Sensitive human plasma preparations packaged reliably and safely
- High safety due to numerous visual controls
- Anti-counterfeit labelling with process-stable colour change varnish
- Comprehensive integration into the operational MES (Manufacturing Execution System)
Requirements
Biotherapeutics manufacturer CSL Behring relies on an all-in-one solution from Schubert-Pharma
Pharmaceutical packaging in a fully integrated compact system:
Pharmaceutical packaging is a highly sensitive and demanding process that is one of the most vital disciplines of packaging technology. The elevated safety requirements to guarantee effective protection against undermixing or manipulation of the products usually require additional process steps, which are sometimes only offered by specialist suppliers. Schubert-Pharma designed a compact line for CSL Behring AG in Berne in which all packaging steps are bundled. From product labelling and cartoning to pharmaceutical packaging onto the pallet, every step is also comprehensively integrated into the company’s production control system.
The promise of saving and improving lives is the driving force behind the specialist manufacturer of biotherapeutics for the treatment of rare and serious diseases. In over 100 years of its successful history, the CSL Limited parent company, of which CSL Behring is a part, has grown to become one of the world’s leading biotechnology companies. It now provides the broadest range of human-plasma-derived and recombinant therapies in the industry. The company is especially committed to patients with coagulation disorders or immunological diseases. However, their therapeutics are also used for other rare diseases. The most state-of-the-art and forward-looking working conditions are a top priority for the biotechnology company, for which it has already received several awards. For the company’s current modernisation for ready-to-ship packaging, CSL Behring relied on its collaboration with the experts in pharmaceutical packaging from Schubert-Pharma. The new line now packs two vial sizes in ten different packaging configurations in compliance with the highest pharmaceutical safety standards.
Solution
Pharmaceutical packaging in compliance with high pharmaceutical safety standards
The main task was to integrate the different packaging formats and pack sizes of the sensitive pharmaceutical products on a compact, easy-to-operate packaging line – without losing sight of the high safety requirements typical for the pharmaceutical industry. Both 50- and 100-millilitre vials had to be packaged first into individual cartons and then into shipping cartons. Additionally, the booklets, some of which were very extensive and varied, had to be packed into the individual boxes as product information. The combination of two Transmodul sections and the additional integration into the operational production control system yielded a line for pharmaceutical packaging, which packs the sensitive human plasma preparations in the two required vial sizes ready for dispatch – safely and with absolute reliability. The system is also impressive in terms of its ergonomic design and uniform operating concept, one of Schubert’s unique selling points. Furthermore, a low stock of spare parts and therefore less maintenance work is necessary.
Pharmaceutical packaging as a complete solution: From product labelling to the shipping carton on the pallet, everything in one space-saving packaging line.
The process-stable laser printing with a colour change varnish in combination with the various legally compliant, anti-counterfeit labelling and the packaging materials represented a real challenge. However, working with the laser supplier and the packaging manufacturer, the team successfully came up with a specific solution in several iterative loops.
Tamara Huber
Project Manager at Csl Behring, November 2020
Technical Details
A compact multi-talent
The solution which was delivered is a space-saving cartoner consisting of five TLM frames, reliably and safely integrates all requirements in one line. Two Transmodul sections efficiently connect the individual process steps. In the line, the cartons are first erected and then the booklets are inserted. In parallel, the already labelled vials are fed onto a conveyor belt. Four F4 robots pre-group the vials on a Transmodul, which then moves to the filling station. Eight cartons at a time are loaded there. After sealing, three laser printers are used to print various markings.
Full control
To ensure that the packaging process succeeds, the system was extensively integrated into the company’s MES (Manufacturing Execution System), including serialisation and aggregation. In line with the highest quality and safety standards, visual checks are carried out at key points in the packaging process by Schubert’s own image processing system. Moreover, numerous code readers check the labelling of the sensitive products and their correct assignment to the outer packaging, which is also checked in advance.
Everything in colour
Another challenge was the process-stable laser printing. The colour change varnish used had to be perfectly compatible with the various legally compliant, anti-counterfeit labels and the packaging material. Thanks to the very good, interdisciplinary collaboration between the Schubert experts, the laser supplier and the packaging material manufacturer, a specific solution was developed that meets the high safety requirements at all times and offers potential for further development in the future.
Overall performance
- 2 vial sizes
- 10 Packaging combinations
- 200 vials per minute
- Format changeover in 5 to 30 minutes
- Compact machine layout
- Transmodul in use
Two Transmodul sections connect all process steps very efficiently with the production control system, taking into account the high safety precautions requirements typical of the pharmaceutical industry
Full control: Code readers check the labelling of the products and their correct allocation to the outer packaging.
