HOME PRACTICAL EXPERTISE

STERItalks 

LIVE DISCUSSION

Why joining the conversation?

 

    • Opportunity to get fast and free advice

    • Talking to experts

    • Sharing of practical & hands-on experience

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.

Design your next customized training!

Fedegari can create your own program and deliver you a unique learning experience.

We offer customized training modules for personnel who seek to acquire deeper knowledge about specific subjects.

Different technical courses covering the science behind the processes and practical advice on cycle development, performance and validation activities can be delivered to guarantee the highest performances to your team.

Join the conversation!
I authorize the use of my personal data in compliance with UE Regulation n.67/2016 on the protection of natural persons with regard to the processing of personal data (GDPR). My details will not be communicated or disclosed to third parties , and I may require at any time, the access, the rectification, the erasure, the restriction, the portability and to object their use (according to Articles 15, 16, 17, 18, 20, 21) by sending an e-mail privacy@fedegari.com.

THE SPEAKERS

Lucia Maita, R&D Specialist 
Fedegari Group
Lucia Maita, R&D Specialist Fedegari Group
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.
Samantha Kay, R&D Specialist Fedegari Group
Samantha Kay, R&D Specialist 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!

EBook_Fedegari

E-training

Understanding Moist Heat Sterilization and Validation Aspects

Principles, Application & Challenges

1
Basics of sterilization
2
Understanding sterility assurance concepts, D-value, Z-value, F0
3
How to select the appropriate steam sterilizer according to the load type

4
Treatment of porous and liquid loads

5
Main factors that strongly impact the outcome of a sterilization process

6
Selecting the validation methodologies according to load attributes: overkill, bioburden/biological indicator and bioburden-based approach

7
Defining the “worst case” load

8
Performing physical and microbiological studies

9
Validation equipment (TC’s, CI’s, BI’s): selection, placement and results interpretation

FCDV_prodotto_fedegari

E-training

Insights in Chemical Bio-Decontamination

Design, Application & Validation of H2O2 Processes

1
Overview of vaporized hydrogen peroxide technology
2
Critical process parameters and examples of relevant case studies

3
Validation activities: enclosure evaluation and CI’s, BI’s and TC’s utilization

FCTS_fedegari_product

E-training

Overcoming Challenges in a Sterility Testing Isolator

Testing Procedures and Environmental Monitoring

1
Guidance on conducting sterility testing and environmental monitoring
2
Practical advice on consumables, equipment, design, application and challenges

3
Achievieng the highest level of safety and testing confidence

Do you need more information?

Contact us to create your own program. We can deliver you a unique learning experience.

Request your customized training offer to acquire deeper knowledge about specific subjects.

We will cover the science behind the processes and practical advice to guarantee the highest performances to your team.