Is There a Numerical Relationship Between Time and Temperature for Steam Sterilization?
Medical Product Manufacturing News (MPMN) turned to Nelson Laboratories’ Founder and Chief Science Officer, Dr. Jerry Nelson, as an expert source to answer questions about sterilization and biocompatibility for its online “Ask the Experts” section.
Here is the most recent question posed to Dr. Nelson:
By Tina May and Brent Shelley, Nelson Laboratories
Standard sterility and biocompatibility tests are already an essential part of many manufacturers’ protocols. What may not be as commonly understood, however, are the different ways a product can be contaminated during production, packaging and even cleaning processes. To avoid detrimental contamination, manufacturers should test their devices for, what Nelson Laboratories calls, Residual Manufacturing Materials (RMM).
by Amy Karren, Microbiology Section Leader, SM(NRCM), Nelson Laboratories
Bacterial endotoxin can be introduced to the human body by medical devices and pharmaceutical products through direct or indirect contact with blood, lymph nodes, and with cerebral spinal or brainstem contact if they are not properly manufactured or cleaned. Bacterial Endotoxin Testing is also referred to as the
Limulus Amebocyte Lysate (LAL) Test. Bacterial endotoxin contamination can present high fever and potentially cause death among humans.