Contract services
Contract manufacturers and packagers are investing in their operations to meet rising demand. Several firms have added capacity
for filling solid dosage forms in bottles (A+ Secure Packaging, Almac, Pharma Packaging Solutions, Reed-Lane).
Contact manufacturers have also invested in new lines dedicated to blister packaging. One blister line integrates blister
foil printing, checkweighing and vision inspection. The 200-per-minute line handles a range of materials, including polyvinyl
chloride (PVC), PVC/polyvinylidene chloride, Aclar, and aluminum/aluminum (UPS 4 blister line from Uhlmann, installed at Almac).
A UK-based specialist in clinical trials and small batches has installed an aseptic vial line for small-volume parenterals.
The line primarily fills volumes ranging from 2–20 mL, but could handle vials up to 100 mL (SCM Pharma).
A year-old stick-packaging line forms, fills and seals 400 mg to 3 g of moisture-sensitive pharmaceuticals and probiotics
in narrow, foillaminate packs. Especially wellsuited to products for paediatric and geriatric populations that are intended
to be mixed with food, the fully integrated line operates in a humidity- and temperature-controlled environment. Rated at
1000 packs per minute, the line doses 10 packs at a time and loads finished packs into 7-, 14-, 28- or 56-count cartons (Stick-pack
contract packaging service, Ropack).
An on-site, visual inspection service provides equipment, certified technicians and service without the capital investment,
integration, maintenance and training issues associated with purchasing equipment. With several models available, equipment
can be matched to the application and installed in line or as a standalone unit. Scalable contracts adjust to changes in usage
(contract inspection service utilising Viswill (formerly Kanebo) equipment, Visionspect Division of Daiichi Jitsugyo Viswill).
Aseptic filling
A fully integrated filling line for presterilised 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 servodriven 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 higherspeed 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,
sterilising/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.).
Cozzoli’s VR2PP aseptic filler with single-use product path is designed for Class 100 cleanrooms.
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A vial filler/capper provides feedback statistics on machine performance including applied torque. The serialisation-ready
system tares bottles before filling, checkweighs and applies stoppers and caps. Pumps are matched to product characteristics
(Bambino vial filler, Capmatic).
QS Systems bowl feeders from Service Engineering feature quick-connect latches and simple lift-off components.
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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 presterilised 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).
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
multichamber 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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