Sterilizing Gases

Gaseous Sterilization

Continuing the series on USP, <1229.7> addresses gaseous sterilization.  Sterilizing gases are typically used when exposure to other methods (heat or radiation) could damage the materials or equipment.  The most common gases used for sterilization include ethylene oxide (EO), ozone, mixed oxides of nitrogen, and chlorine dioxide.  According to USP, “EO’s ability to penetrate through polymers, cellulosics,…

Immersion in a Chemical Solution

Liquid-Phase Sterilization

USP <1229.6> covers Liquid-Phase Sterilization. The traditional methods for sterilization include steam and dry heat, whereas Liquid-Phase sterilization requires immersion in a chemical solution. Per USP, “a number of chemical agents, such as aldehydes, acids, bases, and strong oxidants in solution, under the appropriate conditions, are capable of destroying bacteria and fungi, including both vegetative…

BIs for Sterilization

Biological Indicators for Sterilization

USP <1229.5> is dedicated specifically to the concept of using biological indicators during sterilization cycles. As discussed in a previous Blog (October 14, 2016), USP provides this definition: “A biological indicator (BI) is a well-characterized preparation of a specific microorganism that has known resistance to a specific sterilization process.” Since we’ve already discussed what a biological…

Removal of Microorganisms

Sterilizing Filtration of Liquids

Items can be sterilized by either destroying the microorganisms (such as using an Autoclave) or by physically removing them (by filtration).  According to USP <1229.4> “The physical removal of microorganisms depends on the bioburden of the solution to be filtered, the properties of the solution, the filtration conditions, and the filter itself.”  There are a number…

Contamination control program

Monitoring of Bioburden

Bioburden is defined as the number of bacteria living on a surface that has not been sterilized. A bioburden test determines the total number of viable microorganisms in or on a medical device. USP <1229.3>, Monitoring of Bioburden, sets up the requirement to monitor bioburden as part of your contamination-control program for sterilization processes. When…

Liquid Sterilization

Moist Heat Sterilization

USP <1229.2> is titled Moist Heat Sterilization of Aqueous Liquids.  This chapter discusses the sterilization of items such as in-process aqueous liquids, suspensions, laboratory media, and biological waste materials.  As described by USP, “sterilization of liquids in containers is accomplished by application of heat to the container, heating of the container wall, and ultimately heating of the internal…

14+ Years of Expertise

Compliance and Validation Services Expert Spotlight

Mesa Labs’ Compliance and Validation Services expert Zach Sparks has more than 14 years’ experience in: IQ/OQ/PQ qualifications and temperature mapping of incubators, freezers, refrigerators, autoclaves, depyrogenation ovens, and lyophilizers. Cleanroom qualifications, including viable and non-viable particulate monitoring for routine monitoring and ability to determine the placement of the non-viable particulate measuring equipment to meet…

Steam Sterilization

Steam Sterilization

The most common of all sterilization methods is steam. This is a nontoxic, inexpensive and sporicidal process. It rapidly heats and has the ability to penetrate fabric. Steam sterilization is achieved by exposing products to saturated steam at high temperatures (ranging from 121C to 134C), at a required pressure and for a specified time. Requirements…