IMA Life and Kawasaki Robotics breaking ground in pharmaceutical processing innovations
In response to increasingly stringent regulations for the production of injectable drugs, IMA Life has been pioneering a solution whose technologies hinge on the integrated use of advanced robotics. Both European and North American guidelines, respectively the cGMP Annex 1 and FDA guidelines, are demanding closer attention with regard to eliminating the risk of contamination. The development of INJECTA, IMA Life’s fill-finish processing solution for RTU components, which handles injectables in aseptic conditions under isolator, owes a significant part of its ongoing success to the excellent partnership built between IMA Life engineering team and Kawasaki Robotics experts.
Manipulation robots: a recommendation taken seriously
Strongly advised as a risk minimisation strategy in aseptic processing environments, the implementation of manipulation robots was at the heart of the fully robotic concept envisaged by IMA Life. The robotic solutions integrated with INJECTA consist of several modules, each equipped with one or more robots capable of automating the entire production process and suitable for being configured so as to create layouts according to production needs and required protocols.
Why Kawasaki Robotics are making the difference
Customisation, understanding the pharmaceutical sector and an integrated approach were the key factors leading to the successful implementation of Kawasaki’s MC004-V robots within a concept comprising three key elements: machine, isolator and robot.
Looking closely at the contribution made by Kawasaki Robotics, it is important to underline the efforts made to personalise the model in several ways in order to fit perfectly with the aseptic processing environment. The robot features 6 degrees of freedom, a VPHP-resistant coating, 4 kg payload, optimal hygienic design, and has a hollow wrist with fully integrated wiring and piping to avoid their exposure in the aseptic area.
Designing robots suitable for integration in a Grade A area, where critical pharmaceutical processes are carried out, will have a radical impact on the mechanical design and performance of the anthropomorphic system. IMA Life and Kawasaki Robotics accomplished all the necessary steps to ensure the integrated robotic solution addressed each aspect successfully.
Frauenhofer Ipa was commissioned to perform lab tests with an aim to validate the use of the MC004-V robot in aseptic areas. Design aspects were considered in view of washing operations as well as aerodynamics evaluated using smoke tests carried out under laminar flow. Decontamination aspects, resistance to VPHP and the impact in the logarithmic reduction of the microbiological load over time (D-value) were also examined.
The result of the IMA Life – Kawasaki Robotics partnership has led to two important factors:
Robotic technologies have evolved faster than ever for the pharmaceutical industry thanks to the tailored approach adopted by Kawasaki Robotics and IMA Life.
Dedicated efforts have been far more effective in reaching the ambitious goals indicated in international guidelines governing the manufacturing of sterile medicinal products.