ISO Certification

ISO Certification

Seeking certification to ISO 9001 and/or 13485 is not a requirement, but highly preferred by our customers. Both Mesa sites made the choice to achieve ISO certification, and we pay a registrar to verify our continued compliance with these regulations. ISO 9001 is not specific to medical devices but primarily for the Quality System. ISO…

ISO-11138-1 Part 2

ISO 11138-1, Part 2

In ISO 11138-1, Part 2 covers Biological indicators for ethylene oxide sterilization processes. As stated under the scope of this section, “This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide…

ISO 11138-1

ISO 11138-1: Sterilization of Health Care Products – Biological Indicators

Another standard we follow, as a biological indicator manufacturer, is ISO 11138-1.  This is titled “Sterilization of health care products – Biological indicators”.  According to the standard, “This part of ISO 11138 specifies general requirements for production, labeling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for…

New Methods

New Sterilization Methods

The final section of USP that is related to biological indicators and sterilization types is <1229.12>. This section addresses the concept of new sterilization methods. According to USP, “Sterilization processes are developed for the elimination of viable microorganisms while preserving the essential physical, chemical, and biological properties of the materials subjected to them. Where this cannot…

Vapor Sterilization

Vapor Phase Sterilization

Another method for sterilization is vapor phase.  USP <1229.11> addresses this subject, starting out by saying “Sterilization can be accomplished using sporicidal agents suspended in air (i.e., vapor).  Sterilizing agents that operate in this fashion include hydrogen peroxide (H2O2), peracetic acid (CH3CO3CH), formaldehyde (CH2O), and glutaraldehyde [CH2(CH2CHO)2] in aqueous solution.”  One difference between this method…

Great Expressions Dental Centers Receives First Ever Summit Compliance Award

Mesa Labs announced the recipient of the first ever Summit Compliance Award to Great Expressions Dental Centers as recognition of their organization-wide commitment to infection control, demonstrated by achieving the highest levels of weekly, biological sterilization monitoring compliance. Their commitment helps assure that sterilization equipment is functioning properly, which is a critical measure in keeping…

Radiation Sterilization

The next USP chapter in this series, <1229.10>, discusses radiation sterilization.  This process “utilizes the lethal effect of various forms of radiation as a means of microbial destruction.”  There are two primary types of radiation:  ionizing (gamma, x-ray or beam) and nonionizing (microwave, infrared, x-ray, ultraviolet light). Because of how radiation works, there is potential…

Sterilization Focused

Dry Heat Sterilization

Dry heat sterilization was one of the earliest forms of sterilization practiced.  This process is accomplished by utilizing conduction methods (heat is absorbed by the exterior surface and passed inward to the next layer).  Dry heat does most of the damage by oxidizing molecules.  The essential cell components are destroyed and the organism is killed.  Exposure times…