Processo de produção
The significance of the new LVP installation for patients is that, being a fully automated line with an isolator, it eliminates human contact from the filling process. With the new line, our liquid products will be filled in different-sized vials within the isolator, before the machine stoppers the vials and capsules them. After that, the vials will be taken out of the isolator to resume their journey in the whole process.
When we talk of “the LVP line”, we are actually referring to many specialised, precision machines, from the vial washing machine to the isolator, combined together. This line was designed specifically for us and tailor-made to our requirements. I am proud that I was involved in the factory acceptance test (FAT) of the new machine at the vendor’s facilities – I learned a lot during that time. The experience allowed me to evolve into my current role as sub project manager for the site acceptance test (SAT). We installed the new line in the first quarter of 2017. This required one part of the building to be shut down in order to rebuild the area. Now that the LVP filling line has been delivered and installed, we are at the site acceptance phase. This stage is to determine that the new machines work according to our user requirement specifications (URS).
The new installation is a fully automated line with an isolator which eliminates human contact from the filling process.
The SAT is performed with experts from the manufacturer and our LVP line operators. We perform a large series of tests, to see that the installation performs to our expectations. We run different test formats every day on the different stations of the line, from vial washing to the printing of the ink jet number. They include checking that the machine is putting the stoppers on the vials correctly, which assures vial integrity. This is important because if the stopper is not put on correctly, one cannot cap the vial. After the SAT has been successfully completed, the next steps are the installation qualification (IQ) and the operational qualification (OQ). We aim to hand over the equipment to production in 2019, when the plan is to implement operation 24 hours per day, seven days per week.
The new filling lines represent a significant investment of time and money. One cannot order such complex machines from a catalogue, and it takes many months of detailed tests and calibrations before one can manufacture our products to the desired quality. Every little detail is vital and important.
I started with Octapharma in 2012, as an operator in the pharmaceutical department of our Stockholm site, and became responsible for writing standard operating procedures (SOPs) for production processes. Today, as an inter-site team member, I work closely with other Octapharma production sites, building relationships and sharing experiences with colleagues. Our shared goal is to have standardised procedures. The corporate filling lines and freeze driers (FLFD) project installed similar filling lines in Stockholm and Springe. My role now is to standardise the working routines and create SOPs in the local languages, with the aim to have the same routines at both sites. An SOP is like a recipe: if you follow its instructions, you should always get the same result. It is rewarding to work with the other sites to develop standardised procedures. Our efforts will also have a positive impact on future installations at other sites.
I love working in the pharmaceutical industry because I learn new things every day and our daily work is for patients who really need our products. You maybe don’t think you have achieved something significant in one day but, actually, a small thing can have a big impact. When I think of our patients, I want to give them the best. You know that the work you do is helping people in need.
Processo de produção