Our Services
Boulder Sterilization is committed to maintaining the sterilization capacity to keep queue times limited to days rather than weeks.
We are also committed to getting sterilization validation times limited to weeks rather than months. We have couriers available to get your product back in your hands immediately. In most cases, your product will be ready to return shipment within 3-4 business days of when it’s received.
Core Services
From product design and development to sterilization and even packaging, we’re got you covered!
EO Sterilization
We can validate your product in our 3M Steri-Vac™ sterilizer chamber in accordance with ISO 11135 and CFR 820 requirements.The Steri-Vac 8XL gas sterilizer/aerator is a compact unit designed to sterilize medical devices using ethylene oxide gas. It utilizes a fully automatic control system for operator safety and to ensure that proper sterilization conditions are met.
Regulatory
We'll work with you to make sure your product meets all regulatory, quality and clinical compliance regulations both domestically and internationally.We can guide you on every aspect of global medical device clinical regulations (ISO 13485:2016 certification through Boulder BioMed), and offer full regulatory and quality affairs on an outsourcing basis.
Design
We're experts in providing all aspects of product design and development while focusing on microbiology and sterilization methods for new products.In addition, Boulder Sterilization is proficient in design controls and new product development support including FDA and ISO support.
Other Services
Boulder Sterilization is a subsidiary of Boulder iQ. Boulder iQ offers clinical, scientific, technical, regulatory and quality consulting services, medical device design and development, and cleanroom manufacturing and assembly services.
Medical Device Design and Development
Regulatory due diligence
Global compliance support
Quality Management Implementation
Internal and External Audits
Regulatory Remediation Support
US FDA Submissions (510(k)s, IDEs, Q-Subs, PMAa, 513(g)s, etc.)
Global Regulatory Submissions
EU MDR/IVDR Technical File Documentation for CE Marking
Clinical Evaluation Reports, CEP, and PCFU
Contact Assembly, Manufacturing, and Packaging Services, including validations
EO Sterilization Methods
We are your solution for sterilization and packaging related services!
EO Sterilization Services
Sterilization Process Development
Sterilization Qualification, Validation, Routine Monitoring, and Requalification
Product Validation Support
Product Change Revalidation
R&D Testing and Biocompatibility Evaluations
Packaging Validation
EO Cycle Development and Validation
We can validate your product in our 3M Steri-Vac™ sterilizer chamber in preparation for routine sterilization at our facility, in accordance with ISO 11135 series requirements and US FDA QSRs and EPS regulations.
Chamber Dimension
Width: 51 cm (20 in)
Depth: 97cm (38 in)
Height: 46cm (18in)
Diagonal: 117cm (46in)
Basket Dimension
Width: 46cm (18in)
Depth: 91cm (36in)
Height: 20cm (8in)
Sterilization
Boulder Sterilization works with you to ensure the correct product is sterilized, a rationalization for the product selection and sterilization method, and ensure enough cycles were performed. The validation cycles are monitored using process challenge devices (PCD) and biological indicators (BIs) for your specific product monitoring routine production. Boulder Sterilization ensures the bioburden testing is completed, the bacteriostasis and fungistasis (B/F) test is done, and the Ethylene Oxide (EO) residuals, ethylene chlorohydrin (ECH), and ethylene glycol (EG) analysis is completed to demonstrate the safety of products sterilized by EO by determining compliance with accepted residual limits for the products intended use.
Cycle Development
On-Site Work and Final Protocol/Report preparation for EO cycle development in compliance with ISO 11135 series. Sterilization Parameters are designed to meet your optimized product requirements. EO cycle development is completed through the lethal rate release cycles.
Ethylene Oxide Sterilization Validation
Boulder Sterilization’s sterilization validations provide a confirmation by examination and provision of objective evidence that the requirements of the globally recognized sterilization methods prescribed in the ISO 11135 series. The EO sterilization validation process at Boulder Sterilization includes qualification, process parameters, validations, and routine activities, and is performed to your specific product and package requirements.
The most used EO Sterilization validation is the ISO 11135 “Overkill Method Release” (formally called the “Standard Conventional”) because of its ease of use and robust Sterility Assurance Level (SAL) results.
Additional Information
- Batch Release
- Some medical devices are in R&D and the product or package design are not yet frozen. In these instances, Boulder Sterilization can do a “Batch” release per ISO 11135, Annex E for a single lot release.
- EO Cycle Studies for Product and Packaging Evaluation
- It may be advantageous to complete a separate study to subject the product’s validated load configuration through two complete sterilization cycles (referred to as a “2X EO Process”). This EO validation helps you maintain inventory of your product by avoiding the need to discard expensive products in the event of an unforeseen occurrence.
- As the 2X EO Process presents a greater challenge to the sterilization process, product functionality validation/verification, package integrity, and EO/ECH Residue testing are required.
- Temperature and Humidity Monitoring
- Boulder iQ has calibrated data loggers to provide data on the product temperature and relative humidity during the EO sterilization process.