InterTech Design Report (DR-166)
Can superior MicroScale Leak Testing speed the time-to-market for critically needed biomed products?
ANSWER: YES, ASTM F2338 and ASTM F3287- compatible InterTech systems – testing down to single digit microliters per minute – are fast becoming a proven boon to new product development for a wide range of global life science product innovators.
The Challenge: Historians of science widely recognize that many, if not most, of the most significant scientific breakthroughs over time have happened when the insights from one research sphere cross-pollinate another. Consider, for example, that even the first two approved COVID19 vaccines would more properly trace back to mRNA research for cancer cures that started in the ‘90s. If cancer research had remained in an air-tight silo removed from vaccine research, we all would not be celebrating the arrival of the first two COVID19 vaccines now approved for wide-scale clinical use. Many recognize that breaking down silos is just as relevant to breakthrough progress in the engineering realm. It’s timely to ask – Can biomed applications accelerate the pace of product development by harnessing the long-proven best-in-class testing technologies widely used in other applications that involve highly reliable and affordable micro-leak testing?
The InterTech Solution
Recent history has shown that global leaders in biomed product manufacture are often gaining market share because they have used the same superior InterTech MicroScale Leak Test technologies long proven in other industries, such as high-precisions automotive components.
By doing so, these best-in-class biomed product manufacturers accelerate their time-to-market for a wide range of medical products requiring superior microleak testing. These turnkey microleak testing solutions – for both in-line testing and audit testing – have at their core. InterTech’s unsurpassed patented test technologies – superior mass flow test sensors, pressure decay test sensor designs, and unique test fixtures. InterTech’s Test Engineering Team – said to be the world’s deepest bench of test engineering talent – is now being relied on by the world’s leading innovators of wearables, combined products, and medical devices.
Test Process and Solution:
InterTech MicroScale Leak Testing solutions are compatible with relevant ASTM standards, including ASTM F2338 and ASTM F3287
COVID19 Diagnostic Sample Transfer Device
Audit & Production Testing Test Cells
Parts are audit tested to a 0.008 sccm (8 microliters/min) limit at 682-710 mbar with GR&R < 10%. A dual channel InterTech MED75 micro leak tester controls the test cycle. Parts are production tested to a 0.008 sccm (8 microliters/min) limit at 682-710 mbar with GR&R < 20%. A dual channel InterTech MED75 micro leak tester controls the test cycle. 16 parts are tested every 2.8 seconds
Moisture Resistance Testing of Combination Products
Cannisters of asthma inhalation devices are tested by InterTech to a leak rate of 0.2 sccm (200 microliters/min) in 0.75 seconds test time. Two InterTech dual channel MED75 mass flow instruments perform required leak/moisture-proof testing at a rate of 120 parts per minute
Container Closure Integrity (CCI) Test of Sealed
Pharmaceutical Containers
InterTech MicroScale leak testing technology is used by a leading pharmaceutical manufacturer for Container Closure Integrity audit testing to identify leaks as small as 0.002 sccm (2 microliters/min) equivalent to less than a 0.5 micron hole size.
Benefits:
•InterTech’s patented MicroScale leak test technology eliminates the errors (both false positives and false negatives) inherent in previously used pressure testing methods.
• Time-to-market for high throughput manufacture of fast clinical testing instruments is reduced by 50%.
• 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.
• Capital investment to create new manufacturing lines for test technology is reduced by a factor of 10 – optimizing floor space and reducing work in process.
• Online access to test instruments and all test cell controls enables remote machine acceptance and installation supervision, required by pandemic safety considerations. This remote online access also creates significant savings in time to as well as significant savings in time needed for launch of new in-line and/or audit test systems.
• Product quality traceability is assured by deterministic test technology that eliminates potential for lapses in operator judgement over entire product lifecycle
Key Features:
• Container Closure Integrity testing is fast, accurate and reliable.
• 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.
• 21 CFR 11 data requirements are built into InterTech test instruments and testing solutions.
• EtherNet/IP capability of test instruments allows seamless integration of test data with all quality assurance systems.