As a result of serialization legislation, pharmaceutical manufacturers must now ensure that labels printed at a late stage contain all of the data required for compliance. This includes customizing product labels for certain markets, customers or products by adding variable data to labels or packaging. This avoids the need to stock individual packaging materials for
As a result of serialization legislation, pharmaceutical manufacturers must now ensure that labels printed at a late stage contain all of the data required for compliance. This includes customizing product labels for certain markets, customers or products by adding variable data to labels or packaging. This avoids the need to stock individual packaging materials for each variant.
The flexible production of smaller batch sizes has also introduced new requirements for automatic and fast changeovers. If you’re a pharma manufacturer, how can you implement a tamper-evident, flexible solution for low- and medium-volume production?
Why late-stage customization?
Governments worldwide have developed regulations to safeguard patients and consumers by preventing false or counterfeit medicines from entering the supply chain. This includes medicines with fake packaging; the wrong ingredients; low levels of the active ingredients; and that infringe trademark law or don’t comply with intellectual property rights.
In the EU, pharmaceutical products must be labelled and packaged according to each country’s requirements. Counterfeiting can be reduced significantly by product serialization, using a system to track and trace medicines throughout the supply chain. Serialization of prescription medicines is now mandatory in the EU and many other regions. You’re required to have certain security features on prescription medicines, including a Unique Identifier (UI) for each product in the form of a 2D-Datamatrix code and an ‘anti-tampering device’ (e.g. a seal on the folding box).
These security features are verified by a system that identifies the product and guarantees correctness and a minimum labeling and sealing quality. Manufacturers must upload serial numbers to a database after production; and physicians, pharmacies and hospitals etc. must verify the packages before giving them to the patient.
Greater flexibility and efficiency in the supply chain is also needed. Packaging lot sizes are becoming increasingly smaller and you must be able to respond immediately to changing market requirements.
However, small lot sizes can lead to lower productivity and overall equipment effectiveness (OEE). Downtime for format changes reduces the efficiency of a packaging line and increases the cost per unit. New processes, using the latest digital printing technologies, are therefore needed for packaging even the smallest lot sizes.
Benefits of late-stage customization include less storage space; lower costs (with logistic warehouses replaced by one centralized warehouse); a reduction in stored material value; and less rework and re-packing due to errors or changes in regulations.
Combining customization, serialization and decreasing batch sizes
Under the new regulations, all pharmaceutical products will need a unique serial number. By combining serialization and small batch sizes and integrating both digital printing processes into one step, late-stage customization can result in both compliance and cost-effective production.
There are several options for late-stage customization. Serialization and customizing can take place at a contract packaging facility, in logistics centers or on the packaging line. Primary packed materials can be shipped to decentralized packaging depots. The information (e.g. translations, specific market information and traceability data) can be printed digitally when an order is placed. Late-stage customization could also include over-labeling or applying date labels (e.g. for clinical trials).
There could also be a need for shipping small lots with specific components for different markets; or various product strengths and numbers of products per carton. Material can be shipped in bulk and fed to a packaging line. All market-specific data can then be printed, inspected and moved into the next supply chain step.
Late-stage customization can involve different technical requirements. For example, serialization might involve using only monochrome printing of text and symbols; individual color markings could be added without serialization; or you could use large-scale color printing with symbols and serialization. An ideal solution must enable fast changeovers of both data and format.
If serialization and late-stage customization take place directly before packaging, considerable savings can be achieved in storage and logistics costs, along with more versatile production and the easier supply of small batches.
Finding a flexible, tamper-evident solution
If you need an easy, tamper-evident and flexible solution for late-stage customization, especially for low and medium volume production, it’s worth considering a flexible serialization station (e.g. a packaging machine that combines manual feeding, robotics, printing and sealing). This can handle manual feeding and can automatically separate the products and transfer them to the printhead for customization with variable data, such as product codes, serial number and refund number.
You can prepare orders and load the master data from the serialization database or ERP system. Set-up can be carried out via a menu, including loading the variable data print profile and the position of the tamper-evident seal (applied to the carton by a robot). The station includes a robot-guided machine vision system that checks the label presence and print quality, validates text and checks the Datamatrix code. The system will reject products with poor print quality, incorrect printing or insufficient seals.
The serialization station can include product weighing and can be operated via a large, intuitive industrial touchscreen. It’s a safe option even for breakable primary packaging such as syringes. It can generate all the reports, including a production report, error reports, the status of the serial numbers used, and an Audit Trail Report. A full audit trail, which is part of the regulatory requirements, assures record integrity and security.
Late-stage customization is vital due to the latest serialization legislation. It can also be an opportunity for finding a solution that can handle both serialization and the production of small batch sizes without any loss of operational effectiveness.