Animal Byproduct-Free Solutions for Medical Devices
- Alphagary, an Orbia business
- May 30
- 2 min read
When several customers asked for assurance that medical grade compounds were safe for patient contact, especially those products containing animal-derived components, Alphagary set out to develop PVC compounds that did not contain any animal-based components.
After extensive lab development and third-party testing confirmation regarding biological reactivity (to be consistent with our other medical-grade compounds), Alphagary introduced a series of extrusion grade compounds designed with the “GBF” acronym.
Recognizing Mad Cow Disease / TSE
Transmissible Spongiform Encephalopathies (TSE) are a group of progressive diseases that affect various mammalian species, including humans. These diseases attack the brain and nervous system, leading to impaired brain function. Over time, this causes people to develop a variety of symptoms that worsen over time. The best-known of these diseases is BSE or 'Mad Cow Disease'. Research indicates that these diseases spread from infected animals by way of certain proteins known as “prions”. Contact with infected tissues is the most direct route for transmission, but concerns began to rise about the potential for indirect contact by way of medical and dental devices made with animal by-products.
Although agencies in the United States and Europe had provided evidence and regulatory documents confirming the safety of animal-based tallow against the spread of TSE when processed properly, some customers felt their marketing efforts were enhanced by providing complete assurance against the spread of TSE by eliminating animal-based components entirely.
Reformulating PVC Compounds to Address TSE
Where the applications demanded it, our formulations were reviewed, and any incidence of animal-based components identified. These ingredients were then replaced with materials based on either petroleum feedstocks or vegetable sources.
To help customers reduce the amount of testing required for requalification, biological reactivity testing was completed on representative products to show they were biocompatible. Also, to mitigate supply disruptions, as well as cost variability, R&D developed a simplified stabilizer system with components that are less susceptible to variations.
Alphagary continues to refine GBF designated products in-line with customer requirements. Materials are available for a variety of medical, dental and food-contact applications for those customers who desire complete assurance against the spread of TSE in their medical/dental products portfolio.
Please contact our technical sales team for more information or if you have any questions.
