IRVING, Texas, Oct. 19, 2021 /PRNewswire/ -- Darling
Ingredients Inc.'s (NYSE: DAR) health brand, Rousselot®,
the global leader of collagen-based solutions, today launches
Quali-Pure™, a range of gelatins for biomedical applications with
controlled endotoxin levels. The latest addition to Rousselot
Biomedical's rapidly expanding portfolio, Quali-Pure has been
specifically designed for a variety of applications including
embolization, wound healing, drug delivery, vaccines and
hemostatics. Quali-Pure delivers biocompatibility,
biodegradability, controlled endotoxin levels, and batch-to-batch
consistency, and fully supports medical device compliance with ISO
22442 and the new EU Medical Device Regulation (MDR) standards.
Biomedical gelatins
The Quali-Pure range of high-quality gelatins offers device
manufacturers an endotoxin-controlled gelatin, that delivers the
optimal functional properties, as well as meeting the standards
required to comply with the enhanced regulatory requirements.
Quali-Pure gelatins come with full traceability, documentation and
viral safety.
"We are excited with this new product in our portfolio", says
Tanja Vervust, Director at Rousselot Biomedical. It will give peace
of mind to our customers who can rest assured knowing the quality,
batch-to-batch consistency and purity of our Quali-Pure gelatin
range will contribute to overcoming the challenges they may face on
the pathway to approval of their biomedical applications."
Quali-Pure is the latest addition to the Rousselot Biomedical
portfolio that consists of X-Pure® biomedical gelatins,
hydrolyzed gelatins and modified gelatins with endotoxin levels
that are amongst the lowest in the world.
New EU MDR compliance requirements
Medical device producers are facing increased safety
requirements for biomaterials. From May
2024, all devices placed on the European market must conform
with the new EU Medical Device Regulation (MDR). Regulation (EU)
2017/745 on Medical Devices (the MDR) has replaced the existing
medical devices Directive (93/42/EEC) (MDD) and the active
implantable medical devices Directive (90/385/EEC) (AIMDD). In
addition, the ISO standard 22442 has been updated to bring it
further in line with global requirements for medical devices.
Quali-Pure provides the supporting documentation for full
compliance of medical devices with the new MDR requirements and
with ISO 22442. "We design all of our biomedical gelatins with
safety in mind. We aim to pro-actively support our customers
towards regulatory compliance with full and documented traceability
up to the farm (ISO 2242-2), validated viral inactivation (ISO
22442-3) and IPEC GMP compliance," says Kathleen Jacobs, Regulatory Affairs
Director at Rousselot Biomedical.
Quali-Pure gelatins are available from October 2021, and Quali-Pure hydrolyzed gelatins
are expected to be added to the portfolio in the near future.
New Quali-Pure gelatins will be presented for the first time at
the Compamed trade fair (booth 13F70) from 15th to
18th November in Düsseldorf.
Rousselot® Biomedical
As the most recent strategic segment within Rousselot, we have
drawn upon Rousselot's 130+ years of worldwide expertise and proven
track record of pharmaceutical gelatins and collagens to develop
innovative ranges of purified, modified and non-modified gelatins
and collagens for biomedical applications. Offering unique
advantages to assure performance, quality and safety from bench to
clinic, Rousselot® X-Pure® and Rousselot® Quali-Pure™ provide
consistent quality and are backed by strong scientific data and
on-going research. Rousselot Biomedical is committed to support
end-to-end partnerships to help "Advancing medical science".
https://www.rousselot.com/biomedical
About Darling
Darling Ingredients Inc. (NYSE: DAR) is a world leading producer
of organic ingredients, generating a wide array of sustainable
protein and fat products while being one of the largest producers
of renewable clean energy. With operations on five continents,
Darling collects waste streams from the agri-food industry,
repurposing into specialty ingredients, such as hydrolyzed
collagen, edible and feed-grade fats, animal proteins and meals,
plasma, pet food ingredients, fuel feedstocks, and green bioenergy.
Darling Ingredients named one of the 50 Sustainability and Climate
Leaders in 2021, to learn more Darling Ingredients: The greenest
Company on the planet - 50 Sustainability & Climate Leaders
(50climateleaders.com). The Company sells its ingredients around
the globe and works to strengthen our promise for a better
tomorrow, creating product applications for health, nutrients and
bioenergy while optimizing our services to the food chain. Darling
is a 50% joint venture partner in Diamond
Green Diesel (DGD), North
America's largest renewable diesel manufacturer, currently
producing approximately 290 million gallons of renewable diesel
annually which products reduce Greenhouse Gas (GHG) emissions by up
to 85% compared to fossil fuels. For additional information, visit
the Company's website at http://www.darlingii.com.
Rousselot
Caroline
Brochard-Garnier
Director of Communications & PR, Rousselot
[e] caroline.brochard-garnier@rousselot.com
Sciad Communications
Maria
Patey
[e] maria@sciad.com
Investor Relations
Jim
Stark
VP, Investor Relations
[e] james.stark@darlingii.com
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