Sterilization Validation Process

Daily flow chart of ethylene oxide sterilization validation :

Ethylene oxide sterilization validation workflow:

1	Sterilization suitability analysis of the products	Marketing department is responsible for collecting product information;
		Technical department is responsible for sterilization suitability analysis of the products;
		Marketing department makes a preliminary quotation for EO sterilization validation and routine sterilization.
2	Contract review and sign	Marketing department sends Technical requirement of Ethylene Oxide sterilization validation to the customer, and filled by customers.
		Marketing department shall have the Ethylene Oxide sterilization validation contract according to Technical requirement of Ethylene Oxide sterilization validation.
		Both parties shall review and sign the Ethylene Oxide sterilization validation contract.
3	Sterilization validation—Preparation	Marketing department sends production order of EO sterilization validation to the technical department and the laboratory.
		Marketing department sends Preparation list for sterilization validation to the customer, and the customer prepares dunnage and testing samples.
		Both parties identify the most difficult location for sterilization. Technical department shall make validation protocol and get its approval from clients
		Technical department shall implement sterilization validation according to the sterilization validation protocol
		The laboratory implements various tests.
4	Sterilization validation - implementation	Technical department prepares the sterilization validation report, provides it to the customer for approval.
		Customer approves sterilization validation report;
5	Sterilization validation - completion	Technical department shall clean the remaining dunnage and testing samples and inform the customer to take them back.
		Technical department prepares the customer specifications for routine sterilization according to the sterilization validation report provides customer the under controlled documentation.
		The quality department signs a quality agreement with the customer;
6	Routine sterilization	Marketing department signs the sterilization processing contract according to the customer sterilization requirements.
		The production department implements EO sterilization process;
		The quality department provides the batch records after sterilization