Responsibility Matrix


Responsibilities

For Irradiated products, the manufacturer keeps the ultimate responsibility for his product. Irradiator is only responsible for dose delivery under validated plant parameters. Responsibilities are normally defined as follows:

Topic IRRADIATOR MANUFACTURER
Definition of the dose range  
Validation of the dose definition  
Validation of the dose suitability  
Microbiological validation  
Treatment SOP  
Irradiator Commissioning  
Definition of the loading pattern  
Assurance of the loading pattern  
Dosimetry  
Release of the Final product  
Stability tests  
Packaging  
Responsibility for transports  
 
 
 
 
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