would guess that many people who read our blog, have worked with medical
devices, or have ever had an intravenous injection in a hospital will be
familiar with the luer connecter. This small device enables the connection of
drug delivery devices and accessories. It might be fair to say
Leak testing and leak
detection is a broad field and includes methods for detecting environmentally
damaging or hazardous leaks in process industries and distribution networks,
water leakage in buildings, swimming pool leaks and, of course, methods used in
manufacturing to ensure product performance and safety. For this introduction
When it comes to breathing tubes, CPAP tubes, and any devices with similar air masks that support respiration, too much or too little air flow will impact the amount of oxygen the user gets, which can be dangerous. Air flow within these devices must fall within a very tightly specified
Multi-part assemblies or parts with several discrete cavities present challenges for their manufacturers. Each pathway must be leak free and importantly there must be no cross-talk between cavities. To maintain throughput, it might be necessary to employ several leak testers or create a complicated system using a PLC and several
US FDA guidelines for storing and protecting electronic records—known as 21 CFR Part 11—have been in place for more than 20 years. However, due to advancements in technology and innovation, combined with the sheer volume of data being generated, the regulation has never been as relevant as it is today
In this post we are going to look at the challenges of testing drug delivery devices.
There are many different types of drug delivery device, but they all have things in common – an inlet port and an outlet port, a flow restrictor (regulator) and a bypass valve. These components
A short or reduced cycle time is often touted as a key differentiator in many instruments, because a reduction in cycle time can lead to improved efficiency and optimized profit potential. Leak testers are no different, and as a manufacturer of leak testers, one of our goals in the R&D
These days it seems uncovering the truth is getting harder and harder, day by day. Fake news? How do I know if it’s fake or not? False social media accounts. How would I tell the difference?
Truth and the concept of truth are becoming devalued. To tell the truth. Truthfully.
#1 Cycle Time is Impacted by Multiple Variables
Most medical device manufacturers have high-volume production lines and want fast cycle times to ensure the most efficient manufacturing process. A shorter cycle time can negatively impact reliability and repeatability, which should never be sacrificed for speed. Cycle time is also impacted
This article is a 3-part series
Part 3 – Consolidation of companies within the medical device manufacturing industry is creating challenges relating to globalization
Consolidation of companies within the industry is creating challenges relating to global integration, such as language and communication issues, uniformity of processes,