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 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.
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, 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.
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.
Vetter now offers its filling services for high-quality sterile water for injection (sWFI) syringes with 5 years of stability data.
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 (www.boschpackaging.com) FXS nested syringe filling.