EtO Sterilization & Treatment
Sterile Services (Singapore) Pte. Ltd. sterilizes medical devices ranging from syringe injections, catheters, medical gowns, surgical kits and many more medical devices.
Validation Support
Sterilization assurance of EtO requires an excellent correlation between each product character in considering packaging barriers and sterilization parameters (temperature, humidity, gas concentration and time).
Sterile Services (Singapore) Pte. Ltd. supports customer validation study with accordance to ISO 11135 standard.
1. Meeting with the Customer
Meeting with the Customer
- Confirmation of Customer Requirements
- Confirmation of Product Definition
- Confirmation of Validation Approach, Procedure
- Confirmation of the responsibility
- Confirmation of Validation Protocol
- Confirmation of Schedule
2. Product Definition
Confirmation of Product Detail:
1. Physical description of medical device.
2. Intended use of the medical device.
3. Whether the medical device is single use or multiple use.
4. Design characteristics that would affect the choice of sterilization process.(Resistance of Heat, Humidity, pressure and etc)
5. Raw materials/manufacturing condition that could affect microbiological quality.
6. Required sterility assurance level (SAL).
7. Selection of packaging barriers.
8. Loading pattern: requirements for a specific load or mixed loading patterns, or range of acceptable loading pattern.(Maximum load, highest density product, longest pathway product).
9. Compatibility with the sterilant gas or gas mixture and EO processing conditions (precondition, sterilization and aeration processes).
Product Family/Processing Category:
Defining product families and/or processing category that can be sterilized in the same EO sterilization process.
3. Establish Protocol
Establish Protocol
The documents including the procedure, and defined acceptance criteria prior to initiation of testing.
Validation of a process shall be performed according to an approved protocol.
4. Process Definition Study
Process Development
Development of the sterilization process to achieve the sterilization assurance level (SAL).
5. Performance Qualification Study (“Overkill” Half Cycle Approach)
Fractional Cycle
1. Selection of the process challenge device (PCD)
2. Product sterility test
3. BI (PCD) sterility test
Half Cycle
1. BI (PCD) sterility test
2. Cycle performance evaluation
3. Load temperature and humidity mapping
Full Cycle
1. BI (PCD) sterility test
2. Cycle performance evaluation
3. Load temperature and humidity mapping
4. EO/ECH residual testing (for 1X and 2X processing)
6. Validation Report
Validation Report
The validation report shall describe or reference specific qualified product, defined load configurations and the documented specification for the EO sterilization process.
- Document the IQ, OQ status.
- Document the validation data including microbiological test results.
- Document the cycle performance results.
- Documentation of the validated sterilization process including the process parameters and their tolerances.
7. EtO Sterilization Process Specification
EtO Sterilization Process Specification
Document a sterilization process specification including the newly validated sterilization process (e.g. procedure, loading pattern, sterilization parameters to apply, aeration time, number and positions of Biological indicators, etc).
8. Technical Agreement and/or Quality Agreement
Technical Agreement and/or Quality Agreement
Document a technical agreement and/or Quality Agreement with customer and Sterile Services (Singapore) Pte. Ltd.
9. Routine Cycle
Routine Cycle
1. Confirmation of the scheduling
2. Booking the customer sterilization process
3. Receiving the customer product load.
4. Incoming Inspection
5. Sterilization Process
6. Aeration Process
7. Biological Indicator Incubation Record
8. Reviewing Sterilization Cycle Record
9. Issue Certificate of Sterilization
10. Outgoing Inspection
11. Ship out to Customer
Transportation / Storage
Sterile Services (Singapore) Pte. Ltd. works with a transportation company and can provide you with logistical assistance for both outbound and inbound trips.