To meet the changing pharma and biopharma industry needs of today, packaging equipment has evolved to accommodate challenging flexibility and productivity demands. Depending on the product, equipment needs can be wide-ranging, from large-scale manufacturing to small batches requiring frequent changeovers, and all on the same packaging line.
 
Christian Treitel, head of pharma business development at Bosch Packaging Technology discusses the pharma/biopharma trends that are impacting packaging equipment, the latest capabilities, and serialization needs.
 
For in-depth coverage of pharmaceutical packaging equipment trends, with perspectives from both equipment manufacturers and contract packagers, see the upcoming March issue of Contract Pharma. –KB
 
Contract Pharma: What are the growth areas or trends you’re seeing from Pharma/Biopharma that are impacting packaging equipment?
 
Christian Treitel: In the coming years, we will see even stronger discrepancies between the different pharmaceutical branches and markets. Price pressure due to generics and biosimilars is pressing large-scale manufacturing to become more efficient. Since many global drug producers have shifted their focus to the development of new formulations, they have outsourced their filling, closing and packaging operations to contract manufacturers. The latter’s main concerns are flexibility and productivity. Processing and packaging equipment must be adaptable to different products, packaging formats and speeds at consistently high output rates.
 
In parallel, biopharmaceutical companies, laboratories and research facilities are producing smaller amounts of targeted drugs, for instance for the treatment of cancer or orphan diseases that affect only a small population of patients worldwide. They require flexible platforms that can handle small batches in larger time intervals, while ensuring the highest safety for both operators and products. Smaller batches, however, mean more frequent changeovers, cleaning and documentation. Therefore, the goal is to make changeover times shorter, and more convenient for the operator.
 
CP: What are some of the latest capabilities/recent advances with packaging equipment?
 
CT: As far as primary packaging of liquid dosage forms is concerned, manufacturers of pre-sterilized glass packaging are making an important contribution to new developments and ease of use. While pre-sterilized syringes have been in the market for many years, some of these manufacturers have now started the production and development of pre-sterilized, ready-to-fill vials and cartridges. Since the preparatory steps for these pre-sterilized containers have already been carried out by the supplier, the purchase and operation of upstream machines for loading and washing, or for sterilization and depyrogenation is no longer necessary. New machine developments, such as the FXS Combi from Bosch, make it possible to fill and close all three packaging types on one single platform.
 
For secondary packaging, safety, speed and reliability are the most decisive characteristics. The main challenge lies in quick changes between different products and product combinations. This is why the horizontal cartoning machines from Bosch are based on a universal platform. Customers are able to safely and gently package the required amount and combination of products into different carton sizes using the same machine. This includes primary packaging types such as bottles, vials, syringes, ampoules, tubes, blisters and trays as well as bags, stick packs and sachets.
 
Apart from flexibly exchangeable closing variations for each secondary packaging type, such machines offer numerous possibilities for expansion or upgrades, including end-of-line serialization, aggregation and tamper-evident modules complying with current regulations and safety standards. Appropriate track & trace solutions make it possible to integrate printing, verification, labelling and IT systems into both new and existing product and packaging lines.
 
CP: How are pharma/biopharma packaging needs changing? What changes do you see with respect to the types of drug products being packaged?
 
CT: Due to the rapid growth of high potency APIs (active pharmaceutical ingredients), the requirement for specialized containment is rising continuously. Isolator and containment systems ensure that both operators and the environment are protected from exposure to these highly potent APIs. Ever more complex liquid filling lines call for a precise integration of the filling machine with an isolator and subsequent machines. While the interfaces need to function safely, the overall control systems must be kept simple and easy to operate.
 
In a highly regulated industry, quality remains a top priority. On the one hand, inspection platforms play an important role in assuring product quality of pharmaceuticals. At Achema 2015, Bosch for instance launched two new inspection machines. The AIM 3 offers the possibility to perform both visual inspection and high-voltage leak detection (HVLD) for ampoules and vials on one single platform, while the KHS 1 is a new development emerging from a cooperation of Bosch with Lighthouse Instruments, LLC. It is designed for container closure integrity testing of ampoules, vials, bottles, cartridges and syringes using laser headspace analysis (HSA).
 
On the other hand, regulations push pharmaceutical manufacturers to work on their quality procedures. Here, equipment manufacturers can offer valuable support. For instance, if a pharmaceutical producer is looking to replace existing equipment and wants certain processes to be automated so that manual intervention and human errors can be reduced, Bosch offers support combined with the matching line concepts. Moreover, Connected Industry solutions from Bosch are designed to offer full transparency of the production and supply chain, thus providing for significantly improved quality and efficiency.
 
CP: How is serialization impacting packaging equipment?
 
CT: Serialization requirements are increasing all over the world, and implementation deadlines are approaching fast. Pharmaceutical manufacturers not only need to equip their packaging with an individual serialization code. They must also establish new procedures for the management and storage of serial numbers, which in turn requires the adaptation of their packaging processes. A track & trace system should not only be able to mass-serialize the packed product in the sense of printing a code onto each pack. These codes also need to be verified unambiguously. Moreover, the packs are usually also equipped with a label or integrity seal, before the next packaging layer is added.
 
The entire process needs to be controlled, and the data retrieved at any time. Only this way do producers – and later on the issuing authorities and legislators – have an exact overview of all process steps. This calls for a sophisticated software architecture, which is able to integrate the serial numbers consistently on all levels – from devices, line processes and line management to production and enterprise control. A multi-layer and modular machine and software concept, which is compatible with existing line concepts, is obviously the safest option.