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 years ago about the potential for indirect contact by way of medical and dental devices made with animal by-products.
Mexichem Specialty Compounds customers began to seek assurances that our medical grade compounds were safe for patient contact, especially those products containing animal-derived components. After initial demand from overseas customers, Mexichem Specialty Compounds developed extrusion and moulding grade compounds that we designated with the “GBF” acronym. These products were free of all animal-based components and, therefore, not capable of transferring any prion proteins. As new applications arose, the “GBF” strategy was carried over into other medical products. These are now available for customers who want to eliminate any remote chances of spreading TSE to patients.
An overseas account was in the process of updating and enhancing their product portfolio and asked Mexichem Specialty Compounds to consider providing an extrusion grade compound that did not contain any animal-based components. This product was developed by our Regulated Products R&D team as the 2228GBF series of Medical PVC compounds. Third-party testing confirmed that the biological reactivity was consistent with our other medical grade compounds and suitable for consideration in medical device applications. As other customers came forward with new applications, we continued the conversion process to moulding compounds as well as products developed to comply with various restrictions on plasticizers, especially phthalates.
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.
For various disposable medical devices, it was important to consolidate product lines to reduce lead times, increase product homogeneity and better manage costs.
Requalifying medical products is an expensive and involved process; one that includes strict regulatory oversight. The costs alone are sometimes a deterrent to customers switching to alternative materials.
Where the applications demanded it, our formulations were reviewed, and any incidence of animal-based components identified. These then replaced with materials that were based on either petroleum feedstocks or vegetable sources and marketed as new product lines. For example, the 2228GBF PVC compounds series designed as a non-phthalate, sterilizable (gamma, ETO and other current methods), bovine-free and water blush resistant compound. 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 these variations.
The original customer bought the 2228GBF PVC compound, and when the selections expanded to other products, more customers began to buy these animal by-product free solutions. Mexichem Specialty Compounds now supplies a number of GBF type products that are available for a variety of medical, dental and food-contact applications. These products are available worldwide to customers who desire complete assurance against the spread of TSE in their medical/dental products portfolio.