To Protect and Package - Pharmaceutical Technology

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PharmTech Europe

To Protect and Package
Products at INTERPHEX focused on protection, compliance, and deterring counterfeiting. This article contains bonus online-exclusive material.

Pharmaceutical Technology
Volume 33, Issue 5

Turnkey line

Mega Pumps addresses various pharmaceutical packaging needs with a wide range of pump sizes and styles, including airless.
Preintegrated turnkey lines expedite startup. Shown at INTERPHEX with accumulation tables at both ends, one turnkey line fills, caps, and labels containers ranging from 25 to 85 mm in diameter and from 40 to 115 mm in height. Bottles feed into an electronic solid-dose counter that fills 60 bottles/min. Features include optical beam sensors, toolless changeover, and touch-screen operator interface (FTC 12 Electronic Tablet and Capsule Counter, Marchesini Packaging Machinery, West Caldwell, NJ).

Screw caps are fed to an intermittent-motion starwheel screw capper, which also features toolless changeover as well as a reject station with reject verification (ML 55 capper with ECO 200/400 cap feeder, Marchesini). After capping, bottles move though an automatic pressure-sensitive labeler. The stepper-driven labeling head handles label sizes from 10 to 120 mm wide and from 13 to 190 mm long. Options include reject with reject verification, thermal-transfer or hot-stamp printing, barcode scanning, and a vision system (SL 200 pressure-sensitive labeler, Marchesini). The line also can be equipped with a bottle unscrambler, desiccant inserter, cottoner, induction sealer, cartoner, bundler, or case packer (ECO-Tablet Line, Marchesini).

Disposable components

An airless pump on NeoPacs barrier tube protects product quality and shelf life.
Single-use components can eliminate hours of cleaning and validation work while increasing line flexibility. A single-use product path also cuts changeover time and the consumption of utilities and cleaning agents while minimizing wastewater generation, cross-contamination, and capital investment in stainless-steel parts.

Bosch's prevalidated, preassembled, and gamma-sterilized single-use system introduced in 2008 was shown in action on a vial filler. An option on all fillers from this company, the disposable system includes a polycarbonate rolling diaphragm pump and disposable filling needles made of stainless steel over-molded with polycarbonate. The latter cost about one-tenth the price of traditional stainless-steel filling needles. The preassembled system also includes all tubing and fittings and can accommodate eight pumps. Already in use for nonsterile products, validation for sterile products is expected to be completed by July 1, 2009.

Each punch die set carries a unique fingerprint and imprints on each pill it makes.
Retrofittable on existing lines, the prevalidated disposable system also allows users to switch back and forth between disposable and multiuse components with a process that's no more complex than a standard product changeover. The flexibility to use single- or multiuse components simplifies the handling of toxic products and accelerates time to market because it eliminates validation related to cleaning and sterility (PreVAS Single-use Dosing System on FLC 3080 vial filling machine, Bosch Packaging Technology, Minneapolis, MN).

Benchtop filler

Maximum flexibility is provided by a semiautomatic benchtop filler that can be ordered with four interchangeable metering systems. Options include peristaltic, gear, lobe, or piston pumps that simply slide in and out during a tool-free changeover. Fill rates include 4.37 L/min for the peristaltic pump, 13.25 L/min for the gear pump, 15.14 L/ min for the lobe pump, and 50 strokes/ min, dispensing 0.1-260 mL per stroke for the piston pump. The servo-motor-controlled, stainless-steel unit handles fill volumes from milliliters to gallons with accuracy of 0.5% and can connect with equipment such as printers. Although targeted to pilot plants, laboratories, and universities, linking two or more microwave-size fillers addresses high volume requirements. A touch screen provides a user-friendly operator interface and access to stored recipes (AdaptaFil Benchtop Filler, Filamatic, Baltimore, MD).

Blow-fill-seal technology

Comparing fingerprints of tablets and punch dies authenticates product at the pill level.
Patent-pending technology combines aseptic blow-fill-seal production with polypropylene construction to produce a delivery system for injectable products that ensures quality, cuts costs, and differentiates product. Other features include a specially designed rubber stopper, a color-coded cap that stays with the vial after opening, and a pop-off opening device that provides one-handed access to the stopper surface. The blow-fill-seal process eliminates problems with aluminum or glass particulates and glass breakage. It also minimizes chances of microbial contamination and protects operators from exposure to the drugs being filled. Furthermore, it eliminates the need to siliconize stoppers and inventory glass vials. Preliminary stability-test results for the system have been positive for several biologic products. (Contract packaging in Secure-Vial blow-fill-seal container, Catalent Pharma Solutions, Somerset, NJ, on equipment from Wei-ler Engineering, Elgin, IL).

Advanced printer

Embossed cartons and labels from Cortegra meet the EU mandate (effective in October 2010) that requires packaging to incorporate product name, formulation, and strength in Braille.
A combination of ink formulation, easy-to-change ink cartridges, solid-state printhead, and advanced print-quality algorithms combine to deliver as many as five lines of high-quality printing and minimal downtime. With a printhead that needs no field service or adjustment and features automatic cleaning and purging, the printer is designed to run for 9000 h (i.e., 18 months of two-shift days) before the user must swap out the core. A smart chip on the ink cartridge allows the printer to select the appropriate print-quality algorithm and track ink consumption. The machine also features one-button startup and shutdown (Videojet 1510 inkjet printer, Videojet Technologies, Wood Dale, IL).


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