EO Sterilization Services

MedClear Sterilization Service offers professional Ethylene Oxide (EO) sterilization services for medical devices, pharmaceutical packaging, cosmetics and other sanitary products. We provide one-stop solution that includes sterilization process development, sterilization process validation and routine sterilization based on customer needs.

Currently, the company has sterilization facilities in Panyu, Guangzhou and Xiegang, Dongguan. Customers can choose the factory closest to their location for sterilization services. Both factories have obtained ISO 13485 and ISO 11135 certificate issued by TÜV SÜD, and have completed registrations with U.S. FDA and Japan's PMDA.

Our factories are equipped with EO sterilizers that meet standard requirements, as well as preconditioning and heating areation equipment. We use fully automated data acquisition and monitoring systems to ensure the accuracy and reliability of the sterilization process.The sterilization process is protected by high-purity nitrogen to effectively eliminate explosion risks and ensure safe execution. Additionally, we employ an advanced EO Scrubbers to ensure emissions comply with strict environmental regulations.

Sterilization Factory

Xiegang, Dongguan

Dongguan Sterilization Factory

Plant area: 3500m²，Providing ample space for our operations and services

Annual sterilization capacity: 40000m³

Offer flexible volume options including 6m³, 10m³, 25m³, and 50m³

Map

Panyu, Guangzhou

Guangzhou Sterilization Factory

Plant area: 4000m²，Providing ample space for our operations and services

Annual sterilization capacity: 50000m³

Offer flexible volume options including 6m³, 10m³, 20m³, and 50m³

Map

Sterilization Scope

Medical devices

Pharmaceutical packaging

Medical beauty products

Beauty and cosmetics

Laboratory supplies

Sanitary products

Development and Validation of Sterilization Process

Ethylene Oxide Sterilization Validation Workflow

01 Customer Requirement Collection

01-1 The Marketing Department collects customer information, guides customers to fill out the "Project Requirement Collection Form," and, if necessary, customers provide evaluation samples.
01-2 The Technical and Quality Departments conduct a preliminary analysis and assessment of the product.
01-3 The Marketing Department provides a quotation based on the needs discussed and offers a preliminary project schedule.

02 Contract Review and Signing

02-1 Once the quotation is confirmed by both parties, the Marketing Department fills out the "Sterilization Validation Project Contract Review Form" and coordinates with relevant departments for contract review.
02-2 After passing the contract review, a "Ethylene Oxide Sterilization Process Validation Agreement" is signed with the customer.

03 Sterilization Validation - Preparation

03-1 The Marketing Department provides the "Sterilization Validation Schedule" to the customer.
03-2 The Marketing Department guides the customer to fill out the "Sterilization Product Information Collection Form" which is then provided to the Technical Department to produce the "Ethylene Oxide Sterilization Validation protocol" for customer approval.
03-3 The Marketing Department lists a "Validation Samples Preparation List" and the customer prepares the samples accordingly.

04 Sterilization Validation - Implementation

04-1 The Technical Department carries out the sterilization validation activities according to the "Sterilization Validation Procedure" and the "Ethylene Oxide Sterilization Validation Plan".
04-2 The Marketing Department communicates with the customer about project progress in a timely manner.

05 Sterilization Validation - Handover

05-1 At the end of sterilization validation, the "Ethylene Oxide Sterilization Validation Report" is generated and provided to the customer for approval.
05-2 The Technical Department produces "Sterilization Cycle Specification Card" and " Sterilization Device Master Record".
05-3 The Technical and Marketing Departments organize project handover documents, with the Marketing Department filling out the "Document Handover Checklist" to be signed by the customer and returned after confirmation.

06 Routine Sterilization Agreement Signing

06-1 The Marketing Department signs a "Product Sterilization Service Agreement" with the customer.
06-2 The Marketing and Technical Departments organize relevant departments for the handover of routine sterilization operations.

Ethylene Oxide Sterilization Validation Technical Process

Installation Qualification(IQ) & Operational Qualification(OQ)

Already completed by MedClear

Test before sterilization validation

Bioburden test

15 days

Temperature and humidity penetration test

Study the temperature and humidity profile of the product loading after refrigerating and preconditioning

3 days

Fractional cycles *1

> Resistance study for IPCD, EPCD and product bioburden
> Sterility test for IPCD, EPCD and product

20 days

Half cycle (lower limit parameter) *3

>Demonstrate achievement of the required product SAL
>IPCD and EPCD test

30 days

Full cycle (upper limit parameter) *2

>Study the EO/ECH residue and product performance after multiple sterilization cycles
>EO/ECH residue and product performance test

≥3 days

Full cycle (daily parameters) *1

>Demonstrate that the specified acceptance criteria are met for the duration of the proposed rountine process specification and reproducibility of the process

10 days

Routine Sterilization

Routine Sterilization Processing Workflow

01 Demand Submission

01-1 The Marketing Department collects monthly/weekly sterilization plans from customers, provides them to the Sterilization Center for capacity assessment and preliminary scheduling.
01-2 Customers submit sterilization processing requests in advance, providing product information and delivery requirements for sterilization.

02 Order Review and Sterilization Schedule Planning

02-1 The Sterilization Center and the Marketing Department review orders, confirm delivery dates with customer feedback, and finalize the delivery date upon mutual agreement.
02-2 The Sterilization Center finalizes the sterilization schedule based on the agreed delivery date.

03 Customer Delivery

Customers deliver goods at the agreed time, fill out the "Goods Delivery Form" and ship it with the goods.

04 Sterilization

The Sterilization Center carries out sterilization according to the schedule.

05 Sterilization Release

The Quality Department reviews the sterilization batch records and approves the release of sterilization.

06 Customer Pickup

After sterilization is complete, customer service representative notifies the customer to pick up the goods.

07 Provision of Sterilization Batch Records

Sterilization batch records are provided to the customer.

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EO Sterilization Services Sterilization Factory Sterilization Scope Development and Validation of Sterilization Process Routine Sterilization

EO Sterilization Services

EO Sterilization Services

Sterilization Factory

Dongguan Sterilization Factory

Guangzhou Sterilization Factory

Sterilization Scope

Development and Validation of Sterilization Process

Ethylene Oxide Sterilization Validation Workflow

01 Customer Requirement Collection

02 Contract Review and Signing

03 Sterilization Validation - Preparation

04 Sterilization Validation - Implementation

05 Sterilization Validation - Handover

06 Routine Sterilization Agreement Signing

Ethylene Oxide Sterilization Validation Technical Process

Installation Qualification(IQ) & Operational Qualification(OQ)

Test before sterilization validation

Temperature and humidity penetration test

Fractional cycles *1

Half cycle (lower limit parameter) *3

Full cycle (upper limit parameter) *2

Full cycle (daily parameters) *1

Routine Sterilization

Routine Sterilization Processing Workflow

01 Demand Submission

02 Order Review and Sterilization Schedule Planning

03 Customer Delivery

04 Sterilization

05 Sterilization Release

06 Customer Pickup

07 Provision of Sterilization Batch Records

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