How can throughput on ventilator and related respiratory treatment technology keep up with the demands of the current and future pandemics?

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The COVID-19 pandemic has transformed demand for oxygen delivery systems overnight.  Global health care specialists warn that the world’s manufacturing systems need to also prepare us for pandemics to come.   Whether your company is an automotive or other manufacturer newly moving into ventilator manufacture, or is an existing ventilator manufacturer seeking to multiply production several fold, any and all production bottlenecks need to be eliminated to meet this skyrocketing demand.

Context on Ventilator Applications

Historically, testing of oxygen delivery devices pre-market release has posed a significant hurdle.  Rapidly manufactured ventilator systems must function with precise control of pressures, oxygen volumes, failsafe toggle between on-demand and automatic mandatory ventilation, and allow clinicians to manage tidal volumes, respiratory rates and more.    Machine design must also allow for infection control either via disposable parts or easy decontamination.

InterTech Expert Instrumentation replaces error-prone mechanical components such as bellows used for calibration of oxygen delivery systems to significantly improve system response times and repeatability.

Contact IDC for full application details and new design reports on ventilator and related respiratory treatment technology testing

21 CFR Part 11 Compliance – IDC application know-how

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CFR Part 11 applies to drug manufacturers, biotech companies, medical device manufacturers, contract research organizations, and several other FDA-regulated industries (such as food and beverage manufacturing) – some companies use Part 11 as a guide to assure that they are utilizing good processes for managing their electronic training records and other documents.Med75 Leak tester

Accurate record generation means that records entered into the system must be completely retrievable without unexpected alteration or unrecorded changes. There are many ways InterTech products and equipment can help Medical Device Users towards 21CFR11 compliance. Accurate record generation means that records entered into the system are completely retrievable without unexpected alteration or unrecorded changes.

InterTech Instrumentation and Application expertise provides turnkey customized solution for leak testing applications that guarantees single source Gauge R & R gauge compliance capability, guarantying the speed and reliability of the measurement values acquired by the system. In audit and production applications IDC instrumentation testing results determine quality, safety, strength, efficacy, or purity related to product release and product quality.

Contact IDC for application details.

InterTech’s innovative sealing mechanisms for audit tests of small parts can be relied upon to shorten time-to-market

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Many of the latest generation product designs rely on the integrity of small dimension parts to function as designed, and/or to be leak-proof. This is true of a wide range of applications that now incorporate small die cast or molded parts from AV EV, to latest generation medical devices, and more.

Speeding audit testing is not only a matter of using best in class test technology. Fixture design must also allow for consistent test results, and the quick changes that an aggressive R&D team creating and testing myriad new product designs requires.

InterTech’s fixture designs for small part R&D, like other InterTech innovations to streamline all new product audit testing, are similarly low-cost.

Gauge R&R of 1 -20% for small parts is assured.

A wide range of part variety is accommodated on the same stand, saving time and money.

Versatile InterTech instruments make it easy to add, edit and change programs and part parameters.

For example, you can remotely control pressure limits and fill times, upper and lower calibration factors and many other variables.

Rigorous testing of electronics’ sealed enclosures to IP67 standard

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The Challenge:

• Smart Phones
• Medical Wearables & disposables
• Cameras for AV applications
• Radar/Lidar Enclosures
• And more…

These and similar electronics-based products can only be reliable if and when they are able to withstand dirt and water. Specifically, these electronics-based components must all meet or exceed IP67 ingress ratings. That means they must be totally protected against dust and protected against the ingress of water in a harmful quantity after immersion in 1 meter of water for up to 30 minutes.

Without proper IP 67 testing of sealed enclosure integrity, the lifespan and performance of a fast growing array of consumer and industrial electronics components cannot be assured.

An InterTech M1075y leak detector is used for fast and accurate testing to meet IP67 requirements. InterTech test technology automatically compensates for external changes such as temperature, and a unique test-centric design assures gage accuracy.

Mass flow leak testing with the InterTech M1075 is non- destructive, clean and easily handles specifications of 0.5 sccm at pressure of 0.2 to 0.3 bar with fast test times. Because it effectively checks for gross leaks prior to fine leak testing absolute reliability is ensured.

Studies of test instruments for best-match leak testing technology

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Systematic studies of the leak tester technologies offered by instrument manufacturers can reveal superior best-match technology quickly, if and when gauge R&R is specified along with other test capability metrics.

Pandemic related products such as ventilators, respirators and clinical testing machines must be brought to market quickly. The requirements to assure functionality and integrity of these medical products is in many aspects quite similar to those historically faced by the automotive manufacturers who are newly entering these markets. For example, leak-proof filtration systems are critical to both many automotive and medical parts.

If manufacturers make the wrong sourcing decisions when creating new product assembly lines for ventilators and similar, they will inevitably encumber their products with higher price tags, or create testing bottlenecks on production, or both.

The ability of manufacturers of medical equipment needed to handle the skyrocketing demands created by the pandemic hinges on finding best-match test technology for products that must be fail-safe.

Contact IDC for complete details on a leading technology paper on comparative studies.

Combination products are therapeutic and diagnostic products that combine drugs, devices, and / or biological products

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Combination products are therapeutic and diagnostic products that combine drugs, devices, and / or biological products. Because combination products involve components that would normally be regulated under different types of regulatory authorities they raise challenging regulatory, policy, and review management challenges. Med75 Leak tester

Differences in regulatory requirements for component testing impacts the processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing needs, manufacturing and quality control and any post-approval modifications.

Contact IDC for design insights on how our medical device testing technologies such as the M1075 contribute to the challenges in manufacturing and quality control in these key medical product areas.

Drug and device combination product (DDCP)

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Mechanical and chemical testing are needed to bring complex drug-delivery products and other combination products to market. A growing number of combination products, along with the overall growth of the pharmaceutical and biologics industry, is driving demand for a more-complex arsenal of tests

Drug and device combination product (DDCP) is merging chemical and mechanical disciplines- it is required by FDA/EMA to have both drug stability as well as the device functionality tests on the same stability program.

M1075 Leak Test Instrumentation

The demands increase for the combined mechanical and chemical testing services to demonstrate that both drug and device are stable and functional through the shelf life of the combination product. IDC with its M1075 medical device testers is providing leading edge technology in such key areas ensuring quality of end products.

These tests play an important role in determining the safety and effectiveness of combination products and are used to show that contaminants from the manufacture, fill, or seal process have not compromised the drug product.

Contact IDC for application details.

Ventilators, respirators and clinical testing machines – IDC Know-How and Application Expertise

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Pandemic related products such as ventilators, respirators and clinical testing machines must be brought to market quickly.

The requirements to assure functionality and integrity of these medical products is in many aspects quite similar to those historically faced by the automotive manufacturers who are newly entering these markets.
For example, leak-proof filtration systems are critical to both many automotive and medical parts.

If manufacturers make the wrong sourcing decisions when creating new product assembly lines for ventilators and similar, they will inevitably encumber their products with higher price tags, or create testing bottlenecks on production, or both.

Contact IDC for latest design reports on how to apply its proven testing technologies in key medical device areas.

Can comparative studies of test instruments be applied to assure that best-match leak testing technology for a specific application is being used?

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Systematic studies of leak tester technologies offered by instrument manufacturers can reveal superior best-match technology quickly, if and when gauge R&R is specified along with other test capability metrics.

InterTech Development Company now works with prospective customers to assure that a head-to-head comparison of InterTech leak testers is made with instruments from 3 or more other global market leaders in leak test technology.

Criteria of specific targets for decreasing test cycle time while maintaining gauge R&R are specified.

Contact IDC for the latest design report on the latest comparative studies based on application requirements.

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