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News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Innovations for 2012
Servo technology and software are bringing a new level of automation to pharmaceutical packaging. Software not only automates functions, but also simplifies the work of packaging line operators as well as the collection and analysis of productivity data. One new software product oversees multiple quality-control systems on a single packaging line or multiple lines in one or more facilities. A dashboard system and color-coded machine icons on the operator interface quickly alert operators and management to quality problems in real time so remedial action can be taken and downtime can be minimized or eliminated. Remote setup prevents unauthorized changes to settings and errors and supports consistent operation across lines and facilities. The program currently oversees checkweighers, metal detectors, and X-ray inspectors and will accommodate machine-vision systems in 2012 (ProdX software, Mettler-Toledo).
Software's potential to simplify operation is particularly evident in machine vision, a technology with a reputation for being difficult to set up, operate, and change over. In one system, Windows-based software oversees as many as four color or monochrome cameras and performs tasks, including inspecting labels, caps, containers, and fill levels, confirming the presence and condition of a tamper ring, and verifying date and lot codes and one- and two-dimensional barcodes. Capable of checking 2000 metal, glass, or plastic containers each minute, the system includes an integrated reject system (TotalVu Sensor vision system with Teledyne Dalsa cameras, Teledyne TapTone).
Serialization and traceability
With pedigree regulations looming or already in place in some countries, interest is high in implementing serialization systems that generate the supporting data. One serialization-ready printer–applicator prints a two-dimensional DataMatrix code and human-readable data on a label before applying it. A built-in camera verifies print quality (BL400VTEXL label printer and application, Marchesini Group). Data transmission, aggregation, and storage is provided by integrated hardware and software (Systech Serialized Product Tracking, Systech International).
One taggant-based technology enables smooth adoption by blending the taggants in ink, varnish, thermal-transfer ribbon, resin, or film. In its latest iteration, taggants are combined with inkjet ink that's invisible under visible or ultraviolet light. Detection of the alphanumeric characters or barcode printed with the taggant-equipped ink is only possible with a programmable handheld reader, which provides authentication in seconds. Tight oversight of the supply chain ensures secure handling of taggant carrier materials (Traceless AD inkjet ink and reader, Eastman Kodak).
Braille on labels
When European 2004/27/CE directive took effect on Jan. 1, 2006, it made braille labeling mandatory on all new pharmaceutical packaging. Since then, a growing number of options have been introduced to help pharmaceutical packagers comply.
To overcome a lack of harmonization in the configuration of braille messages, one producer of shrink-sleeve labels has standardized character string alignment on the left and reading from left to right. It also specified the distance between dots, their width, their height, the distance between each group of six dots (which corresponds to a letter) and interlines. A proprietary marking method and morphing tool ensure characters are formed in compliance with parameters and do not become distorted during the heat-shrinking process (Sleever Braille, Sleever International).
Better cold-chain practices
Single-use product-contact parts
Attendees at INTERPHEX 2011 also had a chance to explore the possibility of converting to single-use product-contact parts. A single-use fluid path ensures purity, simplifies validation, and expedites changeover on high-throughput peristaltic filling and capping systems (AsepticSU single-use fluid path technology, Flexicon Liquid Filling).
Pharmaceutical packagers switching to disposable product paths have a growing number of pump choices, including 6- and 50-cm3 peristaltic pumps as well as a rolling diaphragm pump (PreVAS Single-use Dosing System, Robert Bosch Packaging Technology).
The appeal of skinny stick packs includes ease of opening, ease of dispensing, and portability, plus the convenience and accuracy of single-dose dispensing. In response to rising interest in this flexible packaging format, Pharma Tech Industries, a contract manufacturer and packager of powder products, installed a machine that forms, crimps, fills, and seals the slender, cylindrical packs (Stik Pak S/N 307 machine, Ropak Manufacturing).
Set up to handle 10 lanes simultaneously, the machine produces 600 stick packs/min and features in-line collation and cartoning, as well as a color touch-screen operator interface. Servo-driven continuous motion corrects deviations. An adjustable dosing system allows tool-less changeover of dosing-specific components.
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, firstname.lastname@example.org
1 K. Abdelkader, R.M. Akers, and M.J. Akers, "Sterile Prefilled Syringes: Market Dynamics & Current Issues in Manufacturing & Control," in Prefilled Syringes, Innovations that Meet Growing Demand (ONdrugDelivery, Newtimber, UK, 2005), p. 4.