In pharmaceutical manufacturing, there is the need to use sterile water in production and cleaning activities. This water is needed to ensure that the products are safe for human use. USP purified water and USP water for injection are both identified by the FDA as ingredients for use in pharmaceuticals.[1] There are many methods for the creation of these types of waters. These methods utilize a system to create the purity or sterility. One such system is an RO system. There are many different requirements for water systems including validation requirements, testing requirements, and more.

The Reverse Osmosis (RO) water system utilizes filtration and pressure to separate pure water from the less pure solution.[2] Both the water that feeds into the system and the product water should be monitored for microbiological activity. Product water is the final purified water that comes out of the system. The microbiological activity should meet the requirements set either in the USP or by the FDA. If any microbiological activity is detected above the limits, then the water from the system cannot be used. The root cause must be determined, the issue corrected, and the system revalidated before use can resume.  

All equipment used in the system needs to be qualified and the system must undergo periodic validations to ensure the water produced actually meets the requirements of purified water.2 The qualification and validation should follow the FDA guidelines for validation. Without conducting proper validation of the system, it may not be used for manufacturing purposes. Failing to properly validate the RO system will likely result in a finding during an FDA inspection, meaning that a 483 will be issued.

Water systems are tricky, the requirements surrounding their usage are extensive and each requirement must be met in order for the water system to be used. EMMA International can help understand these requirements, find the appropriate labs for testing, and even help validate the system. Whether an RO system or any other type, EMMA International can help. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (August 2014) Water for Pharmaceutical Use, Retrieved 4/16/2022 from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/water-pharmacuetical-use

[2] FDA (August 2014) Reverse Osmosis, Retrieved 4/16/2022 from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/reverse-osmosis

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