Sterilization is crucial for medical device safety. At Qualentra Global, we specialize in sterilization validation services aligned with ISO 11135, ISO 11137, and ISO 14937. Through our CRO network, we provide comprehensive solutions to ensure regulatory compliance, minimize risks, and enhance patient safety.
- Sterilization Method Selection (EO, Gamma, E-beam, Autoclave, etc.)
- Sterilization Validation Studies & Protocol Development
- Microbial Load & Bioburden Testing
- Sterility Assurance Level (SAL) Calculation
- Process Monitoring & Control Plan
- Sterilization Validation
End-to-End Lifecycle – 6 Stages of Sterilization Validation
Sterilization Method Evaluation
Assess the most appropriate sterilization method based on device material, design, and regulatory requirements.
Microbial Load & Bioburden Assessment
Determine the initial microbial load of the device and perform bioburden testing to guide validation.
Sterilization Validation Protocol Development
Develop detailed validation protocols, including parameters for validation, testing, and acceptance criteria.
Sterilization Process Execution
Conduct sterilization cycles according to validated protocols, ensuring that devices meet required standards.
Sterility Assurance Level (SAL) Calculation
Calculate the SAL to ensure that the sterilization process provides a sufficiently low probability of a viable microorganism surviving.
Regulatory Submission & CRO Coordination
Support regulatory filings and documentation, and coordinate with CROs for final validation studies, including ongoing process monitoring.
100%
Compliance with ISO 11135 and ISO 11137
40%
Reduced Validation Time
0
Major Findings in Sterilization Audits
Frequently asked questions
SAL is the probability that a viable microorganism is present after sterilization. A common target for medical devices is a SAL of 10-6, meaning there is a 1 in a million chance that a microorganism survives. It ensures device safety and regulatory compliance.
Yes, we offer validation for various sterilization methods, including Ethylene Oxide (EO), Gamma Radiation, E-beam, and Autoclave, depending on device material and regulatory requirements.
Validation typically takes 6-8 weeks, depending on the complexity of the device and the sterilization method. However, we leverage CRO partnerships to speed up the process and meet tight timelines.