Chemical Engineering April 2020 - 43

Attribute
TABLE 1. PROPERTIES OF USP WATER GRADES
USP - Purified Water
Incoming feedwater quality
Conductivity (μS/cm at 250°C)
Bacteria (CFU)
Endotoxin units (EU) per mL
TOC (mg/L)
Meets EPA/WHO drinking water requirements
<1.3
<100/1 mL
N/A
0.5
products (Figure 2).
There are two grades of water
quality that manufacturers of pharmaceutical
and personal-care products
may need: USP Purified Water
or USP Water-for-Injection (WFI).
Both grades have specific minimum
levels for certain parameters. These
include total organic carbon (TOC)
content, as well as the amount of
bacteria and endotoxins for WFI.
Another important parameter is conductivity,
which provides an indication
of inorganic materials present
in water, and is usually expressed
in units of microSiemens (µS) per
centimeter. The primary difference
between the two grades is the more
rigorous set of standards for microbial
control required for WFI, as
shown in Table 1, and the incoming
water quality, for which USP Purified
Water is based off of requirements
set forth by the U.S. Environmental
Protection Agency (EPA; Washington,
D.C.; www.epa.gov) and the
World Health Organization (WHO;
Geneva, Switzerland; www.who.int).
A variety of water-treatment techUSP
- WFI
Purified
<1.3
<10/100 mL
<0.25
0.5
nologies are utilized to achieve these
quality standards and typically include
a combination of softeners,
carbon filtration, UV light, particle
filtration, reverse osmosis, ion exchange,
electrodeionization and
final filtration. In addition, the water
treatment system should be regularly
sanitized to prevent the growth
of bacteria by using chemical, heat
or ozone technology.
Medical industry
The healthcare market has very
specific high-purity water-quality
needs tied to various applications
within hospitals, clinical-care facilities
and medical research institutions
(Figure 3). International and
national standards authorities have
established water-quality guidelines
to ensure the highest-quality care
can be provided to patients. Highpurity
water is critical as a feedwater
source to equipment in four key
application areas, described in the
following sections.
Clinical chemistry and pathology.
Reagent-grade water is necessary
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FIGURE 2. The production of pharmaceutical and personal-care products requires water that meets specific
guidelines set forth by the Unites States Pharmacopeia (USP) organization
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Chemical Engineering April 2020

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