The development and manufacture of pharma/biopharmaceuticals has undergone significant change as advances in science and technology allow for more personalized medicine, innovative biopharmaceuticals and immuno-therapies, as well as greater access to them. Moreover, the packaging of these products has proven equally complex. Sophisticated, high-tech systems are needed to address the most diverse drug product requirements. –KB
 
Dr. Johannes Rauschnabel, chief pharma expert at Bosch Packaging Technology commented on pharma and biopharma trends impacting the industry.
 
“We see biopharmaceuticals as the current megatrend in a large part of the pharmaceutical industry. Thanks to the access to more complex substances, completely new forms of treatment are emerging. Groundbreaking changes are occurring in the area of biologics for the treatment of cancer and autoimmune diseases, as well as rare illnesses affecting a very small group of patients. Moreover, the first biosimilars have been approved during the past two years. For patients, this development is a great progression, since many drugs are now produced in larger quantities and are sold at significantly lower prices.”
 
Dr. Rauschnabel added, “The pharmerging markets are experiencing a similar situation with cancer treatment. Here, generic cytostatic drugs offer access to therapies that were previously very difficult to obtain or not available at all. In the area of vaccines, targeted campaigns are promoted by WHO or UNICEF, and pharmaceutical companies are also committed to providing cost-efficient solutions for the development of new vaccines to fight epidemics, such as malaria, HIV, Zika and Ebola.
 
What are some of the challenges customers face with pharmaceutical packaging?
 
Dr. Rauschnabel of Bosch Packaging Technology said, “Biologic processes are becoming more complex and guidelines stricter. The effective protection of humans and products from each other requires suitable separation technology. In the manufacture of liquid pharmaceuticals, isolators are the main method of choice. To ensure sterility and stability, for instance of lyophilized products, container closure integrity (CCI) testing is gaining importance, especially since the revision of the USP general chapter 1207, calling for more quantitative, non-destructive CCI test methods. Examples are high-voltage leak detection (HVLD) or headspace analysis (HSA).”
 
Michele Leonardi, Packaging Division sales manager for MG America noted the following challenges:
·      More and more components per sellable unit (Robotics are helping to solve this issue);
·      More and more products to run on each line (smaller batches for more SKU’s);
·      Serialization requirement (customized equipment)
 
Chris Siegele, Serialization Specialist for Omega Design Corporation added,
“Material handling challenges are not new, but finding the right partner to handle all types and shapes of bottles, cartons, vials, jars; symmetrical, asymmetrical; plastic, glass, etc. can be challenging.  To successfully overcome these challenges manufacturers choose material handling experts that deliver solutions combining versatility with reliability.”
 
How are pharma/biopharma packaging needs changing? 

Peter Goff, chief executive officer of HERMA US, said “The need for improved product security is never-ending. For a labeling machinery supplier such as HERMA, this means considering all ways that a mislabeled drug could get into the supply chain and eliminating them. For example, the HERMA 132 M high speed wrap around labeling machine will remove “bad ” labels automatically meaning that only labels that have been verified by the vision system are applied to product. In combination with the helper code commonly being used in serialized production lines the chance of an incorrect label on a bottle passing through the line is almost nonexistent.” 
 
What equipment capabilities will be needed going forward?
 
According to Dr. Rauschnabel, Chief Pharma Expert, Bosch Packaging Technology, “New digitization developments are entering the market. Amongst others, software modules help to control and monitor production and quality data as well as logistic processes according to customer requirements. Easy-to-handle user interfaces, such as Bosch’s HMI 4.0 not only facilitate the operator’s work but the current machine and production status can be clearly visualized from the global level down to a single machine. Drug producers can obtain fast recipe and count values of a machine. Furthermore, Apps ensure that a transparent overview of machine data is delivered to mobile devices – no matter where the operator or line manager is within the production facility.
 
For in-depth coverage, see Contract Pharma’s upcoming March Issue featuring Packaging Equipment Technology Trends

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