Newsletter | July 17, 2025

07.17.25 -- Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

FEATURED EDITORIAL

Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

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

A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

INDUSTRY INSIGHTS

High-Volume Manufacturing: Essential Points To Consider Before You Scale Up

White Paper | B. Braun OEM Division

To successfully scale to high-volume manufacturing, planning is required for streamlining the production process and minimizing the changes that could add unnecessary time and expense to the process.

Innovative Multilayer Extrusion Technology Solves Product Redesign Challenges

Case Study | Nordson MEDICAL

A multinational medical device company successfully worked to redesign a component used in cardiovascular surgery.

Choosing The Right Contract Manufacturing Partner

Article | Brett Saddoris, Accumold

Accumold emphasizes values-aligned partnerships, precision micro molding, scalability, and sustainability to help medical device OEMs find the right CMO for long-term manufacturing success.

RESOURCES

Expert Tool Transfer: Ensuring A Rapid Return To Production

Medbio

The Use Of Injectable Packaging From Early Development To Commercialization

West Pharmaceutical Services, Inc.

ARTICLES YOU MAY HAVE MISSED

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What To Expect When You Move Into Production For The First Time

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Bracing For The Impact Of The Federal Workforce Reduction

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Cleaning: Understanding Populations And Sample Sizes

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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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