Pharmaceutical Water & Utilities Testing

Water Testing

The water utilized for pharmaceutical manufacturing, cleaning, and cooling must be pure, to ensure that your end product is not contaminated. Likewise, the microbial air quality in cleanrooms and other controlled environments must be tested, to demonstrate the control of viable (living microorganisms) and non-viable particles.

The Importance of Water Testing in the Pharmaceutical Industry

The quality of pharmaceuticals depends a great deal on the purity of water used in a manufacturing process. The United States Pharmacopeia (USP) has a series of testing methods and specifications that are recognized as the standard for the industry.

These are framework on which the FDA bases its inspection criteria. Testing determines whether the water used in the manufacturing process is fit for purpose.

Types of Pharmaceutical Water Analysis

There are many analyses utilized in water testing in the pharmaceutical industry. These include:

Total Organic Carbon (TOC) — A TOC test checks for the presence of organic compounds containing carbon, which may indicate impurities in the water supply.
Bioburden — Microbiological contamination can have a negative impact on the finished product. Ensuring that water is free from microbial proliferation ensures that no extraneous contaminating material is contributed to the final dosage form.
Water Conductivity — Evaluates the presence of specific ions including chloride and phosphate by introducing an electrical current into the water supply. If these ions are present, the current will flow through the water.
Biofilms — When present in a water supply, certain bacteria will leave a film that can contaminate and impact its purity. Checking for these ensures not only the quality of the water but also the performance of delivery systems.

BA Sciences offers a complete line of compressed gas and purified water testing services with a rapid turnaround time. Our experienced staff can help you determine the specific pharmaceutical water testing capabilities you need and assist with sample collection.

Utilities Testing Services

Bioburden Water Testing USP <1231>, “Water for Pharmaceutical Purposes”
TOC Testing of Water Systems, USP <643> “Total Organic Carbon,” with a Sievers® 900 TOC Analyzer
USP Water Testing, USP <645>, “Water Conductivity”
Bacterial Endotoxin Testing, USP <85>, “Bacterial Endotoxins Test”
Bioburden testing
Purified Water System Validations
Compressed Gas Monitoring for Water Vapor, Hydrocarbon, Viable, and Non-Viable
Clean Dry Air Characterization
Air Viable and Nonviable Testing
Water Vapor Level Confirmation
Hydrocarbon Testing