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International Standards

ISO 11607

Introducing ISO 11607 - Industrial Physics
International ISO 11607 is the standard test method to inspect the packaging of terminally sterilized medical devices. It lays out which materials are acceptable and what the sterile barrier and packaging systems need to achieve.

Sterilized medical device packaging must assure that the contents inside are guaranteed to remain sterile until opened – from the moment it is sealed, throughout transportation, and into the consumer’s hands.

The ISO 11607 standard provides a full guide on packaging validation – from how a package can meet this requirement, to how manufacturers can document the process.

It’s an overall standard for a manufacturer to meet. They must carry out several tests to ensure package integrity and strength, so they can guarantee that the product contained will meet its intended shelf-life.

The ISO 11607 testing process
The ISO 11607 standard is conveniently split into two parts, covering the demands on packaging for terminally sterilized medical devices. A short description of each follows:

ISO 11607 1: Part one establishes the requirements and methods for testing the sterile barrier systems and packaging systems. To make sure that they remain terminally sterilized from factory to end user.
ISO 11607 2: Part two sets out a manufacturer’s process requirements when creating a sterile barrier system for a medical device. How can they minimize any risk of contamination in the factory and through the supply chain?

ISO 11607 testing devices
So, how can Industrial Physics improve your ISO 11607 testing?

Several of our machines and devices are built to support everything from burst testing to leak testing to ISO 11607 standards. Here are some of the most popular:

TME BT Integra-Pack

A high resolution tester for flawless seal integrity testing of porous and non-porous packaging. The intelligent BT Integra-pack is so easy to use, with several automatic modes that help characterize your packaging. It’s ideal for burst (ASTM F1140 and F2054), creep, creep to failure and pressure decay testing of your flexible packaging.

For more information, click here.

TME Worker Integra

Our integrated process control tool makes light work of multi, or single channel, pressure / vacuum decay, occlusion and flow testing. You can rely on this leak detection kit for repeatable and quantitative results. With models available for pressure ranges from 5 to 150 psig; and or vacuum / flow rates from 0.1 to 50,000 sccm.

For more information, click here.

TME Pressure Bubble Tester™

Bubble leak testing with the TME Pressure Bubble Tester is a simple, cost-effective method of detecting and assessing leak rate.

The machine provides low pressure and controlled flow to your sample pouches. And it does so in accordance with the ASTM International F-2096 test method ‘standard test method for detecting gross leaks in packaging by internal pressurization bubble test”.

The TME Pressure Bubble Tester™ is simple to set up, gives you digital pressure readings and offers a low-pressure control range of 0 to 2 psig, with high flow capacity for porous material packages as well as non-porous pouches.

For more information, click here.

TME Solution: leak or leak flow test system

The TME Solution is one of the most reliable long lasting custom and standard leak test instruments in the medical, pharmaceutical and automotive industries.

It offers you highly repeatable, quantitative results from clean, dry tests. And will support many test types, including burst testing, occlusion testing, vacuum testing, and pressure decay, crack, and differential pressure or vacuum testing. Plus it’s available in configurations up to four ports - with dual switching also available to maximize operator productivity.

In conjunction with custom fixtures, accessories, and engineering support, the TME Solution provides a complete turnkey solution to your leak and flow testing needs.

For more information, click here.

The TME Worker Leak and Leak Flow Tester

An affordable, dependable leak and occlusion tester for your day-in, day-out leak testing, flow testing, and occlusion testing requirements.The TME Worker Leak and Leak Flow Tester can be configured as a leak Tester, a leak and flow tester, or a leak and occlusion tester and is available in pressure or vacuum models.

It’s an efficient, reliable, high resolution (0.0001psi or 0.01 mbar) test instrument with pressure ranges available up to 300 psig and flow ranges available from 10 sccm to 10 lpm.

For more information - click here.
Your global test and inspection partner for ISO 11607
If you would like to learn more about ISO 11607, check out our full article explaining ISO 11607 and the medical packaging process - click here.

You can also find out more about the products and services we offer to the medical device industry by checking the link here.