Process validation of platelet concentrates and plasma units - Evaluation of three different apheresis devices

Background

To further ensure the supply of our oncological patients with platelet concentrates, three different apheresis machines were compared within the scope of a process validation. In addition to measurable product quality, donor feedback and employee handling of equipment are important process components. For this reason, major focus was placed on latter two aspects.

Methods

As part of the process validation, the critical process parameters (CPP) and critical material attributes (CMA) were used to determine the critical quality attributes (CQA). Besides these measurable quality attributes, questionnaires were used to evaluate the three different apheresis devices by the same donors and operators. It was planned to perform ten thrombocytapheresis and six plasmapheresis procedures with each device. Testing included platelet content, volume, residual cell count, pH, platelet aggregation, sterility, and swirling effect for the platelet concentrates. The following parameters were determined for the obtained plasmas: Residual cell counts, coagulation factor VIII, total protein and sterility.

Results

see Table 1

The total process time (including set-up times, donation time, post donation activities), the product yield (platelet per unit, single versus double units) and the possibility of plasma donation were identified as particularly relevant CPPs.

For the CMAs, the set configuration was identified, in particular the size of the primary label and other additional materials required.

Conclusion

Based on the results of the surveys and the measured quality control parameters, and taking into account our customer requirements, a clear preference was established from the three apheresis machines evaluated. Device qualification was performed after installation with a total number of 12 additional runs per device.

Offenlegung Interessenkonflikt:

The authors declare that there is no conflict of interest.

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