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WORLD LEADER IN TEST TECHNOLOGY

Microscale Leak & Flow Testing

InterTech MicroScale leak & flow testing technology are implemented for the diffusive flow testing of filter membranes.

Application

The diffusion testing of membrane filters that can only be bubble tested (not diffusion tested) by the current generation of integrity testers such as the Pall Flowstar 5. Testing in the lab or in the assembly area to meet R&D and audit testing requirements

Target application: sterilization filter assemblies (generally in the range of 0.05 to 0.2 micron pore size)

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Technology

Some diffusion testing basics that are used to determine application parameters 

Diffusive Flow= k*Area*Differential Pressure

Diffusive Flow test pressure= 0.8 Bubble Point

IPA Diffusive Flow= 2-3 x Water Diffusive Flow approx.

IPA Bubble Point= 1/3 x Water Bubble Point approx.

InterTech Test Process & Parameters

Pressure range:  3.0 psig - 60 psig standard 

Other pressure ranges available if required

Instrument Flow range: 350 microliter/min Full Scale

Diffusion Flow Test Limit: 5-300 microliter/min

Note: in general filter area >200 cm3 will flow in excess of 300 microliters/min

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Our Applications Engineers are on-call to provide no-cost consultations

InterTech’s turnkey test solutions consistently lower medical device, and medical product testing costs by 25% or more. To achieve these cost reductions and maintain GMP standards, InterTech utilizes an encyclopedic knowledge base of test fixture design and a wide array of leak test technology methodologies for medical device manufacturers. Contact our applications engineers for help.

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Notes

Diffusive airflow measurements have their advantage in addition to serving as indicators of filter integrity. They can more precisely reveal filter incompatibilities. They can be used to gauge the completeness of a filter's wettability, and they are more revealing of a filter's clean water flow properties. In almost all its applications, however, diffusive airflow integrity testing requires defining the diffusive airflow curve by way of multipoint measurements using the liquid product in question. This is especially true in filter validation contexts where product-specific testing is necessitated. Once the full diffusional airflow curve has been elucidated, single-point diffusional flow testing is warranted, as in production integrity testing settings. Single point diffusive flow testing can be used as a standard integrity test method for use in the pharmaceutical production environment.

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Please contact InterTech for further information or help with your test application. We are happy to answer any questions you may have. Give us a call at 847-679-3377 or fill out the form and we'll be in touch as soon as possible.

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