To most of the world, water is water. It’s clean or dirty, salty or fresh. But to biopharmaceutical companies it’s a dynamic resource, which comes in many different forms and grades. Water is a raw material, a solvent, a critical component for many formulations and manufacturing steps; it can even be an active ingredient.

If you’re in the biopharmaceutical field, chances are many liters of H2O stream through your facility every year. Knowing how to maximize the types and sources can significantly improve your company’s efficiency. Managing your water and associated regulations can also help to avoid potentially hazardous contamination, which affects products, compliance and end-consumers.

What is Purified Water?

Purified water is water that has been mechanically filtered or processed to remove — or at least neutralize — any potential contaminants. The two most common purification methods are distillation and deionization, though many combinations exist to cater for various uses. Deionization for example, removes all negatively charged anions, but it won’t directly remove bacteria and viruses.

By definition, purified water will need to comply with certain limits for physical and chemical properties, including:

• Resistivity: a measure of electrical conductivity
• Total Organic Carbon (TOC): Low levels typically indicate high quality water and purification methods
• Bioburden: the total number of organisms within the sample. More specific breakdowns can test for contaminants such as endotoxins, which signal the presence of gram-negative bacteria.

Water Types for Clinical Use

While both international and national guidelines differ slightly, most follow a grade 1-3 or type I–IV system.

For bioprocessing, clinical diagnostics or eventual consumer products, minimum grades will be specified for each application. As a guideline:

• Type I+ is the highest quality; going above and beyond established purity requirements
• Type I (ultrapure water) is required for sensitive analytical tests, such as gas chromatography. It’s also used for in vitro fertilization and other mammalian treatments
• Type II+ is the minimum grade for many laboratory applications, designed to carry low levels of inorganic impurities
• Type II is also used frequently in the lab, for media preparation and as a buffer
• Type III is used outside of the direct experiment e.g. to rinse beakers, fill water baths or grow plants

While these are the broad water grades, even ultrapure water may need additional treatment steps depending on your lab applications:

• Molecular biologists may need to remove common enzymes that break down DNA and RNA molecules
• Microbiology experiments require totally sterilized water, to avoid cross-contamination
• Analysis of trace metals requires a clean base — water with all trace metals removed

Ongoing Testing

The other half of efficient water use is knowing when and how to test it. Water is never a fixed grade; it’s a property (or lack of) that must be regularly tested and maintained. A number of different agencies regulate water purity levels for scientific applications. These include:

• US Pharmacopeia (USP)
• American Chemical Society (ACS)
• American Society for Testing and Materials (ASTM)
• National Committee for Clinical Laboratory Standards (NCCLS)
• The International Organization for Standardization (ISO)

Many industry-specific agencies, such as the Federal Drug Administration, take their cue from these central organizations. Depending on your facilities location and your eventual market, regional regulations such as the European Pharmacopeia may also apply.

These ever-changing restrictions can begin to weigh your company down, diverting precious resources away from your core scientific aims. Drawing on the expertise of a trust-worthy, specialized water testing company such as Ultimate Labs can help you navigate the most efficient path. They’ll let you know if your testing protocol meets USP standards, or if you’re doing too much.

Staying Afloat

In the world of laboratory science, standard bottled water is not a “pure” option — regardless of what mountain spring, tropical island or ancient aquifer it’s sourced from. Scientists need water that meets their research and production needs, satisfies compliance and safeguards the purity of final products. Meeting those requirements and maintaining them are equally important; an area where outside resources can help.

For more information contact:

Hank Nowak
SVP, Commercial Operations
Infinity Laboratories
phone: 843-475-0155
e-mail: hnowak@infinitylaboratories.com

Infinity Laboratories was founded in 1991 on the bedrock principles of excellence, integrity, and quality. Today, the Company is a national chemical and microbiological testing laboratory servicing the pharmaceutical, biotechnology and medical device industries.

For more information about Infinity Laboratories, please visit infinitylaboratories.com