India’s First Fully Integrated ETO Sterilization & Packaging Solution for Medical Devices
- Bhavya Shah
- Sep 15
- 4 min read
One Roof. Complete Control. India’s First True End-to-End ETO Sterilization Solution
In today’s healthcare industry, ETO sterilization in India has become a critical requirement for ensuring device safety, sterility assurance, and regulatory compliance. However, manufacturers often face challenges due to fragmented services across tooling, packaging, sterilization, and validation workflows.
At Steris Surgical Solutions, we offer India’s first fully integrated end-to-end ETO sterilization solution for medical device manufacturers. Our platform combines advanced mold creation for medical devices, validated sterilization cycles, Tyvek packaging for sterilization, and comprehensive audit-ready sterilization process support — all under one roof. Built on scientific rigor and industry best practices, our services enable manufacturers to meet compliance requirements while preparing for certifications like CDSCO medical device approval in India and ISO 13485 QMS.
This integrated approach, typically found in global corporations, is now available to healthcare innovators across India.
Sterile Packaging Solutions for Medical Devices are Essential for Medical Device Manufacturers
Sterile packaging solutions for medical devices require precision, traceability, and consistency from the design phase through packaging and post-sterilization validation. At Steris, we streamline this process by combining all critical steps into one comprehensive solution.
This approach reduces variability, supports faster Class A and B medical device sterilization, and ensures that documentation is aligned with audit expectations. By providing validated sterilization services, we help manufacturers meet global and local regulatory demands with confidence.
Mold Creation for Medical Devices — The Foundation of Sterility and Compliance
Our tooling and mold creation for medical devices services are built to meet the highest standards for material compatibility, precision, and repeatability. Effective sterilization begins with accurately manufactured device components that support sterilant exposure and prevent microbial retention.
Our Mold Capabilities:
VMC (Vertical Machining Center) precision ensures micron-level tolerances for complex device geometries
Thermoforming and vacuum forming techniques create consistent, defect-free components that maintain structural integrity during sterilization cycles
Diamond-polished molds improve surface finish, minimizing particulate contamination and enhancing sterilization outcomes
Material-specific designs ensure compatibility with polymers, elastomers, and composites used in medical device manufacturing.
Medical Devices We Support:
✔ Laparoscopic instruments with intricate channels and sealed joints requiring sterilization-friendly geometries
✔ Syringes and needle assemblies demanding smooth surfaces and tight tolerances for fluid delivery
✔ Catheter assemblies with flexible, thin-wall designs requiring uniform sterilant diffusion
✔ Orthopedic implants needing rigid, load-bearing structures compatible with sterilization cycles
✔ Diagnostic kits and sampling devices requiring sterile packaging and validated handling procedures
Our tooling solutions are engineered to meet device-specific requirements while ensuring compatibility with sterilization parameters — creating a robust foundation for safe and compliant manufacturing.
Sterilization Packaging Solutions Designed for Compliance and Process Integrity
Packaging plays an integral role in sterilization assurance. Our approach ensures that medical devices remain protected and traceable from production through distribution.
Blister packaging for sterilization ensures uniform sterilant flow while maintaining device integrity during transport
Tyvek packaging for sterilization offers microbial barrier protection with breathability, allowing effective gas sterilization cycles
Customized labeling solutions integrate batch codes, sterilization logs, and traceability for seamless audit reviews
Packaging validation protocols confirm barrier strength, seal integrity, and microbial resistance as per industry guidelines
Our packaging solutions are rigorously tested to support sterilization processes without compromising device functionality — essential for manufacturers targeting global and local markets.
Validated ETO Sterilization Services Tailored to Material and Design Requirements
ETO sterilization requires a finely balanced approach to gas concentration, temperature, humidity, and cycle duration. At Steris, our validated sterilization services are optimized for diverse device geometries and material profiles.
Cycle engineering ensures uniform exposure for devices with complex shapes and multi-material constructions
Load mapping and aeration protocols guarantee consistent sterilant distribution and safe off-gassing
Material compatibility assessments prevent degradation while maximizing sterilization efficiency
Real-time monitoring and process control ensure that cycles meet reproducibility and safety standards
These scientifically designed cycles enable manufacturers to confidently pursue Class A and B medical device sterilization, knowing that their devices are processed to the highest standards.
Audit-Ready Sterilization Process with Traceability and Documentation Support
At Steris Surgical Solutions, audit readiness is integral to every process. Our structured documentation ensures that validation, packaging, and sterilization procedures are easily traceable and aligned with industry expectations.
Our audit-ready sterilization process includes:
Installation Qualification (IQ) verifying equipment and environment readiness
Operational Qualification (OQ) confirming process stability and repeatability
Performance Qualification (PQ) validating sterilization effectiveness under worst-case load scenarios
Biological Indicator (BI) reports using spore-based testing methods to confirm microbial inactivation
Sterility testing protocols aligned with accepted global methodologies for final product validation
We create a seamless audit trail that simplifies compliance reviews and helps manufacturers align with both national and global regulatory frameworks.
Why Choose Steris Surgical Solutions for ETO Sterilization in India
✔ India’s first fully integrated ETO sterilization platform combining tooling, packaging, sterilization, and validation
✔ Mold creation for medical devices tailored to meet functional and sterilization requirements across diverse applications
✔ Tyvek packaging for sterilization and validated barrier solutions that support microbial control and process safety
✔ Audit-ready sterilization process with structured documentation, validation protocols, and traceability systems
✔ Support for Class A and B medical device sterilization with scientifically engineered cycles and material-specific solutions
✔ Compliance-driven practices aligned with global standards and CDSCO medical device approval pathways
— Redefining Sterility and Manufacturing Excellence in India
The medical device industry is evolving, and so are the demands for safer, more traceable, and validated sterilization solutions. At Steris Surgical Solutions, we are at the forefront of this transformation — offering manufacturers a scientifically robust, fully integrated platform that delivers precision tooling, validated sterilization, and audit-ready documentation under one roof. With one roof and complete control, manufacturers gain a trusted partner equipped to meet today’s needs and tomorrow’s challenges — enabling safer products, faster approvals, and enhanced operational efficiency.
Partner with us and experience the future of ETO sterilization in India — where expertise, technology, and process integrity come together to set new industry benchmarks.