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A flexible filler is a single filling line capable of processing vials, syringes, and cartridges. Traditionally a filling line is designed to process only one container type. By using a flexible filler, the drug innovator or contract manufacturer can decrease capital expenditure, decrease facility “footprint,” improve product and format-parts change over, and reduce product loss.
Courtesy of Bausch + Ströbel
Flexible fillers are rapidly becoming commonplace in many high-value, low-volume applications. They are most commonly outfitted with isolators; but restricted access barrier systems (RABS) are also still utilized. Batch sizes typically range from 100 to 20,000 units, making them ideal for process development, product characterization, clinical trials, and small-scale commercial runs.
There are some notable differences between the two main types of flexible fillers: 1) modular/adaptive and 2) robotic.
Modular/adaptive fillers use modules or stations that can be changed depending on the container type. The filling technology and processes tend to be similar to traditional fillers – such as stoppers, plungers, and seals being transferred by feeder bowls and tracks. The containers, however, are usually in nest and tub formats. An example of a modular/adaptive filler is seen in the image above.
Robotic fillers use robotic arms and vision systems (minimizing format change parts). Unlike traditional or other flexible fillers, robotic fillers require that all container closure components must be introduced and processed via a nest and tub configuration. There are limited, or no, steps in which the container is removed from the nest, resulting in the need for alternative closures systems – different from that of the common stopper and aluminum seal. Plastic snap-cap systems, which incorporate an embedded stopper, have been developed specifically to address this need. An example of a robotic filler is seen in the following image.
Courtesy of Vanrx Pharmasystems
Given the different requirements of the two flexible filler systems, it is critical to ensure both selection of correct components, and proper package configurations. Collaboration with the West account team will greatly improve the rate of success. In addition, as part of West’s Integrated Solutions Program, West can help Simplify the Journey™ with fill/finish support services from early development through small-scale commercialization.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
There is increasing demand for advanced manufacturing technologies for fill-finish operations of parenteral drug products. To meet manufacturing requirements for multiple container and component types, flexible fill-finish equipment is at the forefront of most pharmaceutical, biotech, and CDMOs’ fill-finish strategy. Flexible fill-finish technology is suitable for variable batch sizes allowing for scaling from clinical to commercial in multiple drug delivery presentations. With the ability to launch in vial configurations, prefilled syringes, or other combination products including devices, flexible fillers are beneficial to drug developers who are looking for lifecycle management of their drug products.
For many pharmaceutical manufacturers, commercial filling lines are simply a part of the manufacturing process. But when a drug is still in development or requires prescreen stability testing for new primary container selection , small-quantity filling can be difficult. To send such quantities to a contract manufacturer or commercial lines, such as isolator or RABs, can be expensive and time consuming.
To continue to learn and innovate is truly a daunting task. The journey to success has many ups and downs, but the end of that journey is not necessarily about knowing what worked or did not, but what to do with those learnings. In West’s journey to becoming a world leader in integrated containment and delivery (i.e., our learning experience), we continue to focus on market needs and listen to the voice of the customer.
The need for <a href="/sitecore/service/notfound.aspx?item=web%3a%7b8E02CCA4-F229-4EDC-93A4-6A837E7FA55E%7d%40en">advanced containment solutions</a>, and novel fill-finish processing to enable implementation of these solutions, continues to grow as more complex drug products enter multiple pipelines. As biotech companies develop these complex drug products, the integration of product and process knowledge is crucial to delivering product safety, quality, identity, potency, and purity. And as biotech companies seek partners to help accelerate their development processes, West is committed to leading multi-disciplined, high-performance teams in developing optimal fill-finish solutions for novel packaging and container systems. This dynamic partnership is well-illustrated by the following case study.
In March technical experts from both West and SCHOTT joined together to share insight on the current trends and challenges of the injectable drug market. The two companies held technical seminars sharing their knowledge and expertise related to component and container selection, as well as the integration of primary packaging for filling from clinical to scale up. <br />
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