Hello, and Welcome to this series of podcast related to microbiology and the medical devices industry.
The theme of this program is focused on microbiology within the medical products and devices industry.
The microbiologist has many areas of support within this industry. Many times, the least he or she does is practice in the laboratory. There are many activities required by the regulatory and controlled environment in which the industry operates. Laboratory tasks, on most occasions, are performed by analysts or laboratory technicians. The microbiologist focuses on other activities aimed at supporting manufacturing, complying with regulatory requirements, failure and non-conformance investigations, quality system audits, validations, product sterilization program management, validation, and maintenance of the sterilization process, among many that we will be discussing later.
The work a microbiologist does in the industry has a lot of span within different department across the Organization. Microbiology services and laboratory testing are important for determining the integrity of the clean rooms where the product is being manufactured. Its daily work relates to sterilization, contamination control program of processes, and product quality. This series will discuss some of the fundamental knowledge, roles and responsibilities of a microbiologist in a medical device industry.
