At BBio quality comes first, the department Quality Control measures this quality
At BBio we make reliable vaccines in a high-quality production facility. The safety, efficacy and identity of each production batch is checked by the Quality Control (QC) department. Not only end products are tested, all surfaces, the water and air in the production areas are also tested at QC. This is how we measure the quality of our products.
Ingrid, Research Technician, explains: “at BBio we must be fully in control of our processes. This way we can guarantee the reliability of our vaccines. At the microbiology lab where I work, we test every week to ensure that bacteria are not growing where they should not be. Water samples are taken from all the various tap points. We measure the air by letting the air flow past an agar plate with a kind of vacuum cleaner. If there is a bacteria in the air, we catch it on the plate. And contact agar plates are applied to surfaces by sort of stamping them. These samples are taken by production and sent to our lab. There, the plates are placed in an incubator to see whether bacteria will grow on them.” Because bacteria do not all like the same temperature or the same media, the microbiology lab has a whole series of incubators where the samples are examined at different temperatures. “I started as an intern in this laboratory and have now been working here for 28 years. No day is the same. Of course, all tests are carried out according to a fixed protocol, but there is always a chance that a contamination occurs and then we have to get to work! Some tests have to be done immediately, so sometimes we also have to work during the weekend. However, we work with a very nice team and we look after each other. Together we ensure that the work is distributed evenly. Microbiology is really in my heart, I like that the results are visible with the bare eye. You can count the bacterial colonies on the plates. I have done all the tests during the time I have worked here, but this is what I like most. I am also responsible for the planning of the department, and I try to plan according to the interests of my colleagues,” Ingrid adds.
The Quality Engineer ensures that the regular process continues in the event of deviations
To ensure that each production batch meets the correct criteria, QC carries out many tests. For example, we test whether no foreign viruses have entered the vials and whether there is sufficient active substance in the vials. Very occasionally a test gives an invalid result or the result falls outside the stated specifications, then a Quality Engineer is called in. Evelien is one of the Quality Engineers at QC: “If we receive an abnormal test result, it is my job to find the root cause of this. I first check whether the test has been carried out correctly, then the sampling process of this polio bulk is checked. Once all these activities have been carried out according to protocol, the production process is examined. “Then we go back into the process together with the production people. My role is smaller in this as there are also Quality Engineers in the production departments.”
There are also deviations that can occur during QC. Once this has happened, Evelien also investigates the cause of this and the impact of the deviation. Determining this impact is often done in collaboration with the Qualified Person, the person who ultimately certifies our products for use. A thorough root cause investigation is then very important, as only then will the preventive or corrective measures be most effective. With properly implemented measures, the deviations will not quickly occur again.
In this way, a Quality Engineer ensures that the regular process can continue in the event of deviations. Evelien: “The fact that I consult with all departments makes my work very enjoyable. I have been working at BBio since 2006, I started here as an analyst and grew into this position because I enjoy investigating the causes of deviations and I can make proposals for improvement. I take the long travel time from Brabant to Bilthoven for granted, I wouldn’t trade this for a job closer to home.”
Maintenance of equipment at Quality Control
A lot of equipment is needed to perform all tests properly. Oscar and Angelien, Technical and Project Engineer, ensure that all equipment works. “We are the first points of contact for equipment within QC and ensure that people are and remain trained to use the equipment, guide repairers and supervise the purchase of new equipment,” says Oscar. Both have a laboratory background. Angelien: “I worked here in the laboratory and at that time no one was really responsible for maintaining the equipment. I had the most affinity with technology, so I eventually became the first point of contact. This is how we discovered how useful it is to have a Technical Engineer at Quality Control. We have the knowledge of the methods used and maintain the documentation. Sometimes we can carry out repairs ourselves and otherwise we can employ a technician. The technicians are hired by the Engineering & Maintenance department, so we mainly make the report and try to communicate as clearly as possible what the problem entails. In addition, we also guide the technicians when they conduct the repairs.” Because no one was really responsible for maintenance for a while, there is some backlog. “One of the biggest frustrations in the laboratory is overdue maintenance. This was also a motivation for me to make the switch to this position. There is work to be done and it is much rewarding when I can make a difference by, for example, replacing all the pipettes. It is a very useful function and the result is greatly appreciated by my colleagues,” says Angelien.
From pH meters to complex machines, the two engineers are jointly responsible for more than 600 different devices spread over two laboratories. Last summer, BBio put a new laboratory into use, a BSL-3 laboratory with strict safety procedures. Oscar: “Because people first have to change clothes to work in this laboratory and shower afterwards, we try to solve malfunctions ourselves, sometimes with video support. It is a completely new laboratory and there are still some teething problems to be solved. I also notice that the people who work there still have to become familiar with the equipment. Sometimes I am called in even though the solution turns out to be quite simple. Familiarizing people with the equipment is also part of our duties.” Both engineers indicate that the variety is what makes the work so much fun. “We talk to a lot of people, manage many different devices and work together with many departments,” Oscar explains. “Every day is different, an emergency can come in, or a special piece of equipment can break down. Last month there was a power outage; With so much equipment under our management we know that something will break and it sure did.” Angelien adds: “I don’t want to go back to the laboratory, this job is much more varied.”
At BBio, raw materials required for production are tested, the vaccines are tested before they are released for use and the production environments are checked. In this way, together we ensure that our vaccines meet the correct criteria and we make quality measurable.
Would you like to contribute to this? BBio is looking for people to strengthen our Quality Control department! Take a quick look at our vacancies page to view our open vacancies.