the floor open for innovation.

AlpVision, Switzerland

AlpVision of Vevey has launched a new covert security feature that is either applied to the transparent varnish layer of the packaging or the labelling. The system provides a very high level of covert security for packaging and labelling. There is no requirement for special inks or tags: just a pattern of micro-holes invisible to the naked eye, generated in the varnish layer as part of standard printing processes. This covert security feature is applied without any alterations to the production process, thereby maintaining standard production speeds.

An ordinary office scanner or PDA camera is used to detect the covert marking. Security checking can be performed anywhere, as there is no requirement for a fixed data network connection. The image can be further analysed to identify the SKU attached to a genuine product and thereby uncover a possible grey market diversion.

Catalent Pharma Solutions, USA

Headquartered in Somerset, New Jersey, Catalent is a leading provider of pharma packaging services. From in-house design to manufacturing, the company provides the most complete packaging services on the market. Its specialisations include:

* contract services: blister and carded-blister packaging, bottle filling, and pouch/sachet/strip packaging

* pharma printed components: folding cartons, inserts/outserts and labels

* speciality packaging: proprietary designs include the RxBarrier Plus compliance delivery system for oral solid medications and DelStrip unit-dose delivery systems for thin film strips

* clinical supply services: packaging of all dosage forms, comparator sourcing, clinical labelling, patient kit assembly and global storage and distribution, together with returned drug services.

Chesapeake Corporation, USA

Chesapeake has developed the Pro-tex anti-counterfeiting solution. This system is used to verify product authenticity. Each unit is assigned its own unique alphanumeric character identification code which can be verified via mobile phone against a secure database. If the consumer registers the code for the first time, they will receive confirmation by a return SMS. However, if the code has already been registered or is not recorded on the database, an instant SMS will alert the consumer.

Gerresheimer, Germany

Gerresheimer of Düsseldorf recently won the World Packaging Organisation Silver President's Award for its range of pharma closures for tablets with integrated desiccant, marketed under the Duma plastics trademark. The closures have also won the German Packaging Award and WorldStar 2007. Special high-quality containers have already been equipped for some time with closures in which an integrated drying element absorbs atmospheric moisture. Previously, the generally applicable standard for pharma packaging production necessitated the outsourcing of these desiccant elements from external suppliers, thereafter being inserted into closure caps.

However, Gerresheimer manufactures the Twist-Off and Handy Cap closure systems in a single connected work process under one roof. This avoids unnecessary transportation and eliminates external influences. This is particularly pertinent to the pharma industry, as each outsourced element has to be individually licensed.

Hapa, Switzerland

Hapa of Zürich has launched its 800 series, incorporating UV Drop On Demand (DOD) digital printing technology. This realises extremely high-quality printing due to sophisticated drop placement. It can print at full blister, carton or label web width. The company has augmented the Hapa 800 range with two new models - the CartonJet and LabelJet. The CartonJet handles prefolded and glued cartons, whilst the LabelJet is available in reel-to-reel or inline versions. The company has also launched the Hapa 237 flexo foil printer, incorporating a DOD printhead, thereby providing a solution to medicine traceability compliance. It facilitates tracking and tracing of product from manufacturer to dispensary, maintaining patient safety and eliminating counterfeit products.

Heidelberger Druckmaschinen, Germany

Heidelberger Druckmaschinen has launched the Linoprint DOD system for individual decorating and marking of folding boxes, labels and blister packs, realising up to 720dpi. Modular Linoprint systems can be integrated with both existing and new lines. The Linoprint system processes variable data, enabling the print motifs to be modified without any interruption to the production process. Different language versions or production-related data can be imprinted. Linoprint technology paves the way for the individual printing even of extremely small runs, right down to single batches. Linoprint can be integrated anywhere in the production line, even after the packaging has been filled.

Körber Medipak, Germany

Hamburg-based MediSeal (part of Körber Medipak) has launched the new multifunctional CP500 blister machine. This has been specially designed for packaging ampoules, syringes and medical devices with a deep forming depth. It provides exceptional flexibility. For many years, MediSeal has concentrated on modern servo technology, guaranteeing a flexible, yet economical, systems concept. The machines are modular, enabling customers' individual requirements to be integrated.

Medica, UK

All EU pharma packaging must be imprinted with Braille information by 2010. Medica Packaging of Redditch, Worcestershire (part of the Benson Group) has bucked the trend, being the first UK plant to install Bobst's AccuBraille system for Braille embossing. The makeready is efficient, when compared with a 'diecut & emboss' makeready, or the two makereadies required if embossing is undertaken as a separate run.

The rotary process is low-impact, thus extending tool life. The lower AccuBraille tools are universal, reducing external toolmaker costs. Only one embossing tool is required per job, instead of one per blank station, cutting tooling costs even further. Extra 'male' tools can be made-ready 'off-machine' whilst the previous job runs, again cutting makeready times.

Mikoh Corporation, USA

Headquartered in McLean, Virginia, Mikoh develops and supplies e-pedigree solutions by storing critical information in an easily accessible form that does not require a line of sight between readers and RFID tags. RFID can also be harnessed to assist with product recalls, should they prove necessary. Manufacturers may easily find the final recipients of pharmaceutical lot numbers. By using RFID, companies can track individual pharmaceutical shipments through to the final point of sale.

Although RFID is recognised as a promising solution, the vast majority of labels are not physically secure. Conventional tags can be easily moved from one item to another without affecting the RFID function. Nothing prevents the opening of a shipping carton full of pharmaceuticals, removal of all RFID tags and their fixing to counterfeit items. It is even easier to remove the RFID tags and leave them in the empty carton. Track-and-trace systems only detect the presence of the tag - not the product itself. To prevent theft and counterfeiting, RFID tags must include tamper evidence connected to the RFID function. Tamper-evident RFID technology, such as Smart&Secure technology from Mikoh, addresses physical tag security by establishing if there has been tampering or removal of an RFID label. A more advanced version enables the tag to be read after tampering, but alerts the reading device that the tag has been compromised.

Multisorb Technologies, Germany

Multisorb Technologies of Düsseldorf, a leader in advanced active packaging technology, has entered into partnership with Neutroplast Indústria de Embalagens Plásticas to offer a Multiform Coated Solid Form (CSF) Closure System for HDPE pharmaceutical bottles. The system combines Multisorb's Multiform CSF concentrated desiccant with Neutroplast's screw closure.

The Multiform CSF is a compact silica gel desiccant that incorporates condensed density technology. Fitted into the Neutroplast's screw closure as part of the container closure system, it operates as an active barrier, adsorbing moisture ingress.

NXP Semiconductors, The Netherlands

RFID promises to revolutionise the pharma industry and has already benefited some of the industry's leading players, such as Pfizer. One of the biggest problems is drug counterfeiting. The FDA is currently investigating how RFID could be used to fight this growing problem, and has stated that it has strongest potential for securing the supply chain. If drugs are RFID-tagged at item level, they can be quickly and accurately tracked from the manufacturer up to the pharmacy. As they enter and leave each link in the distribution chain, the drugs are scanned and authenticated. At present, Pfizer is leading the field, having decided to use high-frequency-based RFID tags on Viagra products.

PBI-Dansensor, Denmark

Headquartered in Ringsted, PBI-Dansensor has developed the CheckMate II headspace gas analyser. This incorporates a fast, accurate sensor that requires a very small headspace sample for oxygen testing or tests an oxygen/carbon dioxide gas mix. A complete self-diagnosis function monitors the analyser, detecting the most common user errors and setting off warning alarms, together with capturing and printing the error message in conjuction with the test results.

An integrated pump with reduced gas sampling start-up ensures easy, faultless operation, following insertion of the syringe into the package. An efficient water trap provides sensor protection. This prevents liquids taken in with the air sample from coming in contact with the sensor. A protected Smart Pen syringe is also available as an optional feature. CheckMate II features self-diagnostics and documentation functions, providing complete traceability to satisfy the ISO 9001:2000 standard.

Rexam, UK

Headquartered in London, Rexam is currently developing a new healthcare packaging solution that combines both RFID and barcoding, resulting in a reliable, adaptable solution for all filling lines. The Rexam process involves an EPC-compliant barcode, printed on a standard label, which is then read and sent to an RFID reader for encoding in the RFID embedded container. The only requirement of the packaging line is the encoding conveyor and the customer's label, incorporating the serialised bar code. The encoding conveyor is being developed to reach speeds of up to 300PPM.

Sensor Products, USA

A new EU has stated that all prescription drugs dispensed directly to patients are packaged in unit-dose packages. It is thus anticipated that there will be an expansion in the global use of blister seal applications. A temperature-testing package offered by Sensor Products of Madison, New Jersey has been developed to ensure that the heat-sealing temperatures for blister packaging are achieved. The temperature-testing sensor package comprises a tactile temperature-indicating material known as Thermex combined with the Topaq temperature analysis system. This provides an effective solution for testing and analysing heat-sealing bar temperatures throughout production.

Thermex reveals high and low temperature areas in the seal tool that are not detected by other devices. It quickly and permanently changes colour to indicate temperature distribution across a heated surface. The intensity of the colour change is directly allied to the temperature exposure, indicating high or low temperature areas. Topaq enables detailed digitised images to be obtained from the Thermex temperature-indicating sensor paper. Analysis of heat distribution can be viewed in 2D and 3D pseudocolour images.

Siemens, Germany

Nürnberg-based Siemens has launched a new Auto ID system. This provides positive confirmation that the correct packaging materials, inserts and leaflets have been used. It also indicates the relationship between the individual product and corresponding data recorded in the process, thereby ensuring the reliable ejection of defective products. In a packaging line protected against manual intervention, Auto ID prevents defective products from entering the transportation packaging.

The labelling of pharmaceutical products with an electronic pedigree is already being discussed in some US states. Data matrix codes are applied to solid and flexible materials at an extremely low cost via various printing methods. The data code can be fully reconstructed, even if a quarter of the code area is illegible. The product code may be directly imprinted on the packaging using a data matrix code or stored on an RFID tag. With RFID, in-house logistical processes and distribution systems benefit from the rapid bulk acquisition of all information about a delivery. The possibility of saving all data necessary for logistical control directly on the transport medium also requires the use of rewritable RFID tags, at least on circulating transport units.

Sigpack Systems, Switzerland

Sigpack Systems (a Bosch Packaging Technology company) has developed an automated packaging line for Burgopak, an innovative packaging style that incorporates a sliding mechanism. Burgopak is a WorldStar award-winning concept, suitable for application to a wide range of packages, particularly for pharmaceutical applications.

Developed by the UK-based Burgopak design agency, Sigpack Systems was commissioned to develop and manufacture an installation for automated packaging production. Burgopak packaging is easy to handle, being particularly suitable for pharmaceuticals, which require written instructions for usage. The blisters containing pills, capsules or tablets and the information leaflet automatically remain connected.

Uhlmann, Germany

Laupheim-based Uhlmann has launched its B 1660 blister machine. Operating at speeds up to 700 blisters/minute, the machine processes all forming material types. This PLC-controlled machine can also be programmed to run quietly in whisper mode. The system also incorporates such features as a quick, efficient tool-change system. Depending on requirements, the customer can choose between continuous-motion rotary sealing (B 1660 MTK) and intermittent-motion platen sealing (B 1660 MTI). The rotary sealing blister machine B 1660 MTK, combined with a vibratory feeder, is suitable for production of standard blisters for symmetrical products. Continuous-motion production is typical for this process. On the other hand, pharmaceutical manufacturers processing calendar and sample packs, for example, use the intermittent motion platen-sealing system.

West Pharmaceutical Services, Germany

Located in Eschweiler, West has developed Spectra, designed to enable drug manufacturers to incorporate multiple layers of protection, enhancing patient safety, combating drug counterfeiting and maintaining supply chain security. The system provides enhanced patient safety with point-of-use instructions. It operates as an identification method, eliminating processing errors and helping authenticate products.

Spectra can also operate as a deterrent against drug counterfeiting and provide item-level, track-and-trace capability. Furthermore, West Spectra RFID facilitates the incorporation of secure and unique electronic data on the item itself, including the compliant number and such additional information as product information and/or manufacturer information. It is thus possible to incorporate easily updated, readable information on the item as it passes through the supply chain, providing a solution to the FDA's e-pedigree recommendations.

Concluding remarks

At present, it is undeniable that the majority of developments in pharma packaging are taking place in the sector of authenticity identification. This is a major concern, particularly due to the permeation of counterfeit products, many of which emanate from the Far East. Such developments render counterfeiting as virtually impossible and ensure peace of mind for pharmacists and doctors.

Please note that many product names are trade marks or registered trade marks and should be treated as such.

For more information go to www.alpvision.com; www.catalent.com; www.chesapeakecorp.com; www.gerresheimer.com; www.hapa.ch; www.heidelberg.com; www.koerber-medipak.com; www.linoprint.de; www.medicapackaging.co.uk; www.mediseal.de; www.mikoh.com; www.multisorb.com; www.nxp.com; www.pbi-dansensor.com; www.rexam.com; www.sensorprod.com/sample; www.siemens.co.uk/automation; www.sigpacksystems.com; www.uhlmann.de and westpharma.com.

Catalent Pharma supplies blister and carded-blister packaging, bottle filling, and pouch/sachet/strip packaging A range of pharma solutions The Körber Medipak CP500 machine manufactures blisters with large forming depths for ampoules, vials, syringes and medical devices Packaging medical devices The Hapa 237 flexo-foil printer features a DOD printhead, ensuring compliance with forthcoming legislation on medicine traceability Helping with traceability The PBI-Dansensor CheckMate II new-generation package headspace gas analyser is supremely efficient Checking the headspace The innovative Burgopak, manufactured on Sigpack Systems' machines, is ideal for pharma applications, which require written dosage instructions Sliding out the instructions