ASEP-TECH® Blow/Fill/Seal systems are ideally suited for packaging injectable products, including small volume parenterals 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 advantage 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
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.