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LABELING IN THE PHARMACEUTICAL INDUSTRY
Vials, medical bottles, jars, folding boxes, pharmaceutical boxes, blisters, ampoules, cartridges, tubes and other pharmaceutical packaging are subject to extensive legal requirements with regard to labeling. Complete traceability and high cycle rates pose further challenges in the labeling and marking of pharmaceutical products.
The labeling requirements in the pharmaceutical industry are particularly high compared to other industries.
Serialization & aggregation
Track & Trace solutions for complete traceability
Tamper-evident solutions for counterfeit-proof packaging
For safe labeling For drugs and other pharmaceutical products, different technologies have to be integrated into compact systems:
Control & verification
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Pharmaceutical-specific labeling systems from b + b - pharmaceutical labeling made easy:
more than 35 years of experience in the development of pharmaceutical-specific solutions
modular complete solutions consisting of: serialization, labeling and aggregation
individual and tailor-made solutions tailored to your production conditions and
Serialize, label and automate securely with b + b as your partner
Our fully automatic labeling solutions - four examples specifically for the labeling of pharmaceuticals:
SAFE LABELING IN THE PHARMACEUTICAL INDUSTRY
The aim of drug labeling is to prevent counterfeit drugs from getting into the hands of patients. For this reason, prescription drugs must have a package-specific number on their outer packaging, as well as a device to prevent manipulation - for example by means of seal labeling. Using the package-specific number and the tamper protection, the medication can be checked for authenticity and intactness before it is dispensed.
These measures make it more difficult to place counterfeit drugs on the market. This can only have a positive effect on the protection of public health.
Application of variable data
Printing process for high production speed
Integration of provisions possible
Integration into existing production lines
Verification of variable data
Label presence control
Serialization & aggregation
Reliability in the transmission of serial numbers
Hardware and software solution
HIGH REQUIREMENTS IN PHARMACEUTICAL LABELING
The demands on the pharmaceutical industry are higher than in any other industry. Serialization , aggregation and tamper-evident labeling are becoming increasingly important. Correct labeling of drugs is the basis for compliance with serialization and aggregation requirements.
To meet serialization requirements for prescription drugs, labeling systems can be used be equipped with powerful printing systems and camera and control systems. The products and labels should be checked for illegible serial numbers or damaged data matrix codes and then ejected. The safe traceability of drugs and their packaging is thus guaranteed.
For the printing and serialization of flat or unfolded folding boxes, b + b offers various manual to fully automatic serialization devices.
Manual solutions are suitable for coding small batches. Semi to fully automatic devices, on the other hand, are suitable for the serialization of larger batches.
All systems are provided with a sensibly dimensioned touch panel HMI, which of course fulfills the FDA requirement 21 CFR Part 11 (Audit Trail). Furthermore, all of our systems offer the option of switching to RE-WORK mode directly within the system and taking samples at any time.
Our fully automatic labeling and serialization solutions - selected examples specifically for the serialization of pharmaceuticals:
Transparent from production to the patient through:
Identification of the folding boxes with a unique serial number
Aggregation of the individual folding boxes in the next packaging unit (e.g. carton)
Aggregation of the packaging units on the shipping unit (e.g. pallet)
Global provision of the serial number and aggregation data
An important step in making safe medicines
Improvement of the quality management
Documentation of the supply chain from the manufacturer to the end user
Reducing product aging within the supply chain
Improvement in product data accuracy and preservation of this data
New possibilities in CRM (customer relationship)
Improved product safety and increased customer trust
Securing entrepreneurial profitability by avoiding product piracy
The advantages are apparent:
Track & Trace solution in the pharmaceutical supply chain
In order to declare war on counterfeit drugs, the EU Directive 20211/62 EU, which was passed in 2011, established the legal framework for a Europe-wide security system. Prescription drugs must therefore demonstrate a tamper-evident closure as a security feature. Sealing labels or L- or T-shaped labels are suitable for implementing tamper-evident labeling.
The labels must be applied to the folding box in such a way that approx. Half of the label is applied to the flap and the other half to the body. A high level of precision is required here, as sealing labels are usually small label formats. From a business point of view, the manufacturer uses common round or square labels .
The label material and especially the adhesive are important when choosing. 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 designed so that it destroys itself and leaves corresponding visible residues on the folding box or visibly damaging the folding box - a security perforation on the label can also be useful here. The label can be used on various packaging materials and surfaces.
Cameras, light barriers and other control units can check the presence of the anti-manipulation protection. Incorrectly labeled products can be rejected via a reject station be sorted out.
Tamper-evident labelers do the closure labeling to protect against counterfeiting of folding boxes or vials. Depending on the batch size, manual, semi-automatic or fully automatic labeling systems are suitable. Two-sided corner labeling is possible with all systems.
Our tamper-evident labelers - selected examples specifically for cap labeling of pharmaceuticals:
A quality management system in accordance with GMP standards (Good Manufacturing Practice) ensures high-quality manufacturing of pharmaceuticals.
b + b labelers are developed and manufactured in accordance with GMP standards.
b + b offers GMP-compliant labelers and serialization and aggregation systems
An aggregation of drug packaging is not mandatory according to the new EU regulation. In order to ensure complete traceability , the aggregation of the packaging bundles, boxes and pallets makes sense.
During aggregation, a "mother-child relationship" is created between the individual products and the packaging unit:
facilitates the traceability of the individual drug
makes its product route more transparent
Logistics processes are simplified
Product recalls can be completed more quickly
reporting stolen products can be carried out more quickly
Customs offices can record delivery contents more quickly
b + b offers various manual, semi-automatic to fully automatic aggregation systems and hybrid systems.
LABELERS FOR PHARMACEUTICAL PRODUCTS
Packaging for pharmaceuticals in the pharmaceutical industry is characterized by diverse and sometimes irregularly designed product and packaging formats. The products are manufactured under strong hygienic environments (clean rooms or highly air-conditioned and controlled rooms). These conditions must be taken into account in the labeling process.
The product formats in the pharmaceutical industry differ greatly: whether pens, syringes, ampoules, cartridges, folding boxes, bottles or vials - b + b offers the right semi-automatic or fully automatic labeling system for every environmental condition, surface, product format and label.
SUCCESS STORIES IN PHARMACEUTICAL LABELING
As a manufacturer of pharmaceutical labeling machines, b + b has already implemented many projects for well-known manufacturers, contract packers and re-importers
More than 30 years of experience in special machine construction for the pharmaceutical industry
Specialized and industry-specific labeling solutions
High-performance labeling machines that meet the requirements of drug labeling