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EQ sterilization

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Medical Devices

环氧乙烷灭菌

 

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环氧乙烷灭菌

 

Sterilization processes of ethylene oxide sterilization workshop are as follows:

环氧乙烷灭菌

 

Ethylene oxide sterilization flow chart

环氧乙烷灭菌

 

Flow chart for ethylene oxide sterilization validation process

 

01

Sterilization suitability analysis ofthe 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 quotationfor EO sterilization validation and routine sterilization.

02

Contract review and sign

Marketing department sendst T echnical requirement of Ethylene Oxide sterilization validation to the client

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.

03

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 client, and the client prepares dunnage and testing samples.

Technical department prepares the sterilization validation protocol, and provide to the client after approval.

The client approvals the sterilizationvalidation protocol.

04

Sterilization validation一implementation

Both parties identify the most difficult location for sterilization.

Technical department shall implement sterilization validation according to the sterilization validation protocol

05

Sterilization validation一completion

Technical department prepares the sterilization validation report, and provide to the client after approval.

client approvals the sterilization validation report;

Technical department shall clean the remaining dunnage and testing samples and inform the client to take them back.

06

Routine sterilization

Technical department prepares the client specifications of routine sterilization according to the sterilization validation report and provides to the client under controlled documentation.

Marketing department signs the sterilization processing contract according to the client sterilization requirements.

The production department implements EO sterilization process;

The quality department provides the batch records after sterilization