Newsletter | July 8, 2025

07.08.25 -- Cleaning: Understanding Populations And Sample Sizes

FEATURED EDITORIAL

Cleaning: Understanding Populations And Sample Sizes

By Andrew Walsh, Thomas Altmann, Joshua Anthes, Ralph Basile, et al.

This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

INDUSTRY INSIGHTS

Look, Ma! How I Solved These Disposable Diagnostic Device Challenges

Article | By Zach Hayman, Accumold

Disposable diagnostic devices combine typical medtech design hurdles with high-volume production considerations, limiting the list of vendors capable of excelling — or even operating — in this space. 

Extruded Medical Tubing: Process Parameters, Equipment Play Critical Role

Application Note | Nordson MEDICAL

Most medical tubing specifications comprise a drawing of a tube with the material, dimensions, and tolerances. However, parameters associated with the production of the tubing are also key.

Canon DC Brushless Servo Motors: Powerful Precision In A Petite Package

Article | By Koji Mizobata, Canon USA, Inc. Optoelectronic Components

Canon DC brushless servo motors’ combination of compact size, high torque, precision positioning, and high response make them ideal for medical and industrial applications.

Ensure Safety And Compliance With A Guide To Sterilization Validation

Article | Mesa Laboratories

Sterilization validation is vital in pharma and medical device manufacturing to ensure product safety and regulatory compliance. 

RESOURCES

Medical Grade Capacitors: MD Series

Knowles Precision Devices DLI

ARTICLES YOU MAY HAVE MISSED

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Key Regulatory Landscapes For SaMD Around The World

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A Look At Elsa, The FDA's New AI Digital Assistant

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Neuromodulation Dominates The U.S. Market For Neurological Devices

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Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis

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China's Medical Device Market: A Land Of Opportunity And Challenges

BULLETIN BOARD

Tubing Configurator

The IDEX Health & Science Tubing Configurator enables fully customized fluidic tubing assemblies with selectable materials, sizes, fittings, threads, colors, and labeling options.

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