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.

Cobots come of age in manufacturing – IDC insights

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Collaborative robots have emerged as a fast-growing technology that can satisfy the demand for automation and flexibility in manufacturing with the potential to reduce labour costs, assist workers doing tedious tasks, and improve workplace safety.

In this design report we carry out a review of pressure decay and mass flow leak testing methods, and then explore the new technologies impacting decisions on how to best configure leak test systems including Integrated Robotics.

Test-intensive assembly lines

Key Insights include:

  • Updates to Mass Flow Test Methods
  • Customized Sensor Technology
  • Patented Innovations for Large Part Testing
  • Robotics and Calibrations
  • Harnessing IoT Benefits

Contact IDC for report details and download.

Medical Device Manufacturers Require Tighter Leak Test Requirements

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Tighter leak rate requirements are driving demand for smarter equipment in medical device manufacturing. In many cases Medical devices often form a barrier between fluids or gases that could create dangerous conditions for patients if they are allowed to mix.

Some products are the route for delivery or extraction of fluids.

M1075 Leak Test Instrumentation

Leak Testing Application

Complete or partial blockage of medical devices can fatal consequences as can the failure of a device to deliver the correct dosage or application.

Small, flexible materials are always a challenge, because they are difficult to handle. IDC has developed several new leak testing products that are designed to reduce this time-consuming process.

Contact us for our design reports on these latest test methodologies.

Leak Detection FAQ – Solving Automotive & Medical Device Manufacturing Testing Challenges

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Can we speed up leak testing of medical bags used in a widening array of medical applications?

As the uses of plastic medical bags continue to multiply, so do the challenges. Intertech offers a solution to speed up the leak testing of medical bags through InterTech MED 75 leak test technology. These superior MED 75 test instruments have unsurpassed test accuracies with automated R&R modes through proprietary leak test circuit designs incorporating patented mass flow solid-state sensors at their core.

 Will the AV/EV revolution require entirely new testing technologies for automotive manufacturers as well?

Many of the latest generation test instruments perfected for other applications are already being used in global AV & EV manufacturing plants. InterTech M1075 Leak Testers have proprietary leak test circuit designs incorporating patented mass flow solid-state sensors at their core.

How can manufacturing of newer generation micro-dosing smart drug delivery systems be done reliably and affordably

With a wide range of diseases requiring very precise dosing of pharmaceuticals in micro amounts, medical device manufacturers are faced with the challenge of new drug delivery and monitoring systems. Intertech offers the M1075-01y-D, a small volume upstream leak tester that can detect leaks of .08 sccm with a total test time of 10 seconds and GR&R of less than 20% for the latest generation of inflatable membrane drug delivery devices.

Is it Possible to Test Medical Tubing for Both Small Leaks and Unimpeded Flow at rate of 3.75 Seconds per Part While Also Meeting ISO 13485 Requirements?

Yes, it is possible to test medical tubing for small leaks at a rate of 3.75 seconds while also meeting ISO 13485 requirements! EtherNet/IP enabled InterTech Med75 dual function leak and flow test instruments fully test 16 parts per minute with GR&R of less than 20% in accordance with ISO 13485 Requirements for Maintaining Consistent Quality Systems.

Can soft super-flexible medical products be leak tested accurately and quickly?

Manufacturers of medical devices and products are being called upon to find new ways to help support homecare—proven to have better clinical outcomes for many treatments and almost always preferred by patients. Today’s advanced wound care products that create negative pressure environments to accelerate healing are good examples. IDC offers superior leak testing technology for medical products that ensure accurate and quick results.

 How to conduct air and oil testing?

Knowing which test mode to choose – air or hydraulic – requires a deep understanding of test methods, production line realities, and other application requirements. InterTech’s M1075 Functional Test Instrument offers hydraulic testing and air testing with real-time test graph results with accepting or reject status.

Can We Speed Up Large Part Leak Testing?

Leak testing large volume automotive components –transfer cases, oil pan assemblies, reservoirs, intake manifolds, and transmissions, and the like– poses a different set of challenges than those of testing smaller parts. However, large part leak testing can be sped up through utilizing mass flow leak testing technologies.

Are your medical device manufacturing methods liability-proof?

Intertech offers a solution for leak testing for medical devices utilizing InterTech M1075 Leak Tester which ensures accurate leak testing for plastic medical bags of various sizes at a pressure of 35 kPa (5 psig) to detect 0.5 sccm leaks that are equivalent to leaks from a 5 micron hole while meeting ISO 13485 requirements.

Intertech Development Company’s Automotive, Medical, & Industrial Testing Expertise 

In addition to the frequently asked questions, Intertech Development can provide you with the answers to your concerns in relation to the service, application, and concerns for testing automotive, medical, and industrial components.We are here to help you solve your automotive & medical device testing challenges. For more information on leak tests and how to ensure that your part will function as planned, contact the team at IDC today!

How Digital Infrastructure and Testing Technology Can Help During the COVID-19 Crisis

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As the Internet of Things is one of the most important technologies in everyday lives, it is important to utilize its capabilities with the situation that we are currently in regarding the COVID-19 pandemic. The Internet of Things (IoT) includes some core procedures: full spectrum perception, reliable transmission, and intelligent processing, and can be applied for the prevention and control of the COVID 19 and other respiratory infections and more.

Utilizing the Internet Of Things and InterTech Development Company’s Resources for COVID-19

By combining leak testing sensors, information technology, medical device nous, and real-time networking devices, IoT with InterTech knowledge can and does provide real-time communication between hospitals, patients, and medical devices which all improve current medical conditions in ensuring totally reliable devices use such as Ventilators.

For more information on the Internet of Things and how you can utilize IDC’s expertise and testing technology to ensure top-notch functionality of medical devices such as ventilators, contact the team at IDC today.

Testing Devices for Respiratory Ventilators – Gas Flow Analyzers for Ventilators

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Importance of Mechanical Ventilators & Respirators

To support patients with severe respiratory conditions that impact the lungs such as acute respiratory distress syndrome (a form of respiratory failure where the lungs become severely inflamed due to an infection or injury and can’t provide the body’s vital organs with enough oxygen), pneumonia, and COVID-19, ventilators are used to help patients breathe by getting oxygen into the lungs and get rid of carbon dioxide.

Respiratory Ventilator Manufacturing Challenges

With the current situation and increase in demand for medical ventilators, manufacturing experts and medical device makers are faced with the dilemma of whether newer companies that are not as familiar with this regulated sector are able to easily repurpose their shops to create these ventilators. In addition, the functionality ventilators are also questioned on how efficient and accurate they can simulate regular breathing patterns.

Gas Flow Analyzers for Ventilators:

Intertech Development Company offers a solution to testing the functionality for respiratory ventilators by providing precise electronic control of the vacuum ramp rate simulates different breathing patterns. IDC test devices for respiratory ventilators/instrumentation can confer a therapeutic benefit on a patient and ensure that specifications are adhered to and are acceptable for clinicians.

We have considerable test experiences and expertise in the Medical Device arena. Example applications include testing portable oxygen conservation devices (OCD) that minimize oxygen use because there are only flows when triggered by inspiration in a natural breathing cycle.

InterTech Medical Device Unit

The complete functional test of the system supplied by IDC for varying pressure ranges includes an auto triggering test to ensure that it does not operate unintentionally, a sensitivity test to detect the vacuum level at which the unit pulses, a pulse volume test at various positions to verify that the delivered volume is within the specification of each setting, continuous flow tests by selecting the control flow, a battery test at low-voltage pulse settings that test monitoring volumes, and an apnea test.

Ventilator Specification Requirements:

Our gas flow analyzers for ventilators are capable of simulating breathing functions to trigger a ventilator including adjustable inspiratory pressure and failure. Option to check ventilator over-pressure fail-safe function. Interactive HMI to provide operator prompts to select ventilator settings through the test cycle. Provide measurement of ventilator functions and provide alarms for:
• Respiratory rate / Inspiratory: Expiratory ratio (I:E)
• Plateau and peak inspiratory pressure expiratory pressure (PEEP), 0 to 100 cmH2O
• Tidal volume from 100mL to 800 mL

Intertech Development Company is ISO 9001 Registered and ISO 17025 Accredited. For more information on our testing technology capabilities and testing device for respiratory ventilators, contact the team at InterTech Development Company.

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