ABSTRACT
【Objective】 To compare the effectiveness of the old mode of blood isolation and batch release (the old mode) and the new mode in Chengdu, so as to provide basis for optimizing working strategy. 【Methods】 1) The blood testing report was released one by one in the old mode but released uniformly in accordance with the blood batches classified by blood storage and supply department in the new mode. 2) In the old mode, apheresis platelet samples were detected by serological testing first and nucleic acid testing(NAT) later, and whole blood samples were reasonably arranged according to blood inventory and detection workload. In the new mode, platelets samples collected within our center headquarters were detected by serological test and NAT simultaneously, while those collected outside the center complied with the old strategy. As for whole blood, the same batch samples classified by blood storage and supply department should be arranged to the detection line with the fewest samples.3) The turnaround time(TAT) in the laboratory (referred to as sample TAT) and the TAT in the blood to-detect stock (referred to as blood TAT) in two phases(year 2016 vs 2018, pre- and post- the new mode), involving 164 748 and 179 488 blood samples, were compared by SPSS25.0 software. The constituent ratio of the TATs were compared with Chi-square test, and the difference of blood TAT between old and new mode were compared with Mann-Whitney U test. 【Results】 1) Significant difference was noticed in constituent ratio of TATs between old and new mode (P<0.05). 2)The blood TATof apheresis platelets using the new mode was 0.95(QR: 0.22)days, with the median 0.20 days shorter than that the old mode.. The blood TAT of whole blood in the new mode was 3.77 (QR: 1.99) days, with the median 0.90 days shorter than that in the old mode, and the difference was statistically significant (P<0.05). 【Conclusion】 Compared with the old mode, the new mode showed the following advantages: 1) It can realize the unified issuing of testing reports of blood with the same batch, contribute to the early discovery of errors that occurred during blood donation process, and located the errors wihin intra-batches for investigation. 2) It can advance the issuing of blood testing reports of the same batch. 3) It can make the flow of samples and blood with the same batch between different departments more standardized and orderly, and optimize the process of blood sorting thus shortening blood TAT. 4) It can realize the counting and checking of samples, within the same batch, at different states, so as to minimize the error issuing of unqualified blood and to-detect blood, and is more conducive to ensure the quality, safety and timely supply of blood.
ABSTRACT
Objective: To establish the batch release criteria of Gardenia jasminoides intermediate purification process based on statistical process control technology in order to ensure the batch-to-batch consistency and stability. Methods: Forty-eight batches of G. jasminoides intermediate purified solution were collected as the calibration set. The content of chlorogenic acid, shanzhiside, geniposidic acid, deacetyl asperulosidic acid methyl ester, genipin-1-β-D-gentiobioside, geniposide, and total acid were determined to establish the quantitative release criteria. Near-infrared spectra (NIRS) were acquired to establish the qualitative release criteria. Seventeen batches of G. jasminoides intermediate purified solution were prepared under different process conditions by the Box-Behnken experimental design. They were regarded as the validation set to verify the feasibility of the established quantitative and qualitative release criteria. Results: The established quantitative release ranges were: chlorogenic acid 5.753-6.713 mg/g, shanzhiside 9.456-10.723 mg/g, geniposidic acid 3.313-4.401 mg/g, deacetyl asperulosidic acid methyl ester 15.260-16.419 mg/g, genipin-1-β-D-gentiobioside 30.529-33.473 mg/g, geniposide 165.17-175.16 mg/g, and total acid 45.028-53.118 mg/g, respectively. The established qualitative release upper limits were: Hotelling T2 = 4.067 8 and DModX = 1.218 8. For sample 1, 5, 7, 9, 10, 14-17 from the validation set, the content of quality control indicators satisfied the quantitative release criteria and NIRS satisfied the qualitative release criteria. Conclusion: Based on NIRS and statistical process control technology, the developed quantitative and qualitative release criteria are simple and feasible. They could be used for the production quality control of G. jasminoides intermediate purification process.