Microorganism Free

Sterilization Assurance

A sterile medical device is one that is free of viable microorganisms. USP requires that “articles intended to be sterile must attain a ≤ 10-6 probability of a non-sterile unit, i.e., less than or equal to one chance in one million that viable bioburden microorganisms are present.” This is known as the sterility assurance level…

Sterilization

Sterilization

USP <1229> addresses the subject of sterilization.  As a general information chapter, it “provides an overview of the concepts and principles involved in sterilization (by various modes) of compendial articles that must be sterile.”   Included in this main document is information on:  validation of sterilization processes, establishing and justifying sterilization processes that rely on microbial…

Viable Spore Counts

Population Assay

Each biological indicator (BI) that is manufactured contains a known number of microorganisms (also referred to as spores).  In order to confirm that the BI actually contains the expected number of spores, an individual will need to perform a population assay.  In USP <55>, this is referred to as Total Viable Spore Count.  This particular…

New Release!

Mesa Releases a New 24-hour Biological Indicator for the Sterrad® Sterilization Process

ExpoSure™ has received its 510(k) as a direct replacement product for monitoring the Sterrad® sterilization process. Mesa Labs announces the introduction of a new biological indicator (BI), ExpoSure™. The ExpoSure™ BI is a self-contained biological indicator (SCBI) for use in monitoring the efficacy of the following STERRAD® sterilization cycles: STERRAD® 50 STERRAD® 100S (Short &…

Microbiological Test System

What is a Biological Indicator?

Chapter 55 of the USP is titled “Biological Indicators – Resistance Performance Tests”.  Within the introduction, a definition of biological indicators is provided:  “A biological indicator (BI) is a well-characterized preparation of a specific microorganism with a known resistance to a specific sterilization process.”  To expand on this definition, a BI is essentially a microbiological…

BI Manufacturers Must Comply

U.S. Pharmacopeia

The U.S. Pharmacopeial Convention publishes a compilation of drug-related information, once a year, for the United States of America.  This publication is known as the USP (U.S. Pharmacopeia).  While designed to provide information on drugs or drug ingredients, as well as setting standards for dietary supplements and food ingredients, the USP also provides guidance (procedures,…

The Next Step...

Risk Management Report

The next part of our discussion on Risk Management is in regards to the Risk Management Report.  ISO 14971 states that “prior to release for commercial distribution of the medical device, the manufacturer shall carry out a review of the risk management process.  This review shall at least ensure that:  the risk management plan has…

Residual Risk

Weighing the Severity of Risk

The next step in risk management is to evaluate any Residual Risk that remains after the Risk Control measures are implemented.  It is important that the risk is identified and assessed properly.  According to ISO 14971, “If the residual risk is not judged acceptable using these criteria, further risk control measures shall be applied.” Your…