CorrTest Integrity Kit
About the Work
When MilliporeSigma needed to quickly transition manufacturing of their CorrTest® mix and fill solution, they turned to a partner they already trusted. CorrTest® is used to integrity test and clean membranes filters before production—a critical step in ensuring biopharmaceutical production processes are free of unwanted bacteria and viruses. The stakes for quality and reliability are high.
Build by Boyd partnered with MilliporeSigma—extending a relationship now approaching 30 years—to develop and validate the mix and fill process, establish a cGMP manufacturing operation, and assume full supply chain management for ongoing commercial production.
Process Development & Validation
Process DevelopmentProcess Validation
Manufacturing
Liquid Media ManufacturingPackaging
Supply Chain Management
Material SourcingSupply Chain Management
Process Development & Validation
Transitioning the CorrTest® solution to Build by Boyd required developing a new mix and fill process and validating it fully to ISO 13485 standards—ensuring the rigor that a product this critical to biopharmaceutical manufacturing demands.
With the process validated and the operation established, MilliporeSigma had the confidence of a compliant, reliable manufacturing partner capable of sustaining long-term supply.
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Manufacturing
Build by Boyd manufactures CorrTest® in a clean cGMP environment, compounding ultrapure water with specified raw materials in a closed, heated Mobius® mixing tank before pumping the solution into sterilized carboys for final fill.
The operation is built around the quality and process control that a solution used in biopharmaceutical membrane testing demands—consistent, compliant, and reliable across every production run.
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Supply Chain Management
Build by Boyd manages the full supply chain for CorrTest® ingredients and components as part of the manufacturing partnership. The team maintains raw material inventory aligned to forecasted demand, ensuring MilliporeSigma has uninterrupted supply of a solution that plays a critical role in their filtration cartridge assembly process.
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Outcomes
MilliporeSigma successfully transitioned CorrTest® manufacturing to Build by Boyd, ensuring uninterrupted supply of a solution critical to biopharmaceutical filtration integrity. The program deepened one of Build by Boyd's longest and most trusted manufacturing partnerships—and demonstrated the reliability that has made MilliporeSigma a strategic account for nearly three decades.
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Rapid Manufacturing Transfer
Build by Boyd developed and validated the CorrTest® mix and fill process quickly and to ISO 13485 standards, meeting MilliporeSigma's timeline requirements without compromising the quality a critical biopharmaceutical application demands.
Reliable Commercial Supply
A cGMP manufacturing operation built around ultrapure water compounding, closed mixing, and sterilized final fill gives MilliporeSigma a dependable, compliant supply of CorrTest® solution for ongoing filtration cartridge production.
25+ Year Partnership
The CorrTest® program reflects the depth of a relationship built over nearly three decades—one in which MilliporeSigma continues to rely on Build by Boyd to bring new innovations to market with the quality and performance that have earned repeated recognition for excellence.