■CAPA Tamper Evidence (TE)
In order to ensure the safety of pharmaceutical products along the entire supply chain, more and more packaging units are being provided with tamper-evident seals to prevent the distribution of counterfeit medicines. In the context of Track & Trace, this is an important step, in addition to labelling and data processing, in which scanware, as a specialist for quality assurance in the pharmaceutical industry with more than 30 years of experience, is reliably at your side.
With CAPA Tamper Evidence scanware offers a flexible station at which pharmaceutical packaging is sealed with tamper-evident labels. Various functionalities can also be integrated. The use of clear, fluorescent tamper-evident labels on the sides is standard.
Particularly in the case of prescription-only medicines, the highest level of security can be ensured by serialisation, aggregation and end-to-end inspection of the production and distribution data. Here, the processing of serialised and aggregated data can be made possible by using the line manager IMPERA.
■Inspection Criteria and Objects
- Folding boxes
- Presence of labels
- Position of labels
Optional examination criteria:
- Label printing (1D and 2D codes as well as plain text)
■Advantages of the Tamper Evidence Station
High positioning accuracy of the Tamper-Evidence labels through precise object guidance and optimal use of sensors.
Adjustment to the size of the carton is tool-free. Operation is only from the front; there are no walking distances. Likewise, the label reels can be changed while the machine is running, so that productivity on the line remains constantly high.
The labelling position on the folding carton is variable and can be shifted electronically.
The station has a modular design, enabling it to be adapted to your general conditions and specifications. The construction is robust, mobile and ergonomic. The easy-to-clean stainless steel housing protects the station from dirt and wear.
High-quality standard components and thus efficient spare parts supply, excellent power transmission through the use of planetary gears and wear-free drives through brushless motors. The system can be retrofitted if your needs or regulations such as the EU Directive 2011/62/EU change.
■Functionalities of the Tamper Evidence Station
Sealing and cross-checking
The most common configuration level offers the application of the tamper-proof labels, as well as the presence check with sensors. Here, the product sensor controls the starting point of labelling, ejection and length measurement of the carton. Another sensor monitors the products in the good lane and thus performs the ejection countercheck.
Sealing and position monitoring
Alternatively, in the version of the station with print inspection, the positioning of the security labels can also be inspected by using camera heads and the SIGNUM Print labelling inspection system.
Combination with print – sealing printed packages
If a scanware print station CAPA Mark & Verify is already in use, it is possible to dock the Tamper Evidence unit and control it via CAPA Mark & Verify. This is also possible from a corner.
Thanks to the low necessary drying time of approx. 0.7 sec*, it is ensured that the application of seal labels does not smear the print, even at the highest machine speed.
Combination with print – print on label (optional)
Printing of the tamper-evident labels in the downstream process and subsequent overprint inspection can also be implemented
Labelling from above (optional)
It is also possible to apply a label from above, e.g. Bollini, in addition to sealing the folding box flap. These additional security features further reduce the possibility of tampering with the medicines.
A pusher can be installed to eject heavy cartons and fragile products such as glass bottles
By installing a label pre-winder, label reel changes can be carried out without stopping production. High-speed packaging lines can thus achieve the highest productivity.
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■Combination Mark & Verify and Tamper Evidence
CAPA TE is the ideal retrofit solution for existing Mark & Verify stations. The station is suitable for the scanware station CAPA MV as well as for third-party systems.
The two stations can be installed next to each other without any problems, but can also be placed across a corner. In the latter case, the stations are connected to each other via a conveyor belt. This makes it possible to dock at any line.
■Functions of CAPA Mark & Verify + Tamper Evidence
In combination with CAPA MV, CAPA TE is operated via the Mark & Verify Station.
Visualisation takes place on the scanware GUI. It is characterised by a uniform structure across all scanware systems and simple operation.
The folding box is printed on the CAPA MV. It is very precise due to double-sided folding box guidance. Printers from Wolke, REA, Bluhm and Domino are used. Other printer types, e.g. DoD, can also be implemented on request.
The product sensor controls the starting point of printing, camera pick-up, ejection and length measurement of the folding carton. Another sensor monitors the products in the good lane and, in addition to the ejection counter-check, also takes over the jam control.
■Top Quality Hardware
The station was designed in such a way that complete operation is possible from the front. There is no need to “walk around the machine”. Furthermore, in combination with CAPA Mark & Verify, the station ensures that the print is not smeared when labels are applied, as the necessary drying time of approx. 0.7 sec* is given, even at maximum machine speed. Adjustment to the folding box size is possible without tools.
Digital position indicators enable reproducible settings.
Another sensor monitors the products in the good lane and thus takes over the ejection counter-check as well as the jam control.
When integrated into an existing line, linking with upstream and downstream machines is of course possible.
Tamper Evidence sealing
Labelling from the side is implemented as standard and is performed by the HERMA 400 labeller with a positioning accuracy of 0.5 mm. Labelling is designed for all commercially available closure schemes and can be adjusted without tools.
Labels can be applied from above (e.g. Bollini).
If desired, the station can be equipped with two label storage units. Rolls can be changed in a short time without stopping the machine. The use of clear, fluorescent labels is implemented as standard.
For folding boxes weighing up to 300 g, ejection is by blowing. In the case of heavier units or delicate objects, ejection is carried out by a pusher that pushes defective folding boxes onto a conveyor belt. This protects the objects from bumps, knocks and falling.
- Positioning accuracy of ± 0.5 mm
- Labeller HERMA 400 or cab IXOR
The labelling system is designed for all common closure schemes and can be adjusted without tools.
- 300 cartons per minute with a transport distance of 50 mm
- Label sizes:
A, B = min. 15 × 15 mm, max. 50 × 40 mm (UV sensor)
- A, B = min. 15 × 30 mm, max. 50 × 40 mm (gloss sensor)
■Maximum Sizes of the Standard Folding Box
Length = 60-220 mm
Width = 15-220 mm
Height = 20-120 mm
Larger folding box heights are possible on request.
300 folding boxes with a transport distance of 50 mm can be inspected per minute.