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Published: May 17, 2010
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A Few Words about Printing

Inline labelling systems increase efficiency and safety

By: Luc Van de Vel, Multivac Sepp Haggenmüller GmbH & Co. KG, Wolfertschwenden, Germany

A matter of safety

The Medtech Manufacturer’s Blueprint
The strictest standards for packaging in the medical and pharmaceutical sectors currently are defined by US FDA’s 21 CFR Part 11. Among other things, these guidelines call for an audit trail that collects all of the machine information, an electronic signature function with user administration, and display of the recipe history. Furthermore, all parameters have to be stored in a system that is protected from manipulation. The requirements of 21 CFR Part 11 serve as a blueprint for manufacturers of medical or pharmaceutical packaging systems or modules who aspire to compete at an international level.

The design and manufacture of medical devices and pharmaceutical products is strictly defined by regulatory authorities such as US FDA, Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) as well as ISO, EN and DIN standards and CGMP guidelines. The objective, of course, is to ensure that medical devices and drugs that are put on the market are safe for users. Efficient labelling systems that are part of a packaging line have a role to play in achieving this goal. We have to ensure that patients receive a genuine product and not a fake, which could put their health or even their lives in danger.

The central quality element
Adulterated or ineffective substances are not the only things that can endanger users. Incorrect, incomplete or illegible information on the box, label or patient information sheet also has the potential to do harm. Consequently, efficient printing systems can be key enablers of quality management in the medical device and pharmaceutical sectors. Not only do the systems produce user information, but they also provide seamless documentation of the process from the primary and secondary packaging stages through the entire transportation chain to the consumer.
 
Documentation requirements, especially in relation to safety issues, are understandably complex in the medical and pharmaceutical sectors. In addition to statutory track-and-trace rules, manufacturers must print labels that comply with local language requirements and national laws.
 
To meet these requirements and to satisfy demand for just-in-time shipment from customers and to supply smaller markets, manufacturers are reducing batch sizes and building flexibility into their processes. Smaller batch sizes will inevitably lead to inefficient results if the packaging stations are connected in a conventional serial manner. The setup-to-run-time ratio can become disproportionate in such cases. Line efficiency can tumble below 30%, since changeovers in a packaging line involve more than the flick of a switch: the line must be cleaned and inspected for residue, a new print module must be installed and all of these actions must be appropriately documented.
 
Improving process security
Reducing setup time to increase productivity during the packaging process should be a priority. By separating out some of the process components, especially those that involve labelling, productivity can be considerably improved. For instance, batches for different countries can be merged for blister packing or cartoning operations, and then separated for custom processes.
 
It should be noted that late-stage customisation will require combining preselected, standard print elements with variable text and graphics in a single process that can be initiated at a moment’s notice. In addition to being flexible, the printing process must produce high-quality results and be cleanroom compatible.
 
Inline printing systems incorporated in packaging systems such as thermoforming lines for medical applications have to meet the requirements outlined above. These systems should be capable of printing on virtually any packaging material used in the medical and pharmaceutical industries, including medical paper, Tyvek film, laminates and aluminium.
Fully digital printing systems engender flexibility and productivity as well as improved overall equipment effectiveness. But to achieve a zero-defect level, the entire computer-to-print process must be controlled. Validation is the only way to document that the controls are in place and in operation at all times. Therefore, machine design, build, operation and installation must be qualified and monitored in order to ensure quality and compliance with each and every impression.
 
The following requirements should be fulfilled by inline printing systems integrated in packaging lines:
  • The colours should resist wear and smearing to enable use of the system in a cleanroom. 
  • The inline printing system should have a device for the random and continuous generation of pack numbers to support track-and-trace systems.
  • The system should be able to process fixed and variable data simultaneously.
  • Failures should be detected immediately by sensors and flagged.
  • Inspection systems should be integrated at the in-feed and out-feed stations to ensure that the correct information has been applied to the correct product.
  • An integrated vision system should ensure that printing is correct and complete.
  • The printing process should be largely independent of the machine sequence to ensure that machine stops do not disrupt the printing process and affect print quality.
 
Reducing cost and complexity
High-performance inline printing systems used in conjunction with packaging machines make an important contribution to increasing line efficiency and process security. Inline printing minimises potential sources of error because it avoids the use of preprinted materials that might not contain information corresponding to the product. The basic data is stored in a database and called up specifically for the product being packed. This also ensures that multi-national organisations that pack at a local level maintain data consistency because all sites access the same system.
 
The integrated processing of text and graphical elements stored in the database and newly added print images simplifies material flow by avoiding the need to source expensive preprints from external suppliers and storing large numbers of printing plates and preprinted materials. The system also reduces waste and scrap rates.
 
Overall, inline printing systems reduce process complexity and cost to the benefit of everyone in the healthcare supply chain. 
 
Luc Van de Vel is Director of Business Unit MCI (Medical and Cosmetics Industry) at Multivac Sepp Haggenmüller GmbH & Co. KG, based in Wolfertschwenden, Germany. He has more than 20 years’ experience in the packaging and pharmaceutical industries.
 

 

Published in European Medical Device Technology, May 2010, Volume 1, No. 5



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