PHARMACEUTICAL / USP WATER TESTING
Pacific BioLabs is now offering complete USP Purified Water Monograph testing including Total Organic Carbon, Conductivity, and Microbial Enumeration tests. We also offer support services such as sample collection and data trending.
Purified Water Testing
Purified water is a key component in the manufacturing of virtually all pharmaceutical products. Water purification systems must be validated to insure that the specified quality of water is consistently produced. Pacific BioLabs is the leading provider of laboratory testing services for validation of pharmaceutical water systems. If manufacturing plants are located near our laboratory in Hercules, water samples can be collected by our technicians. Alternatively, the manufacturer's employees can collect the samples and ship them to Pacific BioLabs for analysis. Samples for microbiological testing will be put on test the day that the samples are received. Bacterial endotoxin and chemistry testing will be completed within five work days. Please call client services to discuss your water system validation requirements.
All water purification systems must be monitored regularly to verify the quality of the water produced. Water purification systems can potentially harbor high levels of bacteria. Bacterial or chemical purity problems with water can compromise the quality of finished products. Pacific BioLabs can supply containers for collecting water samples. Please call client services to request supplies.
The United States Pharmacopeia USP <1231> Water for Pharmaceutical Purposes provides information on water quality attributes. These waters are typically produced in large volumes by systems which include purification stations and distribution piping. This chapter includes guidance on the validation and qualification of water purification, storage and distribution systems. TOC, conductivity and microbiological tests are an integral component of a validation program.
USP contains monographs related to Water for Injection (WFI) and Purified Water (PW). WFI is intended for use in the preparation of parenteral solutions. PW may be used for sterile dosage forms, other than for parenteral administration. Total Organic Carbon (USP <643>) and Water Conductivity (USP <645>) must be tested to meet the monograph requirements.
Total Organic Carbon (TOC) Testing
Total Organic Carbon (USP <643>) is an indirect measure of organic compounds present in water measured as carbon. Organic contaminants may be introduced into pharmaceutical waters from the source water, the purification system materials and biofilm. TOC testing is also used to monitor the performance of water purification and distribution systems.
Water Conductivity (USP <645>) is used to measure water purity and suitability to use in pharmaceutical applications. The electrical conductivity in water is a measure of the ion-facilitated electron flow through it. Water conductivity is affected by extraneous ions introduced as contaminants. An increase in water conductivity is inversely proportional to its purity.
Microbial Enumeration is an integral component of a water system monitoring program to assess the microbiological quality of the water produced. A well designed monitoring program will detect adverse trends that are potentially harmful to finished products, processes, or consumers. At Pacific BioLabs we conduct classical culture methods such as pour plates, spread plates, membrane filtration and most probable number (MPN). The membrane filtration method is generally preferred because larger sample volumes can be tested hence increasing the method sensitivity. We can use high-nutrient media such as Plate Count Agar (PCA) for the isolation of heterotrophic bacteria and/or low-nutrient media such as R2A for the isolation of slow growing “oligotrophic” bacteria.