USP Water Testing

USP Water Testing

As everyone knows, water is a critical component for supporting nearly all forms of life on planet Earth. This includes microscopic forms of life such as those which inhabit water. Some water-borne microorganisms such as bacterial pathogens can prove to be quite harmful towards humans and other animals. For this reason, certain uses of water require that it be free of the microscopic organisms which could potentially cause illness, disease and even death in humans and animals.

Water plays a key role in the formulation and manufacturing of pharmaceutical, therapeutic, and cosmetic/personal care products. Given its uses as an ingredient, solvent, and equipment cleaning aid, water must meet appropriate standards, to ensure the purity and quality of the products and processes in which it is used. Pharmaceutical manufacturers are responsible for monitoring the quality of the water that is used in their products and processes, ensuring that it complies fully with all applicable regulatory standards. The United States Pharmacopeia (USP) provides quality standards and test methodologies to be employed in the testing of water that is used in pharmaceutical-related activities. Compendia in jurisdictions outside of the US provide similar standards and methodologies for the testing of water that is used in therapeutic products sold within those jurisdictions.

USP Water Types and Requirements

The USP provides Monographs for many types of water and establishes specifications and test methods for each type, based upon the application for which that type of water is used. The most commonly used USP Water Monographs include:

1. USP Purified Water

This is the most commonly used type of water defined by a USP Monograph. It is primarily used in the formulation of non-sterile pharmaceutical and therapeutic products, and for the cleaning of equipment used to process such products. Although cosmetic and other “non-drug” products are not required to be formulated and processed using USP Purified Water, most manufacturers choose to use it since it reduces the possibility of microbial contamination from water-borne organisms, and it eliminates the possibility of product color, fragrance and flavor interactions with the metallic ions that are often found in “tap” water.

2. USP Water for Injection (WFI)

As its name suggests, this type of water is primarily used to formulate and process injectable (parenteral) products. Although not required, WFI is often used to formulate and process ophthalmic products as well. WFI is required to meet the same specifications outlined for USP Purified Water in addition to specific bacterial endotoxin requirements.

3. USP Pure Steam

This type of water (also referred to as “Clean Steam”) is used where steam or the condensate thereof directly contacts pharmaceutical or therapeutic products, equipment contact surfaces during the processing of such products, the sterilization of such products, or cleaning processes that are not followed up with an additional impurity removal process. The minimum requirements for USP Pure Steam are those found in EPA/EU/WHO Drinking Water standards.

4. USP Sterile Purified Water

This is USP Purified Water that has been sterilized and suitably packaged. Sterile Purified Water is often used when access to a USP Purified Water generating system is not possible or practical.

5. USP Sterile Water for Injection

This is USP WFI which has been sterilized and packaged in single-dose containers smaller than one liter. Sterile WFI is often used to prepare sterile products, or in production processes where USP WFI or USP Purified Water is required but access to a USP Purified Water generating system is not possible or practical.

USP Water Testing

USP water testing is designed to determine water purity, the absence of objectionable organisms, and their resulting endotoxins. The testing required for each water type depends primarily upon its intended usage. The most common USP water tests are outlined below:

<645> Water Conductivity measures the presence of extraneous ions such as chloride, ammonia and metals which could significantly impact water purity, and its suitability for use in pharmaceutical and therapeutic product applications.

<643> Total Organic Carbon (TOC) is an indirect measurement of organic molecules within water. Although microbiological testing is also used to determine the presence of organic molecules in water, neither test may be used as a substitute for the other.

<61> Microbial Examination of Nonsterile Products: Microbial Enumeration Tests are designed to detect the presence of microorganisms in water.

<62> Microbial Examination of Nonsterile Products: Tests for Specified Microorganisms are designed to detect the presence of specific organisms (i.e., objectionable organisms) in water.

<85> Bacterial Endotoxins Test is designed to determine the presence of endotoxins produced by gram-negative bacteria in water.

<788> Particulate Matter in Injections is designed to determine the presence, and if present, to determine the size of undissolved particles found in solutions intended for injection and parenteral infusion.

Water Purification Systems

The purity and quality of any USP Water-type is strongly dependent upon the efficiency of the purification system that is used to produce it. Each water purification system must be carefully designed to meet the quality and quantity of water that is required by its user. Once installed, water purification systems must be validated prior to first usage, and continually monitored to ensure the on-going purity and quality of the water that it produces. Typical maintenance of water purification systems includes the replacement of consumable items (e.g., filters), regeneration of system elements (e.g., carbon filters, softeners, ion exchange resin beds and Reverse Osmosis Membranes) and system sanitization.

Why Choose CPT for your USP Water Testing?

• More than 43 years of testing expertise under the same Ownership/Management.
• Five (5) highly specialized, state-of-the-art laboratories directed by well-seasoned professionals.
• High level of regulatory compliance relating to GMP, GLP and GCP regulations.
• ISO/IEC 17025:2017 accredited with most USP Water Tests included within our Scope of Accreditation.
• Rapid turn-around times for USP Water Testing.
• Regulatory and Industry-savvy guidance available to all clients at all times.
• Custom tailored testing programs.

Think of CPT as an extension of your Quality Team. Accurate testing conducted within a highly compliant testing environment. USP Water Testing of the highest value. Contact us at your earliest convenience.