دستگاه تولید آب مقطر تزریقیبا قابلیت تولید آب طبق استانداردهای جهانی USP و FDA در ظرفیت های مختلف جهت ارایه به انواع صنایع مانند دارویی و غذایی آماده عرضه می باشد.
Water for Injection—Water for Injection (see the USP
monograph) is used as an excipient in the production of
parenteral and other preparations where product endotoxin
content must be controlled, and in other pharmaceutical
applications, such as cleaning of certain equipment and par
enteral product-contact components. The minimum quality
of sourtion is Drinking Wce or feed water for the generation
ofater as defined by the U.S. EnvironmentalWater for Injec
Protection Agency (EPA), EU, Japan, or WHO. This source
water may be pretreated to render it suitable for subsequent
distillation (or whatever other validated process is used ac
cording to the monograph). The finished water must meet
all of the chemical requirements for Purified Water as well as
an additional bacterial endotoxin specification. Because en
dotoxins are produced by the kinds of microorganisms that
are prone to inhabit water, the equipment and procedures
used by the system to purify, store, and distribute Water for
Injection must be designed to minimize or prevent microbial
contamination as well as remove incoming endotoxins from
the starting water. Water for Injection systems must be vali
dated to reliably and consistently produce and distribute
this quality of water.
The Water for Injection monograph also allows bulk pack
aging for commercial use. In contrast to Sterile Water for
Injection, bulk packaged Water for Injection is not required to
be sterile. However, to preclude significant changes in its
microbial and endotoxins content during storage, this form
of Water for Injection should be prepared and stored in a
fashion that limits microbial growth and/or is simply used in
a timely fashion before microbial proliferation renders it un
suitable for its intended use. Also depending on the material
used for packaging, there could be extractable compounds
leaching into the water from the packaging. Although this
article is required to meet the same chemical purity limits as
the bulk water, packaging extractables will render the pack
aged water less pure than the bulk water. The nature of
these impurities may even render the water an inappropri
ate choice for some applications. It is the user’s responsibil
ity to ensure fitness for use of this packaged article when
used in manufacturing, clinical, or analytical applications
where the purer bulk form of the water is indicated.