为“关键”牙科和医疗产品提供全面的清洁解决方案

清洁在医疗设备制造中增加了价值

Products for use in dentistry and human medicine must meet the most exacting cleanliness standards – e.g.在美国，被列为“关键”的仪器在使用时必须消毒. In order to supply such items in an already sterilized state as an additional customer benefit, 制粒. 布莱塞尔 GmbH invested in a new cleaning and packaging facility that even includes a cleanroom. 大约12,000 different parts undergo in-process and final cleaning in an array of Ecoclean solvent-based cleaning systems and aqueous-type ultrasonic ultra-fine cleaning systems made by UCM AG.

Komet商标起源于1923年, when the 布莱塞尔 brothers founded the factory for dental drills bearing their name. 通过创新, 精密、高品质, the company has evolved into a globally active manufacturer of medical instruments and equipment. Apart from instruments and systems for use in dentistry and dental technology, 布莱塞尔 GmbH & Co. KG's product portfolio also comprises rotary instruments for ENT and neurosurgery, 关节镜下的剃须刀片, 和骨科手术项目如锯片, 导针, 空心螺钉和金属丝. 此外, 作为合同制造商, Komet makes customer-specific products for use in dental implantology as well as high-precision parts for diverse other branches of industry.

可靠符合最严格的清洁标准

尽管其产品在大约100个国家销售, 该公司在Lemgo工厂进行所有的开发和制造, 依赖于超过1,000名员工，约1,000生产单位. “为了进一步改善我们的客户服务, 我们投资了一个新的包装概念和一个约250平方英尺的洁净室.m. 去年. This will enable us to produce up to 10 million instruments in sterile packaging for dental and medical uses each year. 在这种情况下，我们的部分清洁操作也必须全面改进。”, Helge Neitzel报道, 制粒磨具制造主管. 布莱塞尔.

Accordingly, high demands were placed on the new in-process and pre-packaging cleaning equipment. 除了清洁, the specification called for high throughput and availability rates as well as for a flawless  technical documentation. 考虑到零部件和材料的多样性，该公司大约生产12种,000种不同的由碳化物金属合金制成的物品, 不锈钢和其他钢材, ceramics and titanium – it was necessary to provide several solvent-based cleaning systems to perform cleaning between the individual process steps. “这使我们能够隔离物料流，因此, 防止交叉污染。”, 马库斯·贝克尔解释道, 制粒清洁技术组组长. 布莱塞尔. Final product cleaning and the cleaning cycle ahead of product packaging in the cleanroom are performed with ultrasonic ultra-fine cleaning equipment using aqueous media. The company also thought it important to source both system types from the same manufacturer.

清洁试验和设备技术使天平倾斜

寻求有关合格设备制造商的信息, 项目经理们环视了零部件清洁交易会. 制粒. 布莱塞尔随后与六家制造商进行了清洁测试. In the end the company opted for Ecoclean GmbH's solvent-based EcoCbase P2 and Compact 70P cleaning systems. Both models use modified alcohol which removes both polar and non-polar contaminants from the product. 清洗和干燥操作在真空下进行, 所以不需要额外的防爆装置. 当涉及到用于超细清洗的多室系统时, 客户选择了瑞士UCM AG公司提出的解决方案, 一个生态清洁集团公司. “对我们来说，重要的是整体方案——收到的建议, 清洗试验结果, 设备设计与工艺, 业务网络, 还有性价比. Their offering matched our expectations exactly", Helge Neitzel justifies his company's decision.

可重复、快速、高效的溶剂型清洗

Following diverse processing steps such as machining, grinding and coating, approx. 95万个零件每天分两班通过溶剂型清洗工序. 每个控制单元可存储8个清洗程序, 可根据清洗步骤通过条形码选择.

为了可靠地去除各种污染物- e.g., 加工油, 油脂或磨料残渣, 芯片, particles and chemicals from the galvanizing process – the systems possess two flooding tanks each for the pre-cleaning and main cleaning/degreasing operations. Additional steam degreasing features and ultrasound units ensure that the level of cleanliness required for the next downstream operation will be achieved reproducibly and efficiently. “所有这些都是在短治疗周期内完成的. 这一方面是由于高真空功率. 另一方面, the work chamber is filled very quickly thanks to the powerful pumps and large-diameter piping. 事实上, this is a point on which the Ecoclean systems distinguished themselves from competition", Marcus Becker补充道.

Effective reconditioning of the solvent through continuous distillation plus full-flow and bypass filtration likewise contribute to the high cleaning quality. Some filters are equipped with magnetic inserts which improve the retention of metal 芯片.

最后的清洁与直接转移到洁净室

在超声多室系统中用于超细清洗, 布莱塞尔 was particularly impressed by the four-sided overflow feature developed by UCM, 所有的坦克都用哪一种. 在每个水箱里, 清洗液或漂洗液从下面引入, 向上移动, 然后从四周的边缘流出. 因此，异物和颗粒立即从罐中排出. This ensures an intense cleaning treatment of the product while also preventing re-contamination when the parts are lifted out of the bath.

“我们在其他制造商的产品上没有发现这个功能. 我们喜欢UCM系统的另一个细节是所谓的药物托盘. 由于它们的特殊设计, they prevent disease agents from accumulating and settling in the trays from where they might then contaminate the parts to be cleaned,马库斯·贝克尔解释道. The quality of the cleaning and rinsing baths is permanently monitored by sensors, 即使在超精细的清洗过程中.

In order to ensure that the segregation of materials achieved at the in-process cleaning level via the use of multiple cleaning lines will be maintained in final cleaning as well, 第一清洗阶段包括三个槽. 然后是冲洗过程, 另一个清洁步骤, and three rinsing steps of which the last two are carried out with de-mineralized water. 防止热风干燥过程中对零件的再污染, 烘干机配有高效微粒空气过滤器.

“包装前清洁”系统实际上是相同的. Here, the first cleaning step is carried out in a tray, irrespective of product material. 除了HEPA过滤器, 层流箱安装在最后一个漂洗阶段和烘干机上方. 此外, the cleaning system and its conveyor unit are fully enclosed to ensure the cleanliness of all products entering the cleanroom.

对于他们的中间和最后的清洗过程，制粒. 布莱塞尔在每种情况下使用16种清洁程序. Programs are selected via a bar code on the product routing documents, which is read by a scanner. “我们一次最多可以订十二份订单. The control software checks automatically if all parts are to be cleaned by the same program. 如果不是这样的话, 发出警报信号，进程无法启动。”, Marcus Becker解释道.

设备确认，工艺开发和验证

除了一种溶剂型体系, 所有新的清洁设备都符合欧盟和美国食品药品监督管理局(FDA)的要求.S. Food and Drug Administration) rules and the cleaning processes were validated accordingly. “Ecoclean和UCM与我们合作执行了必要的DQ, IQ和OQ鉴定步骤，并准备必要的文件. 他们还帮助我们开发了各种清洁流程. Actually, the new equipment provides us with cleaning capabilities which exceed our current needs. We consider this an investment in the future, just like the new packaging solution and the cleanroom. 这些都有助于我们进一步扩大我们的市场地位，”Helge Neitzel总结道.  

作者:Doris Schulz