Introduction to Microbiology and Sterilization

Form our partners at Sterigenics:
Are you looking for foundational knowledge on microbiology as it relates to sterilization services and testing? Watch this on-demand webinar today by Jennifer Gygi, Expert Technical Consultant from Nelson Labs. Learn the basic vocabulary of microbes, how they are characterized, and where they come from. You will then follow those microbes through the testing process and learn what bioburden is and why it matters as well as examples of different testing procedures. The concept of sterility assurance levels is introduced, with examples and calculations to prove the concept of sterility. Lastly, the importance of monitoring your environment is discussed, along with alert and action levels as dictated in AAMI TIR 52:2014.
About RCA
Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for the resolution of life science challenges:
Life Sciences
Pharmaceutical
Biologic & Biotechnology
Sterile compounding
Medical device
Lab Testing
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA, and globally regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
Founded in 2000
Headquartered in Wisconsin (USA)
Expertise backed by over 500 industry subject matter experts
Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses - Sterigenics®, Nordion®, and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
Commitment to Quality
Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.