Administered parenterally to patients, vaccines and other biologics require specific production processes to optimize both particulate and bioburden control whilst ensuring uncompromised sterility throughout the manufacturing process to maximize patient safety.
Protecting drug products from contamination has led to the development of aseptic transfer and containment methods for clinical and commercial sterile injectable products.
Looking for advanced ways of improving efficiency, reducing cost and increasing sterility assurance, robotic processing is gaining huge popularity for the primary filling of Ready to Use (RTU) containers such as vials, syringes and cartridges. Robotic aseptic fill-finish technology and the use of isolator-barrier systems are emerging as key to keeping pace with these requirements.
Further accelerating the adoption of rate of robotic solutions is the revision of EU GMP Annex 1: Manufacture of Sterile Medicinal Products published in August 2022.
In the revision of Annex 1, Section 2.1 states, “The use of appropriate technologies (e.g., Restricted Access Barriers Systems (RABS), isolators, robotic systems, rapid/alternative methods, and continuous monitoring systems) should be considered to increase the protection of the product.”
Robotic Aseptic Platforms at PCI Pharma Services
Complementing our sterile fill-finish and lyophilization capabilities across North America and Europe, PCI has invested in state-of-the-art robotic technology platforms at both our San Diego, US and Melbourne, Australia facilities.
Utilizing the latest advancements of Cytiva Microcell and SA25 technologies, we deliver flexible aseptic fill-finish solutions for both small and larger-scale production runs across a variety of dosage forms including vials, syringes and cartridges for use in autoinjectors, helping to meet our clients’ scalable aseptic manufacturing needs, delivering products to patients safely and efficiently. Our investment in multiple robotic technologies provides a scalable solution for our clients, meeting clinical requirements from smaller Phase I trials and beyond.
The Microcell platforms in San Diego and Australia offer fully automated, gloveless filling, performed through closed robotic isolator technology that provide both small batch flexibility and standardized manufacturing. The agility of these technologies make it suitable for the production of both personalized medicine batches and clinical trial supplies delivering true speed to patients. Superior drug product quality is assured through advanced automation, removing the need for operator intervention during the filling process and limiting product contact. Importantly, the Microcell technology can fill up to 1,200 units per batch with fill volumes ranging from 1.0 –50mL.
Providing a scalable aseptic solution in support of clients progressing through the clinical lifecycle towards commercialization, the SA25 Aseptic Filling Workstation is a larger-scale, gloveless, isolator-based filling technology offering small and larger scale batch production of up to 20,000 units, supporting fill volumes from 0.2 – 50mL. It provides flexible manufacturing solutions and has the ability to fill multiple delivery device formats including vials, syringes and cartridges through an aseptic process.
For both the Cytiva Microcell and SA25 technologies, precise, programmable robotic functions cover all aspects of the fill process, including isolator leakage tests, VHP sterilization of the container closures, filling into the CCS of choice, capping and batch delivery. They are also compatible with ready-to-use (RTU) containers and closures, removing the container and closure preparation stage, aiding speed of delivery of a quality and sterility assured drug product.
Advantages of Robotic Processing
Speed and Accuracy
Expediting the filling process with automation while increasing accuracy, robotic platforms with high-precision Dynamic Peristaltic Pumps ensure accurate fill volumes with minimal product losses. This is a significant benefit to our clients, who are often developing life-changing, high-value drug products with the need of progressing through the clinical pipeline with efficiency and speed. Minimizing product losses not only conserves valuable drug product and reduces cost, but ensures clinical supply needs are met and key milestones are achieved as the product progresses towards commercialization.
Quality Assurance and Sterility
With a robot performing the processes in a process driven, validated system and utilizing single-use parts, pre-sterilized flow paths and RTU containers, multiple sources of risk are eliminated including; cross-contamination, human error, electro-mechanical filling and closure activity failures, environmental control failures, cleaning and set-up errors; and product loss.
Using press-fit vial closures with integrated rubber stoppers not only reduces the risk of particle contamination but also simplifies the manufacturing process with the press-fit closures being a one-step application that presses closures on top of the vials, versus the traditional two-step process of stoppering and aluminium crimp capping. All this combined means clients are able to move more rapidly through the clinical stages and provide safe, life-changing therapies to patients.
Flexibility
Robotic technologies are designed for maximum flexibility while maintaining high aseptic processing rates. Meeting the needs to fill many different products and process multiple projects with minimal changeover time between batches, provides ultimate savings in time allowing PCI to better support clients who have urgent drug product supply needs.
Seamless Sterile Solutions
The addition of these robotic aseptic fill-finish platforms at our San Diego and Australian facilities enhances our renowned global sterile and lyophilization capabilities. These advanced technologies not only expedite the filling process with automation but being able to pivot between filling multiple dosage formats, brings even broader sterile fill-finish solutions to PCI clients across the entire drug product lifecycle bringing therapies to market with increased speed and safety.
Combining our expertise in aseptic manufacturing with specialist biologic packaging, labeling and cold chain distribution provides a valuable end-to-end solution, simplifying the supply chain while delivering time and cost efficiencies for our client partners.
Spotlight on Robotic Aseptic Processing – by Austin Roberts, Operations ManagerPCI Pharma Services. | As seen in Pharmaceutical Manufacturing and Packing | August 2023.
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