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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.