دستگاه تولید آب خالص

دستگاه تولید آب خالص با 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.

Purified Water—Purified Water (see the USP monograph)
is used as an excipient in the production of nonparenteral
preparations and in other pharmaceutical applications, such
as cleaning of certain equipment and nonparenteral prod-
uct-contact components. Unless otherwise specified, Purified
Water is also to be used for all tests and assays for which
water is indicated (see General Notices and Requirements).
Purified Water is also referenced throughout the USP–NF. Re-
gardless of the font and letter case used in its spelling,
water complying with the Purified Water monograph is in-
tended. Purified Water must meet the requirements for ionic
and organic chemical purity and must be protected from
microbial contamination. The minimal quality of source or

feed water for the production of Purified Water is Drinking
Water. This source water may be purified using unit opera
tions that include deionization, distillation, ion exchange, re
verse osmosis, filtration, or other suitable purification proce
dures. Purified water systems must be validated to reliably
and consistently produce and distribute water of acceptable
chemical and microbiological quality. Purified water systems
that function under ambient conditions are particularly sus
ceptible to the establishment of tenacious biofilms of micro
organisms, which can be the source of undesirable levels of
viable microorganisms or endotoxins in the effluent water.
These systems require frequent sanitization and microbiolog
ical monitoring to ensure water of appropriate microbiologi
cal quality at the points of use.
The Purified Water monograph also allows bulk packaging
for commercial use elsewhere. In contrast to Sterile Purified
Water, bulk packaged Purified Water is not required to be
sterile. Because there is potential for microbial contamina
tion and other quality changes in this bulk packaged non
sterile water, this form of Purified Water should be prepared
and stored in a fashion that limits microbial growth and/or
is simply used in a timely fashion before microbial prolifera
tion renders it unsuitable for its intended use. Also depend
ing on the material used for packaging, there could be ex
tractable 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 packaged water less pure than
the bulk water. The nature of these impurities may even
render the water an inappropriate choice for some applica
tions. It is the user’s responsibility to ensure fitness for use of
this packaged article when used in manufacturing, clinical,
or analytical applications where the pure bulk form of the
water is indicated.