Quality

Our policy commitment is to achieve total customer satisfaction and to meet or exceed the agreed requirements of our customers to all legal and legislative standards. As a fundamental part of our business we have been accredited to ISO 13485 since 1996 and our quality team ensure that our operations are controlled to give the full traceability and conformance we demand for our products and our customers.

Click on the following link for our current ISO 13485 accreditation certificate : PBL ISO 13485 Certificate 2024-2026 (Multi-Site)

Product Packaging

We supply all our powder products in secure, tamper-evident packaging, accommodating a range of order sizes. Whether you require a single kilogram for laboratory use or multiple tonnes for industrial-scale operations, we prioritise customers of all sizes. For larger orders, we also offer packaging in tamper-proof buckets.

Our materials remain shelf-stable when stored in cool, dry conditions. Any quoted expiry date pertains to the packaging rather than the material itself.

Material Testing Services

Plasma Biotal conducts characterisation and testing services to ensure our material is certified for medical use. Through a combination of in-house and independent external testing with approved laboratories we evidence that our calcium phosphates and coatings meet or exceed requirements for use in medical devices according to applicable standards (ISO, ASTM, USP).  

We can generate a complete technical report with a full in-depth expert analysis to further characterise calcium phosphate biomaterials or ceramic coatings on medical devices if required.

Upon request, our experienced team can perform or arrange the following analytical techniques, please contact us through the enquiry form to discuss pricing:

 

 

Composition Testing	Powder Properties	Coating Properties	Qualitative Analysis
Phase Analysis – XRD	Particle Size Distribution : Malvern Mastersizer 3000	Tensile & Shear Testing to ISO 13779-2 / ASTM F1044	Optical Microscopy & Automated image analysis
Ca:P Ratio : XRF	Bulk and Tapped Density : USP <616>	Hardness Testing	Morphology: SEM
Trace elements : ICP-MS/AES	Specific Surface Area: BET Testing N2 / Kr	Dissolution Testing : ASTM F1926	FTIR
	Powder Flow Testing: Angle of repose / Carr Index / Hausner Ratio	Metallographic sectioning: Coating morphology, porosity and substrate coating interface analysis	Bioburden
	Surface Roughness Analysis
	Loss On Drying / Calcination Loss
	Gas Pycnometery
	True Density Testing
	Solubility Product Ksp (ISO 13779-6 A.8)
	pH & Buffering Capacity