InterTech Design Report (DR-180)
Smaller, faster, durable for home care environments or clinical settings – and with UNFAILING accuracy…
The Challenge: Little more than a decade ago, the way in which miniaturized medical devices would come to widely impact patient care was barely imaginable. Not anticipated also were the advances required in medical device manufacturing to assure that these devices would be robust in homecare and clinical environments. Thus, the exigencies of functioning in all environments with unfailing accuracy must be met. Today, these challenges are growing exponentially. Consider, for example, transdermal patches, continuous glucose monitoring systems, with built-in electronics, or the devices with the new AI-powered capabilities – that are on the horizon.
From a leak test engineering standpoint, the enclosure integrity of these newer medical devices depends on reliable microscale leak testing to the most stringent standards. Detecting leaks as small as 0.008 sccm, 8 microliters per minute, equivalent to a 0.5 micron hole is a typical requirement.
Also, test fixture designs must allow for unprecedented tight tolerances common to miniaturized parts and devices such that the testing process doesn’t mar, contaminate or damage the parts or measurement systems.
Simply put, accurate and reliable leak test measurement is non-negotiable.
InterTech Solution: InterTech MicroScale Testing Technology achieves an 8 microliters per minute standard with high repeatability and reliability. These turnkey microleak testing solutions – for both in-line testing and audit testing – have at their core InterTech’s unsurpassed proprietary test technologies. This includes superior mass flow test sensors, pressure decay test sensor designs and unique test fixtures.
InterTech microleak testing solutions have optimized test circuit design fully integrated with superior fixturing and software. Automated test fixtures bypass the testing inconsistency inherent in human operation. Instead, consistent sealing and clamping forces are achieved while insuring stable and repeatable measurements.
By using InterTech’s dual-channel MED75 Leak Tester, medical product manufacturers speed test measurement time by 30% or more in each test channel. This makes the rapid production and scaling of manufacturing solutions in the highly competitive and rapidly changing medical product space readily doable.
Additional Features and Benefits:
All features of InterTech test technology for biomedical manufacturers are designed to deliver significant savings in time to market, as required for in-home and clinical setting product innovations.
InterTech Technology Removes Testing Variability
- The InterTech MED75 MicroScale Leak Tester eliminates the errors (both false positives and false negatives) inherent in previously used pressure testing method.
- A robust product quality traceability system is assured by the implementation of a deterministic analytical test technology.
Built-In Compliance with Biomedical Industry Standards
- GMP compatibility 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.
- InterTech software assures that all test systems adhere to strict ISO/ASTM standards and are compatible with all customer 21 CFR Part 11 systems.
- Operators are able to see leak test measurement values in real time.
- EtherNet/IP capability of test instruments allows seamless integration of test data with all quality assurance systems and remote machine databases.
Case Studies: Medical Buffer Packs – Tested to 10 microliter/min accept limit at 60 kPa
- System is capable of detecting leak range of 1 uL/min to 20 uL/min.
- InterTech MED75y Microscale mass flow leak detector controls test cycle.
- TechPress™ eliminates operator errors and injuries.
Tested to 0.2 sccm at 0.2 bar at rate of 180 parts/hour
- Test cycle of 20 seconds/part.
- Compact designed test stands minimize floor space.
- Using the MED75y leak detector to control all machine functions simplifies wiring and eliminates expensive purchased components including a PLC.
Sealed Pharmaceutical Containers
- Container Closure Integrity audit testing identifies leaks as small as 0.002 sccm (2 microliters/min) – equivalent to less than a 0.2 micron hole size