One partner for everything: KH Medical
The single-use endoscope project demonstrates the process steps that KH Medical implements for its customers worldwide—with more already in the pipeline.
A medical product, complete from a single partner – worldwide. KH Medical has established itself as a contract manufacturer in the medical sector. This means: From the development and production of plastic components, to the procurement of purchased parts, the assembly in clean rooms, and diverse testing procedures, right through to the packaging; customers can obtain everything from a single source, on request. For several years now, KH has been manufacturing single-use endoscopes, providing a well-illustrated process. The entire process was developed in Helmbrechts and is put to use at the KH sites in Helmbrechts and Chodov/Czechia.
Depending on the variant, up to twelve different plastic components (several of them 2C) are produced in the medical injection molding shop using KH tools. Together with the 15 purchased parts, they are ready for assembly (also in the clean room, class 7 & 8), which is a real challenge. The most sophisticated endoscope variant has a shaft measuring approximately 680 millimeters in total and is less than three millimeters in diameter. Other variants are used in ENT or anesthesia. In some variants, there is an additional lever which opens a valve for the suctioning of fluid.
At the end of the manufacturing process, all endoscopes undergo a 100% end-of-line test. They are then placed in blister packs and Tyvek bags, sealed with a certified sealing device, and marked with specially approved labels. DHR documentation (= Device History Record) ensures complete traceability for each batch. Finally, the endoscopes are packed in outer cartons and stacked on pallets, ready for transport to the sterilization facility – and on to the customer’s sales warehouse.
