Cleanliness of Orthopedic Implants

The purpose of cleaning validation is to verify the effectiveness of the cleaning process in reducing physical, chemical and microbial contaminants below a defined level. Cleaning validation studies are carried out according to the ISO 19227 standard.

Evaluating and validating cleaning methods is a challenging task, requiring extensive knowledge of the manufacturing process of orthopedic implants to identify potential contaminants and potential interactions between the cleaning process, implant materials and the environment.

Before starting the cleaning process validation studies, risk assessment studies are carried out and protocols are prepared and submitted for customer approval. Pollutants and cleaning agents used throughout the production process are evaluated separately.

You can contact us for cleaning process validation studies.