Many people are unfamiliar with the concept “Lot Size One”, although it is an important and differentiating element of Pharma 4.0. The concept of a single product quantity for an order is referred to as “Lot Size One”, and it is the complete opposite of mass production. To reduce production costs, most pharmaceutical companies used to produce as much big batches as possible. However, in the era of connected data, a single customer order should not need to be fulfilled from stock in the supply chain, but instead may turn on manufacturing machines to produce that very product.
The need for Mini Batches
The trend toward small batch production is driven by growing demand for personalized treatments, more biologics and biosimilars, and production of orphan drugs intended to treat extremely uncommon diseases. Precision or personalized medicine does not always imply a batch size of one. However, in the coming years, the “one-size-fits-all” approach will become less popular. In line with cutting-edge diagnostics, such as genetic testing, small to extremely small batch sizes of a specific medicine are already required for some treatments. As a result, patients are treated with the best drug at the most optimal dose for them.
It is not only the different doses and drug combinations that are transforming the pharma industry. Additionally, today’s regulatory requirements differ considerably between countries. Manufacturers have to take into account an increasing number of languages and market variations, along with serialization criteria, resulting in increased diversity. Pharmaceutical companies have to manufacture multiple small batches with packaging material containing distinct artwork and unique data.
Challenges of small lot sizes
Small batch production allows pharma companies to be more flexible and responsive to customer demands and market-specific requirements, but it takes away economies of scale. Small lot sizes can lower productivity and overall equipment effectiveness (OEE). Downtime for format changes raises the unit cost and decreases the packaging line’s capacity utilization rate. It is all about how often you run batches, not how fast you run them. In the past, hundreds of products per minute lines were built to meet large batch sizes, however cleaning, changeover, and decontamination between production runs took a lengthy time. Today’s focus is on producing small batches more efficiently, with minimum changeover time in between runs.
Flexible Manufacturing
Graniten has witnessed this shift toward small batch production with our global pharma customers. To serve a smaller patient group, a large number of pharmaceutical companies are producing low volumes of big molecule drugs. “We are managing more and more small batches. Last year, in the bottle packaging department in particular, 70% of the orders were below 3 000 packs” a big pharma company. Previously, manufacturers have been focused on high speed packaging lines designed for mass-market blockbuster drugs, but they must now adapt their equipment to accommodate the current demands of the market. The future leaders of pharma production are developing packaging lines where product changeover can be done in minutes.
Graniten developed its FlexLine packaging system to help pharmaceutical companies increase their efficiency and reduce their costs for their small batch production. Flexline offers a small footprint design, close-to-zero changeover time with no mechanical change between formats. The machine is built on a modular system using robotics allowing specific production configurations (primary and secondary packaging as well as end of line packing) and the possibility for future upgrades.
“The introduction of the Flexline system will give us the possibility to increase efficiency. Managing small batches in Flexline will increase the efficiency of the lines dedicated to only big batches for big volumes and will free these lines from small batches that impact a lot the efficiency” says the system engineer of one of the biggest global pharmaceutical companies.
If you want to learn more about Flexline, please contact us.
