Outsourcing services in the Medical Surface Center

As a service provider for the surface treatment and cleaning of medical products, we meet your expectations of an outsourcing partner with our experience, reliability and expertise. In the Medical Surface Center, we offer premium-quality ultrasonic cleaning and surface treatment of your products as an outsourced service complete with the associated validation documentation. Our aim is to endow your products with the perfect surface. We ensure maximum customer focus and flexibility as part of our outsourcing services. The Medical Surface Center has the flexibility that, in urgent cases, parts supplied in the morning can be processed and returned on the very same day.

The automatic process controls of the cleaning systems as well as chemical and electrochemical process systems guarantee that surface treatment processes are reproducible and that the quality of treated products is consistent. All systems and manual workstations are equipped with stand-alone control systems, which combined form a validated system with a superordinate control system. The control system manages the recipes, checks employee authorizations and carries out tamper-proof archiving of all order data. The direct connection of the sealed final cleaning system to a cleanroom of cleanroom class ISO 8 (the location of final inspection, packaging and laser marking) ensures that the applicable cleanliness criteria as per ISO 19227 for implants and instruments are guaranteed. It goes without saying that ongoing employee training and education, a seamless process control system (monitoring), monitoring of measuring and test equipment as well as a universal and certified quality management system as per EN ISO 13485 are all part and parcel of the KKS Medical Surface Center.

Our range of services is tailored specifically to customers from the medical technology sector with demanding needs. At the customer’s request, we can carry out customer-specific process validations and create the corresponding documentation for the required proof. We can provide professional, comprehensive and reliable support thanks to our many years of experience in relation to customer-specific regulatory requirements and standards in the medical technology sector, our knowledge of planning and implementing process validations for our own production environment in the Medical Surface Center and the wide range of process validations that we have performed.

We have standard validations for the most common surface treatment processes in the medical industry. These have been carried out on a worst-case test piece defined by KKS. If our standard validation is applicable for our customer’s products, the surface treatment of the product can be carried out without a customer-specific process validation. The available validation reports can be used to form an integral part of a medical product file / technical documentation. This saves the customer valuable time and money because it eliminates the need for customer-specific validation.

When it comes to surface treatment, our customers place stringent requirements on the cleanliness of their products. In order to satisfy these, our Medical Surface Center offers final inspection, packaging and laser marking after final cleaning in the cleanroom of cleanroom class ISO 8. All products that have undergone final cleaning are funneled through the automatic final cleaning system and into the cleanroom as part of a fully automatic process, guaranteeing the cleanliness of medical products at all times. Our internal cleanliness acceptance criteria are defined on the basis of ISO 19227.