

Assistance in setting up sterilization systems upon demand, or ensuring that the existing systems comply with standards. Scope includes but is not limited to:
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Initiating the sterilization project, and working with the sterilization manufacturer for the successful launch of the operation
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Providing guidance on the required GMP’s that are associated with the sterilization process
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Determining the layout and flowchart of the sterilization process within the plant
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Specifying the “zones” with the addition of sterilization, ensuring proper segregation between high-care, low- and high-risk areas
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Procedures specific to sterilization process to be written and integrated into the quality management system of the company
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Specifying CCP's of the process and including in the HACCP manuals
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Training of production personnel to handle sterilized goods
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Training on potential post-process contamination risks and preventive measures
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Assistance with the internal and external validation of the sterilization unit
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Training relevant staff member(s) on sampling methods for microbiology testing - quantity and methodology
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Consulting on pre- and post-treatment hygiene and sanitation applied within the factory
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Presentation of the value of sterilization to management, staff, and company's customers.


