High safety standards apply to medicines, and not just to the ingredients used. To exclude effectively the risk of counterfeits, the statutory provisions regarding the serialization or aggregation of pharmaceutical packaging are becoming increasingly strict. Individual packages must be fully traceable back to the manufacturer using Track & Trace technologies. With our TQS (Traceable Quality System) Track & Trace solution – the guarantee for process and product safety – your pharmaceutical production is safe. The machines are compact, adapted to your applications due to their modularity and meet all hygiene and validation requirements. Highly precise Weigh Cells and checkweighers are used for weighing individual tablets and for completeness checking of product packages.
In the following, you will learn more about the areas of application of our Track & Trace and weighing solutions in the pharmaceutical industry.
- Global serialisation and aggregation solutions covering key requirements
- Open and standardised interfaces for an easy integration avoiding vendor lock-in
- High performance checkweighers with throughputs up to 650 value per minute
- Compliance with relevant pharma regulations and validation standards
Consumers demand and expect absolute product safety for medicines. To exclude harm to health and financial losses due to product piracy and counterfeits, lawmakers require complete traceability of medicines from the patient, through the pharmacy, to the manufacturer. Consistent serialization permits the unique identification of the smallest packaging unit.
These can be traced back seamlessly through all aggregation levels, from the single package to the shipping box to the transport pallet. In this way not only are risks identified, more efficient processes are created along the entire supply chain – worldwide. All the codes in the world are, however, of no use if the contents of the package can be simply replaced – for this reason tamper-evident sealing of the medicine is extremely important.
Consistent serialisation guarantees the identification of the smallest packaging unit through a unique product coding and serial number. These can be traced back through all aggregation levels from single packaging , through bundle packing, and shipping box to the pallet. Not only are risks identified, but more efficient processes are created along the entire supply chain.
Traceable Quality is Wipotec’s unique answer to the challenges facing the pharmaceutical industry. Depending on the country in which your products are produced and the country to which they are exported, specific requirements apply to coding and possible additional, country-specific vignettes. Our engineers will accompany you step-by-step during the correct configuration of your machine and will support you during implementation in production. The modular systems can be easily integrated into existing packaging lines and guarantee your future security in a competitive environment.
Machine-readable codes that ensure a globally unique product assignment in the form of a serial number, in conjunction with tamper-proof sealing of individual packs, form the basis for counterfeit-proof medicines. Serialization and consistent aggregation ensure transparency from the origin of the goods to the retailer, thereby creating trust and security.
Serialization of the individual folding boxes begins with stable transfer from the cartoner. Subsequent coding is done either on the side tabs or the top of the folding box. Using a compact labeler, safety labels (tamper-evident) are then applied to prevent illegal opening of the original boxes. When transporting folding boxes from the cartoner, the TQS top-bottom conveyor demonstrates maximum flexibility by adapting to a wide range of folding box formats.
The Traceable Quality System (TQS) machine range offers format-independent aggregation across all packaging levels (bundles, cartons, pallets), tailored to each customer’s individual needs. TQS enables both the summary of serial numbers from multiple single packs into a serial number unique to the bundle, as well as semi-automatic aggregation for manually packed shipping boxes, where the previously aggregated bundles are placed layer by layer in the shipping case by the operator. In this way, the units of a lower packaging level (such as folding boxes or bundles) can be conveniently assigned to the higher packaging level (bundles, shipping cases) enabling the hierarchical relationship to be mapped in a database.
Perfection lies in the detail. Special top-bottom conveyors and toothed belts with proven NT belt technology, optionally supported by synchronization sensors, reliably hold in place delicate folding boxes of widely varying formats and permit flawless printing of the serialization codes. Our solutions for the reliable handling of bottles and ampoules also permit all-round inspection of the cylindrical objects using a 360° camera module. Thermal inkjet and coding systems are available for printing, as well as thermal transfer printers for labels. The highly precise, stable product transport ensures exact coding even at high throughputs. To completely exclude printing errors, the printed codes are checked inline as per the applicable ISO standards and printing errors reliably ejected from the product flow.
The second important safety feature, along with the serialization code, is the tamper-proof sealing of your medicine boxes. The safety labels, also called the tamper-evident seal, are automatically bonded to the tuck flaps by the labeling unit. Your products remain protected against unauthorized tampering and you maintain the consumer’s full trust in your products.
With the quick-to-learn ConfigureFast system, you create the print layout in only three steps using a single software interface. At the same time, the data is sent to the printer and to the image processing system. This eliminates the need to configure individual systems significantly reducing setup times. The production data are also available clearly laid out on the screen and permit you to make further changes to the production process of all fully integrated components such as printers, labelers and cameras from the same intuitive user interface, depending on your permissions. Using standard interfaces, you can easily connect TQS machines or integration modules to existing IT environments. Wipotec is committed to standardizing processes as far as possible. In the GS1 Global Healthcare User Group, we actively participate as a voting member in the development processes for global Serialization Guidelines in the area of pharmaceuticals and medical products. Furthermore, as a founding member and part of the Steering Committee of the Open-SCS Working Group (Open Serialization Communication Standard), we stand for an industrial interoperability standard and are actively engaged against proprietary isolated solutions.
Are vibrations and shocks commonplace in your routine daily production? The design of our Modular Multilane System (MMS) means that we can do a lot to improve stability and ensure exact measured values in your routine production. On request, our Modular Multilane Systems also come with state-of-the-art Active Vibration Compensation. You benefit from this wherever you need high cycle times and exact weighing results in equal measure. You also benefit because, in the majority of cases, there is no need for a separate weigher frame when using a Modular Multilane System solution such as this. As a result, you have the advantage not only of precise weighing results in an extremely efficient production environment, but also of a small installation footprint.
The number of lanes you install will depend entirely on your production requirements. In any case, we will provide you with the basic modules you need which can have a flexible number of slots. When selecting your EMFR Weigh Cells, you can choose between the SX-M-FS, SL-M-FS and SW-M-FS types in combination with our Modular Multilane System. To make installation as easy and efficient as possible, the electronic modules for Weigh Cells, AVC sensor and communication are expandable and communicate with all the usual field bus systems.
Our high-performance checkweighers check your packed or unpacked products down to the milligram. They permit the precise weighing and documentation of even very light objects such as individual tablets – the exact control of ingredient dosing is an important factor in drug safety. By checking the weight of packed products, the completeness of the pack is reliably checked. For quick, reliable weight determination, the Active Vibration Compensation (AVC) function plays an important role that compensates for interference due to vibration in the area around the weigher by an intelligent algorithm. Within fractions of a second, the weight is determined and objects with the wrong weight reliably detected.
The throughput is further increased by means of multilane applications, which weigh several objects in parallel, with consistent accuracy. The checkweighers can be used as stand-alone solutions or integrated into your existing lines as OEM modules. The system reliably and automatically removes packages or objects with the wrong weight from the product flow. To ensure control over sources of error at all times, combined solutions have separate ejection systems for printing errors and objects with incorrect weights. Ejections are always made into separate, lockable ejection chutes.
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