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.
FOCUS OF THIS VIRTUAL EVENT
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.
WHO WILL BENEFIT FROM THIS WEBINAR
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Producers of orthopaedic implants
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Medical professionals
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R&D professionals / medical technicians
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Orthopaedic products designers
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Orthopaedic OEMS
ABOUT LINCOTEK MEDICAL
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
REGISTRATION TO THIS EVENT IS FREE OF CHARGE