Beyond traditional requests takes you beyond expectations
It will be no surprise that as one of the pillars of the Group, IMA Life deals with some of the most stringent demands coming from the pharmaceutical industry. Beyond the traditional requests for short lead times, equipment reliability and the many standards that are taken for granted throughout the market, the division’s team of aseptic processing and freeze-drying experts spread between Italy, China and the USA are faced with a growing number of requirements that have to be addressed in a holistic manner. Many of these demands have transformed the range of IMA Life products into solutions going beyond today’s expectations.
The evolution of robotic technologies
Responding to one recurrent demand to reduce human intervention, we have rapidly expanded our knowledge of robotics, partnering with Kawasaki to ﬁnd the optimum solutions. Using robots streamlines handling, introduces a greater degree of ﬂexibility and reduces the risk of cross-contamination throughout the process. Whereas the heavily mechanical movements of previous machines allowed for speed adjustments and not much more, robots can be programmed to accomplish human-like movements, which are much easier to adapt to different containers. INJECTA, with its crew of six-axis robots, will manipulate tubs, nests, trays, and pre-sterilized RTU components such as vials, syringes and pre-capped cartridges, pre-o-oriented vials in trays as well as bulk-fed sterilized vials.
INJECTA represents a break with the past
Years of dedicated research added to decades of experience in aseptic processing technologies have led to what is considered a pioneering solution for pharmaceutical manufacturers. Implementing a Quality by Design approach, we have developed technologies that answer the toughest demands. We use Computational Fluid Dynamics to study airﬂow behaviour using ﬁnite element analysis to determine airﬂow on a 3D model. We analyse how airﬂow is aﬀected according to variations in pressure, temperature and speed. We run smoke tests to verify what exactly happens in a working scenario. Nothing is left to chance and moreover, the customer is welcome to witness the results ﬁrst hand. What is important to our customer is the minimum risk of cross-contamination, removing any obstacles that obstruct unidirectional airﬂow. Taking part in the tests, onsite or remotely using today’s connectivity, including Factory Acceptance Tests is a way of ensuring everything is done to respect each required speciﬁcation.
Involving the customer at every level
Dealing with such a delicate process, with substances that require isolation technologies, IMA Life and the customer rely on each other to ﬁnd the ideal solution. We welcome a customer who wants to run tests on speciﬁc packaging materials at our test rooms, where working equipment is available to simulate the customer’s factory process.
We can assess contamination risks together in order to bring our solution in line with vital factors regarding the isolator. Today we are developing a system for high-potent substances, whereby the tub or tray is removed from the working area while the syringes are ﬁlled, so it avoids contamination, enabling renesting outside the isolator.
Back to performance-related demands, we are also launching INJECTA 36, our latest version built to manage 36,000 syringes per hour, complete with advanced robotic technologies, ready to address the need to enhance productivity and reduce lead times for injectable medicines. Addressing tomorrow’s needs with future-oriented solutions is now a habit we’re proud to conserve. IMA Life designs and delivers aseptic processing equipment and freeze dryers that are generally integrated into complete processing lines, also supplying solutions for washing, blowing, depyrogenation, loading, unloading and labelling.
Stefano Specchia Product Manager for Aseptic Processing Solutions at IMA Life