Striking the right balance on batch size is difficult for any pharmaceutical company. Manufacturing thousands, if not millions, of identical pack iterations allows medicines to be dispatched to customers quickly, albeit without the capacity to cater to individual client needs.
Choosing to manufacture in smaller batches allows greater flexibility on the part of the pharmaceutical company to issue personalised products and match country-specific requirements, but sees it miss out on economies of scale. However, pharmaceutical companies are moving towards smaller batch sizes while simultaneously maintaining the broad level of supply. This trend has been driven by the rising demand for personalised medicines, as well as a desire to get a product to market quickly after a successful clinical trial, and the fact that many drugs and other small forms of medical equipment are no longer sold in bulk.
Product manager at packaging machinery company Dividella Manuel Huber explains: “This makes the packaging process more complex.
“Pharmaceutical companies cannot just produce one big batch, then split it into smaller batches in the warehouse and ship it to different countries. They have to produce several small batches with packaging material that has different artwork and individual data printed inline. Depending on the end user and its country’s regulations, the product label, leaflet and product container colour varies, even if the drug and dosage stay the same.”
Dividella’s small-footprint lot size one and up concept eases these pain points. This robotic work-cell-based modular system has been designed for top-loading and side-loading cartoning capable of producing optimised pack sizes using 100% mono-material.
Each work cell can be equipped, depending on the production configuration needed, with supply units that are exchangeable in a plug-and-produce manner. The company caters to pharmaceutical manufacturers that are looking to produce small batches (down to one) more efficiently with its upcoming system, which has been designed for the semi and fully automatic packaging of vials, syringes, auto-injectors and other parenteral products.
Huber adds: “Every part of the machine is accessible that Dividella has invested seriously in an augmented reality solution that can help guide technicians and operators through troubleshooting or operating the machine.
“We’ve built in the newest technology to help our customers achieve line clearance and format changes in the fastest, most reliable manner possible.”
The lot size one and up solution is embedded into an intelligent software structure, meaning that the packaging line can be built around anything, from individual work cells to a fully automated production line, and actively track the path of each product and carton through the line.
Huber added: “We aim to deliver full product and data transparency.
“The machine knows how many products were delivered, when the batch was produced, and can state how many were packed and what percentage may have been rejected and why.”
The software can easily be linked up to a line management or manufacturing execution system and provide advantages with several pharma 4.0 features, such as predictive analytics.
Additionally, existing data from an upstream process like filling or inspection can be merged with new data from the line and transferred to the next downstream process, such as case packing or logistics. Serialisation and aggregation are supported as well.
Furthermore, the modular nature of the lot size one and up solution enables easy modification, like the existing NeoTOP and NeoTRAY families of top and side-load cartoning machines.
As a part of the Medipak Systems Group since 2002, Dividella’s clients also enjoy beneficial services that can extend and boost small-batch production with the future work-cell approach. One of these is Werum IT Solutions, which provides the advanced PAS-X MES software that helps to run the lot size one and up packaging line efficiently.
Huber says: “Our sister company, Rondo, also provides a bespoke erecting service.
“It can deliver any batch of pre-erected cartons and then, inside the work cells, the carton is simply filled and closed.”
Perhaps most importantly, Dividella is acutely aware of the need to balance flexibility in the packaging process with sustainability and batch production is no exception.
Huber added: “In today’s production environment, pharma companies have such a large variability in batch size requirements that it is critical to be able to match the production requirements with machine capabilities and throughput. Dividella has the breadth of product portfolio to provide the optimal machine for these requirements.
“This, of course, leads to a more sustainable and environmentally friendly production environment, as well as more efficient operations. We feel that we have to offer the pharmaceutical industry equipment that is more sustainable, without compromising on flexibility.”