استریلیزاسیون ایمپلنت های ارتوپدی با استفاده از روش پرتودهی گاما

استریلیزاسیون ایمپلنت های ارتوپدی با استفاده از روش پرتودهی گاما (بر اساس ISO 11137)

Table of Contents

Objective

Scope

Normative references

General requirements

Quality management system  

   Sterilization sector   

Sterilization requirements   

Documentation   

Sterilizing characterization

Sterilizing method   

Microbial inactivation or killing effect   

Product material effects   

Package material effects   

Process and equipment characterization

    Process   

Process variables and mean of monitoring and controlling       

Equipment   

Irradiator and its characteristics       

Segregation of non-irradiated product from irradiated product       

Conveyor path(s) and location of irradiator       

Irradiation container (tote box) specifications       

Product definition

Package and product specification    

Product microbial conditions before sterilization    

Process definition

Establishing the maximum acceptable dose    

Establishing the sterilization dose    

Validation

Validation of effectiveness of absorbed doses    

Installation qualification (IQ)        

Operational qualification (OQ)        

Performance qualification (PQ)        

Sterility Testing (effectiveness of the killing of the viable bacterial microorganisms)    

Review and approval of validation    

Routine control plan of sterilization process

Routine plan of process qualification and validation sterility test (for Demonstration of continued effectiveness)

Product release from sterilization

Re-validation and re-qualification of sterilization process (assessment of change)