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…

Monitoring & Measurement of Processes

A manufacturing company is required to have suitable methods in place for monitoring and measuring the processes involved in their quality management system.  According to ISO 9001, “These methods shall demonstrate the ability of the processes to achieve planned results.”  Essentially, what this requirement is asking you to do is to confirm that you’re having…

Friday Facts – Management Review

Management Review is a requirement of both 21 CFR 820 and ISO 9001.  21 CFR 820.20 states “Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and…

Amilabo is Now Mesa France!

Mesa Labs is pleased to announce that Amilabo is now Mesa France! Sterilization and process validation/monitoring require a high level of expertise and specialized tools. Mesa Labs’ Biological Indicators (BIs) are specifically designed to meet the most stringent requirements and expectations. With the addition of Mesa Labs’ Lyon, France location (formerly Amilabo), Mesa now brings…

Dr. Sandle on Cleanrooms & Contamination

For pharmaceutical manufacturers, hospitals and other facilities that contain cleanroom technology, the risk of contamination can be avoided by implementing proper environmental controls. These controls range from efficient cleanroom design to implementing gowning procedures. A full, detailed article on what you can do at your facility to maintain workplace safety and prevent contamination is available…

Safety Risk: Duodenoscope Reprocessing

An article published by the Association for the Advancement of Medical Instrumentation (AAMI) on May 20, 2015 acknowledges the safety risk associated with duodenoscope reprocessing. Multidrug-resistant infections associated with reprocessed duodenoscopes has impacted more than one hundred patients, with the risk of involving even more. On May 15, the majority of members of the Gastroenterology…

Why Choose Mesa’s PCD?

Mesa’s PCD products are packaged in a controlled environment consistent with ISO 13485. No matter who the BI supplier is, Mesa controls the Deo with our pouches, meaning our PCD provides the most repeatable barrier to RH and EO, this same repeatability cannot be replicated with other packaged medical devices in typical industry EO sterilization…