Clinical Pharmacy, Meander Medical Centre, Amersfoort, Utrecht, Netherlands
Department of Clinical Pharmacy, Meander Medical Centre, Amersfoort, Utrecht, Netherlands.
Eur J Hosp Pharm. 2024 Aug 22;31(5):447-449. doi: 10.1136/ejhpharm-2022-003633.
Parenteral drug products should be essentially free from visible particulate contamination. To ensure this, every batch produced must be subject to a 100% visual inspection. Monograph 2.9.20 of the European Pharmacopoeia (Ph. Eur.) describes a method for visual inspection of parenteral drug units in front of a black and white panel using a white light source. Nevertheless, several Dutch compounding pharmacies rely on an alternative method for visual inspection by means of polarised light. The objective of this study was to compare the performance of both methods.
Trained technicians in three different hospitals inspected a predetermined set of samples using both methods for visual inspection of parenteral drugs.
The results of this study show that the alternative method for visual inspection yields a higher recovery than the Ph. Eur. method, while no significant difference in false positive results was found.
Based on these findings, it can be concluded that the alternative method for visual inspection by means of polarised light can very well replace the Ph. Eur. method in pharmacy practice, provided that local validation of the alternative method is performed.
注射剂产品应基本无可见微粒污染。为此，每批产品都必须进行 100%的目视检查。欧洲药典（Ph. Eur.）2.9.20 专论描述了一种在黑白面板前使用白光光源对注射用单位进行目视检查的方法。然而，一些荷兰制剂药房依靠偏振光的替代目视检查方法。本研究的目的是比较这两种方法的性能。
在三家不同的医院，经过培训的技术人员使用这两种方法对预定的一组样品进行了注射用药物的目视检查。
本研究结果表明，替代的目视检查方法比 Ph. Eur. 方法的回收率更高，而假阳性结果没有显著差异。
基于这些发现，可以得出结论，只要对替代方法进行了局部验证，那么通过偏振光进行替代目视检查的方法完全可以替代 Ph. Eur. 方法在药学实践中的应用。
