Capabilities
Medical Sterilization
At CellBios, we recognize the crucial role that sterilization plays in the manufacturing of medical devices and products. Ensuring sterility is not just a regulatory requirement; it is a vital step in safeguarding the health and well-being of healthcare professionals and patients alike.
Our advanced sterilization processes are designed to eliminate harmful microorganisms, guaranteeing that every product we deliver is safe, effective, and free from contamination. To uphold the highest standards of sterility, we utilize a combination of Gamma Irradiation, Ethylene Oxide (ETO), and Steam Sterilization. Each of these methods is carefully chosen based on the specific needs of the product, ensuring optimal safety and reliability.
All CellBios products are meticulously packed in Tyvek, PE, HDPE, and multi-layer films to ensure optimal protection. Gamma-destined products undergo Gamma Irradiation at certified sterilization facilities, a proven and highly effective method for sterilizing medical devices. This process ensures that our products are safe, free from contamination, and meet the highest industry standards.
- Sterilization Dosage: Our products are irradiated at a minimum dose of 25 kGy to achieve the desired level of sterility.
- Sterility Assurance Level (SAL): This dose has been validated according to ISO 11137 standards to achieve a 10-6 Sterility Assurance Level (SAL), ensuring that the likelihood of a product being non-sterile is less than one in a million.
- Certificate of Release and Irradiation: After irradiation, the products are shipped with both a Certificate of Release and a Certificate of Irradiation, indicating the sterilization doses applied, providing full transparency to our customers.
Advanced Sterilization Solutions for Delicate Medical Devices
For heat-sensitive products, CellBios offers both in-house Ethylene Oxide (ETO) and Steam sterilization to ensure the highest standards of safety for these products.
ETO sterilization is ideal for products that cannot endure high temperatures, such as certain medical plastics, delicate components. ETO is a gentle yet effective method that ensures thorough sterilization without compromising the integrity of the product.
Steam Sterilization, on the other hand, is widely used for products that can withstand high temperatures, like durable medical devices. This method utilizes pressurized steam to effectively eliminate bacteria, viruses, and other pathogens, ensuring the safety and reliability of the product while maintaining its functionality. Steam sterilization is recognized for its efficiency and effectiveness in a variety of medical and healthcare applications.
ETO Sterilization:
Our ETO sterilization process consists of three essential stages, each carefully controlled to maintain product integrity while ensuring thorough sterilization:
- Pre-conditioning: Products are conditioned by adjusting temperature and humidity to ensure they are prepared to absorb Ethylene Oxide gas efficiently.
- Sterilization: Products are exposed to ETO gas under controlled conditions to eliminate microbial contaminants, ensuring thorough sterilization without compromising quality.
- Aeration: After sterilization, the products undergo aeration to remove any residual ETO gas, making them safe for handling and use.
Steam Sterilization Process:
The steam sterilization process involves three main stages. First, products are gradually pre-heated to the required temperature, ensuring even heat distribution and preparing the materials for the sterilization cycle. Next, the products are exposed to pressurized steam at a specific temperature and duration, effectively eliminating harmful microorganisms such as bacteria, viruses, and fungi. Finally, after sterilization, the products undergo a cooling phase to bring them to a safe handling temperature, ensuring they are ready for use and packaging