Whether you are relatively new to the fill-finish process or an experienced industry professional, the evolving nature of sterile parenteral products and their accompanying technologies and regulations can be daunting. The manufacturing solutions available vary greatly depending on the stage of development (from drug discovery through to commercial production), product demands (high yield and targeted production vs. bulk, high-output production), mode of operation (manual, semi-automated, fully automated), and number of products and formats (static lines vs. multi-modal, flexible systems), to name a few. A knowledgeable aseptic processing partner will be able to help you navigate these important factors and find the solutions that best meet your operational needs.
While bespoke fill-finish solutions may be appropriate for select, highly specialised products, the rise of modular, configurable technology has opened up new possibilities for the pharmaceutical market in general and patient-centred medicine in particular. Why has this been the case? The answer lies in three key performance attributes for any pharmaceutical manufacturer: cost, time, and reliability.
A comprehensive approach to modular configuration addresses these areas with advanced, intuitive designs. Predesigned, prefabricated models significantly reduce lead time and enable accurate project scheduling and estimation, which is critical when planning operational milestones and implementing time-to-market strategies. Modular configurations also significantly lower the cost of a machine, requiring fewer overall engineering hours that would otherwise go towards the bespoke design and build of the line—a significant front-end investment. Additionally, bespoke solutions can come with substantial amounts of troubleshooting and scope adjustments depending on obstacles or new insights that appear as the project progresses.
Bespoke fill lines can also feature first-of-their-kind technology which can be unpredictable and untested in real-world manufacturing situations. At the heart of the choice between a bespoke and configurable approach is the level of uncertainty that an operation is comfortable with. The initial performance of the equipment, along with lifecycle variables like maintenance intervals, durability, and parameters of stock/aftermarket support, are all yet to be determined with bespoke, first-generation technology. Additionally, from a regulatory and operational framework, new technology means new documentation, new testing protocols, and new training materials, all of which are absolutely necessary to a pharmaceutical operation. Here, having well-designed, highly repeatable, and predictable technology is a demonstrable advantage.
AST’s Configurable Modular Technology: Tailored and Proven
Josh Russell demonstrates AST's approach to configuration with the Semi-Automatic Bag Opener (SABO) and Manual Tub Opener (MTO) modules at the 2024 Virtual Pharma Expo.
Configurable modular fill-finish lines consistently perform in four key areas:
Quality: A modular design means that the quality and engineering behind any given technology have been rigorously evaluated, reworked, refined, and go through an ongoing cycle of continuous improvement. New innovations and improvements in materials and engineering technology will continue to inform a module with each new iteration. AST’s modular technology is the result of the best practices and finest craftsmanship available.
Dependability: Solutions featured in a configurable line are tested, proven technologies, which means they have a demonstrated track record of validation, durability, and use logic rooted in real-time manufacturing parameters. They are also backed by data-informed maintenance schedules, troubleshooting services, and spare part and consumable forecasting.
Performance: An aseptic processing operation is a significant investment of time and resources, so the performance of the chosen equipment is paramount. That is why being able to configure a fill-finish line to the specific demands of a drug product, especially for high-value liquid pharmaceuticals that require no waste and high-yield strategies, has changed the way the industry approaches pharmaceutical manufacturing. Modular configuration, when combined with single-use and ready-to-use technology, provides an avenue for manufacturers to leverage solutions that have a proven history of results with a zero-waste approach from the very start of production. This ensures complete product stewardship from the very first container that is run through the machine.
Flexibility: The strength of a configurable approach is in its adaptability. Configuration is not static; it is about having the right building blocks available—an extensive inventory of aseptic processing technologies able to meet the majority of process conditions required by the full range of parenteral drug products. Whether it is adjusting or upgrading a modular block or adding a module to fit a new process, the modular approach is one that is intended to fit and scale with your operation.
