A comprehensive cleaning solution for „critical“ dental and medical products

Cleanliness adds value in medical equipment manufacturing

用于牙科和人类医学的产品必须符合最严格的清洁标准- e.g., instruments classified as "critical" have to be sterile whenever they are used. 为了在已经灭菌的状态下提供这些物品作为额外的客户利益，制粒. 布莱塞尔 GmbH投资了一个新的清洁和包装设备，甚至包括一个无尘室. 大约12,000个不同的部件在过程中和最终的清洗在一系列Ecoclean溶剂型清洗系统和水型超声波超细清洗系统由UCM AG制造.

The Komet trademark has its origin in 1923, 当时布拉塞勒兄弟创立了以他们名字命名的牙钻工厂. Through innovation, precision and high quality, 该公司已发展成为全球活跃的医疗器械和设备制造商. 布莱塞尔 GmbH是一家专门从事牙科和牙科技术领域的仪器和系统的公司 & Co. KG的产品组合还包括耳鼻喉科和神经外科的旋转器械, arthroscopic shaver blades, and orthopedic surgery items such as saw blades, guide pins, cannulated screws and wires. 此外, as a contract manufacturer, Komet为客户提供用于牙科种植的特定产品，以及用于各种其他行业分支的高精度零件.

Reliable compliance with strictest cleanliness standards

Although its products are marketed in around 100 countries, the company conducts all development and manufacturing at its Lemgo site, relying on over 1,000 employees and around 1,000 production units. „In order to further improve our customer service, we invested in a new packaging concept and a cleanroom of around 250 sq.m. 去年. 这将使我们每年能够生产多达1 000万件无菌包装的牙科和医疗器械. Our part cleaning operations had to be fully revamped as well in this context“, reports Helge Neitzel, Head of Abrasive Instrument Manufacturing at 制粒. 布莱塞尔.

因此，对新的过程中和包装前清洁设备提出了很高的要求. Apart from cleanliness, 该规范要求高吞吐量和可用性以及完美的技术文档. Given the diversity of parts and materials – the company produces around 12,000 different items made of carbide metal alloys, stainless-grade and other steels, 陶瓷和钛-有必要提供几种溶剂型清洗系统来执行各个工艺步骤之间的清洗. „This allows us to segregate the material flows and hence, to prevent cross-contaminations“, explains Marcus Becker, Cleaning Technology Group Leader at 制粒. 布莱塞尔. 最终产品的清洗和产品包装前的清洗周期在洁净室中使用超声波超细清洗设备进行. 该公司还认为从同一制造商采购两种系统类型非常重要.

Cleaning trials and equipment technology tipped the scales

In quest of information relating to eligible equipment manufacturers, the project managers looked around at the parts2clean trade fair. 制粒. 布莱塞尔 then performed cleaning tests with six manufacturers. 最终，该公司选择了Ecoclean公司的溶剂型EcoCbase P2和Compact 70P清洁系统. 两种型号都使用改性酒精，从产品中去除极性和非极性污染物. Cleaning and drying operations are performed under vacuum, so no additional explosion protection is necessary. When it came to the multi-chamber systems for ultra-fine cleaning, the customer chose the solution proposed by the Swiss UCM AG, a Ecoclean group company. „What mattered to us was the overall package – the advice received, the cleaning test results, equipment design and technology, the service network, and the price/performance ratio. 他们的产品完全符合我们的期望”，Helge Neitzel为公司的决定辩护.

Reproducible, fast and efficient solvent-based cleaning

按照不同的加工步骤，如加工，磨削和涂层，大约. 950,000 parts pass the solvent-based cleaning processes in two shifts every day. The control units can store eight cleaning programs each, selectable via a bar code depending on the cleaning step.

For reliable removal of the various contaminants – e.g., machining oil, grease or abrasive residue, 芯片, 来自镀锌过程的颗粒和化学物质-该系统拥有两个浸水箱，每个用于预清洗和主清洗/脱脂操作. 额外的蒸汽脱脂功能和超声波装置确保了下一个下游操作所需的清洁度将被重复和有效地实现. „And all this is performed in short treatment cycles. This is due, on the one hand, to the high vacuum power. On the other hand, 由于强大的泵和大直径的管道，工作室很快就充满了. 事实上, 这是生态清洁系统从竞争中脱颖而出的一点。”, Marcus Becker adds.

通过连续蒸馏加上全流和旁路过滤，有效地对溶剂进行再处理，同样有助于提高清洁质量. 有些过滤器配备了磁性插入物，以提高金属屑的保留率.

Final cleaning with direct transfer into the cleanroom

Among ultrasound-based multichamber systems for ultra-fine cleaning, 布莱塞尔对UCM开发的四面溢出功能印象特别深刻, which is used on all tanks. In every tank, the cleaning or rinsing fluid is introduced from below, moves upwards, and then flows out over the rim on all sides. Foreign matter and particles are thus discharged from the tank without delay. 这确保了对产品的强烈清洁处理，同时也防止了零件从浴槽中取出时的再污染.

„We found this feature on no other manufacturer's product. A further detail we liked about UCM's system are the so-called medicinal trays. Due to their special design, 它们可以防止病原体在托盘中积聚和沉淀，从而污染待清洁的部件," Marcus Becker explains. 清洗和冲洗槽的质量由传感器永久监测, even on ultra-fine cleaning processes.

为了确保在过程中通过使用多条清洗线实现物料的分离，在最终清洗中也将保持分离, the first cleaning stage comprises three tanks. These are followed by a rinse process, another cleaning step, 三个清洗步骤，最后两个步骤用去矿化水进行. To prevent any re-contamination of the parts in the hot-air drying process, the dryers are equipped with HEPA filters.

The 'pre-packaging cleaning' system is virtually identical. 在这里，无论产品材料如何，第一步清洗都是在托盘中进行的. In addition to the HEPA filters, laminar flow boxes are fitted above the last rinsing stage and the dryers. 此外, 清洗系统及其输送单元是全封闭的，以确保所有进入洁净室的产品的清洁度.

For their intermediate and final cleaning processes, 制粒. 布莱塞尔 work with 16 cleaning programs in each case. 程序是通过产品路线文件上的条形码选择的，该条形码由扫描仪读取. „We can combine up to twelve orders in one batch. 控制软件自动检查是否所有部件都要用同一程序清洗. If this is not the case, an alarm signal is issued and the process cannot be started", Marcus Becker explains.

Equipment qualification, process development and validation

Except for one solvent-based system, all new cleaning equipment was qualified in compliance with EU and FDA (U.S. 食品药品监督管理局(fda)的规定和相应的清洁过程进行了验证. „Ecoclean and UCM cooperated with us in carrying out the necessary DQ, IQ and OQ qualification steps and in preparing the requisite documentation. They also helped us develop the diverse cleaning processes. 实际上，新设备为我们提供的清洁能力超出了我们目前的需求. 我们认为这是对未来的投资，就像新的包装解决方案和洁净室一样. It all helps us to further expand our market position," Helge Neitzel concludes.  

Author: Doris Schulz