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Questions & Answers:Semi-Automated Visual Inspection
半自动目视检查的问答
In a webinar onsemi-automated visual inspection of parenteralia many basic questionsregarding visual inspection and alsospecific questions with regard to semi-automated inspection were asked and answered.
在关注射剂半自动目视检查的网络研讨会中，询问了许多有关目视检查和半自动检查的问题。
Q: Our productis a non-transparent oil emulsion in 250 ml and 500 ml bags. Is asemi-automated inspection with cameras conceivable?
问：我们的产品是250毫升和500毫升袋装不透明油乳液。使用摄像头进行半自动检查是否可行？
A: Another method for particle detection should be used. The visualinspection of such a 500 ml bag is almost impossible. To ensure that the bag is free of particles another method like filtration should be used.
答：应使用另一种颗粒检查方法。此种500 毫升袋的目视检查几乎是不可能的。为了确保袋子没有颗粒，应采用另一种方法，如过滤。
Q: A questionregarding the qualification of a new production line. How to proceed if youhave neither a qualified system nor qualified staff? Both types of qualification need each other.
问：关于新生产线的确认问题。如果既没有已确认的系统，也没有已确认的员工，如何进行？这两种类型的确认都需要。
A: Qualified employees for manual control must be available. Using them, theprocess of semi-automated visual inspection can be qualified. It is the same ifa fully automated system is to be qualified.
答：必须具备可人工操作的已确认的员工。可使用它们进行半自动目视检查的确认。如果要进行全自动系统的确认，也是同理。
Q: Regardingthe design of a semi-automated machine: Are colors other than black and whiteallowed? As in manual testing. Would grey be better? Is a white backgroundenough?
问：关于半自动设备的设计：是否允许使用黑白以外的颜色？与人工检测一样。灰色会更好吗？仅白色背景足够吗？
A: Black is the best color here. Once in terms of light reflections andoperator fatigue. Grey would also work. In Annex I, there is no specificrequirement for the background colour of a semi-automated system.
A：黑色是最好的颜色。考虑光的反射和操作人员的疲劳度。灰色也可以。GMP附录1没有对半自动系统的背景颜色的要求。
Q: What isrequired for the certification of operators and how can eye breaks / inspectiontimes be documented?
问：操作人员的确认需要什么，如何记录休息/检查的时间？
A: Operators should have an ophthalmologic certificate (80% normal vision) anda qualification that proves that they can sort out the required defects. Pausetimes / inspection times should be recorded using log on / log off of theoperator; manually by hand or automated.
答：操作人员应拥有眼科证明（80% 的正常视力）并证明自己能够发现所要求缺陷的资质。应使用操作员上机/下机记录休息/检查时间；人工或自动记录。
Q: What is anoptimal illumination level (in lux) for the inspection of plastic containers insemi-automated systems? And is there a type of illumination you prefer?
问：在半自动化系统中检查塑料容器的最佳光照水平（以勒克斯表示）是多少？建议使用哪种类型的光照？
A: Higher illuminance levels than glass, but it is up to you to determine thebest illumination for this. Definitely higher than 37500 lux. LED lighting maybe preferred.
答：应使用比玻璃容器更高的照度，但也要根据你的情况确定最佳照明。当然肯定高于 37500 lux 。可以首选 LED 照明。
Q: Should thesmallest particle sizes determined by a Knapp study be systematically includedin the test kits for qualification?
问：由Knapp 试验确定的最小颗粒尺寸是否应系统地包含在确认测试套件中？
A: Yes.
答：是的。
Q: What is youropinion / experience of using polarized lenses in a semi-automated system?
问：在半自动系统中使用偏振镜片您有何看法/经验？
A: Not good. The naked human eye is best and this is what is expected.
答：不好。肉眼是最好的，这也是所要求的。
Q: Is thatcorrect that the visual inspection in front of black and whitebackground on a fully automated system should not exceed 2 seconds?
问：在全自动系统上过黑白背景目视检查的实际不应超过 2 秒，这是否正确？
A: No. The speed of the semi-automated conveyor belt should not be too fast.The maximum speed should mathematically be no less than 2 seconds per object inthe inspection area for the operator.
答：不正确。半自动传送带的速度不应太快。每个物品在操作员的检查区域的实际应不小于 2 秒。
Q: Are thereany special requirements for semi-automated inspection for Japan?
问：日本对半自动检查有什么特殊要求吗？
A: No. Make sure to sort out all particles and cosmetic defects when youdeliver to Japan.
答：没有。出口日本市场时，应区分所有颗粒和外观缺陷。
Q: For acomparative semi-automated versus manual inspection study, do the test kitsizes have to be the same?
问：对于半自动与人工灯检对比研究，测试套件的大小必须相同吗？
A: Yes.
答：是的。
Q: Is thatcorrect that after a 100% semi-automated inspection is completed, a manualinspection based on ISO 2859-1 should be performed?
问：在完成 100% 半自动检查后，应执行基于 ISO 2859-1 的人工检查，这是否正确？
A: Yes, i.e. sampling based on ISO 2859-1 and manual testing of the samples.The size of the AQL sampling depends on the batch size. Inspection Level IIshould be used.
答：是的，也就是，基于ISO 2859-1的抽样和人工检查。AQL 抽样的大小取决于批量大小。应使用检查级别 II。
Q: How oftenshould manual inspection operators be qualified (note: requalified)?
问：人工检查的操作员应多久进行一次确认（注：再确认）？
A: At least once a year.
答：至少每年。
Q: The settingsof the semi-automated system (illumination, rotation speed, etc.) should beselected in such a way that a sufficient inspection process is guaranteedwithout adversely affecting the physico-chemical properties of the product. Howdo you ensure this during qualification?
问：半自动系统的设置（照明、电机转速等）的选择应保证足够的检测过程，而不会对产品的物理化学性能产生不利影响。在确认期间，如何确保这一点？
A: For this purpose, you need to perform a stability study, e.g. with thevalidation batches, and show that your inspection process has no influence onthe product quality.
答：为此，需要执行稳定性研究，例如使用验证批次，并证明检查过程对产品质量没有影响。
Q: Do you havespecial experience with different inspection angles in semi-automated systemswhen testing liquids or lyophilized products.
问：在测试液体或冻干产品时，你是否具有在半自动系统中使用不同检查角度的特殊经验。
A: Through the lens of the semi-automated machine, the inspection angle shouldnot influence the inspection. The lens should be placed so that the operatorcan see the complete unit. For lyophilized products, the only difference isthat the inspection time for the operator should be shortened because visualinspection of the white powder will cause eye fatigue more quickly.
答：通过半自动机器的镜头，检查角度不应影响检测。镜头应放置以使操作人员可以看到整个的产品。对于冻干产品，唯一的区别是，操作人员的检查时长应缩短，因为对白色粉末进行目视检查会更快地导致眼睛疲劳。
文章来源：GMP办公室
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