193
9.4.2.1 Centrifugation
The centrifugation parameters revolutions per minute, temperature, time, acceleration, deceleration are important for the composition and
characteristics of the specifi c components. These critical parameters should be defi ned on the basis of validation data that demonstrate a process that
consistently produces quality products. For each run, the centrifugation records should identify the operator and confi rm that the centrifugation
process was performed according to specifi cations.
9.4.2.2 Separation
After centrifugation, the bag system should be carefully removed from the centrifuge and placed into a plasma expressor or blood separation
system. The different layers of the components red cells, platelets, plasma should be transferred to the satellite bags within the closed systems, in a
manner designed to optimize the harvest of the intended component while minimizing the carry-over of other component fractions.
Alternatively, blood components can be separated during collection by apheresis technology see section 9.3.2..
9.4.2.3 Freezing
Freezing is an important processing step that has an impact on quality, especially of plasma. The rate at which freezing proceeds and the core
temperature are both considered to be important parameters. Rapid plasma freezing prevents or reduces the loss of critical constituents such
as Factor VIII in frozen plasma that is either recovered or obtained by apheresis.
A system should be in place for ensuring that plasma is frozen to the specifi ed core temperature within the time limit, keeping in mind that the freezing
speed will be infl uenced by the type of plasma container, the freezing equipment and the loading pattern, as well as by the volume of plasma. The
validation of the freezing process should consider worst-case scenarios that take into account both minimum and maximum loads and positions in the
freezer. Recording the temperature of plasma units and the freezing time during a freezing process allows one to evaluate the freezing capacity of the
equipment and ensures a standardized freezing process. Validation studies should be available and should demonstrate that the temperature of a frozen
pack reaches the proposed storage temperature following the specifi cations. As indicated above, the aim is to achieve rapid freezing and thereafter to
minimize temperature changes to the frozen plasma.
Freezing of cellular components such as red cells or cellular therapy should follow a well defi ned, validated procedure that ensures the recovery
194
and viability of the intended cellular product during thawing and fi nal preparation steps.
9.4.2.4 Leukocyte reduction
Kategori