Microleak Testing Technologies for Medical Devices

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Proven technologies such as InterTech Development Company’s mass flow leak test systems, enable medical technology innovators and pharmaceutical processors ramp up production of test systems and drugs to dynamic delivery requirements.

Microleak testing technology

InterTech’s microleak testing technology is used for both in-line testing and audit requirements for a wide range of life science products including:  wearables; combined products; and medical devices.

The most stringent leak test standards are readily achieved to typical limits of 8 microliters/minute (0.008 sccm)—or the equivalent hole size of 0.5 microns—with testing times of less than two seconds.

InterTech microleak testing solutions adhere to relevant ASTM standards, including ASTM F2338 and ASTM F3287.

Built-In GMP – Good Manufacturing Practices

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Built-In GMP

GMP implementation is built in to all InterTech solutions—cutting waste and losses, as well as protecting medical manufacturers, drug processors and end-user patients from any negative product safety events.

  • Product quality traceability is assured by deterministic test technology that eliminates potential for lapses in human operator judgements over entire product lifecycle.
  • 21 CFR 11 data requirements are built into all InterTech test instruments and testing solutions.

    Microleak testing technology

  •  EtherNet/IP capability of test instruments allows seamless integration of test data in to all quality assurance systems.
  • InterTech’s patented test technology eliminates the errors (both false positives and false negatives) inherent in previously used pressure testing methods.
  • Online access to test instruments and all test cell controls enables remote machine acceptance and installation supervision, required by pandemic safety considerations.

How global drug manufacturers scale up production of COVID-19 vaccines

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Proven technologies, such as InterTech Development Company’s mass flow leak test systems, enable medical technology innovators and pharmaceutical processors to immediately ramp up production of test systems and drugs to the warp speeds the pandemic requires.

Today however, the success of these superior InterTech test technologies is manifest in a wide range of applications—medical devices, high precision automotive components, and more.

InterTech’s microleak testing technology is used for both in-line testing and audit requirements for a wide range of life science products including:  wearables; combined products; and medical devices.

The most stringent leak test standards are readily achieved to typical limits of 8 microliters/minute (0.008 sccm)—or the equivalent hole size of 0.5 microns—with testing times of less than two seconds.

InterTech microleak testing solutions adhere to relevant ASTM standards, including ASTM F2338 and ASTM F3287.

Deterministic InterTech leak test technology

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InterTech’s patented test technology eliminates the errors (both false positives and false negatives) inherent in previously used pressure testing methods.

A leading manufacturer of COVID-19 rapid testing systems has been able to triple production to help meet the demands of this global emergency—and do so with a savings of more than US$1 million.

Time-to-market for high throughput manufacture of fast clinical testing instruments was reduced by 50%.

Product quality traceability is assured by deterministic InterTech leak test technology that eliminates potential for lapses in human operator judgements over entire product lifecycle.

InterTech’s microleak testing technology – deterministic test technology

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InterTech’s microleak testing technology is used for both in-line testing and audit requirements for a wide range of life science products including:  wearables; combined products; and medical devices.

The most stringent leak test standards are readily achieved to typical limits of 8 microliters/minute (0.008 sccm)—or the equivalent hole size of 0.5 microns—with testing times of less than two seconds.

InterTech microleak testing solutions adhere to relevant ASTM standards, including ASTM F2338 and ASTM F3287.

Proven technologies in micro flow leak test expertise

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Proven technologies, such as InterTech Development Company’s mass flow leak test systems, enable medical technology innovators and pharmaceutical processors to immediately ramp up production of test systems and drugs to the warp speeds the pandemic requires.

InterTech’s Pandemic Rapid Response Engineering Team delivers turnkey solutions with proven test systems that are rapidly deployed out-of-the-box.  These patented InterTech test technologies— superior mass flow test sensors, test sensor designs, and unique test fixtures—were once reflections of out-of-the-box thinking, just like the new vaccines making headlines today.  Today however, the success of these superior InterTech test technologies is manifest in a wide range of applications—medical devices, high precision automotive components, and more.

When it comes to scaling production of leak-proof pharmaceutical processing solutions, rapid test systems, and oxygen delivery systems there is no need to re-invent the wheel.  InterTech’s functional and leak testing expertise are a key part of the rapid response required to overcome the COVID-19 pandemic challenges.

Leak-proof pharmaceutical processing solutions

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When it comes to scaling production of leak-proof pharmaceutical processing solutions, rapid test systems, and oxygen delivery systems – InterTech’s functional and leak testing expertise are a key part of the rapid response required to overcome the COVID-19 pandemic challenges.

InterTech test technologies are manifest in a wide range of applications—medical devices, high precision automotive components, and more.

Stringent leak test standards and InterTech Expertise – Micro Test Technology

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  • Pandemic related products –such as ventilators, respirators and clinical testing machines– must be brought to market quickly.  The requirements to assure functionality and integrity of these medical products is in many aspects quite similar to those historically faced by the automotive manufacturers who are newly entering these markets.Med75 Leak tester
  • For example, leak-proof filtration systems are critical to both many automotive and medical parts.
  • If manufacturers make the wrong sourcing decisions when creating new product assembly lines for ventilators and similar, they inevitably encumber their products with higher price tags, or create testing bottlenecks on production, or both.
  • The ability of manufacturers of medical equipment needed to handle the demands created by the pandemic hinges on finding best-match test technology for products that must be fail-safe.

COVID-19 pandemic challenges and stringent leak test standards

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When it comes to scaling production of leak-proof pharmaceutical processing solutions, rapid test systems, and oxygen delivery systems there is no need to re-invent the wheel.

InterTech’s functional and leak testing expertise are a key part of the rapid response required to overcome the COVID-19 pandemic challenges.

The most stringent leak test standards are readily achieved to typical limits of 8 microliters/minute (0.008 sccm)—or the equivalent hole size of 0.5 microns—with testing times of less than two seconds.

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