The last stage before the product is packaged and administered to the patient is known as fill-finish. The biopharmaceutical industry is transitioning to smaller aseptic batch manufacturing processes as patient treatments move toward the targeted treatment of smaller (personalized) patient populations and away from broad population therapies.
It was not long ago that robots were focused on end-of-line functions in the pharmaceutical industry, like palletizing and case packing.
Robotic integration is currently gaining ground in the primary packaging processes for RTU containers, like syringes, vials, and cartridges. So the only step left in the process is to fill and finish the container, eliminating most process challenges, packaging is pre-prepared in RTU systems.
Robotic solutions supply pharmaceutical manufacturers with a faster, more cost-effective, and flexible method of filling different container formats via the same filling platform, responding to the growing demand for customized packaging, small batches, quick format, and product changeovers together with less user intervention during the filling process.
Conventional systems do not adhere to the requirement for multiple formats, small-batch flexibility, or sizes and repeatable processes that decrease risk. Advances in technology have made robotics compatible with aseptic manufacturing, with complete tolerance to sterilizing agents and almost no particle generation.
Robots provide flexibility, which is an advantage over traditional aseptic machinery. They can be reprogrammed with a minimal investment if an application or container format changes and are fully adaptable.
Loading cell detail on the robotic filling. Image Credit: SP Scientific Products
Robotic filling steps for RTU containers
The vials, syringes, and cartridges are supplied already sterile and clean, ready-to-use in a sealed nest/tub configuration, so no sterilization, washing, or special transportation is needed. The nest with the empty containers is placed in an ISO standard tub, which enables safe transportation and avoids any glass-to-glass contact.
The user transports the nest/tub to their containment area (RABS/Isolator), where it can be debagged automatically and transferred to the next location. The robot arm carefully removes the pre-heated lid during the delidding process and the lid will exit through a mousehole in the baseplate of the restricted access barrier systems (RABS)/isolator chamber into a waste container.
The containers in the nest are only now exposed to the surrounding environment, which is common within an isolator or RABs enclosure, minimizing the risk of potential contamination.
Thanks to the RABS/isolator, the robotic arm provides a clean and safe operation under the aseptic environment, steering clear of any potential contamination from human intervention during lid removal and tub transfer.
Delidding robot. Image Credit: SP Scientific Products
It advances to the next step after the containers in the nest/tub are released from the top, whereby a second robotic arm moves the nest with the empty containers to the filling position.
The filling heads have a fixed position throughout the filling process. It is the robot that transfers the containers and nest to the filling position of each container. This sharply decreases any risk of the production of particles and contamination.
Nest pick and place to remove the nest from the tub. Image Credit: SP Scientific Products
The stoppering is performed in a synchronized manner by placing the appropriate closure element immediately after filling each container; the exposure of the filled container to the environment is kept to a minimum by using this method.
Robot arm for cartridge filling. Image Credit: SP Scientific Products
The robotic arm replaces the nest to its original position within the tub for the next technical process. After all of the containers making up the nest have been filled and stoppered.
While carefully manipulating the nest and vials, which is vital to decrease particle production, unexpected vial shaking and air disturbance, robotic integration into the filling line process provides reliable repeatability of the movements.
This helps to prevent spills and other incidents which would otherwise lead to manual interventions that are unplanned and could compromise the aseptic environment. The entire range of aseptic processing methods and tools are covered by SP, from stability testing, cycle development, pilot and clinical batch production through to full aseptic manufacturing and commercial production batches.
The SP i-Dositecno SY Syringe Filler is a versatile robot filling and plungering/stoppering machine for plastic and glass syringes, vials, and cartridges in a nest.
Every minute, it is able to process up to 200 units with a maximum of 10 nozzles and this system can incorporate an IPC statistic check weighing unit. Complete line solutions with de-lidding, de-baggers, labelers, de-nesters, and rod-inserters are also available. The cleanroom style robot is utilized to position syringes for filling and stoppering and is available for the VHP cleaning option.
Image Credit: SP Scientific Products
About SP Scientific Products
SP is a synergistic collection of well-known, well-established, and highly regarded scientific equipment brands — SP VirTis, SP FTS, SP Hotpack, SP Hull, SP Genevac, SP PennTech, and most recently SP i-Dositecno — joined to create one of the largest and most experienced companies in freeze-drying/lyophilization, complete aseptic fill-finish production lines, centrifugal evaporation and concentration, temperature control/thermal management, glassware washers and controlled environments.
SP is part of SP Industries, Inc., a leading designer, and manufacturer of state-of-the-art laboratory equipment, pharmaceutical manufacturing solutions, laboratory supplies and instruments, and specialty glassware. SP's products support research and production across diverse end-user markets including pharmaceutical, scientific research, industrial, aeronautic, semiconductor, and healthcare. In December 2015, SP Industries was acquired by Harbour Group, a private investment firm founded in 1976. Harbour Group is a privately owned, operations focused company based in St. Louis, Missouri. Headquartered in Warminster, Pennsylvania, SP has production facilities in the USA and in Spain and the UK in Europe and offers a world-wide sales and service network with full product support including training and technical assistance.
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