Electron Beam Irradiation
What are the Benefits of Electron Beam?
E-beam irradiation can penetrate a wide range of materials and deliver the required irradiating dose in just a few seconds, meaning the entire process can take place in minutes. As a result of this short exposure period, the following benefits have been found:
- Optimized processing times
- Improved supply chain efficiencies
- Considerably less oxidative damage to the product
- Reduced color change in any present polymers
- No chemical residuals or induced radioactivity remain on processed products
Electron beam sterilization is supported by the internationally recognized consensus standard, ISO 11137, which describes the approach to validating a process to achieve a defined sterility assurance level (SAL).
Vaporized Hydrogen Peroxide
Steam Sterilization is a simple yet very effective decontamination method. Sterilization is achieved by exposing products to saturated steam at high temperatures (121°C to 134°C).
Product(s) are placed in a device called the autoclave and heated through pressurized steam to kill all microorganisms including spores. The device’s exposure time to steam would be anywhere between 3 to 15 minutes, depending on the generated heat.
Steam sterilization process is not appropriate for many materials due to the high temperatures involved.
Some quarantine/down time is required once products have been sterilized. Sterilized packages need to be allowed to dry before being removed from the autoclave to prevent contamination. Once removed, they must be allowed to cool to ambient temperatures, which may take several hours.
For effective sterilization it is critical that the steam covers all surfaces of the device.
To ensure optimal conditions, many autoclaves have built in meters that display temperature and pressure conditions with respect to time. Biological indicator devices and Indicator tape which changes color are also used to gauge the performance of the autoclave. The chemical tape is placed both inside and outside the sterilized packages, whereas bioindicator devices release spores inside the autoclave. The spores are incubated for 24 hours at the end of which time their growth rate is measured. If the spores have been destroyed it indicates that the sterilization process was effective.
ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:
- Saturated steam venting systems
- Saturated steam active air removal systems
- Air steam mixtures
- Water spray
- Water immersion
ISO 17665 covers sterilization of solid as well as liquid medical devices. According to the standard it is the manufacturer’s responsibility to develop the process and provide guidelines/ instructions for operation and validation of the process. The standard also requires detailed documentation of all conditions that affect the process performance now and in the future. ISO 17665-1 only provides very general guidelines on steam sterilization requirements and operations. ISO 17665-2 tries to describe these guidelines more specifically through the use of examples and further explanation.
How can we help?
Since 2010 GemarMed has been working with both domestic and international customers to formulate and execute successful regulatory activities and quality assurance, exclusively serving the medical device industry.
We can provide expert service to support your sterilization projects:
- Product/packaging design considerations with respect to sterilization
- Product families and procedure kits – establishment of representative device
- Load configuration to meet current and future goals of your company
- Sterilization validation study design
- Process Challenge Device design and feasibility testing
- Single Batch Release
- Annual Requalification, risk assessment in case of Requalification failure
- Assessment of impact of a change on validated sterilization process
- Product adoption into validated sterilization process
- Laboratory testing strategy (microbiology/EO residuals).
- Audit of sterilization subcontractor’ facilities, IQ/OQ reports review
- Project Management
We will be happy to supply additional vital information in the field of sterilization and assist your efforts towards achieving a better product.