关于USP<790>注射剂可见异物的检查的疑问

xukai

想请教下各位老师，根据USP<790>的要求，如何制定可见异物的标准？
根据取样要求“ Sample and inspect the batch using ANSI/ASQ Z1.4 or ISO 2859-1). General Inspection Level II, single sampling plans for normal inspection with an AQL of 0.65%.按ANSI/ASQ Z1.4或ISO 2859-1一般检查水平Ⅱ进行取样和检查，AQL为0.65%”，此处算是明确了可接受限度，但是根据“Inspected units must be free from visible particulates when examined without magnification (except for optical correction as may be required to establish normal vision) against a black background and against a white background.在黑色背景和白色背景前检查，不做任何放大（除非是为了达到正常视力所进行的视力矫正），检测单位不得发现可见颗粒物”，这里是说无可见异物。感觉前后说法不一，质量标准该怎么定呢？



以下是原文：
                                                    Inspection Procedure
    Used along with 100% inspection during the manufacturing process, this procedure is sufficient to demonstrate that the batch is essentially free of visible particulates. A complete program for the control and monitoring of particulate matter remains an essential prerequisite.
    Inspected units must be free from visible particulates when examined without magnification (except for optical correction as may be required to establish normal vision) against a black background and against a white background. Illumination at the inspection point is maintained at a minimum intensity between 2000 and 3750 lux. This can be achieved through the use of two 13-W or 15-W fluorescent lamps (e.g., F13/T5 or F15/T8). The use of a high-frequency ballast to reduce flicker from the
fluorescent lamps is recommended. Alternative light sources (e.g., incandescent, LED) that provide illumination at the point of inspection within the specified minimum intensity range are acceptable. Higher illumination intensity is recommended for examination of colored solutions or product in containers other than clear glass.
    Before performing the inspection, remove any adherent labels from the container, and wash and dry the outside. The unit under inspection should be gently swirled and/or inverted, ensuring that no air bubbles are produced, and inspected for approximately 5 s against each of the backgrounds. The presence of any particles should be recorded.
                                      Sampling at Batch Release (Following 100% Manufacturing Inspection)
    Sample and inspect the batch using ANSI/ASQ Z1.4 or ISO 2859-1). General Inspection Level II, single sampling plans for normal inspection with an AQL of 0.65%. Alternative sampling plans with equivalent or better protection are acceptable. Not more than the specified number of units contains visible particulates.

丁之章

你的理解有误，注意一下后面那个particulate的意思

冰儿

看英文头发晕，看不懂

autocarc2

丁之章 发表于 2016-3-26 09:10
你的理解有误，注意一下后面那个particulate的意思

能否详细解释下。

wsx

前一段讲的是生产过程的灯检标准是没有可见颗粒，后一段是指按照ISO的抽检要求，符合AQL 0.65的界限范围，不是没有。两个标准是针对不同的检查阶段。