Boulder Sterilization is introducing chlorine dioxide (CD) service this summer, making it the sole contract sterilizer to offer CD and ethylene oxide (EO) technologies for the sterilization of medical devices and in-vitro diagnostic products.

Our CD sterilizer is the largest contract CD sterilization chamber in the world, capable of handling large products and large volumes.

Meeting the needs for every product

In offering both CD and EO service, Boulder Sterilization can handle small and large-sized batches, a wide variety of materials, and meet urgent and immediate-service needs. Comprehensive services include:

• Qualification
• Validation (sterilization packaging, with full support)
• Single-lot release
• Cycle development
• Production sterilization
• Engineering sterilization/testing
• Testing
  • Biological indicator
  • Tests of sterility, method suitability
  • EO and ECH residuals
  • Bacterial endotoxin/LAL
  • Bioburden

Getting results, fast

Whether your product calls for EO or CD sterilization, our quick-turn service gets you results, fast. We measure time to complete sterilization in weeks, not months, and provide accurate turnaround times.

• Reduction in validation timeline by 80% – at a 75% cost savings.
• Validations: 8-10 weeks
• Single-lot release: 5-7 weeks
• Engineering R&D sterilization runs: 4 business days
• Production cycles: 4-business day turnaround

Getting results, safely

At Boulder Sterilization, our priority is always safety. We’re committed to meeting the highest standards of quality while consistently providing reliable, consistent, safe service.

EO sterilization service
EO is most often used to sterilize products that are sensitive to heat or moisture, and is compatible with nearly all materials, including metals, plastics, glass, rubber and electronics.

The type of EO sterilizer we use – 3M™ Steri-Vac™ Sterilizer/Aerator 8XL Series – is the type you’ll find installed in hospitals and commercial facilities worldwide. We use a fixed-volume, single-use EO cartridge to assure safe dispensing of a consistent amount of sterilant, every time – a method that both users and regulatory bodies highly regard for safety, consistency and reliability. We maintain a preventive maintenance program with 3M, ensuring minimum downtime.

We are dedicated to minimizing emissions from EO sterilization. In fact, with a catalytic converter system to mitigate outgassing inherent in the process, we are able to reduce EO emissions by 99.9%. Other steps we take include:

• Thoughtful package design to fit more product into each sterilization chamber, resulting in less time sterilizing.
• Sterilization in primary packaging (pouch) to fit more product in the chamber and reduce the amount of cardboard in the chamber.
• Cycle efficiency to maximize the amount of product that can be sterilized per cycle.
• Use of small chambers to make sure each is filled.

 

CD sterilization service
The CD method uses the versatile, environmentally friendly chlorine dioxide gas for effective product sterilization. It works at room temperature, is non-cancerogenic and nonflammable, leaves no post-treatment residuals, and is compatible with nearly all materials, including plastic components and electronics.

Another safety feature is that CD gas has a color (yellow-green) and an odor – similar to chlorine and nitric acid – at safe levels. These provide the ability to accurately measure, monitor and validate in real time, increasing safety throughout the sterilization process. And since it’s possible to smell the gas before it reaches unsafe concentrations, there is ample time to shut down the system and address the situation before any problems occur. Other sterilizing agents cannot be smelled until exposure in high concentrations occurs.

Making the decision: EO or CD

Every product is different, and the method of sterilization will depend on several factors. At Boulder Sterilization, we put our collective experience to work to determine the best fit for your product and your situation.

• Batch size. EO chambers cost less for small batches of product. For large batches, a CD chamber such as Boulder Sterilization’s (size of two pallets) offers more economical quick-turn service because of economies of scale.
• Product size. EO chambers are generally limited to smaller products; at Boulder Sterilization, they are limited to devices no more than 36 inches in length. In contrast, the CD chamber can handle eight-foot-long devices.
• Temperature. While EO runs at a relatively low temperature (60C), it still could affect certain fragile materials. CD, working at room temperature, is compatible with nearly all materials, including plastic components and electronics.

Conclusion

Boulder Sterilization can partner with you through the entire sterilization process – from protocol generation to final report completion – while offering the right service for you to ensure secure, safe and effective processing that exceeds safety standards. And, as part of Boulder iQ, we work as the only U.S. company to offer the combination of clean room final assembly, packaging, and quick-turn EO and CD sterilization with in-house biological testing – a combination that can save you time and money, and speed your product to market.