Programme: - Introduction How to define logistics of bloodprocessing Priority of components

1. Programme: • - Introduction • How to define logistics of bloodprocessing • Priority of components • Influence of regulations • Influence of staff related regulations • Influence of platelets production • Example of optimised logistics • TSF separation and bloodbank logistics

2. Define priority of bloodcomponents • Optimalisation of blood components: • Production of ALL components in MOST excellent quality is NOT possible, define priority: • Plasma; quick separation, fast freezing to optimise quality. Freezing < 3 hr after separation • Platelets, storage for 4 – 24 hours, optimal recovery of platelets, high quality. • This choice of most important component together with method of preparation defines basic algoritms of processing, find acceptable consensus for all components.

3. Influencing the logistics of blood processing External regulations: - Fractionater; max. delay of freezing 3 hr - GMP; different staf for different departments Internal influences: - Organisational priorities; lab and processing - waste costs; - work during late evening/night; personal costs

4. Parameters effecting logistics: method of preparation and choice of bag system. • Different Reduction in Lymphocyte and Granulocyte content by removal of BC from fresh and O/N stored blood. (Z.Rácz, Hungary 1997) • Results of separation: Manual (Q), Separator 1 =TACE(Q) and Separator 2=OPTIPRESS) were compaired with these variabels: • Fresh blood and stored (O/N) • Different sizes of BC taken • Distribution of Lymphocytes/Granulocytes were investigated.

5. Top and Bottom separation: • Simultanious transfer of Plasma and Red Cells. • Buffycoat is NOT transferred • Hard spin for maximal Plasma recovery, up to 4700g for 15 minutes.

6. Conventional Quadruple bag: • Removal of plasma and BC from top of primairy bag. • Transfer of SAGM through same tube. • Quality of components influenced by storage of blood • Platelet production with pooled Single BC or single Dilted BC

7. Results of the study: • Stored blood gives better removal of leukocytes with equal volume of BC removed. • 20-30 ml BC: Fresh Stored • Manual Q: 45% 70% • Auto Q: 60% 78% • Auto TAB: 71% 82%

8. Platelet production Platelet production from whole blood: Triple bag conventional: Platelet Rich Plasma, to be separated by an additional spin in PC and PPP. Quadruple bag conventional: A: Diluted buffy coat to be separated by additional spin in PC and a waste residual BC. B: 4 – 6 single buffycoats to be pooled together with a plasma (or additive solution), to produce a pooled random platelet concentrate. Buffycoats to be pooled within 24 HOURS

9. Basic Processing procedures Platelet production from whole blood: Quadruple TAB bag : Diluted buffycoat to be separated by additional spin in PC and a waste BC. Better results as quadruple Dil BC Triple TAB bag: Single buffy coat to be pooled together with 4-6 and a plasma (PAS etc), to produce a pooled random platelet concentrate. Buffycoats to be pooled within 24 HOURS

10. Basic Processing procedures PERFORMANCE OF SEPARATION TAB CONV Q Triple PRP Plasma recovery +++ ++ - L-reduction RCC +++ ++/+ - Platelet recovery +++ ++ + Separation time 2 – 7 min 2 – 3 min 2 Spin Syphonage effect yes no no Disposable cost +++ ++ +

11. QUALITY OF DIFFERENT COMPONENTS

12. Optimal separation logistics in Rotterdam (NL). • Collection of blood: every day from 09:00 untill 21:00. The collected blood is stored O/N in a incubator of 22°C. • Test samples of blood are tested during the night from 00:00 untill 07:00. • Test results are used to release the collected blood before the processing starts at 08:00. • Unsafe blood is processed separate of safe blood. • Pooling of Buffycoats is always done with safe products, no waste of pools due to positive test results.

13. Alternative for platelet production: Terumo Saving Platelet filter 3 leukodepleted products RBC, PLASMA, PLTS in 1 LGF version: results in small “BC” Some recent tests done:

14. CONFIDENTIAL Results of TSF: Elverum; Norway (5000 col year) Pool of 4, with T-SOL (BC 24hr old) Buffycoat: weight is 62-65 gr netto. Redcell loss: 20- 22 ml in BC. Diluted BC 10 ml plasma. Pool: Volume of 514- 520 ML, HcT= 21 – 23 % (recovery of pooling: 97%) Results: Pooled 6 pools, Plt recovery: 294 – 356 x 109 unit Recovery of second separation: 75 – 93% of pool

15. CONFIDENTIAL Results of TSF: • Maribor, Slovenia: 9 – 13 May 2005. • Pool of 5 BC with PLASMA • Buffycoat: weight is 62-65 gr netto. Redcell loss: 20- 22 ml in BC. Diluted BC 10 ml plasma. • Pooled buffycoats of different ages: • Overnight stored • Two days stored (aggitated) • Three and four days stored (aggitated)

16. CONFIDENTIAL Results of TSF: Maribor, Slovenia: 9 – 13 May 2005. Fresh pooled: (O/N): 240 – 380 Day 2: 342 and 348 Day 3: 332 and 93 (cherry coloured BC’s!!) Day 4: still under investigation. Recovery of pooling: 99% Recovery of sec separation: 75% (1950 rpm 4 m 30 sec) 91- 94 % (1300 rpm for 7 min, acc 8, brake 1)

17. New posibility for TSF saving Platelets Small centres, willing to pool BC, allowing them to have prestorage filtering conditions with pooling untill day 3 (or more) to optimise the logistics of the platelets.