Sterilisation
ETO, Gamma and Steam Sterilisation
ETO Sterilization is one of the most widely utilized and preferred methods of sterilization, especially for products that cannot withstand high temperatures. Being a low-temperature process, ETO sterilization preserves the physical integrity of most medical devices, food products, and cosmetics, making it suitable for a diverse range of applications.
At CellBios, we provide specialized ETO Sterilization services for industries such as Medical Devices, Food, and Cosmetics. Our focus is on helping your business achieve success by matching the right sterilization process to your specific needs. We work closely with you to tailor our services to both your current requirements and future growth, ensuring you have a reliable partner for all your sterilization needs.
Our state-of-the-art ETO Sterilization facilities are strategically located near key production and distribution hubs, enabling fast turnaround times and minimizing logistics costs. We collaborate closely with you to meet your immediate sterilization requirements while supporting your future growth.
Our ETO Sterilization services include the following key features:
- Complete Adherence to Quality Systems and GMP: Our facilities operate under strict Good Manufacturing Practices (GMP), ensuring compliance with global quality standards and regulatory requirements.
- ISO 11135 Compliance: The ETO sterilization process is performed according to the internationally recognized ISO 11135 standards, guaranteeing effective and validated sterilization.
- Biological Indicators for Product Release: We use biological indicators as the basis for product release, ensuring that each batch is tested for sterility and meets the required safety standards.
- Periodic Equipment Validation: To ensure ongoing performance consistency, our sterilization equipment undergoes regular validation and calibration. This guarantees the reliability and effectiveness of our sterilization cycles.
- Automatic Sterilization Systems: Most of our facilities utilize automated sterilization systems that enhance process control, reduce human error, and increase operational efficiency.
- Custom Process Parameters and Validation Support: We offer customized process parameters and provide customer-specific/product-specific validation support. Our team of sterilization experts works closely with you to ensure that the sterilization process aligns perfectly with your product specifications.
We also provide in-house Steam Sterilization services to ensure the safety and sterility of products that can withstand high temperatures. Steam sterilization is an effective method for sterilizing medical devices, surgical instruments, and other heat-resistant products, ensuring they are free from harmful microorganisms and safe for use in healthcare environments.
Key features of our In-house Steam Sterilization services include:
- ISO 17665 Compliance: We follow ISO 17665 standards for steam sterilization, ensuring your products meet international regulatory requirements for safety and effectiveness.
- Validated Process Parameters: Our sterilization cycles are rigorously validated to ensure consistent, reliable results that meet your product-specific needs.
- Regular Equipment Maintenance and Calibration: To ensure optimal performance, our sterilization equipment is regularly maintained and calibrated.
- Automated Control Systems: Our automatic sterilization systems help enhance precision, efficiency, and process consistency, reducing human error.
- Customized Sterilization Solutions: We offer tailored process parameters and product-specific validation support, working closely with you to develop solutions that fit your unique requirements.
In addition to our in-house ETO sterilization services, CellBios also coordinates Gamma Sterilization requirements through trusted outsourced facilities. We carefully select reliable partners who meet the necessary regulatory and quality standards to ensure the same level of consistency and safety as our in-house services. Our coordination services for Gamma Sterilization ensure that your products are handled with the utmost care, safety, and efficiency.