Medical Device Industry
Sun Sterifaab offers high-volume, ISO-compliant ETO sterilization systems tailored for sensitive medical devices. With full validation support, CDSCO licensing assistance, and 24/7 service, we ensure sterility, safety, and global compliance.
About the Industry:
Medical device manufacturing demands sterilization systems that are compatible with sensitive materials such as plastics, silicone, and polymers. These devices often go inside the human body or come into direct contact with blood, tissue, or organs.
Products That Require Sterilization:
- Disposable syringes, surgical gloves, IV sets
- Stents, orthopaedic implants, dental tools
- Diagnostic probes and kits
- Catheters, suction tubes, and dressing kits
- Device packaging (blister packs, pouches)
Importance of Sterilization:
- Ensures sterility assurance level (SAL) as per ISO 13485 and ISO 14937
- Required for CE marking and CDSCO product registration
- Prevents contamination-related recalls
- Enhances global market readiness and export compliance
- Promotes patient safety and device reliability
How Sun Sterifaab Supports the Industry:
- Industrial-grade, high-volume ETO sterilizers with safety interlocks
- PLC-based controls with audit trails and data backup
- Modular ETO chambers, aeration units, and exhaust handling
- Full validation support with biological indicators, chemical indicators & load patterns
- CDSCO licensing support
- Training modules for operators and QA/QC teams
- 24/7 service support and AMC/CMC packages for uninterrupted operations
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