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.

15
MAR
0

News & Press

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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.
9
MAR
0

News & Press

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