Enhance safety aspects
Silicone contains only a small number of additives, reducing the likelihood that harmful substances will be released. The material can therefore contribute to protecting the patient, while also increasing product safety for the medical and pharmaceutical manufacturer.
Polymer specialist Raumedic produces custom-tailored silicone components, including high-grade syringe plungers produced by injection molding. But that’s not all: Thanks to its staff of scientifically-trained professionals, the company’s Regulatory Affairs department can also provide support in preparing product-specific extractables studies. In Raumedic’s own laboratory or in external labs, potentially critical extractables from the material’s interaction with the pharmaceutical formulation can be quantified and evaluated for their toxicological properties.
A focus on customization
Silicone is known for its immense versatility in terms of form and design. At Raumedic, medical engineering and pharmaceutical manufacturers can decide for themselves what their syringe plungers should look like. There are virtually no limits on a manufacturer’s design ideas or size and shape requirements. As a development partner for the medical and pharmaceutical industry, Raumedic’s focus is on custom-tailored product solutions, not mass-produced items.
One clear sign that the silicone plunger is truly custom-tailored involves access to tools: Raumedic provides its customers with an individualized tool from which the geometry of the respective component is manufactured exclusively for them. Geometry modifications and optimizations can also be carried out during the development phase.
Ensure competitive advantages
“We’re able to offer real competitive advantages,” says Jörg Prescher, Head of the Technical Center of Excellence for silicone molding at the Bavarian company. “Personalized consulting is our top priority. From the initial idea, to product development, and right through to industrial manufacturing, we’re there for our customers at every step in the process. We even provide assistance with product approval.”
For instance, the special material formulation for Raumedic silicone plungers is officially registered in a “master file” at the U.S. Food and Drug Administration (FDA). So, medical engineering and pharmaceutical manufacturers that are active on the international market can get their new products approved more quickly and easily not only in the United States, but also all around the world.