Tamper evidence for pharma industry - Modular and flexible solution to protect your products against manipulation
Robatech and its partner W. H. Leary together offer modular and flexible solutions for tamper evidence with serialization codes for track & trace of the packages, quality assurance and gluing methods for safely sealed packages. The solutions comply with the new EU directives for the pharma industry to guarantee patient safety and the marketability of your products.
Cost pressure demands for flexible and efficient solutions
The trend for individual treatment of patients, generic medicines and increasing delivery requirements ask for flexible systems with quick process modification, high system availability and efficient processes. On top of this, product piracy and legal regulations challenge the industry. If it comes to production and packaging of medicines for human, there is no compromise on product safety. Any failure could have unforeseeable consequences.
Being prepared for the new EU directive
This is why the EU directives 2011/62/EU and EN 16679 also known as the “Falsified Medicines Directive” ask for security features for certain medicines to verify "authenticity and identification of individual packaging", and "a device allowing verification of whether the outer packaging has been tampered with". This means by February 2019 each packaging needs individual serialized codes, so partners of the supply chain can verify the packaging and ensure that any illicit opening is immediately apparent.
Serialization codes for track & trace preventing mixed products
Different code reading solutions are offered by W. H. Leary to make sure no mixed products leave the production e.g. color pharmacode, 1D and 2D code reading. With the pharma code the carton gets a unique color code while producing and printing the package. The code is scanned to assure the right package is on the production line exactly meant for the content to be filled. If the code does not match package and content a message appears on the display and measures can be taken immediately.
In addition, a unique inkjet number code is printed on every packaging. This code is linked to a certificate of analyses to identify and track each product individually with the iQ Serialization. This data can be sent in real-time from the production floor to a browser or a smart device. Further, partners of the supply chain can verify the packaging based on the code (1D or 2D) on the outside, which is linked to the database entry as well.
Quality assurance guaranteed by automatic fail-safe solution for faultless products
Every packaging is inspected by detection stations to reliably and safely remove defective products from the production line automatically, without interrupting the machine and reducing productivity. The quality assurance systems provide a secure mean of scanning every single product for multiple defects automatically on the run, ensuring an immediate alert in case of any potential problems.
Gluing packaging flaps for tamper evidence and protection
Tamper evidence solutions ensure that any illicit opening is immediately apparent. Different methods have become established in field use for reliably indicating the initial opening of folding boxes. Gluing the flaps of the box using glue dots is the most economical solution. Depending on your requirements and standards cold glue or a combination of cold glue and hot melt is recommended.
The flaps are sealed by applying glue dots, to gain access to the product and to exchange the contents, the flaps must be cut or torn. This visibly damages the packaging when it is opened for the first time.
Gluing methods in comparison
|Cold glue||Irreversible bonding once set|
Long setting time means extra press sections in the production line.
|Hot melt adhesive||Immediate bonding|
Not temperature resistant. Adhesive softens when heated and hardens again by reducing the temperature. An illicit opening could occur.
|Combi gluing (cold & hot)||Immediate sealing by hot melt and irreversible bonding by cold glue|
Adhesive application systems for reduced operational costs and maximum uptime
Robatech offers adhesive application systems and sensors for hot melt and cold glue with highest safety and quality standards. The jetting heads ensure a consistent and precise adhesive application with a clean cut-off behavior even at high speeds. The hot melt application heads are insulated to protect operators and products against heat. The adhesive application equipment is easy to maintain, reduces operational costs and maximizes uptime.
Sensors detect the exact position and presence of the glue to guarantee every single packaging is securely sealed. The sensors for cold glue even monitor the quantity of glue, which is unique in the market.
Benefits at a glance
Where is this tamper evidence solution used?
In general, tamper evidence is not only a key process in the pharma industry, but also in the food and beverage industry e.g. for bottle sealing or packages with easy opening seal. Robatech solutions are suitable for all of them.