Prefilled Syringes

FDA Grants NovaGuard SA Safety System from West Pharma 510(k) Clearance

The NovaGuard SA (Staked-needle Automatic) Safety System from West Pharmaceutical Services Inc. has received 510(k) clearance from the U.S. FDA. According to the company, the NovaGuard SA safety system helps reduce the risk of needlestick injuries by shielding the exposed needle of a prefilled syringe after use.

Catalent Adding Automated Clinical Packaging to Support Eli Lilly's Growth

Catalent will equip its Philadelphia Clinical Supply Center of Excellence with new automated prefilled syringe clinical packaging lines to support the growth of its partner, Eli Lilly, the company reported in a news release. The line will be able to automatically insert plunger rods as well as apply randomized and non-randomized labels and back-stop clips. Off-line labeling with booklet labels will also be possible.

Vetter Offering Serialization Support Services

Contract developer and manufacturer Vetter has developed a flexible serialization service to support pharmaceutical and biotech companies with their own track-and-trace programs. The service will include printing of Global Trade Item Numbers (GTIN) on packages and other support.

After implementing an initial IT solution, Vetter began implementing an engineering platform for serialization that is expected to be operational by the end of 2014, the company reported in a release.

BD Medical Launches BD Sterifill Advance

BD Medical, a segment of BD (Becton, Dickinson and Company), has launched BD Sterifill Advance, a prefillable polymer syringe specially engineered to deliver large volume injectable drugs by way of intravenous infusion, the company reports in a press release. The syringe can also be used for parenteral administration of pharmaceutical compounds.

Preventing Needlesticks

The European Union's Directive targeting sharps safety should help make needle use safer. But are stricter requirements needed?

Member states of the European Union are now expected to pass national legislation aimed at preventing sharps injuries. EU Council Directive (2010/32/EU), which took effect May 11, 2013, aims “to achieve the safest possible working environment by preventing injuries to workers caused by all medical sharps (including needle-sticks),” reads the document. In other words, hospitals as well as other workplaces where healthcare services are provided are expected to take steps to protect employees from needle sticks.

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Vetter Provides Services for Sterile Water for Injection with 5 Years Stability Data

Contract developer and manufacturer Vetter now offers its filling services for high-quality sterile water for injection (sWFI) syringes with 5 years of stability data.

Bosch Delivers Syringe-Filling Line to Drug Contractor in Italy

IBSA Farmaceutici Italia, a subsidiary of the Swiss Institute Biochimique S.A., aseptically fills and sterilizes syringes. At its site in Lodi, for instance, IBSA fills 16 million pre-filled syringes with sodium hyaluronate for intra-articular and intradermal use and 2.2 million syringes with solvents for freeze-dried powders. To meet increasing demand for prefilled syringes, IBSA added a new production building featuring Bosch Packaging Technology’s ( FXS nested syringe filling.

AMRI Supports Excellagen Prefilled Syringe Launch

Albany Molecular Research Inc. (AMRI; is manufacturing sterile prefilled syringes at its Burlington, Massachusetts, site in support of the U.S. introduction of Cardium Therapeutic’s Excellagen topical gel.
Excellagen is a new, highly refined fibrillar collagen-based gel for treating diabetic foot ulcers, pressure ulcers, and other dermal wounds.
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West Launches Syringe Safety System

West has announced the commercial introduction of its syringe safety system.  The system is designed to help protect against needlestick injury when using a prefilled syringe and will complement West's portfolio of prefilled syringe offerings and technologies, the company said.
West acquired the IP and rights to this system in 2011 and has completed the product development and first phase of commercial scale-up at its safety systems manufacturing center in France.

AMRI Supports Excellagen Pre-filled Syringe Launch

Albany Molecular Research , Inc. (AMRI) ( is manufacturing sterile prefilled syringes  at its Burlington, Massachusetts  site in support of the US introduction of Cardium Therapeutic’s  Excellagen topical gel.
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