Zhongguo shuxue zazhi (Jan 2022)

Establishment and verification of the tightness inspection method of blood products

  • Xiaojie ZHAO,
  • Yali WANG,
  • Yunfei ZHAO,
  • Qiming ZHANG,
  • Mingxiang SONG,
  • Lingli GUO,
  • Zi DOU,
  • Jipeng ZHANG,
  • Xiao LIU

DOI
https://doi.org/10.13303/j.cjbt.issn.1004-549x.2022.01.025
Journal volume & issue
Vol. 35, no. 1
pp. 89 – 92

Abstract

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Objective To establish and verify the vacuum decay method for the tightness inspection of blood products. Methods The method for inspecting the tightness of blood product was established, and the detection limit, linearity, range, accuracy, precision and durability were verified according to the requirements of methodological verification.The validated method was used to check the tightness of blood product packaging. Results The detection limit of this method was 2.5 μm, linear correlation coefficient was r=1, the differential pressure of positive sample was within the allowable range of accuracy, and the durability met the requirements.The RSD of results of 6 repeatability tests and 12 intermediate precision tests were both less than 10%, and all validation items met the verification standards. Conclusion Vacuum decay method can be used to check the tightness of blood products.

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