About Us

Since 1988, we have been at the forefront of HA technologies and have supported clinical trials and researchers by optimising our manufacturing and particle engineering for leading performance. Our novel processes and stringent quality control ensure high phase purity (≥ 95%) and high crystallinity (generally ≥ 90%) in our powder products. PBL’s proprietary HA coating technique preserves the HA lattice, giving us class-leading crystallinity ratios of ~ 85 % in our coatings, which have extensive in-market clinical history as a feature of our customers’ orthopaedic devices.

With over 30 years of experience, Plasma Biotal now has a wide portfolio of bespoke calcium phosphate-based medical materials and solutions. We operate an ISO 13485 approved quality system to ensure we consistently supply quality products according to customer and regulatory requirements. Committed to supporting our customers’ journey from development to market, we help them pioneer better products and healthcare solutions.

Experience & Expertise

We have over 30 years’ experience in the production of calcium phosphate biomaterials and coatings for medical use. Through our experience with the material and our work with academic research we have developed an intricate understanding of how calcium phosphates behave in the body, and how physical and chemical characteristics of the material can be engineered to control its functionality.

A background in scientific research & development

Plasma Biotal has always been a company that values research and development of new medical devices, working closely with researchers since its inception, supporting over 1,300 studies* to date. We offer bespoke solutions by controlling key material characteristics, including particle size, morphology, density, and phase composition. These variables influence properties such as degradation rate, cell attachment, and osteogenic potential, making our materials highly adaptable to diverse research needs.

At Plasma Biotal we pride ourselves on our flexibility, supporting innovation in the medical industry wherever possible; our technical team is well versed in the materials science of calcium phosphates, and will work with you to understand the individual needs of your product, and work to develop a specialised solution.

Through our emphasis on supporting innovative applications of biomaterials, we have been fortunate to contribute to exciting studies, such as RJ Morrison et al., Sci Transl Med 7 (2015)†. This ground-breaking research on bespoke medical devices led to the development of a 4D biodegradable implant—a 3D-printed device that grows with the patient—successfully reinforcing the airways of infant patients with respiratory disorders.

* – Figure based on systematic search of Google Scholar
† – Morrison RJ, Hollister SJ, Niedner MF, et al. Mitigation of tracheobronchomalacia with 3D-printed personalized medical devices in pediatric patients. Sci Transl Med. 2015;7(285):285ra64. doi:10.1126/scitranslmed.3010825

How we started

Formed in April 1991 as a joint venture between Plasma Coatings Ltd and Processing & Chemicals Consultancy Services (PACCS Ltd), Plasma Biotal combined aerospace precision-coating technology with expertise in industrial hydroxyapatite synthesis.

Company Timeline

Pre 1989
PCL & PACCS Pioneer HA Coating Technology Combining aerospace coating expertise from Plasma Coatings Ltd. (PCL) with hydroxyapatite manufacturing experience from PACCS.
1991
Plasma Biotal Ltd. (PBL) Incorporated Following successful preliminary clinical trials, PBL was established as a hydroxyapatite coatings supplier.
Unit 1 Opens in Tideswell PBL breaks ground with the opening of its first manufacturing facility in Tideswell.
First commercially coated device PBL begins coating femoral components for total hip replacements (THR).
1992
PBL manufactures its own CAPTAL hydroxyapatite Completion of chemical plant in Tideswell, enabling in-house production of hydroxyapatite feedstock for medical device coatings.
1996
PBL achieves ISO 9001 Certification Formal medical device regulation was introduced in 1994 in the UK, PBL sought ISO 9001 approval to demonstrate commitment to quality assurance and device traceability before it was mandated in 2002.
1997
PBL Manufactures CAPTAL Beta-Tricalcium Phosphate (β-TCP)
Technological advancements at the chemical plant enable PBL to supply resorbable biomaterials to researchers.
2004
PBL Achieves ISO 13485 Certification Following 2002 regulation improvements, PBL achieved ISO 13485 accreditation, standards. recognising that the company’s QMS meets the rigorous requirements of the medical device industry.
2005
PBL BIOTAL Coating FDA Masterfile Submitted The submission of an FDA Masterfile allows PBL to be recognised as a responsible supplier and supports the sale of PBL-coated devices in the US market.
2017
Plasma Biotal India Ltd. (PBIL) opens – bringing Biotal coatings to India Built as a joint venture between PBL and Biorad Medisys Pvt Ltd, supplying the same high-quality coatings locally to the Asian market.
2019
Fully automated HA spray system installed in PBIL An automated spray arm is installed, enhancing PBL India’s production capacity.
2021
Buxton factory receives ISO 13485 site approval for calcium phosphate powder manufacture PBL’s second UK manufacturing site is completed and operational.
2022
CAPTAL HA / TCP powders FDA Masterfile submitted The submission and acceptance of an FDA Masterfile supported the use of PBL calcium phosphate biomaterials in the U.S. market.
2024
PBL Buxton at Full Production Capacity The new site, featuring a chemical plant, laboratory, powder production facilities, offices, and solar panels, is fully operational, tripling holding capacity and doubling production capacity.

Environmental

Based in the heart of the Peak District national park, it is important we work to minimise our environmental impact. Our location is unique for its high-calcium limestone-rich geology and proximity to the local quarrying industry, which supplies us high purity raw materials, reducing HGV emissions. In addition, our new manufacturing facility is equipped with a solar PV installation, reducing our reliance on unsustainable energy sources in our manufacturing to provide 30 % of our annual demand.

ISO 13485 Certification / FDA Masterfile Submission

Quality control is a central part of Plasma Biotal Ltd. As critical suppliers to the medical industry we operate an ISO 13485 certified quality management system, and we are dedicated to continuous improvement to our products to support the health of end users. We have submitted an FDA Masterfile for our coatings and calcium phosphate products and are specialists in the latest technical standards governing our section of the medical industry.