Gloveless robot system for filling and closing RTU syringes, vials and cartridges
With the latest generation of aseptic filling systems called robocell, groninger meets all the latest regulatory requirements of the pharmaceutical industry and fulfills current trends. In cooperation with the SKAN, groninger developed a glove-free, fully automated filling line based on robot technology. Consequently, human intervention in the core processes of pharmaceutical filling is a thing of the past. Whether installing a filling path or positioning the active or passive germ monitoring - the robocell carries out these processes automatically.
robocell sets standards, especially when it comes to the revision of the EU GMP Annex 1 draft:
- The reduction/elimination of human intervention in the aseptic filling process
- The use of intelligent robotic solutions
- The support of a integral contamination control strategy (CSS)
The contamination control strategy is an essential element for pharmacists and contract fillers. This is why, during development, groninger placed great importance on providing customers and users of the robocell with the best possible support. Detailed CFD considerations of all critical areas as well as the joint development of the isolator and filling line ensure that possible contamination is downgraded to a technically minimal risk.
Maximum flexibility for different packaging container
The robocell is characterized through its high flexibility when using a wide variety of packaging. Whether pre-sterilized syringes, vials or cartridge and the use of conventional aluminum sealing or new snap-on caps, the robocell sets new standards here. While previously available lines still had limitations in terms of packaging or batch sizes, these shortcomings are now completely eliminated with the robocell. Regardless of whether it is a small or medium-sized batch, whether it is a single batch or a campaign, the robocell allows you to implement your wishes.
The shortest changeover times enable the highest OEE values in a segment comparison
In the past, small-batch systems were mainly built based on the approach of making medium-power systems more compact and equipping them with robot technology. The robocell was developed with a completely new approach: No human intervention and the shortest changeover times with a minimal number of format parts. The robots used, which were developed independently at groninger, work completely without format parts and enable a software-based format change in just a few minutes.
Instroduction and installation of direct and indirect product contact parts
Regardless of the implementation of the new Annex 1, there have been a lot of discussions in recent years about the cleaning, sterilization and decontamination of parts that indirectly come into contact with the product and their introduction into aseptic filling lines. Here, too, the robocell shows innovative ways, to do that components have been consistently adapted in order to implement the aseptic introduction as safely as possible.
The implementation of a PUPSIT in robot-supported systems
Pharmacists and contract fillers face a number of challenges as part of the new Annex 1. A key issue here is the implementation of a PUPSIT (pre-use-post-sterility-integrity test). Here, too, the robocell lives up to its reputation and offers solutions to enable a PUPSIT even without glove ports.
robocell areas of application
With its specific properties for maximum product and operator protection, the robocell is not only suitable for use in the filling of synthetic drugs (small molecules), but also, particularly, for the filling of new biological drugs (large molecules), which are manufactured in small batches under the highest containment requirements, such as
- Antibody-drug conjugates (ADCs),
- Orphan drugs,
- Cell & Gene therapies,
- Advanced therapy medicinal products (ATMP).
The line meets the highest process requirements that are required for processing these pharmaceuticals. This definitely includes the requirements of regulatory authorities for containment and aseptic processing and the use of different zone concepts for processing pharmaceutical products with different OEB and BSL levels.
This is what our customers say
We are very proud to be able to put groninger's first robotic filling line into operation.
Do you have any other questions?
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