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)
 
Interpack highlights
Interpack, the triennial packaging show held in Düsseldorf, Germany, showcased many new machines for pharmaceutical packaging during its April 21–27 run.

Counterfeiting prevention also was a theme at this international show. One supplier launched an overt color-shifting film for labels or seals. A series of vacuum-coated layers, some as thin as 5 nm, creates the machine-readable color shift (Color Spectra Film, DuPont Packaging and Industrial Polymers, Security and Solutions business, Wilmington, DE, www.dupont.com).

On the covert side, DNA-marker technology is supplied as a customer-specific ink. Marking the printing with a special pen activates a chemical reaction and generates a luminescent signal that can be measured with a handheld reader. A German pharmaceutical company can trace its HIV and cancer drugs by using marker-impregnated ink to print bar codes on 18 different packages the company uses (Bio-Molecular Fingerprint, DuPont Packaging and Industrial Polymers, Security and Solutions business).

Although it is not yet used in this way, an inkjet coder using food-grade colorant can mark solid dosage forms with bar codes or other images to make counterfeiting more difficult and simplify tracking. Logos, graphics, bar codes, or alpha-numeric characters can be reproduced in four-color process, with monochrome or spot color. The single-lane unit prints images as large as 2.8 in. wide at 500 ft/min, but multiple lanes or wider print widths may be accommodated (Spectra–Merlin FG inkjet coder, Spectra, Inc., Lebanon, NH, www.spectra-inc.com).

Quality control
To reduce manufacturing expenditures, quality costs, and the chance of recalls, a quality control system provides 100% inspection of blisters at line speeds. The modular prototype unit can inspect blister pack seal integrity by using vacuum pressure and camera inspection. Subsequent modules print lidstock and verify printing. Reject mechanisms remove faulty packages from the line before they move to the next step, and feedback control ensures prompt alerts if the process starts drifting out of spec (Visio4U, Uhlmann VisioTec GmbH, Laupheim, Germany, www.uhlmann-visiotec.com).

Vision sensors continue to shrink in size and cost, and are frequently installed on existing equipment for new inspection tasks. Possible jobs include verification of labels, date/lot codes, syringe assemblies, vial stopper alignments, and blister packs, as well as fill level detection and case inspection (PresencePLUS P4 vision sensors, Banner Engineering Corp., Minneapolis, MN, www.bannerengineering.com).

A new generation of vial-inspection machines can check liquid or freeze-dried products and compensate for downstream problems by closing the pockets of the infeed starwheel and then reopening them as soon as the jam or error condition is resolved, thus maximizing operation at full production speed (typically 600 vials, ampules, or cartridges/min). Fixed cameras and an oscillating mirror minimize moving parts and deliver smoother machine movement, while a pitch transformer simplifies changeover for various containers (Seidenader VI 60, Seidenader Maschinenbau GmbH, Markt Schwaben, Germany, www.seidenader.de).

Equipment innovations
Blow–fill–seal machine improvements include larger motors and eliminating hydraulics. Compatible with polypropylene as well as high-density polyethylene, the latest models are designed for maximum uptime with in-line filter testing and reduced changeover time (bottlepack blow–fill–seal machines, rommelag USA Inc., Edison, NJ, www.rommelag.com).

A mobile pallet turner powered by rechargeable batteries makes it easy to replace incoming wooden pallets with aluminum or plastic (or vice versa) for outgoing shipments. Capable of turning loads weighing as much as 1000 kg on pallets measuring up to 1000 x 1200 mm, the standard unit handles load heights as large as 1300 mm (Toppy Pharma, Toppy srl, Bazzano, Italy, www.toppy.it). PT
 

 

 


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