Sterilization

Sterilization is a critical process in the medical device industry, ensuring that products are free from harmful microorganisms. This service includes planning and validating sterilization methods such as Ethylene Oxide, Gamma Radiation, and Electron Beam. 

Proper sterilization is necessary to meet stringent regulatory requirements and to guarantee the safety and effectiveness of the medical device. Whether you're in the initial stages of product development or need to validate an existing process, our expert consultation will guide you through every step to ensure your device meets the highest standards. Reach out today to discuss how we can support your sterilization needs and ensure compliance.

List of Services:

• Modalities
• Ethylene Oxide
• Ionizing Radiation
• Gamma
• Electron Beam
• X-ray
• Preparation of Validation Master Plan (VMP)
• Preparation of Validation Protocols
• Sterilization Validation Execution
• Preparation of Validation Summary Report
• Sterilization QMS Development
• Product Adoptions
• Process Equivalency
• Development and Documentation of Product Families and Processing Groups
• Sterilization Cost Reduction
• Single Batch Sterilization for Small Operations or Special Production
• Failure Investigation
• Sterility Test
• Biological Indicator Test Failure
  
• Dose Audit Failure
  
• EO Parametric Release