Cleaning and Packaging of Coated Orthopaedic Implants


Wednesday, April 12, 2023


02:00 PM Asia/Singapore

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Zakaria El Koura, PhD

Consultant, Lincotek Medical Wuxi
Former Coating and Packaging Manufacturing Engineer, Lincotek Medical Trento

Zakaria El Koura holds a PhD in Physics and has more than six years of experience in designing, validating and monitoring final cleaning and final packaging equipment and processes for orthopaedic implants. He has been actively engaged in the cleaning and packaging project of Lincotek Medical Wuxi since its inception. He helped defining the requirements and establishing the cleaning and packaging processes. He was also responsible for identifying the appropriate equipment and validating it according to both Chinese and international standards.


Orthopaedic implants play a critical role in improving the lives of patients with bone and joint issues. As the demand for these implants continues to rise, so does the need for proper cleaning and packaging procedures to ensure the safety and efficacy of these devices.

Cleaning of orthopaedic implants is an essential step to achieve their biocompatibility and control the microbiological load required for their sterilization process. It is crucial to use effective cleaning methods that do not impair the biocompatibility or performance of the implant. Cleaning validation is necessary to ensure the effectiveness of the cleaning process in reducing physical, chemical, and microbial contaminants. However, evaluating and validating cleaning methods can be challenging, requiring comprehensive knowledge of the manufacturing process and the potential contaminants.

On the other hand, packaging is used to preserve orthopaedic implants from contamination and damage during shipping, handling, and storage. Additionally, final packaging has the purpose of maintaining the sterility of the implant, serves as a means of identification and labelling, and ensures traceability from production to implantation. The packaging validation process involves testing the packaging system under conditions that simulate the actual shipping, handling, and storage conditions that the implant will be subjected to during its distribution and use. The packaging system is evaluated for its ability to protect the implant from damage, and prevent contamination under these conditions.


The webinar “Cleaning and Packaging of Coated Orthopaedic Implants” will focus on the challenges associated with cleaning and packaging of plasma spray-coated orthopaedic implants, as well as key considerations for complying with regulatory requirements and quality standards. Given that the regulatory landscape surrounding medical devices is complex and constantly evolving, staying updated with the latest standards and requirements is imperative. Following this, a general outline of the cleaning and packaging processes and equipment designed and utilized by Lincotek Medical will be presented.

The webinar will start with a comprehensive introduction to plasma spray coatings and their unique characteristics that pose challenges for cleaning and packaging processes. The discussion will encompass a comparison of coatings sprayed under diverse atmospheric conditions (vacuum or atmospheric pressure) and utilizing different materials (titanium or hydroxyapatite).

The presentation of the validation principles and monitoring strategy will elucidate how Lincotek Medical has fulfilled safety and regulatory requirements. In the final part of the seminar, Dr. Zakaria El Koura from Lincotek Medical will highlight some key considerations regarding the cleaning and packaging of challenging surfaces and substrates. For instance, the type of coating employed can impact the cleaning and packaging requirements, with some coatings necessitating more rigorous procedures than others. Similarly, the substrate material used can also influence the cleaning and packaging requirements, emphasizing the importance of tailoring the cleaning and packaging processes to the specific coating and substrate utilized. It is essential to take these factors into account to ensure that the cleaning and packaging procedures are effective in preserving the safety and efficacy of the orthopaedic implants.


  • Producers of orthopaedic implants

  • Medical professionals

  • R&D professionals / medical technicians

  • Orthopaedic products designers

  • Orthopaedic OEMS


Lincotek Medical is a global contract manufacturer providing full-service medical device development and manufacturing for Spine, Reconstruction, Sports Medicine & Trauma, and Extremities markets. With focus on innovation and speed to market, Lincotek Medical partners with orthopedic OEMs to deliver products that enhance quality of life and standard care for patients. It is a unique company with the ability to guide OEM customers through every step of the process, from ideation to high-volume production.

The Wuxi facility focus on the plasma spray coating, the validated process and equipment allows coating of titanium and hydroxyapatite to orthopaedic implants. We also provide cleaning and packaging services to reduce the microbial residues of the coating and prosthesis. Also, our CNAS certified testing centre can provide testing service on coating characteristics and materials. For more information, visit: www.lincotekmedical.com