Sterilization processes for medical device manufacturers

Produktnummer 08-056-24-EN

Training Präsenz / Virtuell
2 Tage
Beginner

Details

The seminar is focused on the essential requirements for the sterilization of medical devices and hygiene monitoring as the basis for the manufacture of sterile medical devices. You will gain a clear overview of the validation and documentation of sterilization processes in the medical device industry in order to ensure a valid manufacturing process in practice.

On this ground the special aspects of the various sterilization processes are presented in this seminar. Specifically, the following standards harmonized under the Medical Devices Directive 93/42/EEC and/or Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices or adopted as the state of the art will be discussed:

(EN) ISO 17665 series
EN ISO 11135
EN ISO 11137 series
EN ISO 14937

Inhalte | Content

Basics of microbiology
Where do microorganisms occur and how are they transmitted?
Procedures for microbial reduction
Cleanrooms and their operation in accordance with the EN ISO 14644 series.
Monitoring program for production hygiene
Method validation
Principles of sterilization validation according to EN ISO 14937
Specific aspects of the various sterilization processes
Overview of (EN) ISO 17665 series, EN ISO 11135, EN ISO 11137 series, EN ISO 14937
Characteristics of sterilization with damp heat
Characteristics of sterilization with ethylene oxide gas
Characteristics of radiation sterilization