A faster, in-house alternative to outsourced ETO sterilization: half the validation time, the same cost, one team.

COTTAGE GROVE, MN, UNITED STATES, July 22, 2026 /EINPresswire.com/ -- VOLTAS, a vertically charged medical device development manufacturing company, offers in-house Ethylene Oxide (ETO) sterilization services, giving medical device companies a validated sterilization pathway without relying on outside vendors. By managing validation and cycle development on-site, VOLTAS cuts the sterilization validation timeline by 50% compared to traditional outsourced processes, at no additional cost to the customer.

ETO sterilization is one of the most common terminal sterilization methods for single-use medical devices, particularly for products that can't withstand heat or radiation-based methods. By bringing this step in-house, VOLTAS removes a stage of the process that has traditionally required manufacturers to ship product out, wait on external scheduling, and manage a separate vendor relationship for validation and documentation.

Sterilization Under the Same Roof as Manufacturing

VOLTAS' ISO 13485 compliant facility now supports ETO sterilization runs ranging from small routine batches to full pallet sterilization, covering both development-stage builds and ongoing commercial volumes.


Services include:
In-house ETO sterilization
Sterile barrier packaging and labeling
Full sterilization validation and cycle development
Cleanroom assembly through sterilization under one roof
Complete regulatory documentation and support


With ETO sterilization in-house, manufacturers no longer have to wait on an external lab's schedule or manage the translation loss that comes with handing a device off between teams. A device can move from cleanroom assembly through a validated ETO cycle without ever leaving the building, with full traceability the whole way through.

One Team, One Set of Documentation

Because sterilization sits alongside VOLTAS' cleanroom assembly, packaging, and regulatory teams, device makers work with a single project team rather than coordinating across multiple vendors. VOLTAS supports terminal sterilization for single-use devices, hardest-to-sterilize studies, and ongoing commercial production, with the regulatory documentation needed to keep submissions and audits on track.

ETO sterilization is available now to startups and established device manufacturers working with VOLTAS.

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About VOLTAS

VOLTAS is a vertically charged medical device development manufacturing company built to eliminate hand-offs, reduce risk, and help teams bring better devices to market faster. By integrating engineering, regulatory, quality, manufacturing, hydrophilic coating, sterilization, marketing, website, and sales teams, VOLTAS supports startups and established companies through every phase of the product development lifecycle from concept to commercialization.

Our accelerated in house services include:

RD
Weekly Prototyping
Animations
Sensors
Wearables
App development
PCB design
LCD screens
Regulatory Services
PreSub / 513g regulatory work
Supplier Sourcing
User Testing
Usability Studies
Form Factor
UV laser etching
RF Welding
Ultrasonic Welding
Mold Flow Analysis
Hydrophilic and Hydrophobic Coatings
Balloon Development Manufacturing
Balloon symmetrical and A-symmetrical
Balloon layer development
Plastic Injection Molding <48”
Micro Plastic Injection Molding <1mm
Die Mold Tooling (Aluminum, Harden Steel, Copper, etc)
Die Mold Tooling Revisions
Packaging Labeling
Blister Tray Development Manufacturing
ETO Sterilization
2 pallet ETO Sterilization
Sterilization Validation
510k Submissions
Regulatory Testing
Marketing
Social Media
Merchant Services
Distribution and Warehousing
Website
Medical Sales Team

For more information, visit voltas.io or book a meeting here

Jason Scherer
Voltas
+1 303-775-2211
jason.scherer@voltas.io
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