ABSTRACT
【Objective】 To establish a management information system (referred to as the system) for plasma collection stations in Zhejiang province, so as to explore the current situation of plasma donors and implement effective supervision in Zhejiang. 【Methods】 The system was developed and connected to four plasma collection stations that were officially operating in Zhejiang in terms of plasma station setting and approval, as well as the publicity, recruitment and management of plasma donors, information management of the whole process of plasma collection, management of deferral plasma donors, plasma quality management and administrative supervision etc. Relevant plasma donor information was uploaded to the system by each plasma station, and information before (January 2016 to December 2020) and after (January 8, 2021 to June 2021) the system was collected. Information included the number of plasma donors/donations, demographic information of eligible plasma donors in the past 5 years, the type of plasma donors, and the deferral donors after the system was activated. The online approval of Plasma Donation Certificate and the intelligent supervision of key points of plasma apheresis stations in Zhejiang were also conducted. The frequency and composition ratio were described, and chi-square test was used for statistical analysis. 【Results】 The system (V1.0) was established and was officially launched on January 8, 2021, realizing the interconnection of blood donation and plasma donation information as well as the unified management of 24 quality indicators. Since the system was applied (January 8, 2021-June 2021), the proportion of donors both donated blood and plasma over the province was 3.56 (832/23 389), and 352 deferred donors were masked by the system. And 30.11% (106/352) , who intended to donate plasma, were deferred due to insufficient interval after blood donation; 11.65% (41/352) due to permanent masking in blood donations; 23.86% (23.86%) , who intended to donate blood, were deferred due to insufficient interval after plasma donation ( 84/352); 34.38% (121/352) due to permanent masking in plasma donations. The median approval rate of four plasma stations applying for Plasma Donation Certificate before the system (January 1, 2016 to January 7, 2021) and after the system (January 8 to June 2021) were 93.38% (10 609/11 361) vs 99.50% (2 602/2 615). Before the system was put into launch, the ratio of male to female donors and the proportion of regular donors showed an overall upward trend, while the age decreased slightly. The median proportion of women in the past 5 years was 61.52 %, significantly higher than that in last 6 months after the launch(58.86%). 【Conclusion】 The application of the system can realize information interconnection between blood centers and plasma collection stations in Zhejiang as well as the real-time supervision of plasma collection process, which is helpful to overcome the shortcomings in plasma donor management.
ABSTRACT
【Objective】 To investigate the changing pattern of polymer content in the manufacturing process of human immunoglobulin, especially the correlation between pH value and polymer content, so as to provide basis for the control of polymer in human immunoglobulin products. 【Methods】 IVIG and HBIG low pH intermediate samples were taken and their pH values were adjusted to different gradients with 0.5 or 0.1 mol/L HCl. The polymer content was detected by HPLC, and the influence of different pH values on polymer content was observed and analyzed. 【Results】 With low pH value, the polymer content of samples increased from <1% to 10% with the decrease of pH value. When pH value was in the range of 3.85~3.10, the polymer content in the samples increased from 0.38% to 15.5% exponentially with the decrease of pH value. The logarithm of polymer was linearly correlated with pH value. 【Conclusion】 When pH value is low, polymer content of human immunoglobulin is significantly affected by pH value. Keeping pH value above 4.0 during the whole manufacturing process of human immunoglobulin is suggested.