Pushing the boundaries of what is possible with ever better products and solutions is the DNA of biotechnology, life sciences and pharmaceuticals. Due to potentially hazardous substances and contamination risks for employees and products, complex processes often have to be carried out under containment conditions. At the same time, the pressure is increasing due to competition, cost increases and a shortage of skilled workers. The new version of EU GMP Annex 1 has also made the regulations even stricter. In particular, there are additional requirements for containment. Robot systems are now explicitly mentioned here.
As a provider of sophisticated clean air and containment solutions, Weiss Pharmatechnik has equipped a safety cabinet with a robot-assisted filling system for biotechnological and pharmaceutical applications. The robotic application was implemented by Goldfuß Engineering GmbH, which specializes in laboratory automation. The Fill&Finish system manufactured in this cooperation is exemplary for the automated and precise filling of vials with an individual injection solution.
The safety cabinet offers a laminar air flow that follows the first air principle in accordance with the new version of EU GMP Annex 1 "Manufacture of Sterile Medicinal Products". During robot operation, it is closed by a continuous safety window. The containers are inserted and any necessary manipulation of the system is carried out with the pane partially open. Like isolators, the safety cabinet can be decontaminated with hydrogen peroxide. Either a stationary or a mobile system can be used for this purpose.
The use of robotics not only makes sense for large batch sizes, but can also ensure more efficient production with greater safety even for small batches. For personnel, the often repetitive tasks are no longer necessary, freeing up capacity for more creative tasks.
