A complete, versatile, fully automated line designed to adapt to the manufacture of different products with the highest quality and in compliance with the new Annex 1 of the GMPs.
The current context of the Covid-19 pandemic requires the pharmaceutical sector to operate in a global and challenging environment, due to the uncertainty of the circumstances, the universal impact of the disease, and the urgency of the search for an effective vaccine.
The need to give a fast response to market requirements is something that drives pharmaceutical equipment manufacturers to react with diligence and social responsibility. This type of situation has become a growing trend, since the need to supply a global market with innovative medicines at a profitable cost is constantly increasing.
To meet this demand, manufacturers of machinery for the pharmaceutical sector must meet two conditions; firstly, the ability to design and supply equipment and advanced technology that is versatile and adaptable to new products and, secondly, knowledge of manufacturing processes and the applications of their equipment, in order to be able to actively collaborate with the end user in the optimisation of processes and the joint development of new ideas.
The IMA Life division offers a wide range of equipment for the processing and aseptic production of liquid and powdered pharmaceutical products, based on a long-established technology with more than 50 years’ history, acquired through direct and continuous collaboration with clients and experts around the world.
The current range of products includes washing machines, sterilisation tunnels, liquid and powder filling machines, labelling machines, containment and isolation systems and freeze-dryers that can be combined with transport and automatic loading and unloading systems.
But IMA is not just “machines”: the company invests heavily in the development of new technologies related not only to the design and manufacture of automatic machines, but also to the improvement and optimisation of processes and the handling of materials.
After years of research and study, using the most advanced technology to develop innovative solutions, the reward is the achievement of the initial objective: to be able to offer comprehensive solutions and to provide close collaboration with its clients in the development of new projects and complete lines.
The essential requirement for successfully managing a project for a complete aseptic production line is to have a team of project leaders trained in team integration and with knowledge of the functional logic of a line, planning, organisation, safety and resource management to achieve the objectives set with the client.
Cooperation agreements with clients enable the exploration of new strategies and open the way to the development of new ideas that provide added value to both the manufacturer and the end user. The completion of the project for the new Reig Jofre injectable product manufacturing plant (Sant Joan Despi, Barcelona) is a clear example: Reig Jofre is growing despite the current context. The sound strategy of the company, which decided to invest in an expansion of its production capacity to strengthen its presence in the national and international market, has provided Reig Jofre with an excellent financial result and may turn the company into an international benchmark manufacturer of a future Covid-19 vaccine.
The construction of the new facilities in Sant Joan Despí (Barcelona) for the manufacture of sterile injectable products, which will be ready to start operating in the second quarter of 2021 and will create 100 new jobs, began in 2019 and has represented an ambitious challenge for Reig Jofre and for IMA Life, which was finally awarded the contract to supply the complete line.
The objective was to design a versatile plant, capable of adapting to current and future requirements, implementing advanced technology and maximising the performance of the line with ambitious and innovative solutions. In addition to the design, manufacturing, installation management and validation of the complete line, IMA has provided an air flow simulation study that gives Reig Jofre detailed knowledge of the air behaviour throughout the process and guarantees the safety of the product and the process.
Reig Jofre’s new production line includes a vial washing machine, a sterilisation tunnel, a state-of-the-art filling line integrated in a grade A containment system, a capsule filler and two freeze dryers with an area of 54 m2 each, equipped with a flexible automatic loading and unloading system.
Reig Jofre has entrusted IMA Life with the construction of the largest and most modern sterile freeze-drying facility in Spain. A complete, versatile, fully automated line designed to adapt to the manufacture of different products with the highest quality and in accordance with the new Annex 1 of the GMPs.
The high-speed line has a capacity of 600 units per minute, with statistical weight control, and 400 units per minute with 100% weight control. The system can work with easily interchangeable volumetric and peristaltic pumps (single-use consumables).
The system includes two high-volume vertical freeze dryers, spread over two heights, fed by an innovative flexible automatic loading and unloading system that guarantees product containment throughout the process and offers a high level of productivity.
The loading system consists of an accumulation table and a mobile platform for the transport of the vials from the table to each of the freeze-dryers, keeping the containers at grade A throughout the process. The flexible loading and unloading solutions make it possible to automatically feed several freeze-dryers with a single system, which optimises the loading and unloading speed and reduces cycle times.
IMA Ibérica, located in Barcelona, provides Reig Jofre with direct technical and after-sales service. The branch has a team of specialised technicians to provide immediate response and minimise downtime.
A collaboration strategy between user and supplier based on “win-win” provides confidence, knowledge and exchange of experiences, and creates the basis for future agreements. The aim is to provide value in a reciprocal way, to find out the interests and objectives of the other party and to seek solutions that benefit both parties. In this case, the outcome can be considered a success for both. IMA has managed to deploy all its capacities and install a modern complete line of sterile products that contributes to the growth of Reig Jofre and to the establishment of the company as a benchmark in the industry.