PDA – Validation of Moist Heat Sterilization Processes
From 23rd to 25th of March, it will take place in person at Fedegari Facility in Sellerville (PA).
What will be the topic of PDA training?
Based on PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control, this training course will provide a foundational understanding of sterilization science that can be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control. Hands-on activities will include actual sterilization cycle operations and execution with data review. The class will then participate in brainstorming over possible solutions to challenges. If the attendee can bring an example of the load item, it will be integrated into the autoclave execution.* This training course has hands-on lab activities.
Moreover, during the training, it will be shown how to calibrate the Kaye equipment applied to Fedegari autoclaves.
Learning Objectives
- Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program
- Develop a decision tree to select the most appropriate sterilization process based on the attributes of the load type
- Utilize the semi-log survivor curve equation in support of the development and ongoing control of the sterilization program
- Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods load types
- List the critical elements of process performance qualification
*PDA courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.
In which Fedegari subsidiary it will take place?
This training course will take place in person, with a limited number of 8 people, at Fedegari Tech Center USA located in Sellersville (PA) within Fedegari Technologies, Inc. facilities.
In Fedegari Tech Center USA customers can benefit from technical support, training and R&D personnel expertise on process and cycle development.
Fedegari Tech Center USA is equipped with the following process machines for hands-on training and tests:
Lab Division:
BINDER incubator
Industrial Division:
FCDV – Chemical bio-decontamination unit (hydrogen peroxide)
FOAF – Steam sterilizer / Steam-air Sterilizer (moist-heat)
FOWS – Washer-sterilizer
FOW – Super-heated water sterilizer
