ASSEMBLY ESSENTIALS

InterTech’s Turnkey Automated Testing Solutions For Biotech, Medical Device and other Life Science Products

ASTM F2338 and ASTM F3287-compliant InterTech MicroScale testing systems-- testing down to microliters per minute—are being used for both in-line testing and audit requirements for a wide range of biotech and medical products.

InterTech’s turnkey automated 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, test sensor designs, and unique test fixtures.   

InterTech MED75 Micro Leak Testers

Note these three of many dozen examples of how the Dual channel InterTech MED75 Micro Leak Testers are used in pharma, medical device and more biotech products--

Container Closure Integrity (CCI Test of Sealed Pharmaceutical Containers identifies leaks as small as 0.002 sccm (2 microliters/min) --equivalent to less than a 0.5 micron hole size.  

COVID19 Diagnostic Sample Transfer Device audit testing (GRR<10%) and production testing (GRR<20%) to a 0.008 sccm (8 microliters/min) limit at 682-710 mbar;  

Moisture Resistance Testing of Combination Products (e.g. cannisters of respiratory inhalation devices) are leak tested at rate of 0.2 sccm (200 microliters/min) in 0.75 seconds test time;

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.  

Medical equipment, Rectangle, Gadget

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.

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.  

September 2021

Material property, Rectangle, Font
Font