An accelerated, internal substitute for contracted ETO sterilization: validation time reduced by 50%, expenses unchanged, working with a single team.
VOLTAS brings the market a choice beyond the major sterilization providers, delivering an internal sterilization process in half the time at an identical price.”— 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, enabling medical device firms to obtain a validated sterilization route without depending on external suppliers. By handling validation and cycle development internally, VOLTAS reduces the time needed for sterilization validation by 50% compared to conventional outsourced approaches, with no extra expense for the client.
ETO sterilization is among the most widely used terminal sterilization techniques for disposable medical devices, especially those that cannot tolerate heat or radiation-based methods. By moving this step in-house, VOLTAS eliminates a phase that traditionally forced manufacturers to ship products away, wait for an outside vendor’s schedule, and manage a separate supplier relationship for validation and paperwork.
Sterilization Performed Alongside Manufacturing
VOLTAS’ ISO 13485 certified facility now accommodates ETO sterilization batches ranging from small routine lots to full pallet loads, serving both development-stage prototypes and ongoing commercial production.
Services include:
On-site ETO sterilization
Sterile barrier packaging and labeling
Complete sterilization validation and cycle development
Cleanroom assembly through sterilization under a single roof
Full regulatory documentation and support
With internal ETO sterilization, manufacturers no longer need to wait for an external lab’s availability or deal with the communication gaps that occur when handing off a device between different teams. A device can progress from cleanroom assembly through a validated ETO cycle without leaving the facility, with full traceability throughout the entire process.
One Team, One Set of Documentation
Since sterilization is integrated with VOLTAS’ cleanroom assembly, packaging, and regulatory departments, device companies engage with a single project team instead of coordinating across multiple vendors. VOLTAS offers terminal sterilization for single-use devices, hardest-to-sterilize studies, and ongoing commercial production, along with the regulatory records needed to maintain submissions and audits on schedule.
ETO sterilization is currently accessible to startups and established device manufacturers partnering with VOLTAS.
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About VOLTAS
VOLTAS is a vertically integrated medical device development manufacturing company designed to reduce hand-offs, lower risk, and help teams bring better devices to market more quickly. By combining engineering, regulatory, quality, manufacturing, hydrophilic coating, sterilization, marketing, website, and sales teams, VOLTAS supports startups and established companies throughout every stage of product development 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 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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