Vox Sanguinis (2014) 107, 140–147 © 2014 International Society of Blood Transfusion DOI: 10.1111/vox.12140
ORIGINAL PAPER
Separation of centrifuged whole blood and pooled buffy coats using the new CompoMat G5: 3 years experience I. J. Bontekoe,1 P. F. van der Meer,1 G. Mast2 & D. de Korte1 1
Department of Product and Process Development, Amsterdam, the Netherlands Processing Department, Sanquin Blood Bank, Amsterdam, the Netherlands.
2
Background and Objectives Semi-automatic separation devices can be used for the separation of centrifuged whole blood into leucoreduced red cell concentrate (LR-RCC), plasma and buffy coat (BC) and to make platelet concentrates (PC) from pooled BCs. To improve and to obtain a more uniform and standardized process, the CompoMat G5 (Fresenius) was implemented, a new-generation semiautomated device. Materials and Methods Uniform programs for WB separation and preparation of PCs were validated, using collection and pooling systems with CompoFlow (CF) closures, which can be automatically opened by the G5. Cell counts were performed and compared with historic data of blood components obtained with the formerly used Compomat G4 and Optipress II. After implementation, different adjustments were made to improve product quality. Results Leucoreduced red cell concentrates (280 – 15 ml, 53 – 5 g haemoglobin) and plasma (317 – 16 ml) met European guidelines. BCs (48 – 2 ml, 042 – 005 l/l, 93 – 25 9 109 platelets) contained a similar platelet (PLT) content as BC prepared before with the Compomat G4. A relatively high percentage (4–6%) of PCs (330 – 17 ml, 330 – 50 9 109 PLT, 012 – 021 9 106 leucocytes) contained 50 9 109/l (data not shown). In routine, QC data confirmed that the number of plasma units with a high level of contamination with platelets (>50 9 109/l) was increased, compared with the Compomat G4s before, on average 7 vs. 2%. Although the number of plasma units that fulfilled the requirement was above the limit of 90%, this was considered an undesirable situation. Changing the order or speed of the presses did not reduce the number of plasma units with too many platelets. The ‘problem’ was solved by changing from the two-step to the one-step centrifugation run, the latter characterized by a higher accumulated centrifugal effect. Results of a full comparison with n = 16 WB are shown in Table 1. Using the one-step run, PLT counts in plasma were significantly lower, but higher in the RCC before filtration. PLT numbers in the BC were comparable. QC data of 2012 of products from all 80 CompoMat G5 devices in use showed similar results (Table 1). Comparison of discarded components due to operation errors in the year before and after implementation resulted in a decrease in discarded RCC (058 vs. 028%; 771 vs. 365 units for production site 1) and BC (037 vs. 016%; 503 vs. 207 units for production site 1) and a slight increase in the discard rate of plasma (012 vs. 018%; 156 vs. 234 units for production site 1), the latter not related to G5 operation (see Discussion).
144 I. J. Bontekoe et al.
Requirement or target value Whole blood Volume, ml Red cell concentrate Volume, ml Haematocrit, l/l Leucocytes, 9109 Platelets, 9109/l Leucoreduced RCC Volume, ml Haematocrit, l/l Haemoglobin, g Leucocytes, 9106 Platelets, 9109/l Buffy coat Volume, ml Haematocrit, l/l Platelets, 9109 Plasma Volume, ml Leucocytes, 9106/l Platelets, 9109/l
520–620
2-step spin 1 G5, n = 16 WB
561 – 3
1-step spin QC data 2012 80 G5, n = 8597 WB
1-step spin 1 G5 n = 16 WB
563 – 2
Table 1. Composition of whole-blood components prepared with CompoMat G5 after two-step or one-step hard spin (mean – SD)
NA
304 063 099 26
– – – –
18 001 057 12
306 063 166 44
– – – –
16 002 056a 20a
>245 050–065 >40 225
ORIGINAL PAPER
Separation of centrifuged whole blood and pooled buffy coats using the new CompoMat G5: 3 years experience I. J. Bontekoe,1 P. F. van der Meer,1 G. Mast2 & D. de Korte1 1
Department of Product and Process Development, Amsterdam, the Netherlands Processing Department, Sanquin Blood Bank, Amsterdam, the Netherlands.
2
Background and Objectives Semi-automatic separation devices can be used for the separation of centrifuged whole blood into leucoreduced red cell concentrate (LR-RCC), plasma and buffy coat (BC) and to make platelet concentrates (PC) from pooled BCs. To improve and to obtain a more uniform and standardized process, the CompoMat G5 (Fresenius) was implemented, a new-generation semiautomated device. Materials and Methods Uniform programs for WB separation and preparation of PCs were validated, using collection and pooling systems with CompoFlow (CF) closures, which can be automatically opened by the G5. Cell counts were performed and compared with historic data of blood components obtained with the formerly used Compomat G4 and Optipress II. After implementation, different adjustments were made to improve product quality. Results Leucoreduced red cell concentrates (280 – 15 ml, 53 – 5 g haemoglobin) and plasma (317 – 16 ml) met European guidelines. BCs (48 – 2 ml, 042 – 005 l/l, 93 – 25 9 109 platelets) contained a similar platelet (PLT) content as BC prepared before with the Compomat G4. A relatively high percentage (4–6%) of PCs (330 – 17 ml, 330 – 50 9 109 PLT, 012 – 021 9 106 leucocytes) contained 50 9 109/l (data not shown). In routine, QC data confirmed that the number of plasma units with a high level of contamination with platelets (>50 9 109/l) was increased, compared with the Compomat G4s before, on average 7 vs. 2%. Although the number of plasma units that fulfilled the requirement was above the limit of 90%, this was considered an undesirable situation. Changing the order or speed of the presses did not reduce the number of plasma units with too many platelets. The ‘problem’ was solved by changing from the two-step to the one-step centrifugation run, the latter characterized by a higher accumulated centrifugal effect. Results of a full comparison with n = 16 WB are shown in Table 1. Using the one-step run, PLT counts in plasma were significantly lower, but higher in the RCC before filtration. PLT numbers in the BC were comparable. QC data of 2012 of products from all 80 CompoMat G5 devices in use showed similar results (Table 1). Comparison of discarded components due to operation errors in the year before and after implementation resulted in a decrease in discarded RCC (058 vs. 028%; 771 vs. 365 units for production site 1) and BC (037 vs. 016%; 503 vs. 207 units for production site 1) and a slight increase in the discard rate of plasma (012 vs. 018%; 156 vs. 234 units for production site 1), the latter not related to G5 operation (see Discussion).
144 I. J. Bontekoe et al.
Requirement or target value Whole blood Volume, ml Red cell concentrate Volume, ml Haematocrit, l/l Leucocytes, 9109 Platelets, 9109/l Leucoreduced RCC Volume, ml Haematocrit, l/l Haemoglobin, g Leucocytes, 9106 Platelets, 9109/l Buffy coat Volume, ml Haematocrit, l/l Platelets, 9109 Plasma Volume, ml Leucocytes, 9106/l Platelets, 9109/l
520–620
2-step spin 1 G5, n = 16 WB
561 – 3
1-step spin QC data 2012 80 G5, n = 8597 WB
1-step spin 1 G5 n = 16 WB
563 – 2
Table 1. Composition of whole-blood components prepared with CompoMat G5 after two-step or one-step hard spin (mean – SD)
NA
304 063 099 26
– – – –
18 001 057 12
306 063 166 44
– – – –
16 002 056a 20a
>245 050–065 >40 225
