Liquid Filling And Packaging System For Pharmaceutical Injectable Products

ASEP-TECH® Blow/Fill/Seal systems are ideally suited for packaging injectable products, including small-volume and large-volume parenterals. Containers are formed, filled, and sealed in one compact machine frame, eliminating many of the steps and additional expenses of conventional processing. Blow/Fill/Seal containers offer tremendous advantages over glass, including weight savings, particle-free processing, resistance to breakage, ease of opening, and recycling capability.

Large Volume Parenteral Manufacturing (LVP)

Large Volume Parenterals are typically injectable products designed for intravenous delivery applications. The large-volume parenteral bottles are most often produced from a resin that can be autoclaved, either at 106° C or 121° C.

Large Volume Parenteral Design Options (LVP)

IV bottles and irrigation bottles can be made in the ASEP-TECH® Blow/Fill/Seal machine from the same mold by interchanging the seal mold to provide different top geometries. Separate injection molded caps can be welded to the blow/fill/seal container to create a multi-entry format, usually used to introduce a secondary medication into the solution prior to dispensing to the patient.

Special diameter ports can be provided on the bottles to accommodate plastic needle-less spikes, designed for infusion administration. Bottles can be designed with
integral hangers.

Small Volume Parenteral Manufacturing (SVP) - 10 to 100 mL

Applications for Small Volume Parenterals include local anesthetics, vaccines, and other traditional injectable products. The 10 to 100 mL range is typically designed for multi-dose applications.

A simple twist-off opening feature can be combined with a controlled diameter formed in the top to accommodate needle-less spikes. Alternatively, a luer lock or luer slip can be provided. Bottles can be designed with folding, integral hangers.

Small Volume Parenteral Manufacturing (SVP) - 2 to 5 mL

Small Volume Parenterals in the 2 to 5 mL range most commonly utilize a luer lock or luer slip fit (vented luer) top geometry. Syringes can be connected directly to the ampoules without a needle, creating an inherently safer delivery method.

A syringe with a needle can also be used since a larger percentage of the smaller ampoules are used to provide diluent to reconstitute lyophilized drugs.

Small Volume Parenteral Insertion Technology (SVP) - 2 to 5 mL

Top geometries for small volume parenteral bottle/ampoule sizes of 100 mL or less can include a multi-entry rubber stopper or controlled diameter, injection molded insert (combined with Weiler's insertion technology). These designs are useful where multiple administration of a drug is required.