Pharmaceutical industry
robocell
Gloveless robotic system for filling and closing RTU syringes, vials and cartridges
With the latest generation of aseptic filling machines, called robocell, groninger meets all the latest regulatory requirements of the pharmaceutical industry and fulfills current trends. Groninger developed a gloveless, fully automated filling line based on robotic 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 viable monitoring - the robocell carries out these processes automatically.
Robocell sets standards, especially when it comes to the revision of the EU GMP Annex 1:
- The reduction/elimination of human intervention in the aseptic filling process
- The use of intelligent robotic solutions
- The support of an integral contamination control strategy (CCS)
robocell highlights
The robocell is characterized by its high flexibility when using a wide variety of packaging. Whether pre-sterilized syringes, vials or cartridges and the use of conventional aluminum caps 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, with the robocell you can meet your requirements.
In the past, small-batch systems were mainly built based on the approach of making medium-power systems more compact and equipping them with robotic technology. The robocell was developed with a completely new approach: No human intervention and the shortest changeover times with a minimum number of format parts. The robots used, which were developed independently at groninger, work completely without format parts and enable software-based format changes in just a few minutes.
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. In this regard, these components have been consistently adapted to implement aseptic insertion as safely as possible.
Pharmaceutical companies and CDMOs 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 sterilization 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 demanded 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.
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