You need the highest level of quality assurance, accuracy, and traceability in your scientific research. However, the inherent variability of biological materials brings unique challenges to establishing standards for in vitro model systems and setting up the ISO-compliant processes to produce them.
To support this need, ATCC offers microbial standards produced under ISO 17034 and ISO/IEC 17025 accredited and ISO 9001 certified processes. These certified reference materials are traceable to the original culture and have confirmed identity, well-defined characteristics, and an established chain of custody, making them ideal for use as biological standards for research and development purposes.
Further, each vial is also accompanied by a certificate of analysis that states the results of each assessed property value, the expiration date of the material, and proper use. These certificates confirm that all necessary procedures were performed to ensure their validity and traceability (ISO Guide 30).
ATCC Certified Reference Material have a number of recommended uses, including:
- Establishing sensitivity, linearity, and specificity during assay validation or implementation
- Challenging assay performance
- Validating or comparing test methods
- Testing and calibration in ISO 17025 labs that stipulate the use of reference materials
- Benchmarking critical assay performance for regulatory submissions and production lot release
ATCC Certified Reference Materials offer the highest level of quality assurance, accuracy, and traceability, and they give you complete confidence that your results are reliable and reproducible. Explore our certified reference materials below to get started.
Learn more about our reference materials
ATCC Certified Reference Materials Highlights
Biological reference materials produced under ISO 17034 and ISO/IEC 17025 accredited and ISO 9001 certified processes set a high biological reference standard. Download this product spotlight to learn more about the features and benefits of these certified materials.Download now
Enhanced Pharmaceutical Sterility Testing Using ATCC Certified Reference Materials
Our microbial certified reference materials for antimicrobial effectiveness testing and microbial enumeration comply with United States Pharmacopeia (USP) guidelines and are ideally suited as standards for the microbiological analysis of pharmaceutical products.Download the application note