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Does the component wrapping affect subvisual particle counts in aseptic dispensing?

机译:成分包装是否会影响无菌分配中的亚目视颗粒计数?

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摘要

Good manufacturing practice (GMP) requires that environmental subvisual particle (SVP) levels are monitored and kept to a minimum during pharmaceutical production, SVPs can present a risk to the finished product and patient safety. It is important to assess all aspects of the production process to ensure that SVP counts are maintained within recommended levels. The objective of the study is to investigate the wrapping of syringes and needles used in aseptic processing and determine whether there is a difference in the number of particles generated by paper compared to plastic wrapping.
机译:良好生产规范(GMP)要求在药品生产过程中监控环境亚视觉颗粒(SVP)的水平并将其保持在最低水平,SVP会对成品和患者安全构成风险。重要的是评估生产过程的各个方面,以确保SVP数量保持在建议的水平内。该研究的目的是研究无菌处理中使用的注射器和针头的包装,并确定与塑料包装相比,纸上产生的颗粒数量是否存在差异。

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