Page 215 - Facility Piping Systems Handbook for Industrial, Commercial, and Healthcare Facilities

WATER TREATMENT AND PURIFICATION

WATER TREATMENT AND PURIFICATION 4.51

Pumps for purified water should be of sanitary design using a double mechanical seal
with product water as the lubricant for the seals. WFI pumps should be type 316L SS, 180
grit and electropolished. A casing drain should be provided.

System Design Considerations
USP/WFI water is used in the pharmaceutical manufacturing process and often becomes
part of the product. Because of this, all aspects of the purification system and distribution
network are subject to inspection and validation by the FDA, which has the responsibility
to determine if the quality of water used is adequate.
The FDA has specific guidelines for selection of stills and RO equipment used for produc-
tion of WFI. In contrast, PW systems can utilize different types of purification equipment, since
the microbial and chemical quality can vary depending on the proposed use of the water.
The purpose of any guidelines or standards is to verify that all pertinent purity require-
ments of the equipment and distribution system conform to current good manufacturing prac-
tice (cGMP), are capable of consistently producing water of the required quality, and are
capable of delivering water that meets the acceptance criteria for water that comes in contact
with product. This investigation also includes verification that the purification equipment
selected be capable of producing water of the required purity, that the quality of installation
for the distribution network produces a piping network capable of delivering water of the
required quality to all outlets, and that the continuing quality of system operation, mainte-
nance, and ongoing testing will consistently provide water of the desired purity.
One typical pharmaceutical water purification flow diagram is shown in Fig. 4.17.

REFERENCES

Blake, R. T., Water Treatment for HVAC and Potable Water Systems, McGraw-Hill, New York.
Brown, J., N. Jayawardena, and Y. Zelmanovich, “Water Systems for Pharmaceutical Facilities,”
Pharmaceutical Engineering Magazine, pp. 14–23, July/August 1991.
Cartwright, Peter S., “Reverse Osmosis and Nanofiltration System Design,” Plumbing Engineer
Magazine, pp. 45–49, March 1994.
Collentro, W. V., “Pharmaceutical Water,” Parts 1 and 2, Ultrapure Water Magazine, November/
December 1992.
Dow Chemical Corporation, Water Conditioner Manual, 1988.
Gorry, M., P. Amin, and D. W. Richardson, Sr.,“Take the Guesswork out of Demineralizer Design,”
Chemical Engineering Magazine, pp. 112–116, March 1994.
Janoschek, R., and G. C. du Moulin, “Ultraviolet Disinfection in Biotechnology: Myth vs Practice,”
BioPharm Magazine, pp. 24–27, January/February 1994.
Meyrick, C. E., “Practical Design of a High Purity Water System,” Pharmaceutical Engineering
Magazine, pp. 20–27, September/October 1989.
Nalco Chemical Company, The Nalco Water Handbook, 2d ed., McGraw-Hill, New York, 1988.
Parekh, B. S., “Get Your Process Water to Come Clean,” Chemical Engineering Magazine, pp. 71–85,
January 1991.
Stenzel, M. H., “Remove Organics by Activated Carbon Adsorption,” Chemical Engineering Progress
Magazine, pp. 36–43, April 1993.
Yeh, K. L. and S. H. Lin, “Looking to Treat Wastewater-Try Ozone,” Chemical Engineering Magazine,
pp. 113–116, May 1993.

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