robocell | Gloveless Robotic Filling Cell

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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. In cooperation with SKAN, 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 the handling of environmental monitoring - the robocell carries out these processes fully automated and without human interventions.

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 smart robotic solutions
The support of an integral contamination control strategy (CCS)

The contamination control strategy is an essential element for pharmaceutical companies and CDMOs. 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.

Robot system for filling and closing RTU packaging materials — robocell with SKAN isolator for processing RTU packaging materials

Maximum flexibility for different packaging materials

The robocell is characterized by its high flexibility when using a wide variety of packaging material. Whether pre-sterilized syringes, vials or cartridges and the use of conventional aluminum caps or snap-on caps, the robocell sets new standards. 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.

Shortest turn around times enable high OEE values

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 which were developed by groninger, work with a reduced number of format parts and enable software-based format changes in just a few minutes.

Introduction 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. In this regard, these components have been consistently adapted to implement aseptic insertion as safely as possible.

The implementation of a PUPSIT in robotic systems

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.

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.