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 1

Part 2

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,

This article is a 3-part series

Part 1

Part 3

Part 2 – Non-compliance can have a tremendous impact on profitability within the medical device manufacturing industry

Ongoing regulatory compliance heavily impacts the development, launch, and manufacture of medical device products. Because of the highly regulated nature of this industry,

Many devices are constructed with passages that must remain open if the product is to function normally when used. During the manufacturing process, it is sometimes possible to inadvertently create a blockage in a passage thus affecting the quality and performance of the device.This will necessitate an occlusion test.

An

This article is a 3-part series

Part 2

Part 3

Part 1 – Product innovation is moving at an unbelievable pace in the medical device manufacturing industry

Product innovation is a key performance indicator (KPI) for the medical device industry. Medical device companies are driven to continuously innovate their processes,