Catching Leaks on the Fly - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Catching Leaks on the Fly
As drug sensitivity increases, on-line testing is likely to become more widespread and enable detection of defective blister cards.


Pharmaceutical Technology


For sensitive, expensive drugs, however, the expense could be justifiable. At least one other alternative is available to drug makers not quite ready to make that investment: surface inspection of the formable web before filling and sealing. This imaging-based system potentially could eliminate some leakers by detecting visually imperceptible cracks, pinholes, and other defects as small as 10 μm at 3.75 m/s. Especially suitable for foil, the unit also can check nontransparent film and laminated paper. Multiple zone inspection prevents rejection of good blisters ("VisioScan," inspection system Uhlmann VisioTec, Towaco, NJ, http://www.uhlmann-visiotec.com/).

Meanwhile, when implementing a leak-testing program, quality specifications for incoming materials must be considered. When looking at in-house quality control, a product's sensitivity and cost will determine whether leak testing is needed, whether it's off- or on-line, and how sensitive the equipment must be. Although it may technically be possible to locate defects measuring just a few micrometers, it's only necessary to do so if a hole that size will affect the product negatively. Other considerations in equipment selection include data-collection and networking capabilities, ease of calibration and validation, material limitations, tooling costs, cycle time, and changeover.

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


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here