APPLICATIONS OF PHARMACEUTICAL USP WATER SYSTEMS IN PHARMACEUTICAL MANUFACTURING, API MANUFACTURING AND MEDICAL DEVICE MANUFACTURING

Blue Spring Corporation manufactures pharmaceutical usp water systems
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BLUE SPRING HAS THE MOST DIVERSIFIED PRODUCT
LINE OF USP WATER SYSTEMS *





PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURING WATER SYSTEM SELECTION GUIDE

APPLICATION
SUGGESTED BLUE SPRING
SYSTEM
Typical medium-sized or large pharmaceutical, or API facility.
Water quality according to USP Water-for-Injection standards.
High bio-purity requirements.  Multiple points of use, such as
compounding, steam sterilization, bottle washing machines,
laboratory.  Frequent use of water during day. Closed loop re-
circulating output without WFI storage tank desirable.
WFI-R-EDI SERIES
Medium-sized or large pharmaceutical, or API facility. Water
quality according to USP Water-for-Injection standards. High bio-
purity requirements.  Single point of use, such as compounding
tank, or WFI storage tank.  
WFI-EDI SERIES
Medium-sized or large pharmaceutical, or API facility. Water
quality according to old USP 22 or earlier Water-for-Injection
standards acceptable.  High bio-purity requirements.  Single point
of use, such as a compounding tank or a WFI storage tank.
WFI SERIES
Small pharmaceutical or API facility, or large pharmacy, or 
pharmaceutical laboratory, or for university research work.  Both
USP Purified Water and USP Water for Injection grades of water
according to USP Water-for-Injection standards required from the
same unit.  Economy and space are main consideration. Infrequent
use of water during day.  
WP-35USP
WP-DI SERIES
Typical medium-sized or large pharmaceutical or API facility, or
dietary supplement facility. Water quality according to USP
Purified-Water-standards. Multiple points of use, such as
compounding, tank cleaning, bottle washer, laboratory use. 
Frequent use of water during day. Closed loop re-circulating
output without WFI storage tank desirable.
WP-R-EDI SERIES
Typical medium-sized or large pharmaceutical or API facility, or
dietary supplement facility. Water quality according to USP
Purified-Water-standards. Single point of use, such as
compounding tank, or storage tank.
WP-EDI SERIES
Large-scale medical device manufacturing, rinsing, testing
operations. Critical devices. Non-pyrogenicity required. High ionic
purity and low TOC required. Water per USP Water-for Injection-
standards.  Multiple production lines, or multiple points of use.
WFI-R-EDI SERIES
Medium-scale medical device facility. Water to be used  for
production, rinsing, testing operation. Critical devices. Non-
pyrogenicity required. High ionic purity and low TOC required.
Water per USP Water-for-Injection standards. 
WFI-EDI SERIES
Small medical device facility.  Water to be used in production,
rinsing, testing operations. Non-critical devices or operations. Non-
pyrogenicity of water, reasonable chemical and ionic purity
required, but no compendial water quality standards to meet.
WP-35
WP-60
WP Series
  Small medical device facility.  Water to be used in production,
rinsing, testing operations. Variety of uses. Water must meet USP
Purified Water or Water for Injection standards in some, but not all
uses.
WP-35USP

WP-DI SERIES
* According to U.S. FDA, USP Purified Water and USP Water-for-Injection are components or “ingredient materials” as they are termed by the USP, intended to be used in the production of drug products. Neither FDA nor USP considers them as drug products. These two water categories are popularly used within pharmaceutical and medical device manufacturing establishments.

Intended for formulation of pharmaceuticals and pharmaceutical ingredients, and for manufacturing of medical devices.  Water purification equipment not intended for direct use as a medical device in medical treatment.  Product water not intended for direct use as a drug in medical treatment.  On-site Installation Qualification, Operational Qualification, Performance Qualification and long-term System Validation is usually required, for establishing long-term consistency of product water quality, under seasonal variations of feed water quality and operating conditions..