Are you struggling with product recovery – either inconsistent or sub-optimal yields? Is your processing time particularly long and/or extending over multiple shifts? Are you considering implementing automated pre-use and post-use IT of liquid filters into your process but unsure how?
The Allegro Connect Bulk Fill System is an automated filtration and filling system designed to accurately and aseptically aliquot bulk product into multiple biocontainer bags or bottles. Minimizing non-recoverable volume within the flow path is central to the design of the system. Automated techniques and novel design features have been incorporated to ensure that bulk fill step yields are consistent and optimal across a variety of bulk filling scenarios.
Configurable to your needs, the system supports a wide range of liquid filter capsules and various filter combinations. The system can fill up to 320 containers with bulk drug substance, process buffer or cell culture media using preconfigured standard accessories. Designed to minimize process risk, the system dispenses product in a sterile single-use flow path, maintaining a closed process at all times. It automatically vents and wets liquid filters, along with performing filter integrity and manifold leak testing. Process risk is further minimized by a comprehensive validation package characterizing extractables as well as particulates, in accordance with current industry expectations.
Uncontrolled risk and preventable product loss at any stage in the manufacturing process is unwelcome. This is accentuated at this critical stage in the process and highlights the need for an efficient, robust and versatile solution to the bulk filling process.
With the cost of manufacturing under constant scrutiny, processes and technologies are consistently being reviewed to increase process productivity and the volume of drug substance produced per year (throughput). Current trends show an increasing number of multi-product facilities being built and/or being retrofitted together with significant investments in automated bioprocessing equipment.
The Allegro Connect Bulk Fill System is a highly configurable platform that can fill drug substance in both biocontainer bags and bottles.
- Automatically fills up to 320 containers – biocontainer bags or bottles, from 1 L to 20 L nominal volumes
- Can support single, serial, or parallel liquid filtration arrangements using up to 2 × 508 mm (20 in.) filter capsules with automated venting, priming and aseptic sampling from the flow path via a sampling port upstream of the final liquid filter.
- Non-recoverable product volume within the system is <2.5% of the feed volume
- If homogeneity of the filtered product is a concern, the system can control an optional mixer, connected aseptically in the flow path after the final filter but before the dispensing station, where a secondary pump is used to dispense the filtered product into the bulk containers
- It can achieve a filling accuracy of within ± 2%, using a single-floor weighing platform per workstation as opposed to one balance per container. This avoids excessive (re-)calibration activities when a multiple scales system is used for the filling process.
The Allegro Connect Bulk Fill System can also be connected with some of our other single-use systems to provide a total bulk fill solution for your process, such as the LevMixer® System or Allegro™ Single-Use Mixers as a feed tank and intermediate tank, and the Allegro buffer totes for buffer or water for injection (WFI) storage.
Scientific and Laboratory Services
The scientific and regulatory knowledge that supports the selection, adoption, and ongoing use of critical process technology – coupled with analytical, imaging and measurement capabilities – creates a versatile and practical resource ready to respond to an ever-changing industry. Pall duplicates these laboratories across the globe and leverages their cumulative knowledge to deliver practical scientific and regulatory support to all process technologies, to keep you moving forward.
The accessibility of local technical support networks minimizes delays in your journey at all points. From the early stage of process development to on-site support for mature processes, Pall’s technical support groups are there to help remove barriers to progress and make your journey as rapid and stress-free as possible. Our knowledge of the technology and the process can be applied to everything from training to troubleshooting and consultancy. Our global team of technology experts is on hand to respond to your changing needs.
Advanced Separation Systems
Operating within the defined design space demands the monitoring and control of critical process parameters to assure product quality. Systems that control critical unit operations and communicate with your existing process components can control process risks and maximize productivity by reducing operator involvement for many processes. Pall applies strong engineering and regulatory understanding to deliver compliant and qualified systems that safeguard and simplify your journey.
Process Development Services
Prior knowledge is a rare and valuable commodity, especially when preparing to take a new direction or when under pressure to deliver to a tight deadline. Take advantage of Pall’s experience, process knowledge and technical know-how to help you achieve your goals. From the optimization of an end-to-end continuous process to establishing the right parameters for a single unit operation, our teams of scientists are ready to work with you and to generate the data you need to make the critical decisions necessary for success.
Arriving at your destination counts for nothing without the necessary paperwork to proceed to the next stage. Pall’s Validation Services are committed to delivering the supporting data packages and analysis required to quantify process risk and support regulatory submission. Our strengths include critical filtration technologies, such as the performance validation of sterilizing grade filtration, and we are at the forefront of the evolving needs in the area of extractables and leachables for all product contact components. We combine the generation of data with interpretation and consultancy to deliver data packages that are ready for regulatory scrutiny, and to ensure there are no barriers to progress.
Servicing and Maintenance
Our range of service packages keeps your equipment protected and well maintained, and includes itemized, pay-as-you-go services, start-up care and training packages, and a variety of post-warranty service plans that include priority response times, discounts for emergency repairs, and flexible payment options. Pall service plans provide total peace of mind and worry-free support throughout the coverage period.