Where will post-COVID molecular diagnostics go next? And how can it get there quicker?

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The Challenge:
The pandemic certainly didn’t invent in-vitro diagnostics, but thought leaders in this medical technology space now recognize how COVID revealed both the potential and challenges inherent in scaling molecular diagnostics.
No matter which disease process clinical interventions based on in vitro diagnostics are aimed at – infectious agents, diabetes, cancer, biomarkers for brain, heart or other organ pathologies, etc. – there is a marked advantage of patient-friendly test methods that use easily collected samples such as saliva, exhalations, or pin prick blood samples. Often though, the quantity of genetic material culled by these sampling techniques is minute. This is the same challenge that researchers faced when studying COVID and immunity.

PCR (Polymerase Chain Reaction) testing – a method developed in the late 20th Century for copying and in effect amplifying very small segments of genetic material – is at the heart of the COVID testing that is now ubiquitous. PCR testing’s ability to do the equivalent of multiplying a minute sample many times over is projected to be the cornerstone of nearly all molecular diagnostic methods in the coming years. In fact, it already is at the heart of most immunodiagnostic and molecular assay tests in clinical laboratories worldwide today. From an engineering standpoint, the integrity of PCR testing requires microscale leak testing to the most stringent standards (e.g. detecting leaks as small as 0.008 sccm, 8 microliters per minute, equivalent to a 0.5 micron hole). Consider also the challenge of then scaling successful molecular diagnostics just as COVID testing has required. If one has not grappled with the challenges of scaling such solutions – and doing so rapidly – this task can appear daunting.

InterTech Solution:
Helping the medical technology innovators that scaled rapid COVID testing is exactly how InterTech has assisted in the taming of the pandemic-creating leak test solutions used in rapid testing systems. These PCR testing solutions were made possible and scalable with InterTech MicroScale Testing Technology to achieve the 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 – superior mass flow test sensors, pressure decay test sensor designs, and unique test fixtures.
InterTech continues to partner with global leaders in in vitro diagnostics and molecular assays requiring leak-proof testing components and assured closed container integrity.

Read InterTech Design Report 178

InterTech Design Report (DR-177)

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Headache-free Testing – and FAST!

The Challenge: Trying to make do with a less skilled workforce? Facing demands for faster deliveries despite supply chain issues? Need dramatic throughput gains to counter inflationary pressures? All this – yet, quality cannot be compromised!!!
Manufacturers of a wide range of products requiring error-free leak and functional testing – medical devices, electronics packaging, pharmaceutical delivery devices, automotive and more – are facing an unprecedented demand to develop smarter ways of managing the real-world pressures of our post-pandemic world. There is far less room for bottlenecks and production drags on manufacture and testing. It’s time to get smarter about testing!

The InterTech Solution: InterTech’s test engineering talent – which has created more patented solutions for best-in-class test technology than any other company in the world – is partnering with leading global manufacturers of test-intensive products to help them work faster and smarter – not harder.  No-cost consultations with InterTech’s Test Engineering Team – in-person or by video consult – can determine which of the family of InterTech Smart Testing Solutions are best matches for your testing challenges.
Some of the InterTech Smart Testing Solutions with potential to significantly impact your bottom line includes: InterTech Universal Leak Tester, Leantest, Ex-Heat, Gauge R&R mode, InterTech Patented Mass Flow Sensors, and Ethernet IP and Webpage Enabled.

Read Design Report DR-177

InterTech Design Report (DR-176)

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Ensuring Your Fuel Filtration System Is On Par With Today’s Engines

The Challenge: Today’s diesel engines and related engine parts must maintain the high-performance levels that both laws and the market require. Common rail fuel injectors, for example, operate at increasingly higher pressures, today up to 2,000-3,100 bar/ 30,000-45, 000 psi. At the same time, emissions regulations are more stringent than ever before, and if anything, will become more demanding in the coming years. These diesel engine considerations – for smooth operation and emission controls – require clean fuel, and the highly functional fuel filter technology that ensures it. If fuel filters are not on par with engine systems, clean fuel becomes elusive. In turn, that means expensive repairs and unplanned downtime for engines, fuel injectors and fuel pumps. Oil and fuel filter designs are continuously improving. Perfecting functional, leak and other tests to ensure both the integrity of filters, as well as optimal testing efficiencies during production, requires a deep bench of test engineering expertise steeped in the nuances of how these related parts – engines, fuel injectors, fuel pumps, and fuel and oil filters work.

The InterTech Solution: InterTech Development Company has been the source of choice for the A-list of global diesel engine and fuel filter innovators for decades. This work has included both partnering with diesel engine and oil and fuel filter design engineers developing prototypes, as well as manufacturing engineers seeking production line efficiencies.

Read Design Report DR-176

InterTech Design Report (DR-175)

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Updating Functional Tests for Accurate Dosing of Higher Viscosity Drugs

Functionally testing medical devices or performing sufficient audit testing to assure quality of drug delivery or blood collection devices are not new requirements. What is new, however, is the need to measure much smaller volumes – as small as one microliter. Medical device manufactures seek to use deterministic test methods to assure the reliability of new generation devices used both in clinical settings and in home self-care environments. These inherent challenges are amplified by recent advances in therapeutic proteins and more targeted drug products that encumber drawing and weighing methods with handling higher viscosity liquids. With these newer drugs, conventional delivery is precluded due to the need for longer injection times to reduce patient discomfort. Instead, smart injectors, infusion pumps and/or digital pills are the drug delivery devices of choice for a wide range of these high viscosity protein-based therapeutics. These devices enable low volume dispensing over a longer period of time. Historically, makers of collection tubes and drug delivery systems have relied on drawing and weighing methods to test the accuracy of their devices. Weighing must be done twice – before and after – introducing significant measurement uncertainties at both stages, as well as an increase in potential effects of ambient temperature variations affecting laminar flow and introducing distortions from vibrations. Traditional drawing and weighing methods are not up to the challenge – whether one is testing in-line or with extensive audit testing – to ensure that the specified drug volumes are delivered accurately. A key objective today is to cultivate a risk-based approach in the product development phase that allows medical device manufacturers to leverage testing as a means to better analyze and ultimately eliminate risks of releasing defective products to clinical and homecare settings.

InterTech Solution & Technology
InterTech’s test method correlates fluids with dry air testing, eliminating the need for cumbersome conventional flowmeters. InterTech MicroScale MED75 testers can detects leaks of 0.008 sccm with a test time of 10 seconds or less and GR&R of less than 20%.
This InterTech technique using the air pressure rise to measure liquid flow significantly improves accuracy and repeatability by eliminating the variable effects of bulk modulus (fluid compressibility) and temperature that distort results in conventional test methods.

Read InterTech Design Report (DR-175)

InterTech Design Report (DR-174)

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When will the transition from Internal Combustion Engines to Electric Vehicles Be Completed?
And, what should your company do in the meantime??
Electric vehicles have indeed moved from drawing boards to reality. However, a survey of the cars on America’s highways confirms that Internal Combustion Engines (ICE) still account for most vehicles on the roads. When there are ubiquitous charging stations that can fully re-charge vehicles in mere minutes that ratio of ICE to EV will likely flip.

InterTech Solution & Technology
InterTech Development Company’s deep bench of test engineering talent – arguably the most experienced test engineering specialists in the world – is now working closely with global Tier 1 and Tier 2 suppliers to the automotive/commercial vehicle ICE industry to find simpler and more efficient solutions for production testing that meet the needs of this moment in the industry. InterTech’s fifty years of developing efficient solutions for production testing in the automotive industry and beyond translates into quick alternatives for lower cost solutions – both in terms of superior testing methods and patented technology that will lower testing costs.

Read InterTech Design Report (DR-174)

InterTech Software Capabilities (DR-173)

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When you bring people, processes, and technology together to manage quality, you collect more than just data. You collect prescriptive insights on how to improve quality.
When an organization’s quality tools and data are completely unified, the underlying intelligence becomes a powerful tool, that can be seamless used by all levels of the organization to reveal its true value. Many items can be classified as data. Information is differentiated from data in that it is useful – often in the form of organized or structured data. Knowledge, on the other hand, is actionable information. Knowledge and wisdom refers to evaluated understanding or an appreciation of WHY and leads to action.

InterTech Software Capabilities
Integrate with many QA Quality Control software solutions on the market.
21 CFR Part 11 compliance.
40 million test record database.
Integrated GR&R software.
Can be used with statistical process control applications.
Helps users and managers dig into root cause, draw comparisons, and spot emerging trends.
Ability to integrate with various smart industrial equipment.
Easy to use and implement.
Quality data is stored in a purpose-built platform, which coordinate sustainable quality management practices.

Read InterTech Design Report (DR-173)

Get to know MD&M West IDC Booth 2355. Medtech and see trends impacting today and tomorrow

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MD&M West is the sourcing home for thousands of different types of suppliers. From medical device components to medical packaging, it has everything, and more, under one roof.

This show will take place on April 12-14, 2022 at the Anaheim Convention Centre, Anaheim, California…..tickets still available.

  • Tuesday, April 12, 2022: 10 a.m. – 5 p.m.
  • Wednesday, April 13, 2022: 10 a.m. – 5 p.m.
  • Thursday, April 14, 2022: 10 a.m. – 4 p.m.

The exhibitor list is posted on the show website.

Package Integrity Testing as Versatile as Your Packaging Design Requirements

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Package Integrity Testing by IDC

  • In a wide range of industries — medical, food and beverage, pharmaceutical, and more — product quality is only as good as the seal on the packaging meant to protect it.

  • InterTech M1075 Package Tester can be deployed for burst and leak audit testing of varying sizes of the entire gamut of flexible, rigid and semi-rigid sealed package designs, porous and non-porous materials.
  • All testing with the InterTech M1075 Package Tester is Compliant with: 21CFR11, ASTM F1140, ASTM F2054, ASTM F2095, and ISO 11607.

Package Integrity Testing as Versatile as Your Packaging Design Imagination

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In a wide range of industries – medical, food and beverage, pharmaceutical, and more – product quality is only as good as the seal on the packaging meant to protect it.

InterTech M1075 Package Tester can be deployed for burst and leak audit testing of varying sizes of the entire gamut of flexible, rigid and semi-rigid sealed package designs, porous and non-porous materials.

Interchangeable and unique fixture designs.

All testing with the InterTech M1075 Package Tester is Compliant with: 21CFR11, ASTM F1140, ASTM F2054, ASTM F2095, and ISO 11607.

Read more in DR172, contact IDC

The InterTech M1075 Package Tester

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In a wide range of industries – medical, food and beverage, pharmaceutical, and more – product quality is only as good as the seal on the packaging meant to protect it.

Check out IDC package tester expertise;

  • Speeds time-to-market for sealed packaging innovations
  • Effortless ASTM & ISO regulatory compliance
  • Fixture design eliminates test errors due to deflection of flexible packaging materials
  • Quick and easy adjustment for testing packages of varying heights and sizes
  • Small footprint
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