Robocell
robocell
Gloveless robot system guarantees the highest product and process safety.
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.
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.
