Performing analytical
methods to test quality

Bernhard Süss Senior Technician QC Analytics 1, Vienna, Austria

Our daily work in Quality Control Analytics is the testing of final containers, intermediates, in-process samples, and stability samples.

I joined Octapharma as an apprentice in 2004. In Quality Control (QC) Analytics, our daily work is the testing of final containers, intermediates, in-process samples and stability samples to ensure that all tested parameters are in their specified limits to guarantee the good quality of our products.

Locating samples for testing in the cooling room.

We receive samples from throughout the production process and test certain parameters. Some of the in-process samples are time critical, so we need to have an efficient schedule for testing to ensure production can continue in good time. Our results of the time-critical in-process samples allow the various production units to proceed with further production steps – in some cases the results confirm that the production steps were done correctly and they can continue the production process. So we have to work very precisely and reliably.

In Analytics 1, we have about 50 different analyses (the combined analytics teams in Vienna use more than 100 test methods). Ten to 15 different methods are performed on average per day. Some methods are used to test ten to 15 samples per day, others up to 50 samples per day. We use our laboratory information management system (LIMS) to manage the samples, analysis and the results. We have flexible working times which must comply with the incoming in-process samples. At 6am, the first samples arrive so some employees are scheduled for the “morning shift” from 6am–2.30pm. Some analysts also do optional evening shifts from 2pm–10pm. We have staff on on-call duty for samples which come during the night, or late in the evening, as the testing times for some in-process samples can shift for various reasons.

Before we start the routine analysis, we print a working list from the LIMS system to see all the samples we have to prepare. We prepare the reagents and the devices used for the method. If we get completely fresh in-process samples, they are usually in liquid state, though they can come in frozen (if they have been stored for a few hours). Our final container samples are stored in a cooling or freezing room. For samples and reagents that must be stored at minus 70 degrees, there are special deep freezers. For lower temperatures, we have liquid nitrogen containers.

In coagulation testing we recreate the process of blood clotting in the laboratory environment. This is my real passion.

The Biuret method. In the presence of protein, a special blue-coloured reagent changes to violet.

If we are testing final container samples of lyophilised (freeze-dried) products, we have to reconstitute them. So for the final container testing of coagulation factor concentrate, like octanine®F or octaplex®, we dissolve the lyophilised product with water to get the liquid product. For some methods, the products have to be further diluted with a special buffer.

I enjoy the versatility of my work. My position involves a combination of performing tests, a lot of office work (writing standard operating procedures, for example) and interesting activities such as instrument qualification, employee training and support. And I occasionally represent my group leader in organisational lab matters.

Coagulation testing is my real passion, because I am also responsible for the automated coagulation analyser, called STA-R. In coagulation testing, we recreate the process of blood clotting in the laboratory environment. For example, we test the concentration of coagulation factor IX (FIX) in octaplex® and octanine®F. Coagulation cannot occur with the FIX product alone, we also need reagents with other coagulation factors naturally present inside the human body and an activator and calcium to start the . We load the reagents into the instrument, then perform a calibration. The instrument measures the clotting time of samples relative to the standard. The sample and the special reagents are pipetted into a cuvette, in which the movement of a small metal ball indicates the progress of clotting. When and if the samples clot, the ball will not roll, so the instrument detects that clotting has occurred. With a high FIX content, for example, the clotting time will be short.

For octagam®, we test amongst others the protein content performing protein determination using the Biuret method. In the presence of protein, a special blue-coloured reagent changes to violet and the intensity of the colour is measured by a photometer.

Electrophoresis is applied to separate the proteins. An electric current is used to separate the proteins applied on a gel. The protein components have a different size and electrical charge and move from one side to another. The bigger the protein component, the less it will move. This separation of possible contained protein components allows us to ensure the purity of a product, such as octagam® or albunorm®.

Plasma is a scarce and precious raw material. Sometimes, when it is your routine daily business, you can forget that. It is important to remember that our raw material comes from humans and that our products are used by humans. Our patients rely on us not only for effective products, but safe products. Every minute, every hour, every action of all staff is very important and makes a difference to the whole system working well. I watched the patient films and to see real patients is a great reminder of the importance of our work. I am proud to work here and feel honoured to be part of the system.

Every batch of final product is tested for compliance and patient safety

100% testing of all specified parameters

100% review of all process parameters

Compliance with all requirements leads to internal release of the batch

Samples of every plasma pool are re-verified for absence of viral markers as well as for virus DNA/RNA

Batches are also tested externally and released by an Official Medicine Control Laboratory (OMCL).

To release the batch of final product, an external control of all defined criteria is required. After this, the medicines can be used by patients.

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