SDC is the foundation of traceability of all our individual plasma donations. This traceability is important for the safe and efficient production of our products; because we must be able to go through the whole production chain in both directions: from final medical product to the plasma donation used to produce the batch, and vice versa. SDC removes rejected donations to guarantee that the donations which will be used in production fulfill all the quality criteria. We only send the good plasma donations to production.
A typical day starts with the control file preparation for the plasma donation batches which will be controlled that day, and to check that everything is prepared to allow the SDC to be performed. The scan of each individual plasma donation allows us to make the link between the physical donation and the data supplied by the plasma collection center.
Once scanned, if a donation is good, it is accepted. The donation is put into a plasma box labelled as “Accepted”. When the box is full with good donations, it is weighed, closed and put in cold room storage before being used in production.
We must respect the donors and their plasma because they take the time to save lives, and do so by giving a part of themselves.
A donation may be rejected by visual rejection criteria, e.g. donation bottle integrity (to avoid a risk of contamination); red cells (which block the filters in the process); or insufficient donation volume. If any of these criteria is met after scanning, we manually enter it into the system, adding all the required data (e.g. carton number).
There are also rejection criteria given directly by our manufacturing execution system, OctaMES. In this case, the virus tests have been uploaded in the system and the corporate quality plasma department entered all relevant data given by the plasma collection center. When I scan the donation, the system makes a specific noise and the screen color changes. This is unmistakable so cannot be accidentally ignored. For positive donations or look backs, specific documentation must be completed to prove that the donations have been removed. All rejected donations are put in a box labelled “Rejected”, put “in jail” in the cold room and then destroyed as biological waste.
In some cases, we begin control of the donations before having all the necessary data. These donations are put in “On hold” boxes. This is the case for plasma with missing polymerase chain reaction (PCR) test results or plasma for which the quarantine date has not been reached. Such boxes are blocked until all the missing data comes in and the inspection can be completed.
After the SDC step, the corporate quality plasma department must approve the plasma for use in production. Then it is transferred to the production site by the transport department. Basic fractionation then begins the process of thawing and pooling the plasma.
We must respect the donors and their plasma because they take the time to save lives, and do so by giving a part of themselves. When I think about our patients, I am always conscious of the importance of our job to improve and save patients’ lives. I also appreciate how lucky I am to have good health.