CRMs grant self-reliance and independence, ultimately increasing efficiency by direct comparison of product performance to a certified reference.
Certified Reference Materials for Antimicrobial Testing
Situ Biosciences is introducing the world’s first Certified Reference Materials (CRMs) designed for use in the performance validation of standard AATCC, ASTM and ISO antimicrobial test methods.
Produced in accordance with ISO 17034 requirements and certified through ISO 17025 accredited laboratory testing, our Certified Reference Materials are intended for use globally by antimicrobial test laboratories.
Our Certified Reference Materials are innovative test standards developed from decades of antimicrobial testing expertise in the global market.
Each unit consists of a sample set of both Treated (orange) and Untreated (white) Test Controls, which are intended to guarantee the highest quality of antimicrobial method performance available and to verify proper ISO 17025 test performance.
Certified Reference Materials are required to be used under certain conditions for ISO 17025 compliance. Our goal is that the inclusion of our Certified Test Controls in Antimicrobial Methods will raise the quality of laboratory testing, and therefore product performance, throughout the industry.
The use of Certified Treated and Untreated Test Controls comes with a wide variety of benefits:
You Can Certify Your Results
Utilization of Situ Biosciences’ Certified Treated and Untreated Test Controls when performing applicable Standard Antimicrobial Methods, and achieving of the Certified Values, validates your ISO 17025 method performance and certifies your results. This additionally allows for use of the SBSC Certified stamp in your test report, communicating to your customers and regulatory agencies that you strive to perform or obtain the highest level of antimicrobial testing available.
Increase Insight into Product Performance
CRMs will provide insight into the performance of the product, allowing you to create long term control charts to monitor the performance of your products. This insight will allow a customer to make strategic decisions when implementing any design changes to that product or any future products that are developed.
Remove Potential of In-House Controls Invalidating Your Testing
Many Standard Antimicrobial Methods have validity criteria requiring an untreated control to demonstrate microorganism growth, which labs traditionally use an In-House Control to satisfy. When the In-House Control doesn’t meet this criteria, your test results may be invalidated. Some antimicrobial methods will additionally have you evaluate a product’s performance by comparing directly to the control. When the In-House Control displays antimicrobial performance, or simply doesn’t promote growth, this harms the result of your product.
Gain and Maintain ISO 17025 Accreditation
Situ Biosciences’ Certified Treated and Untreated Test Controls can be utilized to fulfill the following ISO 17025 Requirements:
- Personnel Training (ISO 17025 § 6.2.5)
- Metrological Traceability (ISO 17025 § 6.5.3)
- Selection, Verification, and Validation of Methods (ISO 17025 § 7.2)
- Measurement Uncertainty (ISO 17025 § 7.6)
- Ensuring Validity of Results (ISO 17025 § 7.7)
- Including Proficiency Testing
- Actions to address risks and opportunities (ISO 17025 § 8.5)
- Improvement (ISO 17025 § 8.6)
For answers to our most frequently asked questions, click here.