Even after the Covid-19 pandemic has subsided, the demand for pharmaceutical products is increasing. But requirements change, and this has an impact on production teams. Medicine packaging machines are not exempt from this. And this only encourages its manufacturers.
The example of vaccines only highlights the importance of pharmaceutical packaging. One in two new medicines approved in the EU is produced by genetic engineering, is particularly sensitive to environmental influences and must be packaged accordingly. In addition, there are increasing regulatory requirements for production technology, such as Annex 1 to Good Manufacturing Practices (GMP guidelines), which was finalized in 2022: this again regulates sterile production and the filling and packaging of medicines, with the aim of reducing the risks of contamination for the medicine.
It is not surprising, therefore, that the pharmaceutical packaging machines market is growing disproportionately, even more than the pharmaceutical market as a whole. Market researchers at Evaluate Pharma, for example, expect the global pharmaceutical industry to grow by 6% annually to reach US$1.6 billion between 2022 and 2028. In parallel, the pharmaceutical packaging market will grow by 8.24% and that of pharmaceutical packaging machines by 7.5% annually, according to the expectations of the market research company Mordor Intelligence.
At the same time, rising costs for packaging and labeling medicines are facing declining revenues for pharmaceutical manufacturers. After the vaccine boom of the Corona years, the pharmaceutical industry is not only fighting against declining sales, but also against the explosion in costs due to the energy crisis. On the stock exchanges, the market value of biotechnology companies has halved, while prices of inputs – including chemical precursors – have increased considerably in 2022. The pharmaceutical industry has been under particular pressure because – as in the EU, for example – it has to sell some of its products at a fixed price.
These and other trends are now also reflected in the requests and specifications of packaging machines: While in the past, for example, filling and sealing machines with high performance and lines designed specifically for a medicine were in demand, today the desire for flexible lines that can be converted quickly – and ideally automatically – to new products and other packaging formats. The trend towards smaller batches plays as important a role here as easier handling. It is observed that the desire for flexible production processes is no longer only expressed by contract manufacturers, the so-called CMOs, but also by original manufacturers.
This evolution is clearly illustrated by the example of injectable preparations, the so-called injectables. Already in the years before the pandemic, machinery manufacturers had recorded strong growth in demand for ready-to-fill syringes. The enormous demand for vaccines in the Corona years 2020 to 2022 had recently caused a revival of bulk packaging such as vials, but in the meantime the share of “ready-to-use” (RTU) syringes is increasing significantly again. With RTU syringes, for example, the medication is drawn directly into a sterile syringe. This not only reduces the risk of contamination during preparation and administration, but also prevents dosing errors.
Customers’ desire to find better packaging solutions for less money is therefore what drives machine manufacturers. And one key word runs through the description of most new developments: Flexibility. Syntegon, for example, has developed the Versynta flexible filling system as a platform with which biopharmaceuticals can be filled into both RTU syringes and bulk containers in the isolator. To considerably reduce project times, the supplier Groninger also focuses on flexibility with the Flexfill concept, but combines it with standardized modules that are also housed in the isolator or RABS. Bausch+Ströbel is also committed to modularization and has radically reduced the number of format parts in the new CombiSys line. Thus, the conversion of the machine is comparatively simple.
Bausch+Ströbel kills two birds with one stone with a new magnetic transport system that moves the packaging material through the machine: Unlike conventional drives, a fixed cycle time is no longer necessary, which increases flexibility. At the same time, the magnetic drive makes scrapers and bellows seals unnecessary, thus eliminating a cause of contamination in the sterile area. Optima has also addressed the transport of packaging materials in the machine: With the new FillCell flat transport system, the main goal is to increase product yield. Especially with expensive active ingredients, it is important to avoid losses during machine start-up.
Machine manufacturers take this requirement into account with new dosing and filling systems, but also with optimized transport, monitoring and labeling solutions. Digital technologies play an increasingly important role here: this starts with the training of operators with virtual reality glasses on digitalized equipment, extends to the seamless recording of production parameters in the manufacturing process, and ends with evaluation and visualization of key figures such as Overall Equipment Effectiveness (OEE), increasingly important in the growing competition of the pharmaceutical industry.
The Körber Group, for example, has dedicated itself to this topic, using its Manufacturing Execution System (MES) to analyze the operational efficiency of biopharmaceutical manufacturing processes from disparate data that was not previously networked. Among other things, this should allow biopharmaceutical manufacturers to significantly accelerate their time to market. Uhlmann Pac-Systeme networks machines and entire plants from any manufacturer via interfaces with new software (Pexcite), enabling centralized monitoring and control. In addition to controlling line efficiency and planning setup times, it also facilitates compliance with regulatory obligations. compliance with regulatory obligations.
The automation strategy of many manufacturers now includes the use of robots, not only at the end of the line, for example to stack medicines packaged on pallets, but already in the sterile isolator. Machinery developers benefit from the fact that, on the one hand, the range of robots suitable for clean rooms continues to grow and, on the other, the costs of robotics continue to fall. Automated solutions are thus increasingly replacing gloved interventions on the isolator, which would otherwise be necessary. And in the demanding sterile production of high-quality medicines, human intervention is increasingly perceived as a nuisance and is replaced by technical solutions.
At machine manufacturer IMA, the aseptic process without a balloon in the isolator is promoted under the name “Injecta”. But the aforementioned machine manufacturers are also following the trend towards aseptic filling without human intervention with their own solutions. The development is consistently implementing the requirements of the new GMP Annex 1. In many places, this also includes dispensing with the laborious sterilization of primary packaging material by using sterile packaging materials.
In general, the packaging of sterile preparations for injection and infusion (parenteral) is very demanding, and the machine technology is expensive. This becomes a problem especially when the success of a medication or the necessary amount is not yet known. Folding box manufacturer Faller Packaging has developed a scalable solution to this problem together with machine manufacturer Schubert-Pharma: It starts with the initial manual loading of ready-made folding box packaging. As demand increases, cobots are used until the process is eventually switched to a fully automatic top-loading machine.
But it is not only the development of processes around the primary packaging of medicines that follows the new demands of pharmacists. The development of secondary packaging in folding boxes, trays and cartons does not stop either. In addition to product flexibility and safety, the most important trends are resource optimization and low CO 2 emissions . And the issue of sustainability is also increasingly permeating companies in the pharmaceutical industry through CSR and ESG criteria.
To improve the recyclability of packaging, Uhlmann, for example, is increasingly betting on packaging made from monomaterial. With the Parenteral Tray Center, the manufacturer has also recently introduced a flexible ‘direct-in-carton’ solution that can package ampoules, vials and syringes both in cardboard trays made of monomaterial and in conventional plastic clamp blister packs. Recyclable packaging places new demands on machine manufacturers. That is why close coordination between the machine supplier and the packaging supplier is important. At Faller Packaging, for example, the approach is called 3R: Redesign, Reduce, Recycle: in addition to the use of new recyclable monomaterials, this also includes testing existing products and processes with the aim of minimizing the use of raw materials and energy.