Interviewer: Today we're here to interview our production manager at Inibsa, Enara, about the opening of a new production line, the L6. Enara, can you tell us a bit more about the process?
ENARA: Let's see... We knew we needed to increase our capacity in order to fill more cartridges, so the decision was made to install a new line. Installing a new line isn't just about buying the equipment and that's that. It involves the construction of the whole classified area as well as all the auxiliary equipment a classified area needs, like an autoclave, peroxide SAS, plus the whole SCADA monitoring system, etc.
INTERVIEWER: I see. Could you tell us about the different phases of the project so we can understand the magnitude of the process?
ENARA: First you need to work out all the people you need to work on the project... You need a multidisciplinary team that includes all the departments involved – staff from engineering, factory maintenance, validations, control and production. Once the team's been set up, you need to define the user requirements. We look at user requirements to define exactly what we need from... each team and area. For example, the line defines precisely what we need; an autoclave, what we're going to... need, and all the equipment, even the SCADA defines the user requirements. Then... Once these have all been submitted to the suppliers, we get an offer, and reach... a financial agreement, and then we can start on the design phases of the installation. Next we'll have a lot of meetings on monitoring the lines. Last of all, we do a risk analysis with the suppliers, and then we get to the fun bit. Things like the SAT for example – accepting the line, for example, checking it works correctly in the supplier's facilities, or the FAT, which is when the line comes here to us, when we can see the line is working perfectly. Or the device. I'm talking about the line now, but it could be another device, or autoclave, or peroxide SAS. Lastly, once the FAT has been done, we carry out all the IQ/OQ validations, and when the validation's finished, we'll start on the PQ process. The PQ isn't just the production process; it begins with the APS, the Aseptic Process Simulation, which is filling cartridges with the specific culture medium; once that's filled, incubated and all in order, that's when we start producing lots.
INTERVIEWER: I see. And in all these phases – and there are a lot of them – what are the main challenges you've faced, the ones you think are most relevant?
ENARA: For me, the main challenge is finding all the staff we need to make the line work. And not just finding them; the HR department has done a great job finding them, but training all the collaborators afterwards.
They need to be trained so that they can then take part in... what we're doing now – the Aseptic Process Simulation. For me, this is the biggest challenge... the most important thing we've had to do. After that, we needed to take on people in other departments like QA, control or maintenance, or the factory, so that we can manage the level of growth we're going to experience.
INTERVIEWER: How many people are we talking about on the new team, more or less?
ENARA: At the operator level there are 12 people. But there are a lot more staff, there's been a lot of movement.
INTERVIEWER: I see. OK, perfect, Enara. Now let's talk about the impact on production. What will this new line mean for Inibsa's production capacity?
ENARA: Running in three shifts from Monday to Friday, this line will represent an increase of around 68 million pre-filled cartridges per year. This means that by 2026... we'll have increased capacity by over 300 million cartridges.
INTERVIEWER: That's amazing. Compared to the lines we already have in the company, is this new line significantly different?
ENARA: This line is very similar to the one we adapted last year, which was line 5, with RABs. This line also has RABs technology, basically barriers, with gloves to prevent the line from opening if you have to intervene with it in any way. This guarantees the product remains aseptic. This line was already built and conceived like this, which means it's much easier to access the different sites to carry out interventions.
INTERVIEWER: And was the training a challenge with that, too?
ENARA: Absolutely. Absolutely.
INTERVIEWER: Of course. And so, a little... question: Can you tell us when this line is going to start?
ENARA: Hard to say! Let's see. At the moment we're working on the Aseptic Process Simulation. There are three lots. Once the filling and incubating finishes and we've taken readings and checked everything is correct and satisfactory, and we hope it will be, we then need to wait for... authorisation from the Spanish Medicines Agency and, once the authorisation has been received, the line can start.
INTERVIEWER: That's great. How do you feel personally about the project, seeing it all take shape and finally getting the wheels in motion?
ENARA: I'm really happy. And... Above all, about the huge effort everyone on the project team has made. Really happy, like I said. And, above all, I'm excited about continuing to play a part in the growth of Inibsa.
INTERVIEWER: Great, Enara. Thanks very much for your time.
ENARA: My pleasure.
INTERVIEWER: And we hope there will be many more projects like this to come, so we can keep growing as a company.
ENARA: Let's hope so. Absolutely.
