1.

Operational/Process Set Point an Ranges

Completed In-Progress
Bioreactors Chromatography Systems
Ultrafiltration Systems Biowaste System
Utilities Vessel Agitator setting – Sartorius Vessels (V-
1830, V-2660, V-1840, V-1810, V-1930, V-
1720 & V-2900)
V-1380_V-1400
V-1420
V-2830

2. Document Revision

URS – shall be Rev 1.0, URS_DQ of the same shall be 1.1

If URS is revised, its revision number shall be 2.0

If URS_DQ is revised, its revision number shall be 2.1

3. URS & CLIA Approved

URS

43 Nos.- Total

Approved and uploaded to Citadon - 41 Nos.

Pending is 2 Nos. (V-1930 Col Eluate Tank & V-1430 Transfer Tank) – reviewed and uploaded to
Citadon with comments, ALB to revert with IFA copy

CLIA –

100 Nos. - Total

83 Nos. - Approved & Uploaded to Citadon.

17 Nos. - Pending.

3 Nos. - Autoclave – under Approval,

8 Nos. - AHU– under review,
1 No. - DPO.- under review,
5 NOS. - TP-3435 and TP-3445, TP-3436 and TP-3446, TP-3406, TP-3416 and TP-3426,
Harvest Centrifuge XF-1410, Homogenizer XH-2560 – 5 Nos – reviewed and uploaded to Citadon
15.11.06

4. Compressed Air FDS

Not available in Citadon

5. CLIAs

DPO – Under review

Homogenizer – uploaded to Citadon – 15.11.06