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Testing Medical Devices and Package Integrity
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Testing Medical Devices and Package Integrity
 
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Testing Medical Devices and Package Integrity
From tmelectronics.com

When a manufacturing firm produces a product designated for use in the medical field, the company must supply one element regardless of part design: assurance. Through the use of in-line product testing and final package testing, a manufacturer can document the steps taken to assure the end user that the product has been examined and has passed the standard testing procedures designated by organizations such as the Food and Drug Administration (FDA), International Standards Organization (ISO), and American Society for Testing and Materials (ASTM). A quality control department, therefore, must be aware of different testing methodologies in order to gain this control and assurance over the production and packaging processes. This report examines different product and package testing procedures, focusing on the pressure decay leak and mass flow tests for product integrity and seal strength and pressure decay leak testing for package integrity. By implementing pressure decay leak testing, mass flow testing, and seal strength testing to a quality control system, a manufacturer of medical devices will gain control over their manufacturing process, and therefore gain quality assurance in the field.

 


Products & Services
Leak testing equipment is used to measure the escape of liquids, vacuum or gases from sealed components or systems.
Material test fixtures and accessories include mechanical testing grips, fixtures, sample heaters, extensometers, specimen cutters, and other specialized test components.
Inspection services examine products, parts, equipment, repairs, services, installations, and facilities to ensure quality, consistency, and condition, as well as conformance to required standards and/or procedures.
Product and component testing services is the evaluation of a finished product or component through performance in electrical, life, environmental exposure, dynamic, ergonomic or other specialized tests.  Also testing to standards such as UL 489, CE or MIL-STD 810.
RoHS testing and compliance services providers test a manufacturer's products for restricted or hazardous substances and certify compliance to RoHS or WEEE standards.
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Product Announcements
TM Electronics, Inc. - Solution-CBC Non-Destructive Blister Card Tester
A non-destructive chamber pressure (or vacuum) decay leak test system for blister cards. System consists of the TME Solution high-resolution leak and flow test instrument with a chamber test fixture... (read more)
TM Electronics, Inc. - TME ND-P/V Chamber Test System
The TME ND-P/V Chamber Fixture enables quantitative leak test results from products that cannot be accessed through an access port, as well as sealed, non-porous flexible medical and pharmaceutical... (read more)
KUNTZ Automation Engineering - Leak Testing
Kuntz has been engaged in Leak Testing equipment for several decades. From pressure testing and pressure decay to destructive burst testing and bubble break point testing to high voltage leak... (read more)
Uson, L.P. - Accurate Leak/Flow Testing - Affordable Versatile
On the benchtop or mounted into your automated system, Qualitek mR is impressively simple to use and highly configurable, accepting a full range of test and transducers. From faucets to fluid bottles,... (read more)
TM Electronics, Inc. - BT-1000 Automated Seal Strength & Integrity Tester
The BT-1000 seal strength and package integrity tester measures the seal strength of porous and non-porous flexible packages using inflation tests such as burst, creep, and creep-to-failure methods,... (read more)
TM Electronics, Inc. - BT-1000-100
Based on the popular BT-1000, this new burst tester has been designed for high pressure test applications, such as plastic and laminate tube inflation. (read more)
TM Electronics, Inc. - Solution-C Non-destructive Chamber Test System
The TME Solution-C Leak Tester performs a non-destructive, pressure or vacuum decay chamber leak test on sealed products or non-porous packages. Tests are repeatable and sensitive (0.0001 psig... (read more)
TM Electronics, Inc. - TME Worker Leak, Flow & Occlusion Tester
The TME Worker™ is a one port, high-res, pressure or vacuum Leak Tester, Leak/Flow Tester, or Leak/Occlusion Tester. Affordable, sensitive (resolution 0.0001 psi), repeatable, reliable, the... (read more)
Uson, L.P. - Functional Tester supports many industrial sensors
Providing the ability to perform any type of functional testing required by your application the Vector Functional Tester can increase your product value, reduce costs and minimize liability in a wide... (read more)
 
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Topics of Interest
Pressure decay is an established method of leak testing which involves the initial inflation of the test object and the establishment of a reference pressure. After a designated amount of time, the... (Read More)
Failsafe leak testing, where one never misclassifies a bad part as a good part, is doable. Better yet, good parts are never misclassified as bad parts and yield is maximized. However, this standard of... (Read More)
International Truck and Engine Corp. produces commercial trucks, mid-range diesel engines, school buses, chassis for motor homes and step vans, and diesel engines for the pickup truck, van and SUV... (Read More)
Testing flexible packaging for burst seal strength and creep resistance continues to be an important aspect in ensuring overall device integrity. An improved method of performing these tests involves... (Read More)
Horsham, Pennsylvania: Precision sealing of integrated circuit packages at high speed requires a backlash-free motion system to produce the highest quality seal. These systems have digital sealing... (Read More)
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Technical Articles
Testing Medical Devices and Package Integrity (.pdf) - Level Sensing
Calculating Factors of Safety for Package Burst and Creep Test Fixtures - Level Sensing
Implications for Process Package Testing in ISO 11607 - Level Sensing
Welding Miniature Devices - Industrial Assembly
Motor Designs To Survive Hostile Environments - Motors
Designing with Inflatable Seals - Machine Design - Seals
Better than metal - Bearings and Bushings
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See more product announcements for Leak Testing Equipment
Tracer Gas Leak Detector H2000 PLUS

Tracer Gas Leak Detector H2000 PLUS
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Powerful Dry Leak Detector ASM 182TD+; ASM 192T2D+

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Compressed Air Leak Detection

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