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



Hallie Forcinio
The use of blister cards, a popular drug-packaging format in Europe for many years, is growing in the United States. This increased popularity results partly from the rising number of drugs that are moisture- or oxygen-sensitive. It also comes from the fact that blister cards can be printed with dosage times, thereby serving as compliance packages that help patients adhere to dosage regimens.

To ensure package integrity, standard operating procedures typically include a testing protocol. Traditionally, leak testing has relied on blue-dye, water-bath, drop, or burst tests. Unfortunately, these tests destroy the package and the product inside, which then must be disposed of in an audited process. For an expensive drug, the cost of product lost to testing quickly mounts to hundreds of dollars per hour. Water-bath and dye tests are relatively time-consuming and exacerbate this cost problem.

Many bad packages often are produced before a problem is identified. As a result, faster, nondestructive testing is replacing destructive methods in many situations. Nondestructive leak testing relies on various technologies, including high-voltage, pressure, vacuum, and imaging.

High-voltage testing

High-voltage electrical testing ensures incoming blister-packaging materials (i.e., formable bottom webs and lidstock material) are free of pinholes. In this test, the company that produces the blister material or lidstock mounts a tester near the end of its production line so the material passes between high-voltage and grounded electrodes before it is wound into rolls. Blister material or lidstock should insulate electrodes from each other. If a pinhole is present, an arc will discharge through the flaw to the ground. With sufficient voltage, the system can detect pinholes smaller than 1 μm ("PDC20" pinhole tester, Clinton Instrument Co., Villa Rica, GA, http://www.clintoninstrument.com/). This level of resolution is more than adequate, because the threshold for detectable pinholes typically is greater than 50 μm.


The "VeriPac 225/BLV" unit from Packaging Technologies and Inspection holds a blister card under vacuum.
Although this test ensures the quality of incoming blister-package materials, it still may be necessary to check finished blister cards to ensure that no damage occurred during the form–fill–seal process and to confirm seal integrity.

Pressure and vacuum testing

Quality-control systems for finished blister packs rely on pressure or vacuum conditions. Most units are operated off-line and allow operators or quality-control personnel to check a periodic sampling of a run such as 8 or 10 packs every 30 min.

One vacuum method relies on the detection of a tracer gas that is present naturally or added by flushing the blister package just before it's sealed. Under vacuum conditions, the gas escapes through any pinholes or cracks that are present and is detected by an infrared sensor ("Pac Guard Model 400," leak tester, Mocon, Minneapolis, MN, http://www.mocon.com/).

Some leak detectors look for pressure or vacuum decay to identify leaks. One dual-mode unit detects defects as small as 5 μm in a pressue or vacuum test cycle that lasts less than 30 s. An audible and visual reject alarm alerts the operator if the blister card fails. The system can store 100 different tests and record 5000 results. A two-way RS232 connection links the unit to a host system or network and enables uploading of test data and downloading of test parameters. Interchangeable test chambers accommodate various card sizes and shapes ("TME Solution-C Blister Card Chamber Test System," TMElectronics, Inc. , Boylston, MA, http://www.tmelectronics.com/).


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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here