大型輸注液微粒子之汙染

PARTICULATE CONTAMINATION IN LARGE VOLUME PARENTERAL SOLUTIONS

大型輸注液微粒子汙染因素非常複雜，其因各藥廠之製造環境、設備、軟體管理、處方等不同而顯現極大之差異，本文擬就微粒子污染源、種類、臨床上之意義、檢測方法之比較、各國藥典對大型輸注液粒子污染之規定等予以探討。醫療行為上輸液套不潔引起之微粒子污染亦加討論。

Particulate matter in large volume parenteral solutions (LVP) is a complex subject. It may be generated in sterile packaging operations at any point in the packaging process, from the packaging material to the final packaging operations. This article contains a general review of the progress made in assessing particles in injectables, a discussion of the nature and sources of particulate contamination including packaging material, manufacturing variables, formulation components, the sets and devices used in administration, the manipulation involving medical staff, and miscellaneous factors. The pathological hazards and clinical significance of such contamination is described. In addition, the current pharmacopoeia limit test for particulate contamination in LVP is presented. Finally, a variety of official instrumental methods for the determination of particulate matter in LVP, including microescopic, electrical zonesensing, light blockage techniques. Each of these particle counting methods is discussed.