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STERItalks
LIVE DISCUSSION
Why joining the conversation?
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Opportunity to get fast and free advice
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Talking to experts
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Sharing of practical & hands-on experience
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What is STERItalks?
Steritalks is a live discussion with our experts on sterilization and related topics. It brings to the participants an easy understanding and sharing of common questions and answers on sterile processes such as sterilization, decontamination, washing and contamination control.
Each session starts with our experts sharing practical knowledge on a specific topic.
You can request your participation at our live sessions to join the conversation.
In case of acceptance, you will receive an invitation with indications to connect via webex.
NEXT SESSIONS
Essentials for a successful validation
Thursday, June 4th, 2020
17:00 – 17:30 Italy (GMT + 2)
11:00 – 11:30 AM EST (GMT – 4)
Understanding Moist Heat Sterilization Principles
SOLD OUT!
Thursday, June 11th, 2020
17:00 – 17:30 Italy (GMT + 2)
11:00 – 11:30 AM EST (GMT – 4)
Deep Dive in Moist Heat Sterilization:
How to Use D and z Parameters
SOLD OUT!
Thursday, June 18th, 2020
17:00 – 17:30 Italy (GMT + 2)
11:00 – 11:30 AM EST (GMT – 4)
F0 Equivalent time
SOLD OUT!
Thursday, June 25th, 2020
17:00 – 17:30 Italy (GMT + 2)
11:00 – 11:30 AM EST (GMT – 4)
How to Use F0:
Learning from Practical Examples
Many professionals contact us to better understand the principles of moist heat sterilization as they are the starting point for setting up a successful validation.
More properly, in the pharmaceutical industry, in order to define a unit as sterile one must be able to certify that less than one unit in a million is exposed to the risk of not being sterile. The probability of finding a nonsterile unit (PNSU = Probability of Non Sterile Unit, or SAL) must therefore be smaller (as mathematical value) than 10-6.
Most of the FDA warning letters regard failure on proving the efficacy of sterilization methods which might demonstrate that sterilized products can achieve a SAL of 10-6.
How can I demonstrate that my product has reached a SAL ≤10-6?
This is one of the questions that we will approach at STERItalks.
THE SPEAKERS
After a Master Degree in Molecular Biology and experience as a research fellow in the National Council of Research, she has specialized with a second level master in current Good Manufactury Practice (cGMPs) and Validation in the Pharmaceutical Industry at the University of Pavia, Italy.
She is currently working on cycle design, development and validation of moist heat sterilization, decontamination with hydrogen peroxide and washing processes at the R&D departmet of Fedegari Group.
She received a B.S. in Biology from Lehigh University and is currently the Research and Development Lead for Fedegari Technologies, Inc. Samantha organizes training at the US facility located outside of Philadelphia, Pennsylvania. The facility is designed for customer collaborations and developing a deeper understanding of the Fedegari equipment and technology. Samantha specializes in cycle development activities for moist heat sterilization autoclaves, as well as hydrogen peroxide decontamination units and isolators.
Download the E-book!
E-training
Understanding Moist Heat Sterilization and Validation Aspects
Principles, Application & Challenges
E-training
Insights in Chemical Bio-Decontamination
Design, Application & Validation of H2O2 Processes
