Chlorine Dioxide Sterilization Services
The Gulf Sterilization Advantage: True Turnkey Validation
Unlike traditional contract sterilizers that require manufacturers to develop their own validation strategies, Gulf Sterilization provides a complete, pre-validated framework that dramatically reduces validation timelines and costs:
• Comprehensive Validation Documentation Suite: Pre-
developed microbiological validation documents aligned with ISO 14937, ISO 11138, and ISO 11737 standards eliminate months of protocol development
• Process Challenge Device (PCD) System: Scientifically
designed PCDs specifically developed for chlorine dioxide sterilization streamline the establishment of worst-case challenge locations
• Device Configuration-Based Challenge Mapping: Our
structured approach systematically identifies and validates critical challenge locations based on your specific device geometry, materials, and packaging
• Risk-Based Validation Framework: Quality planning guided
by ISO 14971 and ISO 24971 ensures regulatory compliance while optimizing validation scope and cost
Established Economical Shipping Providers
We can assist with logistics of shipping your product to our facility and out to your distributor by providing contacts and quotes from consistent, reputable local shippers.
Large Scale Contract Sterilization
We have a variety of chambers utilizing chlorine dioxide sterilization which can accommodate a single box up to multiple pallets of devices or equipment. Chlorine dioxide (CD) gas has been used as a sterilizing agent since the 1980's. It is a true gas at room temperature and has excellent distribution and penetration abilities. CD is a registered sterilant with the US EPA, leaves no harmful residuals, has been shown to reduce endotoxins, is compatible with electronics, and is non-carcinogenic.
Comprehensive Validation Support Our structured validation approach covers all critical elements:
•Cycle Development & Optimization: Product-specific cycle parameters established through systematic testing
• Microbiological Process Qualification: Full or partial kill studies using model PCDs and product sterility resistance data
• Residual Validation: Comprehensive residual testing per ISO 10993-7 and USP 300.10 at certified cGMP laboratories
• Method Suitability Testing: Validated analytical methods ensuring reliable quality control