Efficient and Profitable Capsule Filling: A Quality-Driven Focus

Dietary supplement consumers want products that are convenient and easy to administer, and research shows that capsules remain the preferred dosage form for 42 percent of US consumers thanks to their convenient, versatile, and easy-to-swallow properties¹. A key challenge for nutraceutical manufacturers is ensuring that the finished capsule products they bring to market are innovative and address the latest consumer trends—such as an increasing demand for sustainable, clean label products and greater transparency— while also optimizing production efficiency, productivity, and ultimately profitability. To do this, quality must be built in to all stages of product development. 

Driving quality forward 

There are a number of important factors to consider when developing an encapsulated dosage form to ensure an innovative, high-quality final product. Capsule and capsule-filling equipment suppliers and contract development and manufacturing organizations (CDMOs) can provide support throughout the process, offering brand owners expertise and guidance during R&D and formulation, helping to determine release profiles, select capsules and polymers, and source high-quality raw materials to deliver the desired results. 

Sourcing the highest quality raw materials and ensuring that they are tested for identity, purity, safety, and effectiveness is essential for shaping the success of a finished capsule product, as a product is only as good as the materials used to make it. Additionally, knowing the source of ingredients is very important to 43 percent of US consumers². Collaborating with reliable and trusted suppliers helps to create optimal manufacturing conditions and minimize the risk of material-related problems occurring during processes such as capsule filling. This improves lead-time performance, reduces required inventory levels and costs, and frees up working capital for the manufacturer. 

A Careful Consideration 

After selecting all the raw materials, including the capsule dosage form, manufacturers must carefully consider their choice of capsule-filling equipment. A variety of machines, equipment, and operational processes are used for capsule filling. Taking the time to choose the right machine for each production line plays a large role in maintaining product quality, enhancing yields, and realizing profitability. An encapsulation machine handles hard capsules, following specific setup parameters to open the empty capsule shells, create slugs of powder formulation, insert the slugs into the capsule bodies, then close, lock, and eject the filled capsules. The specific method used to create the slugs of formulation can be adapted depending on the application. When working with nutraceutical ingredients, such as vitamins, botanicals, herbs, and natural extracts, a tamping-style machine is often preferred because it is best equipped to handle the inherent variance in nutraceutical ingredient properties. 

CDMOs working with brand owners can further support the manufacturing process by consulting with customers when selecting equipment for unique formulations. Beyond equipment selection, they can also carry out maintenance evaluations, inspecting the machinery and tooling for damage or wear. Tooling inspections are essential to delivering the best results, as the tooling on a capsule-filling machine is critical for creating the powder slugs and aligning them with the empty capsules for insertion, and worn tooling can increase downtime and reduce yields. CDMOs and suppliers can also enhance capsule-filling productivity by delivering comprehensive, end-to-end service. Process improvement programs, for instance, which assess current practices, processes, and yields, provide manufacturers with a tailored toolkit for navigating enhancements in overall yield. This includes evaluating and optimizing machine speeds to increase throughput, which enables better use of variable labor and utility costs while opening up capacity for growth without requiring additional capital or new equipment. In addition, CDMOs can determine the total business impact and cost savings based on specific recommended improvements in equipment and processes using a savings report based on total cost-in-use. It is important to document these metrics and demonstrate the real-world cost impact of improvements to machines and their processes, so brand owners can make more informed decisions and validate their improvement plans. 

CDMOs can also offer Six Sigma Green Belt-certified staff who operate on the foundation of quality by design. Working alongside manufacturers, Six Sigma support teams can use their knowledge of which dosing options and powder flow characteristics work best with which types of capsule-filling equipment to put systems in place to identify the root cause of any problems that may occur in the manufacturing process. This allows manufacturers to implement preventative measures to gain and maintain full control of quality-driven operations. In addition to consultation and advisory support to help ensure quality, technical experts can also offer current Good Manufacturing Practice (cGMP) training to help ensure that processes meet manufacturers’ quality standards as well as wider industry quality requirements. 

Alongside achieving optimal productivity and unlocking cost savings, it is also important that capsule technologies and operational procedures deliver the latest consumer preferences. For instance, sustainability is growing in importance for consumers, and individuals are increasingly seeking products that are manufactured using sustainable methods that produce less waste. Although the dosage form selection is instrumental to minimizing waste, the capsule-filling machine selection and performance are also crucial, as they allow the opportunity to optimize the amount of formulation in the capsules. 

Leading Solutions 

To develop innovative nutraceutical products that meet consumer demands, produce them efficiently, and maximize profitability, manufacturers must focus on quality at every stage of product development. Working closely with their suppliers and outsourcing partners allows brand owners to truly optimize their operations, from ingredient selection to capsule filling and sealing, and deliver products that will enable them to stand out in a competitive landscape. 

References 

1. NMI SORD study, US – 2018 commissioned by Lonza. 

2. Ibid Lonza research.