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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, & filled by customer. |
| 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 fillers 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, and provide for the customer for approval. |
| Customer approvals the 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 and provides for the customer 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 |
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