Safe. Reliable. Globally Compliant.
At Sina-Sterilgamma, we specialize in Ethylene Oxide (EtO) sterilization—the gold standard for complex, heat- and moisture-sensitive medical devices. Our processes are designed to deliver maximum sterility assurance while maintaining full compliance with ISO 11135 international standards.
Whether you’re a medical device manufacturer, distributor, or healthcare provider, our EtO solutions ensure your products meet the strictest regulatory and safety requirements worldwide.
What We Offer
- ISO 11135-Compliant Sterilization We strictly adhere to globally recognized standards to guarantee sterility and patient safety.
- Full-Cycle Validation (IQ, OQ, PQ) From Installation Qualification (IQ) and Operational Qualification (OQ) to Performance Qualification (PQ), we ensure every cycle is validated, documented, and traceable.
- Bioburden & Biological Indicator Testing Advanced microbial testing methods confirm sterility assurance levels (SAL) for your products with precision and reliability.