June 10, 2005 Volume 1, Number 3
 
 

Investing Time to Make Money: A PAT Implementation Perspective-By John E. Carroll
API Scale-Up During Research and Development-By Nandita P. Shetgiri, Mahesh S. Phansalkar, Sandeep Patil, and Rupesh Kelaskar
Outsourcing Outlook-Seeking a Fresh Start
Packaging Forum-New Systems for Counterfeit Protection and Quality Control
Washington Report-Drug Specifications Under Scrutiny
Contracts, Mergers, and Announcements
People
Calendar
Contact
 
   


New Systems for Counterfeit Protection and Quality Control
Packaging Forum
New Systems for Counterfeit Protection and Quality Control (continued)
 
Quality control
Vision systems continue to evolve. A compact system can support more than one smart camera for infrared or traditional imaging. A high-speed frame grabber processes images at speeds as fast as 1000 frames/s, which is quick enough to freeze an image of a moving bullet or glass breaking. The card-based system plugs into any personal computer. Applications include advanced motion tracking and synchronized data and image acquisition (PCI Express NI PCIe-1429 Frame Grabber, National Instruments, Austin, TX, www.ni.com).

Software that compares electronic files on packaging, labels, inserts, and other printed material identifies differences among files and creates a record of changes in text, fonts, style, and location. The resulting inspection report highlights and numbers differences between two files, notes document differences to the report, and can incorporate proofing comments. The software supports numerous file types including Microsoft Word, PDF, XML, SPL, text, and RTF files in any language. This feature
permits drug makers to check and compare text and artwork revisions. The software is 21 CFR Part 11 compliant and includes filters to handle various fonts. (Docu-Proof C3 Copy+Content Comparator, Global Vision, Montreal, QC, Canada, www.globalvisioninc.com).

A bar code print verification tool introduced this past year now can be equipped with auxiliary heads that compensate for curved or raised surfaces by using a template that ensures the container or blister pack is positioned properly. Capable of grading multiple codes on a single label simultaneously, the system is certified to Uniform Code Council–European Article Numbering standards. A color-coded analysis pinpoints any problems. In addition to bar code verification, the system can perform optical character recognition and check for print blemishes and color registration (Integra 9500 Bar Code Quality Station with LVS Auxiliary Reader, Label Vision Systems, Inc., Peachtree City, GA, www.lvs-inc.com).

For inserts, a stand-alone, vision-based reading station counts and identifies an entire box of 500 parts in a few seconds. The prototype system also can validate color coding and check whether all bar codes match (Integra 9800 Package Insert Counter, Label Vision Systems).

A low-cost, low-resolution camera-based sensor can check 3000 ppm. The camera-based system is primarily used to replace photo eyes and programmable logic control for presence–absence inspections. The system is self-triggering and records any faulty packs (Checker, Cognex Corp., Natick, MA, www.cognex.com).

A camera-based inspection cell for blow–fill–seal containers with a vertical feed and integrated strobe light provides a single-pass alternative to manual inspection. Dropping the containers from above exposes them to a full field of view, enabling an inspection that is faster and more accurate. The turnkey system changes over in less than an hour and can inspect for molding deformities such as voids, pits and holes, broken tabs and twist tops, separated cards (including split cards), wall discoloration, foreign particle inclusions, liquid fill level, and particulates in the liquid. It also can be set up for optical character verification or bar code traceability applications. Rated at 60 items/min, the cell was designed for a company that makes generic ophthalmic products (Ampuscan High-Speed Inspection System for Blow–Fill–Seal Containers, ATS Automation Tooling Systems Inc., Cambridge, ON, Canada, www.atsautomation.com).

Desiccants in sachet or canister form have been joined by a third format: coated desiccants. The pharmaceutical-grade coating eliminates dusting and provides a good surface for printing. A condensed formulation of silica gel, activated carbon, or a combination of the two materials doubles the absorption power of the coated desiccant. The more-powerful desiccant can eliminate the need for double drops and reduce desiccant costs by as much as 30%. Coated desiccant can be produced in various shapes. One style mirrors the size and shape of 1- and 2-g canisters to serve as a drop-in replacement using existing insertion equipment. Rounded edges expedite flow through the insertion machine. Another possibility, a large flat disk, is designed to sit at the bottom of a container, essentially hidden from view (Multiform Coated Solid Form desiccants, Multisorb Technologies, Inc., Buffalo, NY, www.multisorb.com). (continued) 

 

 


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