USP is meeting the needs of the industry now and in the future with new microbial contamination control solutions, through acquisition of Stratix Labs, a microbiology technology company based in Saint Paul, MN.

With the acquisition of Stratix Labs and its suite of ready-to-use products for microbiological quality control testing, USP will now offer reliable, efficient, and convenient tools to enhance microbial contamination control strategies in manufacturing and compounding settings. As demand grows and new modalities emerge, these tools—which are powered by Stratix Labs’ innovative microbial preservation technologies—will help ensure quality throughout the drug development, manufacturing, and preparation process.

Combining Stratix Labs’ microbial quality control tools with USP’s applicable quality standards, will further enhance the accuracy and reliability of microbial contamination control and sterility assurance strategies, boosting regulatory confidence and ensuring the quality and safety of drug products.

New materials to drive microbiological quality control

Precise and efficient products for microbiological quality control testing can help manufacturers and developers reduce contamination for pharmaceutical and biopharmaceutical products.

USP, through the Stratix Labs storefront, now offers:

Enverify™ Test Kits

• Microbial-coated test surfaces for evaluating surface sampling competency
• Helps users validate sampling method from sample collection through transport and lab testing
• Ensures sampling tool and protocols are adequately capable of recovering the microbes from the surfaces found in your facility
• Offers a first-of-its kind, innovative solution to a long-standing industry gap for demonstrating competency in surface testing technique

ReadyNow™ Disinfectant Efficacy

• An innovative platform of pre-inoculated test articles for qualifying disinfectants and antiseptics in pharmaceutical manufacturing
• Enhances efficiency and reliability for critical contamination control processes

Together, Enverify™ and ReadyNow™ provide complementary solutions to ensure effective contamination control in classified pharmaceutical manufacturing environments.

Instant Inoculator™

• A ready-to-use product featuring defined quantities of reference microorganisms coated onto an easy-to-use applicator device
• Facilitates the handling of reference microbes in microbiology QC applications

USP will continue to evaluate and evolve new technologies for microbiological control and sterility to provide manufacturers and developers with the latest solutions to uphold quality and safety.

For non-media inquiries: AMTech@usp.org