Lot Size One is a concept from Pharma 4.0 theory that, in that age of connected data, an individual customer order need no longer be satisfied from stock in the supply chain but might actually trigger a production machine to produce that specific item.

Dividella’s Lot Size One and Up approach, also rooted in 21st-century production and packaging concepts, adopts a robotic work-cell system to boost the flexibility and sustainability of small-batch production.

In doing so, it can relieve stress points for pharmaceutical manufacturers and suppliers at every stage of the production and supply chain.

The need for small lot production

Striking the right balance on batch size is difficult for any pharmaceutical company. Manufacturing thousands or even millions of identical pack iterations ensures ready supply but without catering to individual client needs and incurs huge hidden costs in inventory. Small batch manufacturing gives greater flexibility and responsiveness to customer needs and country-specific requirements but robs the pharma company of economies of scale.

In the 21st century, however, the advent of leveraged data, combined with modern lean production and just in time manufacturing/supply concepts are allowing pharmaceutical companies to square the circle, moving towards smaller batch sizes while simultaneously maintaining ready supply.

The trend to small lot production is driven not just by capability but by need, including rising demand for personalised medicines, desire to get product to market quickly after successful clinical trial and the reality that most drugs and medical devices are no longer sold in bulk.

Small lot challenges

Dividella and its Korber Medipak Systems group stablemates are well aware that this strategic shift raises a whole new set of production and packaging challenges, described by Dividella product manager Manuel Huber.

He said: “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.”

These challenges are increased by ever-tighter regulations against counterfeiting, tampering and demanding full traceability across the supply chain along with the greater reliance on temperature controlled products and overall demands for enhanced sustainability and decreased use of plastics.

Customer-centric machines

Dividella’s small-footprint Lot Size One and Up concept eases these stress points by adopting a robotic work-cell-based modular system designed for top-loading and side-loading cartoning capable of producing optimised pack sizes using 100% monomaterials.

Each work cell can be equipped, depending on the production configuration needed, with supply units that are exchangeable in a plug-and-produce manner. Dividella caters to pharmaceutical manufacturers that are looking to produce small batches down to individual units 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.

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. In addition, Dividella has invested in an augmented reality solution that can help guide technicians and operators through troubleshooting small batch issues.

Exploiting the power of data

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.

Huber says: “We aim to deliver full product and data transparency with future machines that know 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.”

Integrated approach

Dividella’s innovations are part of a modular and integrated approach to intelligent small batch production implemented across the Medipak Systems Group.

Thus Dividella’s clients also enjoy beneficial services such as advanced PAS-X MES software from Werum IT Solutions that helps to run the Lot Size One and Up packaging line efficiently or the bespoke erecting service from Rondo that can deliver any batch of pre-erected cartons that are filled and closed inside the work cells.

Dividella has the breadth of product portfolio to provide optimal machine solutions for emerging requirements, leading to a more sustainable and environmentally friendly production environment, as well as more efficient operations.

Huber added: “We feel that we have to offer the pharmaceutical industry equipment that is more sustainable, without compromising on flexibility.”