An accelerated, internal alternative to contracted ETO sterilization: validation time cut in half, same price, unified team.
VOLTAS now delivers a market option distinct from the larger sterilization providers, featuring an internal sterilization process completed in half the time at the same cost.”— Jason SchererCOTTAGE GROVE, MN, UNITED STATES, July 22, 2026 /EINPresswire.com/ — VOLTAS, a vertically integrated medical device development and manufacturing company, now provides in-house Ethylene Oxide (ETO) sterilization services, granting medical device firms a validated sterilization path that does not depend on external suppliers. By handling validation and cycle development internally, VOLTAS reduces the sterilization validation timeline by 50% compared to conventional outsourced approaches, with no extra charge to the client.
ETO sterilization ranks among the most widely used terminal sterilization techniques for single-use medical devices, especially for products unable to endure heat or radiation-based methods. By incorporating this step within its own facility, VOLTAS eliminates a process phase that has historically required manufacturers to ship products off-site, wait for external scheduling, and oversee a separate vendor relationship for validation and paperwork.
Sterilization Performed Alongside Manufacturing Operations
VOLTAS’ ISO 13485 certified site now accommodates ETO sterilization cycles ranging from small routine lots to full pallet sterilization, addressing both development-stage builds and ongoing commercial quantities.
Offerings include:
In-house ETO sterilization
Sterile barrier packaging and labeling
Comprehensive sterilization validation and cycle development
Cleanroom assembly through sterilization under a single roof
Full regulatory documentation and support
With ETO sterilization performed on-site, manufacturers no longer need to rely on an external lab’s availability or contend with the communication gaps that occur when transferring a device between different teams. A device can progress from cleanroom assembly through a validated ETO cycle without leaving the building, supported by complete traceability at every stage.
A Single Team, One Set of Records
Since sterilization is integrated with VOLTAS’ cleanroom assembly, packaging, and regulatory departments, device developers collaborate with one project team instead of coordinating among multiple suppliers. VOLTAS supports terminal sterilization for single-use devices, hardest-to-sterilize studies, and recurring commercial production, along with the regulatory documentation necessary for maintaining submissions and audits on schedule.
ETO sterilization is currently accessible to both startups and established device manufacturers working with VOLTAS.
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About VOLTAS
VOLTAS is a vertically integrated medical device development and manufacturing company designed to minimize hand-offs, lower risk, and enable teams to bring superior devices to market more quickly. By consolidating engineering, regulatory, quality, manufacturing, hydrophilic coating, sterilization, marketing, website, and sales teams, VOLTAS supports startups and established firms through every stage of the product development lifecycle from concept to commercialization.
Our accelerated in-house services include:
R&D
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 Asymmetrical
Balloon Layer Development
Plastic Injection Molding <48”
Micro Plastic Injection Molding <1mm
Die Mold Tooling (Aluminum, Hardened 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 details, visit voltas.io or schedule a meeting here
Jason Scherer
Voltas
+1 303-775-2211
jason.scherer@voltas.io
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