Medical Device Sterilization Services
Expert Support for Safe, Compliant, and Efficient Device Sterilization
At Cretex Medical | QTS we offer a full suite of medical device sterilization management services designed to help you achieve sterility assurance, regulatory compliance, and speed to market. Our certified microbiologists and engineers provide hands-on guidance throughout the process, from protocol development to third-party lab coordination, so you can focus on what you do best: delivering life-changing medical technologies.
At QTS you’ll work hand in hand with industry-leading sterilization experts.
Flexible Sterilization Management Solutions
Sterilization isn’t one-size-fits-all. We can partner with you to execute your sterilization plan or work with you to determine the most effective and efficient method based on your device design, materials, and regulatory requirements.
Sterilization Methods:
- Ethylene Oxide (EO / EtO)
- Gamma Irradiation
- Electron Beam (E-Beam)
- X-ray
- Moist Heat (Steam)
- Custom methods based on unique product needs
Whether you’re starting a new validation or transferring an existing process, we provide seamless coordination from start to finish.
Our experts stay up to date on ever-evolving sterilization technology so they can provide you with the best advice.
QSTERILE®: Fast-Track Sterilization Pre-Validation
Need EO sterilization without the delay and cost of a full validation? Our QSTERILE pre-validated EO cycle provides a ready-to-use sterilization process that meets industry standards. By adopting QSTERILE you can:
- Avoid the time and cost of custom validations
- Leverage a proven, compliant EO cycle
- Accelerate your product timeline
Our pre-validated solutions ensure compliance and safety while driving cost savings.
Validation & Testing Coordination
Our sterilization experts oversee every step of the validation process, helping you meet strict industry standards while reducing time, cost, and risk. We also manage production-cycle coordination and third-party testing partnerships, giving you a single point of contact and total project visibility.
Sterilization Validations:
- EO sterilization validations
- Gamma/E-beam/x-ray dose setting & audits
- Annual EO requalification assessments and periodic requalification studies
Laboratory Testing Management:
We partner with a variety of labs to offer the microbiological and chemical tests needed to validate and ensure ongoing compliance of your sterilization process.
- Bioburden testing
- Microbial identification
- Product & BI sterility testing
- Endotoxin testing
- EO residuals testing
We work with testing labs who employ advanced technology and reliable procedures.
Reduce Risk with Routine Test Schedule Management
Sterilization compliance requires consistency. Our team actively monitors important milestones such as periodic requalifications and dose audits, notifying you in advance to keep your project on track and regulatory-ready.
We help you avoid delays and non-conformances through:
- Proactive process management
- Meticulous documentation
- Timely alerts for testing and audit requirements
- Bioburden data trending
Proactive testing management reduces the risk of delay or nonconformance.
Cost-Effective Product Family Grouping
Looking to reduce the cost of validations? Our microbiologists and engineers can help establish product families, allowing a single representative device to stand in for multiple SKUs during validation. We support:
- EO and radiation sterilization family groupings
- Justification of family logic
- Selection of representative products
This strategic approach allows you to minimize testing while staying fully compliant with global sterilization standards.
Product family groupings help simplify and streamline the validation process.
Let’s Talk About Your Sterilization Strategy
Whether you’re launching a new device and want help choosing your sterilization modality, or looking to transfer an existing manufacturing line with an established sterilization process, QTS has the capabilities and expertise to simplify your life.
Contact us to start the conversation.
