Another important milestone in the cooperation between Luye Pharma Group Ltd. and HEUFT Systems Technology (Shanghai) Co. Ltd: the fully equipped HEUFTspotter II PHS vial inspector which can currently be seen live at the CPhI Worldwide in Frankfurt and at the CIPM China passed the Site Acceptance Test (SAT) at the Luye location in Nanjing last week. It thus fulfils all the requirements to ensure full drug safety there.
绿叶制药集团有限公司与海富检测包装系统技术（上海）有限公司双方合作的另一个重要里程碑：目前正在法兰克福CPhI世界制药展和中国国际制药机械博览会（CIPM China)现场展示的HEUFT spotter II PHS 西林瓶检测设备上周在南京绿叶工厂顺利通过了现场验收测试（SAT）。该设备实现了所有的检测要求，确保了药品的全面安全性。

After the successful preliminary Factory Acceptance Test (FAT) at the HEUFT production facilty in Burgbrohl, Germany, the straight-through inspection system has also proved its detection and rejection reliability where it will soon actually be in demand: directly in the new clean room packaging plant of one of the leading Chinese pharmaceutical manufacturers. Under real production conditions 1,000 20 ml vials each filled with lyophilized cancer preparations were sent into the compact HEUFT spotter II PHS in three test runs in order to check whether it is able to detect and remove each one of them which does not fulfil the specific safety and quality criteria of Luye Nanjing. And in fact: with a full 100 per cent accuracy – the 100 injection containers with typical faults were reliably detected in all three test runs and consistently rejected.
自设备在HEUFT德国布格布罗尔（Burgbrohl）成功通过工厂验收测试（FAT）后, 该直线式检测系统再次证明了其精确的检测性和剔除的可靠性，该设备将被安装在一个中国领先的制药公司的全新洁净的包装车间内。在实际生产中，采用1000个装有抗癌冻干制剂的20毫升西林瓶，在设计精简的HEUFT spotter II PHS 重复运行三次，验证该设备是否能够检测出不符合南京绿叶相关安全质量标准的所有西林瓶并且能否将不合格西林瓶全部剔除。事实上：得益于其100%的检测精度—该设备在三次测试中均可以可靠地检测出100个具有代表性缺陷的西林瓶并可以将不合格品一一剔除。

This applies in particular to a function specially adapted on site which detects the slight colour change of the sensitive lyophilisate occurring under the influence of oxygen. Shrunken lyo cakes, foreign matter above the product, cracks in the side wall and defective, leaking flanged caps were also reliably identified in all cases during the optical all-around inspection. And the unique pulsed HEUFT X-ray technology even made the smallest glass splinters visible in the freeze-dried medicine during the SAT in Nanjing.
根据现场实际要求，该设备开发了一个特殊的检测功能，检测出因氧气原因导致制品微微变色的不合格产品。冻干粉饼的萎缩、产品上的异物、侧壁上的裂纹以及轧盖不良的泄漏等都能够通过光学视觉进行全方位检测、准确可靠的识别。在南京SAT测试中，HEUFT独特的脉冲X射线检测技术甚至检测出冻干药品内部微小的玻璃碎。

Convincing detection accuracy
有说服力的检测精度

The acceptance also resulted in convincing values with regard to the false rejection rate: the proportion of good containers incorrectly rejected was less than four percent, a large proportion of them due to minor, non-critical deviations which were detected during the flanged cap inspection. However these can also be specifically taught in as good with the integrated HEUFT reflexx² image processing technology which should further reduce the false rejection rate in the future.
在验收测试中，该设备在误剔除的表现也是相当有说服力的。合格品的误剔除率小于4%以下。大部分剔除是由于轧盖检测中较小的、非关键的误差。利用综合的HEUFTreflexx²图像处理技术也可以通过自动寻找参数功能特定将其设置为合格容器，从而在未来能进一步降低误剔除率。

The SAT thus delivered really excellent results at Luye Nanjing which were subsequently celebrated with a drink.
此项现场验收测试SAT在南京绿叶着实取得了非常优异的表现，测试双方随后一起举杯庆祝验收顺利通过完成。