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at Booth 2154

BioSpectra Launches Bulk Mfg. Process


For high purity GMP grades of sodium hydroxide solutions.

BioSpectra has launched a new, dedicated, bulk manufacturing process for high purity GMP grades of sodium hydroxide solutions made with USP purified and WFI grade water meeting specialty BET specifications that does not rely on the use of pellets.
The new three step manufacturing process is located at BioSpectra’s fully cGMP compliant, 150,000 square foot, FDA registered and inspected facility in Bangor PA. Products became commercially available in April 2019. The overall system is capable of producing over 1,000,000 liters per year of various molarities of high purity, low chloride, sodium hydroxide, made with USP or WFI grade water.
Products to be launched sequentially will include 2N, 5N, 10N, 25% and 50% blends in package sizes ranging from 1000 liter totes, 200 liter drum, 19 & 10 liter pail and 4 & 1 liter bottles. This system will be the cornerstone of a new GMP, large-volume-liquid manufacturing area, that will produce many other core, key GMP-LVLs, according to the company.
BioSpectra is exhibiting at CPhI North America at booth 407.