Assistance in setting up sterilization systems upon demand, or ensuring that the existing systems comply with standards. Scope includes but is not limited to: 
 

  • Initiating the sterilization project, and working with the sterilization manufacturer for the successful launch of the operation

  • Providing guidance on the required GMP’s that are associated with the sterilization process

  • Determining the layout and flowchart of the sterilization process within the plant 

  • Specifying the “zones” with the addition of sterilization, ensuring proper segregation between high-care, low- and high-risk areas

  • Procedures specific to sterilization process to be written and integrated into the quality management system of the company

  • Specifying CCP's of the process and including in the HACCP manuals

  • Training of production personnel to handle sterilized goods

  • Training on potential post-process contamination risks and preventive measures 

  • Assistance with the internal and external validation of the sterilization unit 

  • Training relevant staff member(s) on sampling methods for microbiology testing - quantity and methodology

  • Consulting on pre- and post-treatment hygiene and sanitation applied within the factory

  • Presentation of the value of sterilization to management, staff, and company's customers. 

 

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​© 2013 Karasu Consulting

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