SGD Pharma speeds up time to market with industry first Ready-to-Use SG EZ-fill® Nest & Tub packaging solution for molded glass vials for parenteral drugs
SGD Pharma announces that its 20ml EasyLyo molded glass Type I vials are now available Ready-to-Use (RTU) in SG EZ-fill® Nest & Tub – an industry-recognized state-of-the-art secondary packaging format.
Puteaux Cedex, FRANCE – 15th June 2021: Increased demand for parenteral drugs generated by the Covid-19 pandemic has resulted in additional pressures being placed on biopharmaceutical companies to accelerate their time-to-market. This new RTU primary and secondary packaging combination from SGD Pharma offers biopharmaceutical producers the flexibility they need to deliver innovative medicines to patients significantly faster.
SGD Pharma was the first molded glass manufacturer to offer
RTU vials at an industrial scale for injectable drugs in 2019, and its
partnership with Stevanato Group has enabled the company to be the first to
market with 20ml EasyLyo molded glass Type I vials in EZ-fill® Nest & Tub. RTU
Type I molded glass vials are delivered pre-sterilized in Nest & Tubs ready
for automated fill and finish, skipping up-front washing and depyrogenation steps
in an aseptic environment and allowing pharma companies to focus on core
business activities to expedite product launches.
Nest &
Tub is a secondary packaging solution required for combi-lines used for fill
and finish. It is largely adopted by contract manufacturing organizations
(CMOs) and contract development manufacturing organizations (CDMOs) for processing
a variety of primary packaging containers including vials, syringes, and
cartridges for optimal manufacturing flexibility. The Nest & Tub solution avoids
glass-to-glass contact, protecting the sterility and the integrity of each vial. With the introduction of SGD
Pharma’s RTU molded glass packaging solution in EZ-fill® Nest & Tub, drug
manufacturers can accelerate their time-to-market for small to medium batches with minimal
filling line changes.
SGD Pharma identified 20ml EasyLyo molded glass Type I vials,
part of the Sterinity
platform, as a priority for development in Nest & Tub packaging due to the
specific needs of biopharmaceutical companies to protect the safety of
lyophilized drugs. EasyLyo’s optimized heel radius reduces the risk of costly
breakages in the freeze-drier and by removing the vials’ base mold marks,
manufacturers can achieve uniform cakes through maximized heat transfer. The
uniform wall thickness of EasyLyo vials improves their cosmetic appearance,
providing better inspectability compared with standard molded glass.
Alexander Bautista, Product Manager
Sterinity Platform, confirms: “Our new 20ml EasyLyo molded glass Type I RTU
vial in Nest & Tub is an optimal packaging option for biologics and
innovative treatments that require glass vials with large volumes for
parenteral use. The chemical and mechanical resistance of our Type I molded
glass vials ensure reduced risk of delamination and breakages; in particular
for drugs manufactured via lyophilization. This meets the needs of innovative
drug manufacturers through all the stages of drug development, especially the
early phases and the transition from clinical to commercial.”
With the same external dimension as
20R tubular vials, adopting 20ml EasyLyo molded glass Type I vials will only
require minor changes on the filling line and allow the same freeze-drier shelf
configuration. This makes it simple for drug manufacturers to adopt a
multi-source approach or add molded glass vials to their primary packaging
portfolio. Customers looking to add Type I molded glass vials as an alternative
packaging solution are advised to start stability testing to ensure supply
chain continuity in the event of shortages.
Molded glass represents
approximately 40% of the injectable vials market: its higher mechanical
resistance reduces the risk of breakages during fill/finish and harsh
processing conditions such as lyophilization, safeguarding valuable drug
products and sensitive molecules, such as oncology therapies. Improved chemical
performance minimizes extractables and particle contamination to meet United
States Pharmacopoeia (USP) <660> and USP <1660> guidelines.
The new 20ml EasyLyo molded Type
I glass vials in Nest & Tub are in stock and available in both flint and
amber glass. The
Letter of Authorization (LOA) to the Drug Master Files (DMF) for our
Ready-To-Use molded glass vials, pre-sterilized in the EZ-fill® platform of SG Ompi, will be available from early July. For more information about RTU
molded glass vials from SGD Pharma, please watch our webinar on-demand or download our white paper.
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