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



The ideal blister-pack leak tester
Many leak detectors rely solely on vacuum decay. If a leak is present when the vacuum is pulled, air leaves the flawed blister cavity and creates a concave surface in the lidstock. If the card is leak-free, the lidstock over each cavity domes slightly from the internal air pressure. There are various ways to measure these surface changes, including contact methods such as proximity sensors and load cells and noncontact imaging systems. Each has advantages and disadvantages.

Proximity sensors require complex tools to position them above each blister cavity. Hence, each blister format requires its own array. This requirement is an expensive proposition in tooling, operation, and validation if multiple blister formats must be inspected.

A load cell measures how much the lidstock pushes against it. Load cells can be difficult to adjust and validate because each cavity requires a corresponding cell. The technology also may be impractical for blister formats with cavities that are arranged extremely close together.

Imaging-based testing

Some imaging systems use a laser as a light source. These systems can be affected by variations in reflectivity caused by printing on the lidstock. The systems also require considerable precision because the center point of each blister must be identified to reveal changes in position.

Another camera-based system combines vacuum technology with indirect imaging. Key to this patented and patent-pending equipment is a flexible bladder positioned over the blister as it rests in the test fixture. The flexible membrane serves several purposes. During the test, it supports the seal and prevents deformation and peeling. It also increases the sensitivity of the pressure measurements. Finally, covering the lidstock not only eliminates problems the imaging system might have with printed or glossy surfaces, but also provides a clear indication of the flaw locations and identifies leaks as tiny as 3.5 μm.

After a test cycle of less than 10 s, results are presented in numerical, statistical, and image formats. The touch-screen operator interface and personal-computer–based controller also network with a printer and database to print and archive test results. Changeover is almost instantaneous and requires lifting out one fixture and setting a new one in its place. Once in position, the machine reads a notched identification code on the fixture and sets test parameters for the new blister card ("VeriPac 225/BLV," vacuum leak-testing system, Packaging Technologies and Inspection, LLC, Tuckahoe, NY, http://www.ptiusa.com/).


FYI
To increase throughput, test fixtures can be designed to hold four blisters. In addition, the semiautomatic machine could be equipped with a shuttle system that would allow the operator to remove a tested card and replace it with an untested card while a test cycle is running. With suitable integration and material-handling hardware, an on-line model could perform 100% inspections. Moving leak testing on-line would require integration with the blister-packaging machine and related material handling. Most likely, this would take the form of a pick-and-place device that would move the blister cards to the leak tester and then back onto the line. In addition, the tester itself would probably require multiple stations to keep up with line speeds. This means on-line testing could cost significantly more than off-line testing, perhaps as much as 10 times more. Experts say it also would be harder to validate.


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
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
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: Pharmaceutical Technology,
Click here