ISO 11607 – Answering Manufacturers’ Most Common Questions

ISO 11607 is the defining standard for medical package testing and validation. As the consensus standard for the Food & Drug Administration (FDA), no device can expect to find its way to market without an in-depth understanding of the standard and how to meet the requirements it spells out.

By |2021-09-29T14:12:26-07:00September 29th, 2021|LSO Blog, Medical Package Testing|

When Should You Start Real-time Aging?

Lots of medical device manufacturers focus on accelerated aging and successfully establishing an estimated shelf life for medical devices. But another aging test often gets overlooked – real-time aging. Learn the right time to start real-time aging and some best practices for results that comply with ISO 11607.

By |2021-09-02T17:44:27-07:00September 2nd, 2021|Medical Package Testing|

Medical Device Packaging Validation and ISO 11607

Medical device, pharmaceutical, and biotech companies must follow stringent medical device packaging validation processes to obtain what they need for an FDA or EU submission: The coveted validation report. Your terminally sterilized medical devices cannot [...]

By |2021-07-20T10:15:38-07:00May 14th, 2021|LSO Blog, Medical Package Testing|

Medical Device Package Distribution Testing: Shake, Rattle, and Roll

Medical device distribution testing is an important part of delivering your product to market. Learn more about the “shake, rattle, and roll” medical package testing method.

By |2021-07-20T10:15:44-07:00October 6th, 2020|LSO Blog, Medical Package Testing|

What is the Difference Between Real Time Aging and Accelerated Aging in Medical Package Testing?

Learn the difference between real time aging and accelerated aging for your medical device package testing project.

By |2021-07-20T10:15:46-07:00September 25th, 2020|LSO Blog, Medical Package Testing|

Design Terminally Sterile Packaging: 3 Ways to Prevent ISO 11607 Package Design Failure (Infographic)

Your medical device product likely needs terminally sterile package design to deliver to market. At this point, you’ve progressed through product development and likely developed a sterilization process. You’ve now arrived at performance testing the sterile barrier system. But you may have concerns about the best way to evaluate your packaging system.

By |2021-07-20T10:15:48-07:00March 31st, 2020|LSO Blog, Medical Package Testing|

Dye Penetration Testing – Recent ASTM Enhancements

Dye penetration testing is a common method of checking for seal leaks in medical packaging such as pouches, trays, and blisters. The intent of this article is to review and clarify the recent developments in [...]

By |2021-07-20T10:15:53-07:00May 16th, 2014|LSO Blog, Medical Package Testing|

3 Key tools to mitigate ISO 11607 Package Design failure

As a project leader for medical device manufacturing, there is one area in particular that I feel can really derail projects.  When a project reaches me, often times the packaging has already been created and [...]

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