Aseptic filling
A fully integrated filling line for pre-sterilized syringes starts with automatic bag and tub openers and features an integrated
checkweigher. A combi-filling station accommodates traditional or single-use product paths as well as rolling diaphragm or
peristaltic pumps (FXS line, Bosch Packaging, shown running syringes from Schott North America and stoppers from West Pharmaceutical
Services).
A servo-driven, double-tool, rotary filler/capper indexes two containers at a time to handle up to 70 containers per min.
Container size changes require removal and installation of the appropriate dedicated starwheel. Height adjustment is automated.
The machine is typically integrated with a rotary table at the infeed and a label applicator and accumulation table at the
outfeed (3020 DT monoblock, M&O Perry Industries).
A compact system designed for Class 100 cleanrooms features a peristaltic pump and single-use product path. Available with
two, four, six or eight filling heads, the servo-driven unit automates both container height and nozzle stroke adjustments.
The filler handles container diameters ranging from 16 to 76 mm (⅝ to 3 in) at up to 30 cycles per min. Maximum container
height is 203mm (8 in) (VR2PP series liquid filling machine, Cozzoli Machine Co.).
Peristaltic and rotary piston pump options are available on a higher-speed filling/stoppering machine capable of handling
100 vials per min. Tool-less changeover adjusts the unit for vial sizes from 2–100 mL. The system integrates with vial washing,
sterilizing/depyrogenation tunnel, capping, and tray-loading equipment as well as a Class A restricted access barrier system.
Options include pre- and post-fill gas flushing, in-line process control, automatic fill adjustment and automatic vial reject
(FS-22 Filling/Stopper Inserting Machine, PennTech Machinery Corp.).
A vial filler/capper provides feedback statistics on machine performance including applied torque. The serialization-ready
system tares bottles before filling, checkweighs, and applies stoppers and caps. Pumps are matched to product characteristics
(Bambino vial filler, Capmatic).
Cozzoli's VR2PP aseptic filler with single-use product path is designed for Class 100 cleanrooms.
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A servo-driven benchtop system, equipped with a peristaltic pump and single-use product path or rotary piston pump, fills
and applies stoppers to pre-sterilized nested vials (2–20 mL) or Hypac syringes (0.5–20 mL). Bottom-up filling with vacuum
seal prevents air bubbles in the product. The stoppering function also depends on vacuum. Programmable logic controller automates
all operations except placement and removal of the nest of containers (FSM modular syringe and vial filling system, Colanar)
Another tabletop system fills infusion bags. The semiautomatic machine requires manual feeding of the bags and sealing caps
and is capable of filling about eight, 500-mL bags per min. Other bag sizes include 50, 100, 250 and 1000 mL (Plümatex-BFM
007-SFC Filling and Sealing Machine, Plümat North America).
QS Systems bowl feeders from Service Engineering feature simple lift-off components.
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A variety of bag structures are available for infusions and other intravenous products. Three-layer coextruded polypropylene
bags with a highly inert, weldable inner layer protect sensitive products and can be produced in a variety of single- and
multi-chamber styles with various ports and connectors (Inerta bags, Technoflex). For products that must be frozen or for
cryogenic stem cell preservation, bags, tubing, and connectors are made of a material capable of withstanding temperatures
from -10 to -196 °C (Ethylene vinyl acetate bag, tubing, and connectors, Technoflex).
A three-dimensional (3D) video based on CAD drawings of equipment provides a virtual look at how various fillers and integrated
machines work. Although currently used as a marketing tool to showcase turnkey line capabilities, the 3D technology has potential
as a training aid (interactive 3D virtual tour, Optima pharma).
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