Water system for OSD

Water System
1

For OSD, is it mandatory to have Pure steam and Water for Injection for production and QC works. My understanding is that we need Purified water for production and QC. Please advise

Thanks

2

For OSD most of the manufacturing units use purified water but for QC it is better to use distilled water.

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3

Noted. Even for regulatory markets, only PW is enough for manufacturing of OSD units? Because, it appears like Chinese companies use distilled water (WFI) for the manufacturing of OSD, Please advise

4

No regulatory agency recommends distilled water for OSD.

5

Thanks for your kind reply sir

6

For OSD purified water

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7

For OSD Purified Required Water parameter as below:
Conductivity: < 1.3 us/cm at 25 C
pH: 5.0 to 7.0
If hot loop: 65 to 70 C temperature (Cond. at 65 C is 2.4 uc/cm)
Velocity: >1.3 m/s
PW Loop MOC: SS 316L

8

Thanks

9

Sir why it is mandatory to use distilled water for qc both are same only the process of purification is different?

10

It is not mandatory, but advised. This is due to the purer nature of WFI so it will generate less interference with QC tests than PW would.

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