To provide safe and sterile products, manufacturers must determine and describe appropriate sterilization cycle parameters through a sterilization validation process. In support of these efforts, iFyber offers customized sterilization validation services for organizations using supercritical carbon dioxide (scCO2) sterilization systems. During the sterilization validation process, our multidisciplinary team will help guide you in process and cycle optimization, material compatibility studies, measurement of sterilant residuals, and development of microbiological recovery and enumeration methods for validating scCO2 terminal sterilization of your medical device or biological product. iFyber has a partnership with NovaSterilis to perform validation services on their equipment and is comfortable with other scCO2 technologies and other novel sterilization processes.
Supercritical CO2 Sterilization
The technology is a novel sterilization method that uses CO2, sterilant additives, and instrumentation to achieve terminal sterilization to a sterility assurance level (SAL) 10-6. When exposed to pressures and temperatures above 73.8 bar and 31°C, respectively, CO2 transitions to a supercritical state, which lends itself to deep penetration of substrates and inactivation of a wide variety of microorganisms.
Through a multi-year collaboration, iFyber has gained an in depth understanding of the scCO2 sterilization technology and has established a partnership with the NovaSterilis team. We are therefore in the unique position to work directly with both NovaSterilis and our clients to design and execute sterilization validations to ensure that the scCO2 sterilization process will consistently achieve the required sterility assurance level (SAL) for regulatory clearance or approval.
What services can iFyber offer?
All products have unique designs, materials, and packaging configurations. Therefore, the sterilization conditions that may be adequate for one product are likely not sufficient for another. Because of this, all sterilization processes must be validated based on the unique characteristics of the specific product. iFyber specializes in designing and executing customized sterilization validation test strategies suited to your needs. Our quality, regulatory, and technical teams can help you navigate these requirements through each of the four phases listed below, including characterization of the scCO2 sterilization agent and development and validation of the scCO2sterilization process per ISO 14937, selection of a process challenge device (PCD), and validation of appropriate biological indicators (BI) per ISO 11138.
PHASE 1: DEVELOPMENT
- Material compatibility and characterization of sterilized products
- Characterization testing strategies
- Regulatory support: Q-submissions and representation at FDA Pre-Sub meetings
- Process challenge device (PCD) identification
- Biological indicator (BI) characterization and validation
- Development of microbiological recovery methods for resistance studies
- Draft work instructions and standard operating procedures (SOPs)
PHASE 2: VERIFICATION
- Develop sterilization process inputs and outputs
- Performance verification
- Quantifying sterilant residuals and chamber mapping
- Survivor curve analysis
- D-value determination
PHASE 3: VALIDATION
- Sterilization validation plan
- Installation Qualification/Operational Qualification (IQ/OQ)
- Performance Qualification (PQ)
- Transfer to manufacturing: re-validation or bridging studies
PHASE 4: REGULATORY SUBMISSIONS
- Drafting sterilization sections for FDA submissions
- Responses to additional information (AI) requests
- Representation at FDA meeting
Why choose iFyber?
The NovaSterilis scCO2 sterilization process is considered a novel sterilization technology; therefore, there are currently no recognized standards outlining sterilization validation requirements. iFyber offers customized sterilization validation services to help clients navigate regulatory requirements, including both sterilization validation plan development and testing. iFyber has worked closely with NovaSterilis to advance the scCO2 technology through the regulatory approval process. iFyber’s multidisciplinary team, which consists of regulatory professionals, chemists, materials scientists, and biologists, can work with clients to design and execute material characterization, microbiological resistance, and sterilization validation testing plans. To date, iFyber has helped both medical device and biologics customers develop and execute scCO2 sterilization validations to submit for FDA clearance or approval. iFyber has also led the regulatory efforts during an Emergency Use Authorization (EUA) filing using the scCO2 sterilization process and has been an integral part in the FDA Innovation Challenge, which aims to accelerate the development and review of the scCO2 sterilization process as an alternative to ethylene oxide (EtO) sterilization.
Contact us today to discuss your sterilization validation needs.
Our BSL-2 testing facilities are fully equipped to handle the sterilization validation testing needs of medical device and biologics companies. We have access to qualified equipment and can work with a variety of challenge microorganisms, including Bacillus atrophaeus and Geobacillus stearothermophilus. We also offer method development services to identify the appropriate microbiological inoculation and recovery methods for your specific product.
What is a novel sterilization method?
A novel sterilization method is a newly developed method for which there is little published information, little history of comprehensive FDA evaluation of sterilization validation data, and no FDA-recognized dedicated consensus standards on development, validation, and routine control. FDA therefore requires additional information to be included for products using a novel sterilization method, including a comprehensive description of the sterilization process, the method used to validate the sterilization process, the sterilization validation protocol, and the sterilization validation data.
What is a biological indicator?
Biological indicators are microorganisms with a defined resistance to a specific sterilization process. Biological indicators help monitor whether the necessary sterilization conditions have been met to kill a specified number of microorganisms. As a novel sterilization method, the resistance characteristics for commercially available biological indicators are not available for the scCO2 sterilization process. iFyber can help clients identify the most resistant organisms to the scCO2 sterilization process for their product and define performance characteristics, including D value determination.
What is a process challenge device?
A process challenge device (PCD) is a test device that provides an equal or greater challenge to the sterilization process as compared to that of the intended device. PCDs often restrict access of the sterilizing agent to a biological indicator (BI) placed inside. An example of a PCD would include a BI placed within additional packaging or a simulated lumen. The PCD can be used during verification and validation testing, as well as routine processing, to demonstrate that the required product SAL is achieved. iFyber can help clients identify the appropriate PCD for their process and validate that the PCD has equal or greater resistance.