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Automation of pharmaceutical packaging saves costs and time, say contract packagers.
Automation plays a role in several pharmaceutical manufacturing operations, including packaging. Specifically, the automation of processes can save resources, time, and money. Outsourcing the packaging of bio/pharmaceutical products can offer sponsor companies and manufacturers a variety of options from clinical development to commercial production.
BioPharm International spoke with Patrick Ferguson, managing director at Tjoapack, and Markus Hörburger, product and service manager at Vetter Pharma International GmbH, about the benefits of automating pharmaceutical packaging and the services contract organizations can provide.
BioPharm: How can automation be used to optimize pharmaceutical packaging?
Hörburger (Vetter): Similar to other industries, the main benefit of automation in pharmaceutical packaging is replacing time-consuming manual assembly and packaging steps. Often, automation also has the advantage of being accompanied by digitalization. Digital processes allow for the gathering of various data around the automated packaging that are a significant basis for the identification of further process improvements (for example, predictive maintenance).
Ferguson (Tjoapack): The introduction of automation into pharmaceutical packaging processes has become the industry standard for any packaging company looking to positively impact the bottom line. Investment in automation has a direct and positive impact on quality, efficiency, productivity, and profitability. Additionally, it allows contract packaging organizations, such as Tjoapack, to be more competitive.
BioPharm: How is automation used for the different types of packaging, such as blister packs, prefilled syringes, vials, bottles, etc.?
Ferguson (Tjoapack): In the pharmaceutical packaging industry, equipment providers have continued to develop solutions to tackle nearly any task. Quality and robustness are being designed into the processes from the ground up. Inspections, verifications, integrity, and repeatability are all standard concepts in terms of the overall design of a particular solution.
While the sequence of individual tasks for the packaging of blisters, prefilled syringes, vials, bottles, kits, etc. are often different from one type of SKU to another, they all have many common attributes where automation is being used. Examples include: presence and verification of packaging component, presence and verification of product (bulk and/or semi-finished goods), presence and verification of labeling, documentation of critical attributes, inspection of components, WIP, and finished goods, [and] serialization and aggregation of packaged goods.
Hörburger (Vetter): Automation adds the most value when various packaging process steps, such as labeling, assembling, and cartooning, can be processed within a fully automated line. Ideally, different packaging types can be processed on one line. For example, syringes can be automatically assembled in safety devices or autoinjectors respectively. Further down the line, syringes, assembled autoinjectors, or safety devices can then be packed in blisters and folding boxes or in more sustainable paper-based solutions depending on customer requirements.
BioPharm: What goes into formulating effective automation strategies for pharma packaging?
Ferguson (Tjoapack): In my opinion, the formulation of an effective automation strategy starts with an evaluation of the process needed to create the end product. Critical inputs include batch size, annual volume, margin, and the tasks required. Obviously, it doesn’t make sense to invest millions of dollars to fully automate a kitting process that runs only 500 units once a year. The investment into an automated solution must make good financial sense. Once the critical data has been collected and evaluated, a strategy can be developed with multiple automation options included. A cost-benefit analysis should then be developed for each option. Depending on the level of investment, proposals are then routed to the appropriate level with collaboration from multiple departments.
Working with equipment manufacturers and solution providers is another critical part of this process. Choosing the right vendor to partner with can make or break a project. Vendors often have standard solutions that work as is or can be customized to your need. When no solution currently exists, a good partner can take your concept and develop a custom, turn-key solution.
Hörburger (Vetter): The development of our packaging strategy starts by considering the needs of the end-user. As a CDMO [contract development and manufacturing organization] in high-quality filling, device assembly, and secondary packaging for injectables, developing an effective automation strategy involves the incorporation of many different assembly and packaging processes. As it pertains specifically to automation, the high complexity of the diverse processes plays a central role in the formulation of a suitable strategy. In addition, the lifecycle status of the products has a major influence on the degree of automation and, therefore, the automation strategy. In early clinical phases when batch sizes are small, highly automated processes can limit flexibility and efficiency. As the product matures, the batch size typically increases. When clinical Phase III is reached or at the launch and associated start of commercial production, highly-automated assembly and packaging processes are preferred.
BioPharm: Which kind of automation services/equipment are available for pharma packaging?
Hörburger (Vetter): Common automation concepts include equipment that is being used for single-packaging processes; for example, assembly as well as the incorporation of a fully integrated line that combines several pieces of equipment for the entire packaging process. Collaborating robots (cobots) are another concept for the automation of pharma packaging. Through the use of cobots, the interaction between employer and machine is achieved, resulting in increased automation of manual processes. At Vetter, we have been using this collaborative approach for several years and are currently using cobots within our secondary packaging lines for feeding-in alcohol swabs. We have also gained experience in the assembly of piston rods and repacking syringes in trays in stand-alone systems.
Ferguson (Tjoapack): Automation comes in a variety of flavors. Many people not familiar with automation think of assembly lines with robots performing all the tasks. Automation in its entirety can range from lights-out operations with virtually no human interaction, to simple line-level, task-specific enhancements to a process. Sensors, gating mechanisms, and other mechanical inputs can easily be added to a line to improve a process and reduce labor and waste. Fully automated solutions can be implemented to perform a full sequence of tasks yielding a quality product with little human intervention. Naturally, the validation of these automated processes is critical.
BioPharm: Why should manufacturers outsource their packaging needs?
Ferguson (Tjoapack): Contract packagers, such as Tjoapack, offer a wide range of services to drug manufacturers that they may not have been able to handle on their own. For example, a manufacturer may have a small-volume product or a unique pack-out that doesn’t fit into their existing capabilities or capacity. The contract packager is able to pool these together with other similar products from other manufacturers, making an investment into automation and technology more feasible (financially). In the end, the manufacturer is able to have their product packaged with a higher level of quality and with an overall reduced cost.
Hörburger (Vetter): Contract manufacturers typically run state-of-the-art production facilities that enable a wide range of services and packaging solutions. As a CDMO, we are a one-stop partner for our customers, offering services that range from clinical and commercial filling to final packaging solutions.
Having a proven track record demonstrates the ability of a CDMO to support customers’ special needs in secondary packaging. This includes production equipment for a broad range of order sizes and formats, broad expertise for country-specific needs, and extensive experience with international authorities. It also demonstrates leaner project coordination, streamlined fill-and-finish services, as well as reduced time to clinic and market.
Susan Haigney is managing editor of BioPharm International
Vol. 35, No. 8
When referring to this article, please cite it as S. Haigney, “Automating Packaging of Bio/Pharmaceuticals,” BioPharm International 35 (8) 2022.