CASE STUDIES
PVC compound solutions for medical and dental products free from animal-derived ingredients
Transmissible Spongiform Encephalopathy (TSE) is a group of progressive diseases that affect various mammal species, including humans. These diseases attack the brain and nervous system, causing their function to deteriorate. Over time, the symptoms worsen progressively.
The most well-known of these diseases is Bovine Spongiform Encephalopathy (BSE), commonly known as mad cow disease. Research suggests that these diseases are transmitted through infected animals via proteins called “prions.”
The most direct route of transmission is contact with infected tissues. However, a few years ago, concerns began to arise that these diseases could potentially be contracted through indirect contact with medical and dental devices made from animal-derived by-products.
Problem
Alphagary Compounds’ customers requested that our medical compounds provide assurance of safety for patients, especially in products that previously contained animal-derived ingredients. Shortly after receiving this request, at Alphagary Compounds we focused on developing extrusion and molding compounds known as “GBF” (Gamma stable Bovine Free).
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Application
One of our international clients was in the process of updating and improving their product portfolio and turned to Alphagary Compounds in search of an extrusion compound that contained no animal-derived ingredients. With this in mind, our Research and Development department for Regulated Products developed the 2228GBF series of medical PVC compounds.
Por otro lado, un laboratorio externo confirmó que la reactividad biológica de nuestros compuestos era consistente con otros ingredientes utilizados en la industria médica, por lo que era viable utilizarlos en productos clínicos. A partir de entonces hemos recibido propuestas de otros clientes para desarrollar nuevas aplicaciones, por lo que hemos continuado con el proceso de crear compuestos con el fin de cumplir con las regulaciones de los plastificantes, especialmente de los ftalatos.
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Challenges
Although several U.S. and European agencies have provided evidence confirming that products developed with animal-derived ingredients are safe when properly processed, some clients believe their sales improved by completely eliminating the possibility of disease transmission caused by contact with animal-derived proteins.
Por lo tanto, para varios dispositivos médicos desechables, fue necesario consolidar las líneas de producción para evitar retrasos en las entregas, aumentar la homogeneidad del compuesto y mejorar la gestión de los costos.
La recalificación de productos médicos es un proceso costoso y complicado, que incluye una supervisión normativa estricta. Los costos por sí solos son a veces un obstáculo para que los clientes hagan el cambio a materiales alternativos.
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Solution
When required by specific applications, our formulations were reviewed and any trace of animal-derived ingredients was identified. These were subsequently replaced with raw materials derived from petroleum or plants, and commercialized as new product lines. For example, the 2228GBF series was designed to deliver a phthalate-free PVC compound that is sterilizable (via gamma rays, ethylene oxide, and other currently used methods), free from bovine-derived ingredients, and water-resistant.
Para ayudar a los clientes a reducir la cantidad de pruebas requeridas para la recalificación, se llevaron a cabo análisis de reactividad biológica en algunos productos representativos para demostrar que eran bio-compatibles. Además, para mitigar las interrupciones de suministro, así como la variabilidad de costos, el departamento de Investigación y Desarrollo creó un sistema estabilizador simplificado con componentes que son menos susceptibles a estas variaciones.
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Results
The initial customer purchased the 2228GBF PVC compound, and as its use expanded to other products, new customers began requesting our animal-free compound solutions.
Hoy en día, distribuimos varios productos GBF para diversos mercados como el médico, dental y el alimenticio. Estos productos están disponibles en todo el mundo para los clientes que requieren seguridad garantizada de que la posibilidad de propagación de las enfermedades EET quedará fuera de sus portafolios de productos médicos y dentales.
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