Newsletter | September 10, 2024

09.10.24 -- Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD

FEATURED EDITORIAL

Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD

The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.

INDUSTRY INSIGHTS

Minimizing Supply Chain Risks With Porous UHMWPE Membrane Alternative

Regulations to reduce the use of PFAS chemicals have led to the potential for porous UHMWPE membrane to serve as a substitute for materials like PTFE, commonly used in medical devices.

Liquid Silicone Rubber (LSR) Vs. High Consistency Silicone Rubber (HCR)

Medical-grade silicone, known for its biocompatibility, is used in both LSR and HCR forms. Discover their distinct properties and applications in medical devices.

Understanding Injectable Drug Container Closure Systems

Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

The Role Of Sensing Technologies In Delivering Personalized Patient Care

Advancements in sensing technologies revolutionize individualized healthcare, from wearables to implantables. Explore key areas where sensors are reshaping personalized care.

Extruded Medical Tubing: Process Parameters, Equipment Play Critical Role

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.

ARTICLES YOU MAY HAVE MISSED

FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection

The Learned Intermediary Doctrine Sees Curious Change In California

Is Your Lab Ready For A LIMS Implementation?

FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

Answer These Questions To Guide Your Prototyping Strategy

RESOURCES

An Innovative And Versatile Drug Delivery Platform

Connect With Med Device Online: