RF Compliance Takes The Complexity Out Of Serialisation
Rotech have launched a new coding system for pharmaceutical manufacturers looking to ensure compliance with the FMD (Falsified Medicines Directive).
With the ability to generate, print and verify serialised 2D codes on cartons, the RF Compliance offers an instant, simple and reliable solution for pharmaceutical manufacturers who need to meet the 2019 FMD deadline.
What is the FMD
The FMD, aimed at reducing the number of falsified medicines infiltrating the legal pharmaceutical supply chain within Europe, was transposed into UK law in 2013.
Once implemented, the regulation will require the serialisation of individual packs, via unique codes encrypted in machine readable 2D datamatrix codes. Manufacturers failing to comply will have to withdraw their products from the European market.
The challenge manufacturers face
“Pharmaceutical manufacturers are all too aware of the need to comply with FMD; the challenge they face is how. The complexity of some of solutions is daunting not just from an integration and operational point of view, but also because of the cost. Our aim, in engineering this latest system was to make it much simpler. The RF Compliance is an easy-to-use, stand-alone system that doesn’t interfere with production or compromise line efficiency,” says Richard Pether, Director at Rotech.
The RF Compliance succeeds Rotech’s RF1 Pharma, combining the modularity and automatic stack-to-stack feeding technology of the first generation coder with a state-of-the-art chassis and advanced controls that enable integrated printing, serialisation and inspection.
“The system generates a unique code for each pack and transmits the codes to the printer on a carton-by-carton basis. Immediately after printing, an integrated camera inspects the barcode, OCR text and pharmacode. Linking all of these processes allows for maximum efficiency and ensures each pack is fully compliant.
Taking the process offline
Whilst many inline coders are capable of reliably producing readable 2D codes, there are several arguments for taking the process offline.
Firstly, datamatrix barcoding requires near perfect presentation of a carton to the printer to achieve the highest verification grade. “Accurate feeding is crucial to consistent print quality, and with an online system, the necessary accuracy will rarely be achieved without the addition of an extra line element that controls the carton during print and inspection. This can have serious space implications and revalidation issues,” says Richard.
Secondly, integrating into the line a coding station that can print and verify datamatrix codes at high speeds can compromise line efficiency. Offline systems such as the RF Compliance offer a way of complying with the new legislation without impacting production.
“By taking this process offline, the cartons are brought to the line ready printed and inspected, eliminating any delays due to coding issues,” says Richard.
Thirdly, whilst continuous inkjet (CIJ) is the printing technology of choice when coding online, the reality is that many CIJ coders struggle to consistently produce 2D codes that meet the ISO/IEC 15415 quality specification. The RF Compliance is supplied as standard with a thermal inkjet (TIJ) printer for superior print quality and simple operation.
The rise in production of the RF Compliance
A prototype of the RF Compliance was previewed at this year’s PPMA, and now Rotech is scaling up production of this high specification system.
The RF Compliance comes complete with a full validation package, a reject system for automatic removal of reject cartons and a shingling (accumulation) conveyor to maintain high throughput. Integral inspection of printed information and pharmacode verifies that datamatrix codes and human readable information such as expiry dates and lot codes are correct. Operator control is via a 12 inch Siemens HMI and the electrical panel is incorporated within the main machine for easy access.
The flexible system can code onto a range of pharmaceutical packaging formats, including cartons, wallets, sleeves and crash-lock cartons, at speeds of up to 200 packs per minute. It can handle pack sizes from 60x70mm up to 350x350mm.
Luxury Packaging demands Premium Coding Solutions
Luxury goods such as premium food, cosmetics and perfume rely on beautiful packaging to deliver their ‘wow factor’.
The last thing manufacturers and brand owners want is expensive, carefully crafted packaging defaced by badly printed codes. High-precision thermal inkjet (TIJ) printing and offline coding systems can provide the solution to meet these challenges, says Richard Pether, director of Rotech.
Stiff market competition calls for packaging which packs a big punch in the time it takes to make a purchasing decision in store. Even premium brands are not immune to on-shelf competition, so the current global growth in demand for luxury goods translates directly into a bigger market for luxury packaging.
The growth of luxury packaging
Luxury packaging is expected to grow twice as fast in Western Europe as packaging overall over the next few years (3% per year versus 1.5%), according to packaging and paper research organisation Smithers Pira. Globally the picture is even brighter, with luxury packaging worth an estimated $14.2 billion in 2014 and forecast to grow to $17.6 billion by 2019. That equates to an average growth rate of almost 5% per annum, with cosmetics and fragrances accounting for the biggest chunk of the market (43% in 2014), followed by premium alcoholic drinks (22%) and tobacco (16%).
Luxury packaging means investing in expensive materials and novel designs, many of which can present a challenge for the coding systems used to print important information such as batch numbers, barcodes and expiry dates. These are often the last things on the minds of packaging designers who are aiming to catch the eye of luxe-loving consumers.
The offline advantage
Elaborate embellishments, unusual shapes or an awkward printing position can leave online printers struggling to position codes correctly on the finished product. For example, a printer might have trouble combining the speed and precision required to print consistently into a tightly-defined space that’s too close to the conveyor, and this can result in ink ending up on the belt rather than the product. Moreover, premium packaging commands a premium price, so even relatively low-frequency errors are likely to be expensive in terms of packaging waste.
Whatever the issue, offline coding offers an affordable and practical solution. Coding packaging such as cartons, sleeves or pouches offline before they are filled enables them to be brought to the production line ready printed. This has considerable advantages for code quality, since coding the pack in its flat form results in a clear, perfectly positioned code. Furthermore, where an online coder is struggling, removing the process from the critical path can speed up the entire line, significantly improving efficiency.
Offline systems take a pile of flat packages and use a friction or vacuum-based feed system to pass them through the printer and out to a finished stack. For example, Rotech’s stack-to-stack feeding technology can take sleeves or cartons from a stack, accurately print the necessary codes, and place the printed sleeve neatly onto another stack at speeds of up to 400 packs per minute, depending on the application.
The short production runs often associated with exclusive or limited edition luxuries are another reason why manufacturers might consider offline coding. Whether production takes place in small batches on a single production line or on several lines operating in parallel, a single offline system should be able to meet all their needs, rather than having to install a printer on each line.
Switch to TIJ
Meanwhile the technology used for coding information has been evolving. Until relatively recently, continuous inkjet (CIJ) was the obvious choice for manufacturers looking to print data onto a variety of packaging. That’s because early water-based TIJ systems struggled to cope with printing on non-porous substrates. The arrival of solvent-based TIJ technology means that this is no longer an issue, however glossy the surface.
TIJ systems can print at a resolution of up to 600dpi. This provides absolute clarity, as well as allowing users to adapt the font of any overprinted information to match the carefully-designed branding on the rest of the package. Font-matching may be less of an advantage with dates and batch numbers, but where coding is used to identify the particular product variant inside the package – such as the shade of lipstick, for instance – it can provide a useful reinforcement for the package’s overall branding.
On the other hand, the colour and print density of TIJ characters can also be varied, so a complementary colour or lighter print can be used if the brand owner prefers coded information to be clear without being too eye-catching.
In contrast, CIJ systems typically print characters using a 7x5 matrix, which doesn’t provide great resolution and cannot hope to match specialist fonts. TIJ also offers more general advantages over CIJ in terms of convenience, cleanliness and cost. The upfront cost of TIJ systems has dropped dramatically as they increase in popularity, which the cost of consumables means TIJ can be up to four times less expensive per character. In addition, rather than the bottles of ink and messy reservoirs of make-up solution associated with CIJ, TIJ systems use a clean, compact, cartridge-based technology that’s virtually maintenance-free.
Of course, TIJ is not without its limitations and is not perfect for every application. That’s why Rotech continues to work with partners to provide coding solutions based on the full range of printing technologies.
Keeping it real
Counterfeiting is yet another challenge facing the owners of luxury brands, with growing demand for luxury goods offering a strong incentive for criminals to try their luck in the potentially lucrative fake goods business. TIJ can help strengthen anti-counterfeiting measures. While the main coding information can be printed as normal, UV-fluorescent inks can also be used to add security information to the pack that only shows up under UV lights. What’s more, the systems used to feed packs through the printer can also be used to add a security label.
RF LITE ONE PROMOTIE
De RF LITE is de meest compacte frictie feeder uit ons gamma. Uitgerust met de INTEGRA ONE printer, krijgt u een 'plug-and-play', startklaar systeem, specifiek ontworpen voor het razendsnel coderen van (food)sleeves, platte verpakking of blisters.
Kan platte verpakking van 30 x 70 mm tot 200 x 300 mm probleemloos aan
Manueel aanpasbaar zijgeleiding en product hoogteverschil regelaar dankzij snelkoppeling
Kan uw product in de lengte of in de breedte coderen afhankelijk van de nood
Speciaal ontworpen beugels voor gemakkelijke integratie en breedte verstelling van de printer
Twee snelheden, zeer gemakkelijk in gebruik
Specifiek ontworpen opvangbak voor snelle doorvoer
INTEGRA ONE datumprinter
Geen onderhoud meer nodig
Printhoogte tot 12,7mm, uitstekende print kwaliteit
Eenvoudig en snelle datum invoer via OLED scherm en Turn-and-Click wiel
Altijd een perfecte print en positie op de verpakking
Inkt cartridge, wissel snel van kleur of cartridge zonder spoeling
5 Reasons To Consider 'Offline Date Coding' Of Food Sleeves
ACCURATE CODE POSITIONING
If you are coding onto sleeves or watchstrap bands positioning can be a real issue. Coding online may struggle to code packs that are awkwardly shaped or have hard-to-reach print areas. On an offline system the pack is presented to the coding device in flat form with the print area readily accessible. This allows for consistently accurate code positioning, increasing line efficiency and reducing waste that results from poorly printed packs
For companies who are coding packs by hand, an automatic offline coding system will reduce labour costs and speed up production.
A SOLUTION FOR PROMOTIONAL LABELING
With the addition of a label applicator, offline coding systems can carry out labelling and coding in one operation. This dual functionality is very useful when producing ‘meal deal’ packs or running promotions. Take a sandwich wedge pack: applying a code online is fairly straightforward, but applying a label at the same time is not so easy due to the awkward pack orientation.
USE TO CODE SHORT RUNS AND TRIAL PRODUCTS
An offline coder is the ideal solution for trial products, it allows you to minimise capital outlay whilst ensuring new products are coded according to retailer and regulatory requirements, without impacting on other production.
EXTRA CAPACITY WHEN YOU NEED IT
Under pressure due to seasonal variations, getting more operators on the job might seem like the easiest way of increasing capacity during seasonal peaks. But in actual fact, purchasing an offline coder to cope with increased production and seasonal lines is usually more cost effective, owing to the speed, flexibility and accuracy benefits it brings.
Thermal Ink Jet Coding Solutions Drive down cost
Cost savings are welcome at any time, but the exceptional pressure being put on manufacturers by today’s rapidly rising raw material prices is forcing many to re-examine their operations for fresh ways to save money and protect their margins. With that in mind, we can expect a surge in popularity for coding systems based on convenient, cost-effective thermal inkjet (TIJ) technology, argues Steve Ryan, UK sales manager at Rotech.
The problem is most acute in price-sensitive markets such as food. The Food and Drink Federation have reported in March 2017 that an overwhelming majority (90% per cent) have seen the price of ingredients and raw materials increase in recent months. They expect these costs to continue to rise over the next two years. Big brands such as such as Marmite, Toblerone and Birds Eye have all hit the headlines, with consumers complaining of empty shelves, ‘shrinkflation’ and rising prices respectively. Manufacturers are therefore looking for ways to maintain their margins without impacting on consumers, and that means making automation cost savings including production peripherals such as coding technology.
When it comes to the technologies used for marking packs with essential data such as barcodes, batch numbers or use by dates, the clear winner in terms convenience, cleanliness, clarity and cost is TIJ, when compared with more-widely used continuous inkjet (CIJ) coding. Until a few years ago, CIJ was the obvious choice to print onto a variety of packaging, largely because TIJ struggled to cope with printing on non-porous substrates. The arrival of solvent-based TIJ technology means that printing on glossy, consumer-ready packaging is no longer an issue, while the cost savings associated with TIJ provide a strong incentive for greater TIJ uptake. Nowadays, TIJ scores against both the above when looking at capital outlay, consumable & disposal costs.
CAPITAL OUTLAY HALVED
Starting with the capital outlay, the initial installed cost of TIJ is around half that of more complex CIJ systems. Industrial TIJ is a younger technology than CIJ and this price advantage is a relatively recent phenomenon that’s emerged as a result of improving economies of scale.
On a related note, the extra complexity of CIJ means that CIJ coding systems are bigger too. They need a separate control unit and pumps, which adds up to a system the size of a chair. In contrast, a TIJ system relies on a self-contained cartridge and typically takes up the same space as a paperback book, making it easy to squeeze into tight spaces around the production line.
What’s more, the gap gets wider throughout the life of the systems, the cost of consumables and service contracts are factored in.
The ongoing cost of consumables stacks up in favour of TIJ. A TIJ cartridge can print around 4 million individual characters (or 400,000 ten-character lines) in its lifetime requiring significantly less expenditure than alternative technologies. A CIJ system prints uses a combination of ink and make-up fluid which can be costly. TIJ most certainly works out more cost effective per character.
Even waste disposal costs come out in favour of TIJ, since TIJ cartridges can be recycled or disposed of in normal waste, whereas containers contaminated with the ink and solvents used in CIJ must be treated as hazardous waste and disposed of by a specialist company attracting further expenditure.
TIJ printers use a simple and robust cartridge system that combines both a printhead and ink supply system. Replacing the print cartridge effectively replaces the entire ink delivery system, and this can be done within a few seconds, minimising downtime and eliminating the need for repairs and service contracts. In contrast, CIJ systems require regular servicing at around 6,000-hour intervals. Services visits attract additional costs to the long term of costs of CIJ.
The other main contender for coding on consumer packaging is thermal transfer (TT) technology. This uses a thermal transfer printhead and ribbon that make contact with a flexible substrate (such as synthetic films or labels). Miniature printing elements located under a glass coating are precisely heated, then pressed against the ribbon to transfer ink to the target substrate. Not only is the initial investment cost lower for TIJ but it’s must less to install than a TT system which requires regular servicing and it can be a headache to dispose of the used ribbon and cores.
RIGHT CODE, RIGHT PLACE, RIGHT PRICE
Of course, TIJ is not without its limitations and is not perfect for every application. That’s why Rotech continues to work with partners to provide coding solutions based on the full range of printing technologies. However, for the majority of packaged consumer products, TIJ offers advantages over CIJ in terms of convenience, cleanliness and clarity, as well as cost.