The line’s functions will include washing vials, sterilizing, and depyrogenating, filling antibiotic powder, closing with stoppers, and crimp-capping the vials. The line will be able to fill powder from 250 mg to 3.0 gm in single dose or multiple dose, with accuracies of +\- 1% of fill volume. Batch sizes will range from 1,750 vials to a maximum 33,000 vials. The required output per hour is 9000 vials of ISO 10R with one-shot dosing.
Powder fillers feature a dual-level supply hopper and agitator that provide a uniform level and density of material to the dosing chamber of each filling head to maximize accuracy and repeatability. Powder fill ranges of 50mg to 75 g can be filled in a single metered dose. Features include the following:
Liquid media validation capability that simplifies powder media testing; automatic filter cleaning operation that eliminates filter-purging waste; enclosed powder pathway from hopper to vial that prevents external contamination; fill-volume adjustments can be individually fine-tuned without tools or stopping operation; multiple dosing capabilities.
Dosing is accomplished by applying a predetermined amount of vacuum to the dosing chamber. Once the chamber is filled with powder, the vacuum cuts off and a pinch valve opens, creating a pathway between the chamber and the filling nozzle. Positive pressure is then applied to the chamber, sending the powder through the nozzle and into the container. The systems’ powder pathway is enclosed, preventing any external contamination.
The filling process requires no scraper blades or particle-generating components that could contaminate sensitive sterile products. There are no abrading parts within the product contact area.