Environmental Engineering Reference
In-Depth Information
13.6 Power Industry Summary
The power industry is important to our economy, and a key water treatment business.
As already noted, power industry water treatment involves many aspects, including the
sale of new and replacement treatment equipment, condensate polishing, components (i.e.,
instruments), disposable items (i.e., ilters, resins, etc.), specialty equipment, and mobile
water treatment services. Common treatment technologies found in deionization equip-
ment are IX, RO, and electrodeionization (EDI). For those active in nanotechnology, there
certainly are areas with potential product opportunities.
The next section of this chapter will examine the pharmaceutical and biopharmaceutical
i ndu s t r y.
13.7 Pharmaceutical Water
This section will examine pharmaceutical water treatment. For the purposes of this sec-
tion, this water treatment segment includes end users who produce pharmaceutical-grade
water because they are required to follow the guidelines set forth by the United States
Pharmacopeial Convention Inc. (USP), or related pharmacopeia standards in other world
regions (i.e., European Pharmacopeia [EP] or Japanese Pharmacopeia [JP]). Examples
include pharmaceutical manufacturers, biopharmaceutical companies, some health-care
device makers, kidney dialysis centers, and the makers of certain consumer products (e.g.,
cosmetics, and contact lens solution, among others) that require pharmaceutical-grade
water.
13.7.1 Background
The pharmaceutical and health-care industry segments and their decisions on water treat-
ment are impacted by the decisions made by outside regulatory bodies. In the case of phar-
maceutical water, the US Food and Drug Administration (FDA) has oversight to inspect
and validate water treatment approaches at facilities. Therefore, end-user facilities design
their water systems and make their purchasing decisions to ensure they remain in compli-
ance with the FDA and any other regulator.
In its oversight, the FDA relies on water quality standards developed through the USP,
a not-for-proit organization based in Rockville, Maryland. The USP was founded in 1820
to create a system of standards for making pharmaceutical drugs in the United States. In
1848, the Drug Import Act passed by Congress recognized the USP as an oficial compen-
dium of standards, a status the organization still holds today.
The USP has a water subcommittee that helps to develop and update USP guidelines
related to pharmaceutical water quality, and testing approaches used to conirm water
quality. These, in turn, are published in the annual
US Pharmacopeia and National Formulary
(
USP-NF
), which is a publication that provides standards for medicines, dosage forms, drug
substances, excipients, medical devices, and dietary supplements [11]. The
USP-NF
con-
tains monographs on a variety of topics, including water treatment guidelines. Different
types of pharmaceutical-grade waters that are produced include Bacteriostatic Water for
Injection, Puriied Water, Sterile Puriied Water, Sterile Water for Inhalation, Sterile Water
