Advances in Parenteral Packaging

New vials and syringes are making an end-user's job easier.

Several suppliers of parenteral packaging are introducing products that help reduce the risk of contamination as well as make an end-user's job easier. For instance, new barrier materials, stoppering mechanisms, and labels reduce the amount of particulate, while preassembled syringes and vials with built-in dispensing mechanisms reduce the number of steps needed to deliver drugs. Many suppliers can even tailor their packaging to meet specific end-user requirements.

A drug-delivery system designed for IV bag reconstitution requires only four steps to prepare an infusion. Bio-Set Infusion is a device fitted onto the top of a standard 20-mm vial with a standard or lyo stopper. To use the system, practitioners only need to remove the cap, connect the infusion bag to the vial via a cannula, mix the contents of the bag with that of the vial, and transfer all contents to the bag. The system helps users save time by enabling them to prepare bags at patient bedsides, avoid accidents with needles, and decrease the chance of infections. Biodome America, Princeton, NJ.

An oral dispenser accurately measures medication. When coupled with a bottle adapter, the dispenser becomes a closed system to cleanly and conveniently transfer liquid medication from a bottle to the dispenser. The oral dispenser bottle is designed to fit the Baxa press-in-bottle-adapter for dispensing medications. The bottles are currently available in 150- and 240-ml sizes. Lawson Mardon Wheaton, Millville, NJ.

A dual-compartment syringe acts as both a pharmaceutical package and a drug-delivery system. Substance lyophilization occurs in the front chamber, and the system is closed and sealed while still in the freeze dryer. Following that, the back chamber of the syringe is filled with a diluent and then also sealed. The result is a closed system with the same stability as two separate vials. By using the Lyo-Ject system, pharmaceutical manufacturers can reduce waste and residual volumes and eliminate the need to overfill vials of lyophilized materials. End-users only need to handle one syringe rather than multiple pieces. Exact titration exists from reconstitution, and the dose is predetermined by the fill volume. Pharma-Turm, an affiliate of Vetter GmbH, Yardley, PA.

Fully automated inspection systems inspect ampules and vials at speeds up to 400 units per minute. The AIM 298/ 598 performs both particulate and cosmetic inspection of injectable products with high accuracy and repeatability. A control system runs under a Windows NT platform and uses Wonderware. The company also offers ampule packing systems and microwave sterilization systems. Eisai USA Inc., Hackensack, NJ.

A manufacturer of glass packaging products has a cross-functional team of product developers who work closely with customers from concept to product launch. Through interviews, QFD, and 3-D CAD/CAM modeling, the team learns about client needs. The vertically integrated manufacturer controls design management from raw materials to the finished product and offers capabilities and expertise to meet the most demanding specifications. Kimble Glass Inc., Vineland, NJ.

All-plastic closures fit onto specially designed glass or plastic vials to provide a secure seal. The Harmony system is designed to work with existing elastomeric stoppers or with preinserted elastomeric liners or stoppers. The absence of a traditional aluminum seal eliminates aluminum particulate matter. A two-stage capping process allows lyophilization application in a single step. Supplied presterilized or ready for sterilization, the system can be outfitted with color-coded closures and printed on, etched, or embossed. A reclosable closure is designed for multiple-use tasks, and a traditional button-style is available for single use. Comar Inc., Buena, NJ.

A line of detachable flag labels incorporate a pharmaceutical-grade, pressure-sensitive adhesive-film substrate. Designed for quick and reliable tracking of unit- and multiple-dose medications, the labels can be applied at high speeds to vials and parenteral barrels. Using an adhesive that is different from the rest of the label, the flag may be detached, imprinted, and applied to patient records. The label can withstand autoclaving. The company can use EDI to transfer designs to clients for proofing. Topflight Corp., York, PA.

An elastomeric formulation is available for syringe components and stoppers in any design. UltraPure 6900 is chemically stable, making it suitable for use with terminally sterilized water for injection and other demanding products. It can handle radiosterilization. American Stelmi Corp., Princeton, NJ.

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