Our Mission
To be the trusted partner for innovative calcium phosphate solutions.
Our Vision
Through our devotion to excellence and unstoppable passion for science, we will be the company of choice for cutting edge calcium phosphate solutions and services worldwide. We meet the highest quality standards at competitive prices enabling our customers to improve lives.
Our Core Values
Trust
Innovation
Excellence
Results
Company Profile
Our roots
The roots of CAM Bioceramics B.V. lie in 1985, when HC Implants B.V. and CAM Implants B.V. were established as a spin-off from the University of Leiden. In 1989, both HC and CAM Implants set up a quality system based on the American cGMP regulations and guidelines. In 1993, Osteotech Inc, an American producer of human allografts, acquired HC and CAM Implants and in 1994 gained the first ISO certification. Following a management buyout in 2002, HC and CAM fused to become CAM Implants B.V. becoming an independent, privately owned company. CAM Implants B.V. changed its name to CAM Bioceramics B.V. in 2008.
Pioneer
In the 1980s, CAM Bioceramics B.V. was the first company to provide innovative HA plasma-sprayed coatings on orthopedic implants. Since then, our pioneering work has led to the worldwide adoption of plasma- sprayed hydroxyapatite coatings. HA Coating was the first step in the formation of the fully-fledged organization CAM Bioceramics is today.
In-house R&D and manufacturing
As a dedicated contract development and manufacturing organization, CAM Bioceramics has set up robust processes to manufacture an extensive
portfolio of orthobiologic calcium phosphates. CAM Bioceramics is able to develop, manufacture and package orthobiologic calcium phosphate powders, granules, blocks and excipients. CAM Bioceramics delivers these components to many industry leaders in the orthopedic, dental and aesthetic sectors.
Robust ISO 13485:2016 compliance
Our entire team at CAM Bioceramics is committed to meeting and exceeding customers’ expectations. Our class-7 cleanrooms enable our experienced staff of engineering, production, and quality assurance & control specialists to produce to robust ISO 13485:2016 compliance, while maintaining a competitive pricing strategy.
Close to global hubs
Our offices and in-house production facilities are located in Leiden Bio Science Park, a leading life sciences cluster. Situated close to Amsterdam Schiphol Airport and other major European and global logistics hubs, we provide a highly reliable service to customers all over the world.
Quality
CAM Bioceramics understands the need for constant high quality. We have a track record in demonstrating our ability to provide calcium phosphates and related services that consistently meet customer needs and the regulatory requirements applicable to medical devices and related services. CAM Bioceramics has established, documented and implemented a quality management system, and maintains its effectiveness through this manual and the associated procedures.
The CAM Bioceramics quality management system is ISO certified:
ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes.
Processes
All of our materials are manufactured using raw materials that we synthesize in-house. With several different production methods available, we can offer a wide range of (custom-made) products. We have production methods for large volumes, as well as efficient processes in place for smaller quantities. From our satisfied customers, we know that we have a unique combination of knowledge, expertise and production capacity.
Our in-house production processes include:
- Spray drying
- Sintering
- Sieving/Classifying
- Milling
- High Shear Granulation
- Crushing
- High Pressure Compressing
Our approach of using in-house production of the raw materials allows us to control the output to the highest possible degree. All of the in-process and final controls you would expect are available:
- XRD, FTIR measurements on chemical composition
- Elemental analyses on impurities
- Laser diffraction, density measurements and SEM imaging for particle characterization
- Tensile strength testing for coating purposes
Our in-process controls guarantee that we comply with applicable standards (ISO 13485:2016, USP and Ph. Eur), and also assure that our batch-to-batch consistency is monitored.
To live up to our reputation, we develop powders and granules using production, rather than lab equipment. This enables us to safeguard process validation and production, without the need to address scaling up issues.
If you have developed an innovative calcium phosphate or similar material yourself, and are looking for an industrial partner to scale up, please contact us.
Partnerships
CAM Bioceramics is a preferred and long-term partner with industry leaders in the orthopedic, dental and biomedical industry.
Started as a university spin-off, CAM Bioceramics has always maintained a close partnership with universities. We are involved in many clinical and
relationship with world-class universities, opens up an impressive network of early innovations and leading-edge technologies. With different production methods available, we offer considerable flexibility to transform a revolutionary idea to upscale production, approved by regulatory bodies.
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