CaP is a supplier of calcium phosphate raw materials for bone grafting/healing applications. Our products are not finished medical devices; they are materials that are intended to be incorporated into medical devices by our customers.
Help choosing the right calcium phosphate
Many device manufacturers know what they are expecting from incorporating a calcium phosphate into a device but do not understand the intricacies of calcium phosphate properties and how they affect the suitability of a given material for a given application. CaP can help to explain how calcium phosphates may function in a given application and can act as a partner in developing a product specification. CaP can also assist in identifying the most economical solution to a problem when there are several functionally correct possibilities.
Calcium phosphates compromise a wide variety of materials and physical forms, and generally only experts in the field have a complete understanding of the possibilities. Therefore, whilst CaP has some standard products, most materials are customised for each application. Possible modifications include:
- physical form – powders, porous granulates, solid monoliths
- crystallinity – materials can be highly crystalline, totally amorphous or somewhere inbetween
- phase purity – materials can be pure or a combination of different phases
- surface area – surface areas can range from a few square metres/gram up to several hundred square metres/gram
- porosity – materials can be porous or nonporous, and can have a variety of pore sizes distributed between macro and micro porosity.
Manufacturing capability
CaP can manufacture virtually any calcium phosphate that may be desired. This is partly because CaP has a wide variety of equipment suitable for carrying out any relevant process and partly because CaP has many years of experience in producing all types of calcium phosphates. Much of the production equipment is available in multiple units of different sizes so the process can be scaled to the order size. Orders of a few hundred grams up to hundreds of kilograms can be efficiently accommodated.
Testing capabilities
CaP has extensive in-house QC testing capabilities to ensure that quality is maintained. It also carries out procedures that are difficult to find at commercial laboratories such as dissolution and solubility testing. Testing services are available to customers who want help with developing a calcium phosphate-based product. In some cases testing services can also be provided to non-customers but this is not the norm.
Quality system
As mentioned above, CaP is certified to ISO 9001-2015. This ensures full traceability of all production steps for all products. As part of the development process for new processes/products, CaP carries out formal process validations. These validation reports and all production records are available for customer audits.
About CaP
The founders of CaP have many years of experience in bone grafting materials including allograft bone and demineralized allograft bone as well as calcium phosphates. This background is helpful in advising customers on how calcium phosphates can be applied to their products.
CaP Biomaterials, which was founded in 2006, is located in East Troy, WI which is about 35 miles from Milwaukee WI and 85 miles from Chicago, IL. This is near the geographic center of the US orthopedic device industry.
