SODIUM HYDROXIDE SOLUTIONS FOR BIOPHARMA, PHARMA AND FOOD SECTORS

For over 40 years, Micro-Bio has been a trusted cGMP manufacturer of sodium hydroxide solutions. We ship directly to our global biopharmaceutical, pharmaceutical and food customers.

As the raw material manufacturer of sodium hydroxide, we provide our customers with a secure and reliable supply of this mission critical raw material.

The advantages of sourcing hydroxide solutions directly from Micro-Bio include:

Product Quality: Through our electrolysis process, Micro-Bio produces cGMP grade NaOH.
Quality assurance: As a manufacturer, we adhere to ISO 9001:2015 standards and implement cGMP controls. This ensures full control and traceability throughout our operations, from the receipt of raw materials to manufacturing, storage, filling, and delivery. Our in-house laboratory conducts comprehensive testing of our NaOH, adhering to multiple international pharmacopeial standards for full compliance.
Supply chain: By working with Micro-Bio, our customers benefit from consistent and uninterrupted supply, reducing the risk of shortages or delays. Also, working directly with the manufacturer ensures compliance with cGMP sourcing guidelines.
Technical Support: Micro-Bio offer technical support and expertise, assisting customers with product selection, handling, and storage requirements.
Traceability: We maintain detailed records of production processes, including raw material sourcing and quality control testing. Records are kept for
Compliance: using cGMP manufactured Sodium Hydroxide ensures compliance with regulatory requirements.
Product offering: We provide the best available lead times, bespoke concentrations, versatile delivery options, and customised packaging solutions.

Applications

Sodium Hydroxide (NaOH) is a critical material used in various steps of biopharmaceutical manufacturing processes, including protein purification, chromatography, and buffer preparation. The amount of NaOH used in each process can vary depending on the specific protein being produced and the purification method used. However, some biopharmaceutical manufacturing processes that use a significant amount of NaOH include:

Cleaning and sanitisation agent

Sodium hydroxide is an effective cleaning agent due to its strong alkaline properties, which help to break down organic residues and remove impurities. It is commonly used in the cleaning of bioreactors, mixing vessels, and other equipment involved in biopharmaceutical production. In addition, sodium hydroxide is used as a disinfectant for cleanroom surfaces and equipment.
Chromatography to purify biopharmaceuticals and biologics

Chromatography is a widely used technique for protein purification in biopharmaceutical manufacturing. In this process, NaOH is used to adjust the pH of the chromatography buffer to optimize protein binding and elution from the chromatography column.
Buffer production

Retains good buffer capacity and is used across many areas in life sciences production environments.
Chromatography column resin cleaning, sanitisation and storage

Chromatography is a widely used technique for protein purification in biopharmaceutical manufacturing. In this process, NaOH is used to adjust the pH of the chromatography buffer to optimize protein binding and elution from the chromatography column.
PH adjustments and the production of cell culture media

It is used to adjust the pH of the media to the optimal range for cell growth and metabolism. In addition, sodium hydroxide is used to break down cell walls in order to release intracellular components that can be used for further downstream processing.
Water treatment

To control water acidity and to help remove heavy metals from water.

High Purity Sodium Hydroxide Solutions – Documentation

The use of Sodium Hydroxide in biopharmaceutical, pharmaceutical and food manufacturing processes is crucial for ensuring high-quality and consistent products.

We offer Sodium Hydroxide solutions produced under cGMP and ISO: 9001:2015 accredited quality system. Please see link to download Safety Data Sheets. Specifications and other quality related documentation are available on request.

Sodium Hydroxide Solutions Product Guide

Micro-Bio manufactures a wide range of Sodium Hydroxide solutions, from 0.5N to 50% concentrations. We offer these solutions in bulk tankers, IBCs, and various packaging sizes from 5L bottles to 200L barrels.
As a manufacturer, Micro-Bio is equipped to create custom concentrations and adapt delivery formats to meet our customers’ specific requirements.