The primary logical step is to think about the place within the manufacturing course of to most sensibly carry out serialization. Throughout the offset printing of sheets for the later folding cartons? In a contract packaging facility, in particular logistics facilities, or within the packaging strains of pharmaceutical producers? The answer chosen by the pharmaceutical firm will rely upon the present infrastructure in addition to a number of different components.
Subsequently, the benefits and downsides of any given choice, but additionally the alternatives related to them, have to be evaluated nicely prematurely.
Since each product will quickly require a singular serial quantity, the manufacturing of batch sizes of 1 will quickly grow to be obligatory anyway, because it had been. What financial savings in logistics and simplifications can due to this fact be achieved by coding the carton as late as doable?
Curiosity in late stage customization is rising for a motive: particular merchandise and mixed medicine, a rising demand for check batches, and the need to scale back the prices for the logistics dealing with of pre-printed packages in addition to the storage prices for ready-to-ship merchandise reinforce the development in the direction of smaller manufacturing runs. However because the manufacturing quantity as an entire just isn’t lowering, this all occurs on high-performance packaging strains. Manufacturing on order is probably the most pronounced type of this growth.
Small batch processing requires many changeovers and thus packaging strains can now not attain their potential effectivity. In such circumstances, late stage customization can assist preserve their financial viability.
Late stage customization provides numerous prospects to extend value effectivity:
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Minimizing cupboard space within the supply warehouse, for example for 28 nation kinds within the EU; -
Price saving by substitute of logistic warehouses in lots of international locations with one centralized and extra environment friendly supply warehouse for a number of international locations is feasible; -
Dramatic lower of tied-up capital by means of saved materials worth; -
Lower of losses because of injury due to decrease inventory quantity; -
Much less rework required in case of manufacturing errors; and -
Much less re-packing effort in case of adjustments in regulatory labelling.
Probably the most pronounced type of the late stage customization method is manufacturing to order primarily based on an virtually clean folding carton that turns into large-scale printed. A limiting issue could also be its varnish coating that may scale back the adhesion of any ink utilized later within the manufacturing course of. It might due to this fact be essential to make use of an tailored varnish as a substitute.
Late stage customization can happen at numerous levels of technical requirement for various purposes, together with:
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Serialization solely with black print; -
Monochrome printing of symbols and textual content, similar to dosage; -
Coloration print of particular person markings with or with out serialization; and -
Giant-scale colour print with symbols and serialization.
The chance to hyperlink serialization and late stage customization suggests itself, permitting producers to design merchandise which might be each compliant with laws and cost-effective.
The place within the manufacturing course of the place this may be greatest applied relies on a number of components, similar to current infrastructure, manufacturing quantity per product, manufacturing velocity, frequency and length of changeovers, the necessity for expiry date and batch info within the goal market, and plenty of others.
Moreover, questions have to be answered relating to financial savings potentials by means of decreased inventory values, much less cupboard space, and a diminished variety of warehouses in addition to the variety of folding cartons that may characteristic a “country-neutral” design, and prices for printing gear.
Making an allowance for the above-mentioned components, any choice for an answer will likely be as particular person as the necessities and desires of a particular firm.
However, there are typical constellations enabling the whole or partial linking of each marking processes, thereby contributing to a compliant and cost-optimized manufacturing with substantial financial savings potentials relating to warehouses and logistics. Basically, there are the next choices.
Till now, the usual apply has been for the country-specific design to be utilized to the carton by the producer. If that additionally contains serialization, the pharmaceutical producer doesn’t must put money into printing and checking know-how (see additionally Determine 1, situation 1a). The variety of folding carton kinds doesn’t improve by means of serialization, since each nation model requires its personal design anyway. Mixed with late stage customization in a single work step, the folding carton producer can obtain logistics financial savings: they will react rapidly and flexibly when pharmaceutical producers order very small portions.
The 2 above-mentioned steps may also be applied by the packaging firm, which additional will increase flexibility. If serialization and late stage customization happen immediately earlier than packaging, appreciable financial savings will be made relating to storage and logistics, since efforts for procurement, storing, and particularly logistics administration of country-specific packaging are now not required (see Determine 1, situation 1b). Additional benefits embrace a extra versatile manufacturing with out delays attributable to ordering and transporting packaging materials from exterior suppliers, and straightforward provide of very small and check batches.
All present laws enable for serialization and late stage customization to happen utterly offline and earlier than the precise packaging course of, which implies that all marked packaging materials can then be fed right into a principally unchanged line. Thereby, a number of packaging strains will be fed by one digital printing machine. It’s not essential to put money into printing know-how for every particular person packaging line after which incur lack of manufacturing time for its integration.
The presently best-known choice leads itself nicely to large-scale manufacturing: packaging materials already bearing country-specific graphic designs and markings is produced after which serialized for every nation on the packaging line (see Determine 1, situation 2). Relying on the variety of export international locations, it might be essential to inventory many folding carton kinds, which leads to elevated efforts for storage and logistics. A acutely aware choice for the situations 1a or 1b proven in Determine 1 is likely to be useful for each product or product line.
With a purpose to effectively function packaging strains with high-volume manufacturing runs, producers can produce “brite inventory,” i.e. stuffed country- and market-neutral packaging. Nation-specific design and serialization are utilized within the supply warehouse via late stage customization. Thereby, many quick manufacturing runs will be mixed on the packaging line (see Determine 1, situation 3), enhancing its effectivity. It have to be famous that this method is simply appropriate for merchandise with country-neutral main packaging, similar to blisters, and that the bundle insert might need to be multi-lingual, because the packaging can now not be opened afterwards.
If not solely the secondary packaging, such because the folding carton, but additionally the first packaging, such because the blister, should bear a country-specific design and marking, this may also be applied within the logistics warehouse. A rustic-specific design and serialization code is printed on the empty, flat folding carton (see Determine 1, situation 4). On this case, a DataMatrix code containing, for example, the product code, EXP and LOT, has already been utilized to the blister in a blister machine to make sure course of security, stopping mix-ups throughout later marking processes.
This marking and packaging step often takes place within the supply warehouse, the place packing is usually carried out manually. Subsequently, this constellation is best suited for very small batches or very beneficial prescribed drugs with comparatively small portions which might be delivered to many various markets.
Generally, it have to be famous that in all situations that includes late stage customization, a packaging design the place all related sides will be simply reached for country-specific marking by way of a printing system is most favorable. Thereby, expenditures for storage and logistics will be significantly diminished, and entire warehouses will be made redundant.
Regardless of the place precisely serialization takes place, pharmaceutical producers are chargeable for their merchandise. As quickly because the merchandise enter the market, they have to report their serial numbers to a better authority or governmental company. A software program resolution at ISA degree 3 or 4, similar to Atlantic Zeiser’s MedTracker, is required for the administration, and, if required, aggregation of serialization information. This software program should accumulate information from the packaging strains, map aggregation processes, export outcomes, and, relying on the constellation, generate and handle serialization information.
Earlier than investing right into a late stage customization resolution, a number of standards have to be assessed, together with:
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What are the potential financial savings by means of the discount of: inventory worth; administration of many packaging and product variants; storage space; variety of warehouses; losses because of injury; bills because of adjustments in marking necessities; and elevated flexibility; -
What number of folding cartons will be designed in a country-neutral fashion and what’s the amount to be produced per structure; -
How a lot effort outcomes from a presumably essential change of packaging design and packaging approval; -
What are the dealing with prices for a employees of in-house printing store or logistics warehouse; -
Price for printing services; and -
Elevated value of inkjet ink in contrast with offset printing ink.
To handle serialization information, customers want a strong serialization software program which ensures course of security whereas producing, printing, and storing the codes in addition to checking them with a digital camera and transmitting them to downstream processes. Additional necessities embrace appropriate printing know-how that delivers high-quality printing outcomes—relating to distinction, colour brilliance, and lightfastness—for late stage customization purposes and serialization at excessive speeds.
This may be achieved via contact-free drop-on-demand printing mixed with a particular UV ink. DoD colour printers with a 600 dpi decision handle transport speeds of as much as 50 meters per minute. Since most packaging strains aren’t ready for DoD printer integration, offline options are an alternate. These can feed a number of packaging strains, thus implementing late stage customization and serialization in a single step whereas guaranteeing optimum capability utilization.
The robustness of the road and software program design in case of disturbances and malfunctions is a key issue, particularly for serialization. Because of this the machine software program and the machine structure should match the necessities primarily based on sensible experiences, and the interface between the machine and the serialization software program should function seamlessly and with none interference with the intention to guarantee secure processes.
Atlantic Zeiser combines these options in a single resolution: all variable info relating to the market, language, or product is printed on a flat or glued carton one step upstream the packaging course of in a number of colours, whereas serialization takes place throughout the identical work step. As a result of new Omega Professional era of drop-on-demand UV inkjet printers, the Digiline Versa system is able to printing graphics, textual content, and serialization codes in 4 or six colours and to confirm the whole structure via a high-resolution digital camera system.
Resulting from using UV curing inks, the print is particularly high-contrast and proof against water, gentle, and put on. The built-in Distinctive Code Software program ensures course of reliability throughout era, printing, and storing of codes which were checked by a digital camera, together with reporting for downstream processes. Furthermore, the system could be very sturdy relating to disturbances and particular conditions, which is a key issue for serialization. A secure course of requires machine, printer, and software program to be completely coordinated and to have a strong connection to the higher-level serialization software program.
Late stage customization and serialization processes will be mixed at a number of steps in the course of the manufacturing course of. Furthermore, the mix with late stage customization opens up financial savings potentials by means of optimized line utilization and thru appreciable value reductions for storage and logistics. The selection of the method stage the place it makes most financial sense to hyperlink serialization and late stage customization relies on a variety of particular person components. Every pharmaceutical producer will consider these in a different way relating to their merchandise and manufacturing services—corresponding choices are due to this fact company-specific. The above-mentioned situations present mannequin choices with current technical options that may be present in apply.
Producers contemplating the mix of each marking processes ought to due to this fact seek the advice of a one-stop provider of each {hardware} elements and the required serialization software program. Thereby, in-house employees just isn’t burdened with the duties of system integration.
Determine 1: Late stage customization and serialization will be applied at numerous levels in the course of the manufacturing course of. Relying on the person scenario of an organization, it have to be decided the place the implementation makes financial sense. (Courtesy of Atlantic Zeiser)
Stefan Rowinski, Product Supervisor in Atlantic Zeiser‘s „Pharma & Packaging Options” division, specializes within the growth and advertising and marketing of system options for serialization, late stage customization, and monitor and hint purposes. As well as, his experience features a deep data of processes and workflow in delicate environments and information administration options. Previous to his place as a product supervisor, Stefan Rowinski spent years designing, implementing and planning one-stop options for product individualization and headed the initiatives to implement these options. Stefan.rowinski@atlanticzeiser.com
