Suited for biopharmaceutical processing and storage of critical reagents and bulk intermediates such as vaccine and protein therapeutic preparations. Manufactured in a certified ISO 14644-1 Class 7 cleanroom. Containers are lot certified to comply with particulate limits specified in USP <788>, EP 2.9.19, and JP 14th ed. Part 1, Section 24. Packaging is designed for cleanroom applications. Bottle and closure are secured with a tamper-resistant heat-shrink band and packaged in heat-sealed bags to support cleanroom operations. USP Class VI, EP Modified Abnormal Toxicity, and USP <661> physicochemical tests compliant. Bottles meet the requirements for USP Class VI, EP Modified Abnormal Toxicity Test, are non-cytotoxic, pyrogen-free, non-hemolytic, and comply with USP <661> physicochemical guidelines. Resins are free of animal derived components (ADCF). Leakproof.