Process validation for the medical technology industry

Process validation provides proof of suitability, which demonstrates that the process system used in combination with the product to be processed actually delivers the expected results. As per EN ISO 13485 and ISO 9001, processes must be validated – provided that the result cannot be verified by subsequent monitoring or measurement. The concept of validation can be interpreted differently. For instance, “validation” is often used as a generic term that covers both the qualification of systems/equipment and the validation of processes. At KKS, we use the term process validation to refer to the performance qualification of processes.

Every day in the KKS Medical Surface Center, we use validated processes for the surface treatment and final cleaning of medical products.

Take advantage of our experience in process validations!

• Reproducible and reliable processes thanks to KKS worst-case standard validation of processes and methods
• Proven experience of KKS as a developer and outsourcing provider of surface treatment processes and as a systems manufacturer
• State-of-the-art and end-to-end qualified production systems
• Universal and validated data management and production control system for seamless and tamper-proof traceability
• Implementation of customer-specific process validations

The goal of each process or method validation is to provide proof that the combination of all subprocesses and infrastructure systems consistently delivers a predefined result, as per the defined framework conditions regarding the manufacturing process of a product or product group within the considered limits and acceptance criteria.

We have validated the most commonly used surfaces processes in the Medical Surface Center with defined worst-case reference parts. If your products are covered by a validation of this kind, you may dispense with customer-specific validations when outsourcing surface treatment and final cleaning services. It is up to you to decide if the KKS worst-case product meets your specific requirements. We would be happy to support you in making this decision.

In our Medical Surface Center, we can carry out validations on your behalf that are tailored to your processes and products. Since our process systems are qualified and we have the required expertise in house, validation activities are performed within a relatively short time, extremely efficiently and expertly. The necessary analyses within the context of process validations are carried out in independent, accredited laboratories.

Validation at KKS Ultraschall AG is performed as per the following V model:

In a typical validation cycle, several batches are handled on different weekdays, at different times, in different shifts and by different employees. The specific details must be defined in the validation plan (VP). For customer-specific validations, KKS uses KKS templates to create the complete validation documentation for the customer. This includes the following documents:

If all requirements are met during performance qualification, the process is deemed validated with the release of the validation report and approved for regular production. The validated processes are checked with each change and undergo periodic review. If revalidation is found to be necessary, this will be initiated and carried out. Revalidation may also be required due to a change (liquid agent surface treatment, equipment relocation, audit, etc.).