Alert: Packaging World now enhanced for the iPad and iPhone. Watch a quick video preview
 
Download Download this free, 150-page Pharmaceutical Serialization Playbook jam-packed with strategies for success and pitfalls to avoid.  Learn more >>
Article |

Federal 'medicine' for drug errors may be hard to swallow

FDA to ease stability tests for drug packs
Print Reprint
FILED IN:  Package Component  > Closures
     

The Food & Drug Administration has relied on sterility testing by drug manufacturers to ensure that a drug product will be free of microbial contamination throughout the product's dating period. But the agency has long had concerns about the weaknesses of sterility testing. So now it is proposing to allow manufacturers to use container and closure integrity testing instead. The kinds of tests that are anticipated include physicial or chemical tests such as bubble tests pressure/vacuum decay trace gas permeation/leak tests dye penetration tests seal force or electrical conductivity and capacitance tests. In the microbiological category the tests could include microbial challenge or immersion tests. One of the shortcomings of sterility tests is they detect only viable microorganisms present at the time of the test. And even those microorganisms don't show up unless they are capable of growth in the specified culture media. Container and closure tests can detect contamination that occurred at any time during the product's life. They are less time consuming too. Sterility tests generally take a minimum of seven days.

Comments(0)

Add new comment

ADVERTISEMENT
E-BOOK SPECIAL REPORT
42 Best Package Designs
Sign up to receive timely updates from our editors and download this e-book consisting of our editors' picks of most notable package designs. Updated for 2014!
x

 

Newsletters
Don’t miss intelligence crucial to your job and business!
Click on any newsletter to view a sample. Enter your email address below to sign up!
GENERAL INTEREST

New Issue Alert

Packaging World Magazine

eClip

Breaking packaging news

Packaging Insights

Pertinent packaging issues

On the Edge Blog

Workforce Development

PACKAGE DESIGN/
DEVELOPMENT

Greener Package

Sustainable packaging

Shelf Impact

Package design strategies

Each newsletter ranges in frequency from once per month to a few times per month at most.