Avoid product defects

As your global medical device test and inspection partner, we understand how vital it is that your products perform to high standards. It’s critical to ensure your name remains trustworthy throughout the medical industry.

Product defects – no matter how small – can lead to hazardous consequences – impacting your finances, your reputation, and the future of your business.

That’s why having the right test and inspection solutions in place is crucial – so you can be sure that your medical devices and associated packaging is upheld to the according standards.

Take a look at the array of solutions we have on offer for medical device testing.

TME Integra Flex

The Integra Flex allows for easy benchtop testing and shines
when integration to an assembly line is necessary. Its compact rack mount dimensions allow stacked integration which makes the system expandable on demand.

Test Types:
• Pressure/vacuum decay
• Occlusion
• Single Channel

Features:
• Low cost
• Detachable touchscreen HMI
• Intuitive user interface
• FDA CFR21 part 11 integration ready
• Multiple outputs for data collection
• Remote desktop capability
• USB capability for support barcode scanners and more
• Full PLC I/O capabilities
• Resolution – 0.0001 PSIG
• Pressure range: 0-100 PSIG
• Low internal volume for increased leak sensitivity and accuracy

TME Worker Integra

Whether integrated into an existing system or working from a bench, the Worker Integra provides you with an easy-to-use experience while offering highly repeatable and accurate results.

Test Types:

• Pressure/vacuum decay
• Occlusion
• Mass Flow Testing
• Multi or Single channel
• Customizable options available to meet specific and unique customer requirements

Features:

• Touch screen interface
• Concurrent or sequential testing
• High resolution- 0.0001 psig
• FDA CFR21 part 11 data protection
• Ethernet I/P available
• Real time Statistical Process Control
• Multiple data output methods
Features:
• Large touch screen interface
• Easy to use user interface
• FDA CFR21 part 11 conformance
• Multiple outputs for data collection
• Full PLC interface capabilities

TME Solution 

Time tested and proven throughout the medical device community, the TME Solution is the perfect fit for any application and the big brother in the TME leak tester family. A highly versatile instrument, this unit offers highly precise and repeatable results and can meet any application needs.

Test types:
• Pressure/Vacuum Decay
• Occlusion
• Mass Flow Testing
• Crack Testing
• Multi or Single channel

Features:
• Touch screen interface
• Concurrent or sequential testing
• High resolution- 0.0001 psig
• FDA CFR21 part 11 data protection
• Ethernet I/P available
• Real time Statistical Process Control
• Multiple data output methods

TME Pressure Bubble Tester

Low pressure and controlled flow to a package, this instrument meets the requirements of ASTM F2096. The simple system loads packages while lowering and holding the pouch 1” under water to observe bubbles from holes as small as 250 microns.

Features:
• Pressure and flow control
• Low cost
• Digital readout
• Selectable units of measure

Standards:
• ASTM F2096

TME BT Integra Pack

The BT Integra is an intelligent package validation tester for your
ISO 11607 and ASTM package testing needs. With its intelligent automatic detection mode, the BT Integra takes the guesswork out of package testing and setting of parameters.

Test modes for porous and
non-porous packages: burst,
creep, creep to failure, and leak.

Max test pressures:

• 50 and 100 PSI availabilities

Features:

• Automatic and manual modes
• Large graphical display
• Icon driven interface
• Data collection via USB
• FDA 21 CFR Part 11 compliant

Standards:

• ISO-11607,
• ASTM F2054, F1140, F2095
To meet industry standards, fixtures are often needed to test to the appropriate method. Our standard, off the shelf fixtures provide a fast, easy interface for mounting the sample to the system

Test Probe Assembly

The Test Probe Assembly is used to penetrate closed porous or non-porous packages and connect the instrument pneumatic supply and sensor system to the package under test. The drill press style variable height clamping stand allows easy adjustment of probe to various package sizes and configurations.

TS-01-EXP 

You can use the TS-01-EXP with the TME BT Integra-Pack Tester to test flexible porous pouches sealed on three sides. Available in 12 and 24-inch chuck size, this fixture provides a pneumatically driven clamp that will seal the open end of a flexible package during the inflation testing for package seal strength in accordance with ASTM F-1140 and F-2054.

TME Restraining Plate 

The TME restraining plate fixtures provide limiting constraints for package testing in accordance to ASTM 2054 and 2095 (seal strength testing and leak testing).

Standard plates come in two common sizes and are made from high strength lightweight aluminum. Adjustable height from ¼” to 1” to
meet customer specifications for all types of packaging.

Systech EC9031 Oxygen Deficiency Monitors

The EC9031 has been designed with functional safety of paramount importance.

EC9031 oxygen deficiency monitors are used for the continuous monitoring of oxygen levels in confined spaces, storage food areas or where low or high levels of oxygen may pose a hazard to personnel.

At Industrial Physics, we provide packaging, product, and material test and inspection solutions to manufacturers, production lines, and laboratories across the world. It’s our purpose to protect the integrity of our customer’s brands and products.

For us, this is about more than just supplying you with testing equipment, it’s about being there for you as a full-solutions partner.

Whatever your needs are, we’ll work with you to find the right solution for your business. We have a full team of experts to support you.

We offer a full suite of solutions to cover an extensive range of testing requirements for your requirements.

It's our innate desire to continuously learn, innovate, and better ourselves that allows us to provide businesses across a diverse range of industries with the highest quality of test and inspection solutions possible.

Our experts are positioned across the world. And through our collective expertise, we're able to support the unique needs of our customers.

Partner with Industrial Physics and protect your business today.