Newsletter | October 23, 2025

10.23.25 -- Streamline Cleaning Validation With Risk-Based ASTM Methods

SPONSOR

Join 1,000+ pharma, biotech, and drug delivery professionals at the PODD: Partnership Opportunities in Drug Delivery Conference, October 27–28 in Boston. Featuring 10 technology tracks, pharma company spotlights, 1:1 partnering, and more. Attendees will also hear from leaders at companies including AbbVie, Amgen, AstraZeneca, Biogen, Eli Lilly, GSK, Moderna, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and others. Register at PODDConference.com with code LSL20 for 20% off.

FEATURED EDITORIAL

Risk-Based Method Selection For Cleaning Validation Using ASTM Standards

A risk and data-based framework using ASTM standards enables practical, safe, and verifiable cleaning validation, guiding analytical method selection based on HBEL and method sensitivity.

INDUSTRY INSIGHTS

Ethylene Oxide For Industrial Sterilization

Understanding EO sterilization requires careful control of cycle variables and strict safety protocols. Learn how evolving standards and best practices ensure both effective sterilization and compliance.

Essential Points To Consider Before You Scale Up Manufacturing

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.

Optimize Packaging Systems For Distribution Integrity

Ensure medical device safety during transport with ASTM and ISTA-guided testing, robust packaging layers, and validation protocols that protect integrity and prevent contamination.

RESOURCES

Medical Device Solutions: From Concept To Commercialization

Cardiovascular Medical Device And Surgical Components

ARTICLES YOU MAY HAVE MISSED

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Trust But Verify: Validating AI In Pharma's GxP World

Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device

EU MDR: When Products Without An Intended Medical Purpose Meet Medicinal Substances

The Companion Diagnostic Strategy That Combination Product Leaders Need

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