BioSpectra announces GMP grades of Sodium Hydroxide (NaOH) solutions without the use of pellets.

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.

BioSpectra proudly announces the commercial launch of a new, dedicated, bulk manufacturing process for 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. 

BioSpectra has developed its own proprietary process to manufacture high purity Sodium Hydroxide (NaOH) Solutions. Our new three step manufacturing process, located at our fully cGMP compliant, 150,000 square foot, FDA registered and inspected facility in Bangor PA, USA is an industry leading example of our commitment to providing the safest and most secure supply chains. 

Validation of the entire process from test methods to manufacturing system is underway and full reporting will be completed later this year. Products are commercially available starting 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. PBioSpectra proudly announces the commercial launch of a new, dedicated, bulk manufacturing process for 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. BioSpectra has developed its own proprietary process to manufacture high purity Sodium Hydroxide (NaOH) Solutions. 

Our new three step manufacturing process, located at our fully cGMP compliant, 150,000 square foot, FDA registered and inspected facility in Bangor PA, USA is an industry leading example of our commitment to providing the safest and most secure supply chains. Validation of the entire process from test methods to manufacturing system is underway and full reporting will be completed later this year. Products are commercially available starting 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-LVL’s. This system will be the cornerstone of a new GMP, Large-Volume-Liquid manufacturing area, that will produce many other core, key GMP-LVL’s. Visit us at booth #407 for information. 

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