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According to the WHO, more than 10 % of the drugs in the world are counterfeit, and in developing countries up to 30 %. For consumers or patients, counterfeit medicines pose a serious threat to their health. Counterfeit medicines are a matter of patient safety and, in the worst case, survival. In addition to so-called lifestyle products, counterfeit drugs also include cancer drugs, drugs for the treatment of cardiovascular complaints, antibiotics and many other drugs. EU citizens have a right to high-quality, safe and effective medicines.
Directive 2001/83/EC of the European Parliament and of the Council (4 ) lays down rules concerning the manufacture, importation, placing on the market and wholesale distribution of medicinal products within the Union and lays down rules for active substances. The Directive on counterfeit medicinal products enters into force on 2 January 2013. It provides for measures to check the authenticity of medicinal products and to improve the quality of their ingredients. This will increase safety for patients and consumers.
LABELING OF PHARMACEUTICAL PRODUCTS
Why is the labelling of medicinal products so important?
The aim is to prevent counterfeit medicines from getting into the hands of patients. For this reason, prescription medicines must have a pack-specific number on their outer packaging, as well as a device to prevent tampering, for example by means of seal labelling. Using the pack-specific number and the tamper protection, the drugs can be checked for authenticity and integrity before dispensing.
The active ingredients of the drugs and medicines must be produced according to quality standards. It makes no difference whether they are manufactured in the EU or imported into the EU. These rules ensure that European medicines contain only safe, high-quality ingredients.
These measures make it more difficult to market counterfeit medicines. This can only have a positive impact on the protection of public health.
Which labelling solutions are suitable for pharmaceuticals?
The demands on the pharmaceutical industry are higher than in any other industry. Serialisation, aggregation and tamper evident labelling are becoming increasingly important. The basis for compliance with serialization and aggregation requirements is correct labeling of pharmaceuticals.
Packaging of pharmaceuticals in the pharmaceutical industry is characterised by diverse and sometimes irregularly designed product and packaging formats. The products are manufactured in highly hygienic environments (clean rooms or strongly air-conditioned and controlled rooms). These conditions must be taken into account during the labelling process.
The product formats in the pharmaceutical industry sometimes differ greatly: Whether pens, syringes, ampoules, cartridges, folding boxes, bottles or vials - b+b offers the right semi or fully automatic labelling system for every environmental condition, surface, product format and labels.
b+b offers beside the standard solutions for labelling and identification of your products also special special solutions. An example is the special system PDL for the fully automatic labelling of petri dishes. Basically all labelling systems can be extended according to the serialisation requirements. We would be pleased to advise you - just contact us.
TAMPER EVIDENT LABELING OF PHARMACEUTICAL BOXES
As of February 2019, all medicine and pharmaceutical packaging of prescription drugs must have an originalit closure as a safety feature from the EU. The basis for this is EU Directive 2011/62/EU, which will be passed in 2011. Seal labels are suitable for the Tamper Evident labelling of folding boxes. Sealing labels are applied to the tuck-in flaps of the folding boxes and their body so that they are joined together.
The labels must be applied to the folding box in such a way that approximately half of the label is applied to the flap and the other half to the body. High precision is required here, as sealing labels are usually small label formats. From a business management point of view, the manufacturer falls back on common round or square labels.
Important for the selection is the label material and especially the adhesive. This should be heat-resistant, solvent-resistant and moisture-resistant to ensure that the label cannot be peeled off the folding box. The label must be such that it destroys itself and leaves corresponding visible residues on the folding box or visibly damages the folding box - in addition, a security perforation of the label can be useful here. The label can thus be used on various packaging materials and surfaces.
Cameras, light barriers and other control units can be used to check the presence of the anti-tampering protection. Incorrectly labelled products are sorted out via a reject station.
b+b offers you the complete solution for Tamper Evident labelling of pharmaceutical packaging - various manual, semi-automatic and fully automatic solutions for Tamper Evident labelling as well as sealing labels:
PRINT | SERIALIZING FOLDING BOXES
How can folding boxes be printed or serialized according to the EU FMD?
To meet the serialization requirements for prescription drugs, labeling systems can be equipped with powerful printing systems and camera and inspection systems. Products and labels should be inspected and rejected for unreadable serial numbers or damaged data matrix codes. This ensures the reliable traceability of medicines and their packaging. A tool-free format changeover ensures fast changeover to other packaging formats.
For the printing and serialization of flat and unfolded folding boxes, b+b offers different manual to fully automatic serialization devices.
Manual solutions, such as the M-FSM-TIJ, are suitable for coding small batches. Semi-automatic to fully automatic devices, on the other hand, are suitable for the serialization of larger batches.
Marking flat folding boxes:
Marking open folding boxes:
SERIALIZATION IN THE PHARMACEUTICAL INDUSTRY
Approximately 10% of medicines worldwide are affected by counterfeiting - in developing countries up to 30%.
In order to increase security in the regular supply chain, the EU is adopting additional requirements for security measures. Since February 2019, prescription drugs with a first opening protection are marked with a seal label (tamper-evident labelling).
The patient receives the medication only after the medication has been checked for authenticity by a scan in the pharmacy. The pharmacist checks an identification code for each medicine.
Drugs are marked with pack-specific serial numbers, which are stored in a protected database. The system sounds an alarm if an already scanned or unknown number is found.
SUPPLY CHAIN TRACK AND TRACE - CRISTAL
We make your products journey visible!
Transparent from the production to the patient:
Marking the folding boxes with a unique serial number
Aggregation of the individual folding boxes in the next packaging unit (e.g. cardboard)
Aggregation of the packaging units on the shipping unit (e.g. pallet)
Global provision of serial number and aggregation data
The advantages are obvious:
An important step towards the production of safe medicines
Improvement of quality management
Documentation of the supply chain from the manufacturer to the end user
Reduction of product aging within the supply chain
Improving product data accuracy and preservation of this data
New possibilities in CRM (customer relationship)
Improved product safety and increased customer confidence
Safeguarding the company's profitability by avoiding product piracy
High legal requirements are placed on pharmaceutical packaging and its labelling to ensure patient safety. Therefore, the requirements in the pharmaceutical industry are higher than in almost any other branch of industry. To implement the requirements for serialization (also in combination with labeling systems) as well as aggregation (Track & Trace), we offer customer-specific solutions in addition to our standard systems, as well as the necessary software modules, which go far beyond the usual compliance requirements.
No matter whether it is the serialization of small or large batches - you will find the right solution with us. All systems are equipped with a b+b LineManager, which intuitively guides the operating personnel through the processing of the production order. An uninterruptible power supply unit (UPS) prevents data loss in case of an unexpected power failure. All systems are equipped with a sensibly dimensioned touch panel HMI, which of course meets the FDA requirement 21 CFR Part 11 (Audit Trail). Furthermore, all our systems offer the possibility to switch to the RE-WORK mode directly within the system and to take samples at any time.
AGGREGATION OF FOLDING BOXES
An aggregation of pharmaceutical packaging is not mandatory under the new EU regulation. In order to ensure complete traceability, aggregation of packaging bundles, cartons and pallets is useful. During aggregation, a "mother-child relationship" is created between the individual products and the packaging unit. This facilitates the traceability of the individual drug and makes its product path more transparent. Logistics processes are thus simplified, product recalls can be carried out more quickly, the reporting of stolen products can be carried out more quickly and customs offices can record the contents of deliveries more quickly.
b+b offers various manual, semi-automatic to fully automatic aggregation systems and hybrid systems.
Our hybrid systems are used for serialization and aggregation. Both take place in one system. Often only small batches of certain products are serialized, which also have to be aggregated depending on the target market. All systems are available or expandable with 1 to n aggregation levels.
How can aggregation and cartoning processes be made more effective?
The manual sealing of cartons is usually very time-consuming and leads to an interruption of the packaging process. Starting at 40 cartons per day, it makes sense to automate the closing process - this can reduce the required working time by up to 70 %.
b+b offers you a solution for carton sealing and labelling - carton sealing and labelling machine in one - CPS-CW - semi-automatic cartoning and aggregation The flat carton is opened by the operator and placed in the machine. The lower flaps are automatically folded and closed by the machine. The upper flaps are closed by the operator and then conveyed via the transport rollers to the sealer - here it is closed with self-adhesive adhesive material. Depending on requirements, the system can be equipped with a side or top labeler.
Optionally, the system can also serve as an aggregation unit by means of appropriate scanners and cameras. We would be pleased to advise you.
Product aggregation - Carton closure - Labeling of the carton - Front view
Product aggregation - Carton closure - Labeling of the carton - Rear view
In the logistics , there are specific and legal requirements for labeling the load carrier. Pallets must therefore be clearly labeled, for example, so that downstream processes in the supply chain, such as shipping or distribution, can be designed efficiently. The ready-to-ship pallets must be labeled in accordance with GS1. The pallets can be labeled on one side, on both sides or on three sides with GS1-compliant transport labels. To ensure quality, various containers must also be provided with a corner label (tamper evident).
1-sided pallet labeling
2-sided pallet labelling
3-sided pallet labelling
Pallet labeller b+b Fachpack
With the pallet labeler from b + b, all legal and specific requirements can be easily met.