Interphex on Tap

Visiting Interphex allows pharmaceutical manufacturers to compare and contrast pharmaceutical packaging designs, as well as packaging materials, equipment, and services. The 2011 edition of the annual pharmaceutical industry show will be held Mar. 29–31, 2011, at the Jacob K. Javits Convention Center in New York City. The show will feature the latest packaging equipment, track-and-trace technology, outsert preparation and application innovations, single-use systems, barrier materials, and quality-control devices.

Hallie Forcinio

The filling line

At least two suppliers plan to discuss the advantages of blow-fill-seal technology for advanced aseptic liquids. The fully automated process produces large- and small-volume parenteral products. The advantages of forming, filling, and sealing containers under controlled conditions on a single piece of equipment are encouraing pharmaceutical companies worldwide to switch from glass to plastic ampuls, vials, and bottles (Asep-Tech systems, Weiler Engineering, and Bottlepack systems, rommelag).

A maker of filling equipment plans to set up an interactive touch screen at its exhibit to allow visitors to compare their projects to similar applications. The firm also will demonstrate its semiautomatic benchtop filler that can be equipped with a piston, peristaltic, gear, or lobe pump. The multiple pump options make it possible for the unit to handle a fill range from milliliters to gallons and viscosities from aqueous to viscous. Other features of the servo-driven filler include a touch screen operator interface, a recipe database, and a data-transfer capability (AdaptaFil benchtop filler, Filamatic).

We'll be seeing more ...

Inserts and outserts

A modular outsert system folds information sheets with as many as 210 panels. The resulting outserts make up a document that's as much as 23% larger, yet an average of 15% thinner than outserts made on previous models. Thinner outserts handle better manually and mechanically, require less storage and shipping space, and eliminate the need to increase packaging dimensions to accommodate a bigger insert. A single-knife system folds as many as 110 panels measuring as small as 1.125 in.². However, if more panels are needed, second and third knives can be added. The double-knife system produces inserts with as many as 170 1.125-in.² panels. The triple-knife system folds 210 panels measuring as small as 1.25 in.² (MV-11 Outsert System, Vijuk Equipment).

The PharmaMarker 450 Track and Trace System conveys, applies a unique code to, and verifies 450 cartons/min to comply with track-and-trace regulations. (IMAGE COURTESY OF EISAI USA)

The primary folder operates at speeds as high as 14,000 cycles per hour, sets up easily, and needs no make-ready plates. Quick caliper-set rollers, a double-sheet ejection system, feeder setup recall, and intelligent jam detection maximize production efficiency (G&K FA 53 folder, Vijuk).

Folded outserts can be applied to the sides of round, square, or rectangular containers with hot melt adhesive. One machine handles a wide range of outsert sizes, including the thick, heavy documents sometimes needed to comply with content, type, and formatting requirements. A vacuum cup-equipped arm moves in and out to pick an insert and rotates to deliver it to the container. Dual servo motors control the linear and rotating motions, and the vacuum cup holds the insert securely.

Blow-fill-seal machines produce various container sizes and shapes. (IMAGE COURTESY OF WEILER ENGINEERING)

Thin outserts can be handled with the vacuum cup alone, but thick outserts require a combination of pushing and picking. For operations that handle a wide range of outsert thicknesses, the end of the vacuum arm may be a change part, which can be removed and replaced without tools. Integrated with a primary labeler or retrofit, the applicator handles outserts as small as 0.875 × 1.125 × 1.5 in. (22 × 29 × 38 mm) and as large as 2.5 × 4 × 1.5 in. (63 × 100 × 38 mm) at speeds as great as 220 bottles/min (Model 277 Auto-Sert Outsert Applicator, NJM/CLI). A feeder expands the infeed storage capacity to enable run times as long as 1 h without replenishment (Model 276 Carousel Outsert Feeder, NJM/CLI).

An outsert applicator from NJM/CLI handles a wide range of outsert sizes as well as round, square, and rectangular containers. (IMAGE COURTESY OF NJM/CLI)

Track and trace

A track-and-trace system conveys, uniquely marks, and verifies 450 pharmaceutical packages per minute so that individual packages can be tracked through each phase of the packaging line and throughout the distribution system. Positioned immediately downstream of a cartoner, the system conveys each carton past a noncontact laser or thermal inkjet printhead that applies a two-dimensional barcode, batch number, lot number, production date, expiration date, and other desired information, as well as a unique number for mass serialization. The unique, random identifier, known only to the pharmaceutical producer, prevents counterfeiting and facilitates accurate traceability.

The blow-fill-seal process aseptically fills and seals the container while it's still in the mold. Molds frequently are designed to produce two or more containers simultaneously. (IMAGE COURTESY OF ROMMELAG)

Using high-resolution vision technology, the system inspects and verifies printed data and label alignment and records information in an internal database. An air knife blows non-readable cartons into a secure reject bin equipped with a sensor to confirm that a reject has been accepted. A quick-change mechanism expedites adjustments for various carton sizes. Windows-based operation is controlled at the swing-arm-mounted, 17-in. (432-mm) touch screen. Line-management software manages individual or multiple vision sensors, coding devices, checkweighers, and associated equipment across automated production and packaging lines (Line Director Production Line Management Software, Crest Solutions).

The track-and-trace system also uses database-management software to simplify implementation of product traceability (Protrack real-time database management software, Crest Solutions). Employed as a stand-alone system or as a component of an integrated line, the coding and data-collection system enables paperless compliance with existing and upcoming national and international track-and-trace regulations, including Brazil ANVISA, TS (Turkey), French Coding, California ePedigree, Good Automated Manufacturing Practice 5, and 21 CFR Part 11 (PharmaMarker 450, Eisai Machinery USA).

End-ported biocontainers like this one from Meissner Filtration Products meet the growing demand for single-use systems. (PHOTO IS COURTESY OF MEISSNER FILTRATION PRODUCTS)

Barrier material

A foil lamination with a frangible sealant layer keeps product components isolated from each other until they reach the point of use. Breaking the seal permits the contents of each compartment to mix or dispense together. Two distinct heat-seal profiles allow the sealant to produce a permanent seal and a frangible seal. Applications include skin applicators and dual-component products (PerfecPharm P702, Perfecseal).

Single-use systems

A range of end-ported biocontainers meet the growing demand for single-use systems that reduce cleaning requirements and downtime. Available in 50-, 250-, and 500-mL sizes as well as 1-, 2-, 5-, 10-, and 20-L sizes, the polyethylene-based containers offer high gas and water-vapor barrier properties. Custom designs also are available. Biocontainers may be ordered with silicone or thermoplastic elastomer tubing with various connections, and can be specified with or without filter capsules. Certified to be free of animal components, the containers are packaged in an ISO Class 7 cleanroom (TepoFlex biocontainers, Meissner Filtration Products).

Symetix Secure Connection enables remote diagnostics for VeriSym and OptyxSG inspection systems. (PHOTO IS COURTESY OF SYMETIX.)

Quality-control devices

A direct connection between machine and machine builder provides remote access to inspection equipment even if the system is located behind a firewall. The secure link enables remote diagnostics to be conducted and supplies data, images, and other information. If permission is granted, original equipment company engineers can access the machine's user interface, data, images, and logs. Setup is simple and saves the days of engineering and administrative time usually needed to provide access to a machine.

The connection also archives logs and setup parameters securely and makes it possible to transmit logs and batch records to any computer with a network connection. The connection service can be purchased alone or as part of a service package that includes replacement parts and an annual on-site machine audit by a field engineer (Symetix Secure Connection service for VeriSym and OptyxSG inspection systems, Symetix).

Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, editorhal@cs.com.