Newsletter | January 2, 2024

01.02.24 -- Introduction To The New ASTM E3418


Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices

The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.

Harnessing Connectivity In Medical Device Design

Unfortunately, putting a datalogger in a device and connecting it to a networked database is not a panacea. You’ll need to consider the tradeoffs, and you'll need to make the most of your data. And if you are thinking of using AI to help, you'll need to consider that extra layer of complexity.


Tech Talk: VHS Series Solenoid Valve For Bioprinting

Next-generation bioprinters will need fast, precise performance coupled with versatility to create tissue spheroids and extracellular matrix hydrogels. The Lee Company's VHS Series valves have printed a variety of cell cultures with impressive viability and accuracy and are currently in service with numerous commercial customers and research institutions.

Optimizing Your Critical Cleaning Process To Ensure Results

Getting the best results from any cleaner requires proper mixing and cleaning procedures. This article includes mixing directions for aqueous cleaning detergent and methods for monitoring performance.

Streamlining Catheter-Based Medical Devices With Advanced Multilayer Tubing

Medical device manufacturers developing devices for vascular and other applications are demanding polymeric tubing that boasts greater precision, tighter tolerances, and increased functionality. As tubing designs become more complex, so does the extrusion technology to produce them. Multilayer extrusion technology has been at the forefront of these advances.


Understanding The FDA's New Medical Device Cybersecurity Guidelines

Growth Strategies Pushing The Next Wave Of Surgical Robotics

Measurement System Analysis Using Continuous Gage R&R Studies, Part 1

Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2

Emerging Market Trends For Drug Delivery Devices


Micro Medical Device Manufacturing

Mesa UniQ Biological Indicators For Industrial Use

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