Intended Use - Endress+Hauser analytikjena multi N/C pharma HT Operating Manual

Basic information
1.3

Intended use

8
The analyzer can optionally be equipped with an integrated solids module (Swab Test
module). This permits carbon detection in solids in the lower concentration range, e.g.,
during cleaning verification (swab test).
The control and analysis software provides complete data integrity and conforms to the
pharmaceutical guidelines in 21 CFR Part 11 and EudraLex Volume 4 Annex 11.
The device and its components may only be used for the analyses listed in the user man-
ual. Only this specified use is regarded as the intended use, ensuring the safety of the
user and the device.
The analyzer may only be used to determine the total carbon content and the concen-
tration of organic and inorganic bound carbon in aqueous samples.
The analyzer is particularly suited for detection of the listed parameters in drinking wa-
ter, ground water, surface water, ultrapure water and water for pharmaceutical pur-
poses.
When equipped with a nitrogen detector, the analyzer can be used to examine the nitro-
gen content in aqueous samples.
In conjunction with an optional solids module, the total carbon content in solids can be
determined.
No flammable liquids or substances that can form explosive mixtures may be analyzed
with the analyzer. Do not analyze concentrated acids with the analyzer!
Only use the following carrier gases with the device: Oxygen, synthetic air or purified
compressed air.
multi N/C pharma HT