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Syringe Plungers Can Contribute to Patient
Safety
Syringe plungers made of silicone allow for precise dosing of the drug being
administered. Other advantages of this material include its physical/mechanical
properties and the high-chemical purity of its formulation. Finally, silicone
allows for customized product configurations and designs.
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 moulding. 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 productspecific 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 individualised 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 moulding at the Bavarian
company. “Personalised 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. (Ref:
http://www.medicalplasticsnews.com/How%20syringe%20plungers%20can%20contribute%20to%20patient%20safety/) |
