- What does it mean for Inibsa to have successfully passed the FAT of its new L6 line?
The Factory Acceptance Test (FAT) is a crucial milestone in the project launched in 2023. Successfully passing this test confirms that the new production line meets all the established technical and functional requirements.
Having verified that the line operates correctly, we can now transfer L6 to our facilities, where the necessary tasks will be carried out to advance to the next phases of the project. As a result, we expect to meet our deadlines and commission the line on schedule.
- What were the main challenges encountered during the factory tests at Syntegon?
The main constraint from the outset was time. We travelled to Germany with a rather ambitious schedule: we only had five days to perform four functional tests, validate the processes, and verify the schematics and functionalities of the machine. Indeed, the German technical team also expressed reservations about being able to complete the tests within this timeframe.
However, despite some early hurdles and after an initial test run, the team managed to successfully test and verify the correct operation of the machine.
In the end, we managed to complete all the test runs and check the performance of most of the functionalities, concluding that the machine operated in compliance with the required standards. We succeeded against all odds despite the initial difficulties.
- What specific technologies or improvements are incorporated in the new L6 filling line compared to previous machines?
This is our second machine equipped with the RABS system, which enables us to meet the requirements of the new Annex 1 for the filling of sterile products. However, this is the first machine featuring this technology that we have purchased directly from the supplier.
Another key innovation is that it has been designed with a double sterilising filtration system, meaning that we can access markets with stricter regulations.
Furthermore, a number of minor improvements have been incorporated based on our previous experience with other lines, resulting in improved efficiency and optimisation of day-to-day tasks.
- Once the machine arrives in December, what are the next steps to ensure that L6 will be operational by 2025?
We are currently halfway through the process of delivering L6.
Before then, the following tasks must be completed:
- SAT (Site Acceptance Test): This test will check that the line operates properly at our facilities following the disassembly and transport of the machine from Germany
- Validations and qualifications (IQ/OQ/PQ): We will conduct all necessary tests to confirm that production can be performed in accordance with current regulations
- Training and education: All technical and operational staff involved in the day-to-day operation of the line will undergo specific training and education.
An intense but promising few months lie ahead to see the project through to a successful conclusion.
- How will the process of building a new room and installing the line be managed once the equipment arrives at Inibsa?
That's right. A dedicated area is indeed being built for the new line. The L6 project involves not only the installation of a dosing line, but also the installation of all related equipment to guarantee sterile processing conditions.
For this purpose, an area adjacent to the existing L5 line has been made available, which will have the same characteristics. This new area will house a sterile zone, an auxiliary room for unloading sterile material and a space for washing cartridges.
The sterile zone is currently being assembled, with the construction of the first walls and the installation of the necessary services for the correct functioning of the equipment. Furthermore, there is a new autoclave machine and peroxide SAS (sterile access system).
We are now awaiting delivery of the L6 machine so that we can seal off the sterile zone and complete the assembly of the rest of the area. Once the process has been completed, the air conditioning system will be activated to guarantee the required environmental conditions for the process.
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- What will a new cartridge filling line mean for Inibsa in terms of production?
This new line will enable us to increase our production volume to approximately 1,400,000 units per day, helping us to meet market demands and improve our efficiency.
However, the new line will present a challenge in terms of factory staff, as a new multidisciplinary team will need to be trained.
- Finally, on a personal level, what lessons have you learned from this project? What has been most rewarding about this process?
From a technical point of view, this was my first experience working with this type of machinery, which has enabled me to improve my knowledge and delve deeper into sterile processing and technology.
On a personal level, I have benefitted greatly from the opportunity to interact and collaborate with professionals (both internal and external) from different fields. What's more, this experience has allowed me to explore different perspectives and approaches to the same project.
This project has been a process of continuous learning thanks to the diverse challenges encountered on a daily basis, which have helped me grow professionally.
Ultimately, this experience has brought me closer to my team thanks to the positive working environment, even during the most challenging and intense moments of the project.
