U.S.-Based Sterile Manufacturer for Bacteriostatic Laboratory-Grade Water

We are seeking a U.S.-based sterile manufacturing partner for the production of a bacteriostatic laboratory-grade water solution (sterile water with preservative system), intended strictly for research use only (RUO) applications.

Manufacturing must be conducted in a controlled, ISO-classified cleanroom environment, utilizing validated sterile filtration and/or terminal sterilization processes. The selected partner must perform lot-level sterility testing and bacterial endotoxin testing, with appropriate method validation and documentation.

We require a partner capable of scalable production, operating under documented quality systems, and able to provide comprehensive analytical documentation suitable for laboratory and non-clinical research distribution. This includes full batch records, Certificates of Analysis, and supporting quality documentation aligned with applicable U.S. regulatory and quality standards for RUO materials.

The ideal partner will have demonstrated experience in sterile aqueous solution manufacturing and robust quality management systems to support ongoing production and potential scale-up.