21201-9200-0003 Gennova Biopharmaceuticals Ltd

08.06.2022
URS review & rewriting log list

First Review Second Review Comments/Approval

Revision URS file received Received for Second Reviewed & Final Received for Final review
Sr. No. Name of the Equipment Document No. Area Submission by Revision no. Submission by on Second review Final Status
no. from Gennova review from Gennova Submission by Elomatic from Gennova
Elomatic Elomatic from Gennova

1 1800 LPH Chromatography system MMBF/DSP/URS/001-00 DSP 0 21.12.2021 23.12.2021 1 17.03.2022 25.05.2022
2 600 LPH Chromatography system MMBF/DSP/URS/002-00 DSP 0 21.12.2021 23.12.2021 1 17.03.2022
3 180 LPH Chromatography system MMBF/DSP/URS/003-00 DSP 0 21.12.2021 23.12.2021 1 17.03.2022
4 2000 LPH Inline conditioning system MMBF/DSP/URS/007-00 DSP 0 21.12.2021 26.12.2021 1 17.03.2022 24.05.2022

5 TFF system 0.5 to 5.0 m2 for 100 L Tank MMBF/DSP/URS/008-00 DSP 0 21.12.2021 03.01.2022 1 17.03.2022 20.05.2022
6 TFF system 0.5 to 5.0 m2 for 50 L Tank MMBF/DSP/URS/009-00 DSP 0 21.12.2021 03.01.2022 1 17.03.2022
7 TFF system 0.1 to 0.5 m2 for 10 L Tank MMBF/DSP/URS/010-00 DSP 0 21.12.2021 03.01.2022 1 17.03.2022
8 1100 LPH Virus Filtration system MMBF/DSP/URS/011-00 DSP 0 21.12.2021 03.01.2022 1 17.03.2022 24.05.2022
9 180 LPH Virus Filtration system MMBF/DSP/URS/012-00 DSP 0 21.12.2021 03.01.2022 1 17.03.2022
10 SPTFF system 21 m2 MMBF/DSP/URS/013-00 DSP 0 21.12.2021 03.01.2022 1 17.03.2022 24.05.2022
11 Depth Filtration system 1.1 to 5.5 m2 MMBF/DSP/URS/014-00 DSP 0 21.12.2021 03.01.2022 1 17.03.2022 24.05.2022
12 Viral inactivation system 100 L MMBF/DSP/URS/015-00 DSP 0 21.12.2021 31.12.2021 1 17.03.2022 24.05.2022
13 500 L Bioreactor MMBF/USP/URS/001-00 USP 0 24.12.2021 07.01.2022 1 17.03.2022 20.05.2022
14 500 L Tote with load cell mixer MMBF/USP/URS/002-00 USP 0 24.12.2021 12.01.2022 1 17.03.2022 28.05.2022
15 500 L Tote with dolly MMBF/USP/URS/003-00 USP 0 24.12.2021 12.01.2022 0 23.03.2022 28.05.2022
16 200 L Tote with dolly MMBF/USP/URS/004-00 USP 0 24.12.2021 12.01.2022 0 23.03.2022
17 100 L Tote with dolly MMBF/USP/URS/005-00 USP 0 24.12.2021 12.01.2022 0 23.03.2022
18 Automated perfusion system MMBF/USP/URS/006-00 USP 0 24.12.2021 13.01.2022 1 17.03.2022 28.05.2022
19 Electric Jug MMBF/USP/URS/007-00 USP 0 24.12.2021 13.01.2022 0 23.03.2022 28.05.2022
20 500 L Non-Jacketed Stainless steel MMBF/USP/URS/012-00 USP 0 24.12.2021 13.01.2022 1 17.03.2022
21 500 L Tank T3 MMBF/DSP/URS/019-00 DSP 0 27.12.2021 03.01.2022
22 100 L Tank T13 MMBF/DSP/URS/020-00 DSP 0 27.12.2021 03.01.2022
23 1000 L Tank T2 MMBF/DSP/URS/021-00 DSP 0 27.12.2021 03.01.2022
24 2000 L Tank T1 MMBF/DSP/URS/022-00 DSP 0 27.12.2021 03.01.2022
25 200 L Tank T8 MMBF/DSP/URS/023-00 DSP 0 27.12.2021 03.01.2022
24.03.2022 &
26 1000 L Mixing Tote MMBF/DSP/URS/024-00 DSP 0 27.12.2021 04.01.2022 0 29.03.2022 23.05.2022
24.03.2022 &
27 500 L Mixing Tote MMBF/DSP/URS/025-00 DSP 0 27.12.2021 04.01.2022 0 29.03.2022
24.03.2022 &
28 200 L Mixing Tote MMBF/DSP/URS/026-00 DSP 0 27.12.2021 04.01.2022 0 29.03.2022
24.03.2022 &
29 100 L Mixing Tote MMBF/DSP/URS/027-00 DSP 0 27.12.2021 04.01.2022 0 29.03.2022
24.03.2022 &
30 50 L Mixing Tote MMBF/DSP/URS/028-00 DSP 0 27.12.2021 04.01.2022 0 29.03.2022
31 1000 mm chromatography column MMBF/DSP/URS/029-00 DSP 0 27.12.2021 04.01.2022 0 23.03.2022 20.05.2022
32 800 mm chromatography column MMBF/DSP/URS/030-00 DSP 0 27.12.2021 04.01.2022 0 23.03.2022
33 600 mm chromatography column MMBF/DSP/URS/031-00 DSP 0 27.12.2021 04.01.2022 0 23.03.2022
34 450 mm chromatography column MMBF/DSP/URS/032-00 DSP 0 27.12.2021 04.01.2022 0 23.03.2022
35 400 mm chromatography column MMBF/DSP/URS/033-00 DSP 0 27.12.2021 04.01.2022 0 23.03.2022
36 300 mm chromatography column MMBF/DSP/URS/034-00 DSP 0 27.12.2021 04.01.2022 0 23.03.2022
37 200 mm chromatography column MMBF/DSP/URS/035-00 DSP 0 27.12.2021 04.01.2022 0 23.03.2022
38 500 L Tank T5 MMBF/DSP/URS/036-00 DSP 0 27.12.2021 03.01.2022 0
39 Freeze thaw system MMBF/DSP/URS/048-00 DSP 0 28.01.2021 05.02.2022 0 07.04.2022 28.05.2022
Process Support
40 Sterilization Autoclave MMBF/UT/URS/003-00 Eqpts 0 28.01.2021 05.02.2022 0 07.04.2022 28.05.2022
41 Overhead Stirrer MMBF/USP/URS/008-00 USP 0 11.02.2022 20.03.2022 0 24.03.2022 23.05.2022

42 3000L Non-Jacketed Stainless Steel Vessel MMBF/USP/URS/009-00 USP 0 11.02.2022 20.03.2022 0 24.03.2022 23.05.2022
43 Wall Pass through 2 inch MMBF/USP/URS/010-00 USP 0 11.02.2022 28.04.2022 0
44 Cell Counter MMBF/USP/URS/011-00 USP 0 11.02.2022 28.04.2022 0 02.05.2022 08.06.2022
45 Cold Chamber MMBF/USP/URS/013-00 USP 0 11.02.2022 28.04.2022 0
46 Wall Pass through 4 inch MMBF/USP/URS/014-00 USP 0 11.02.2022 28.04.2022 0
Process Support
47 Decontamination Autoclave MMBF/UTI/URS/004-00 Eqpts 0 11.02.2022 20.05.2022 0
Mammalian Multiproduct Bio Manufacturing Production
48 Facility MMBF/ENG/URS/001-00 Facility 0 09.03.2022
Process Support
49 Pure Steam Generator MMBF/UTI/URS/002-00 Eqpts 0 09.03.2022 28.05.2022
50 Column Packing Station MMBF/DSP/URS/043-00 DSP 0 24.03.2022 23.05.2022
51 Resin Slurry MMBF/DSP/URS/044-00 DSP 0 24.03.2022 23.05.2022
52 100 L single use bag MMBF/USP/URS/017-00 USP 0 28.03.2022 23.05.2022
53 Magnetic mixer MMBF/USP/URS/020-00 USP 0 28.03.2022
54 Filter integrity testing MMBF/USP/URS/021-00 USP 0 28.03.2022 23.05.2022
55 TPE Tube welder MMBF/USP/URS/022-00 USP 0 28.03.2022 28.05.2022
56 TPE Tube sealer MMBF/USP/URS/023-00 USP 0 28.03.2022 28.05.2022
57 pH meter MMBF/USP/URS/028-00 USP 0 28.03.2022 23.05.2022
58 Weighing balance 60 Kg MMBF/DSP/URS/038-00 DSP 0 29.03.2022
59 Weighing balance 15 Kg MMBF/DSP/URS/039-00 DSP 0 29.03.2022
60 Weighing balance 06 Kg MMBF/DSP/URS/040-00 DSP 0 29.03.2022
61 Peristaltic Pump 2.9 LPM MMBF/USP/URS/019-00 USP 0 31.03.2022
62 Peristaltic Pump 19LPM MMBF/USP/URS/029-00 USP 0 31.03.2022 23.05.2022
63 220 gm Balance MMBF/USP/URS/036-00 USP 0 31.03.2022
64 3.2 kg Balance MMBF/USP/URS/037-00 USP 0 31.03.2022
65 35 kg Balance MMBF/USP/URS/038-00 USP 0 31.03.2022
66 ph & Conductivity Meter MMBF/DSP/URS/037-00 DSP 0 07.04.2022 28.05.2022
67 Magnetic Stirrer MMBF/DSP/URS/041-00 DSP 0 07.04.2022 23.05.2022
68 Laminar Air flow Unit MMBF/DSP/URS/042-00 DSP 0 07.04.2022 28.05.2022
69 Peristaltic Pump - 26 LPM MMBF/DSP/URS/047-00 DSP 0 07.04.2022
Process Support
70 Purified water distribution system MMBF/ UTI/URS/005 Eqpts 0 15.04.2022 04.05.2022
Process Support
71 Water for Injection Distribution system MMBF/ UTI/URS/006 Eqpts 0 15.04.2022 04.05.2022
Process Support
72 Pure Steam Distribution system MMBF/ UTI/URS/007 Eqpts 0 15.04.2022 04.05.2022
73 HVAC system (AHU system) MMBF/ENG/URS/003 ENG 0 27.04.2022
74 Buffer preparation tanks of group 1 MMBF/ DSP/URS/051 DSP 0 30.04.2022 18.04.2022
75 2 to 8 deg Cold Chamber MMBF/ DSP/URS/049 DSP 0 02.05.2022 08.06.2022
76 - 20 deg Deep Freezer MMBF/ DSP/URS/050 DSP 0 02.05.2022 08.06.2022
77 Seed Bioreactor 20 L MMBF/ USP/URS/015 USP 0 02.05.2022 08.06.2022
78 LN2 SupplyTank MMBF/ USP/URS/016 USP 0 02.05.2022 08.06.2022
79 Cryo storage Tank 200 L MMBF/ USP/URS/018 USP 0 02.05.2022 08.06.2022
80 Vacuum Pump 40 L / min MMBF/ USP/URS/030 USP 0 02.05.2022 08.06.2022
81 800 L -80 Deg Deep Freezer MMBF/ USP/URS/031 USP 0 02.05.2022
82 Shaker Incubator MMBF/ USP/URS/032 USP 0 02.05.2022 08.06.2022
83 Large Centrifuge 3 L MMBF/ USP/URS/033 USP 0 02.05.2022 08.06.2022
84 Small Centrifuge 48 mL MMBF/ USP/URS/034 USP 0 02.05.2022
85 Inverted phase contrast Microscope MMBF/ USP/URS/035 USP 0 02.05.2022 08.06.2022
86 500 L Tote MMBF/DSP/URS/045 DSP 0 05.05.2022 21.05.2022
87 200 L Tote MMBF/DSP/URS/046 DSP 0 05.05.2022 21.05.2022
88 1000 Kg Weighing balance MMBF/USP/URS/027 USP 0 05.05.2022 21.05.2022
89 N2 Gas Distribution system MMBF/ENG/URS/005 ENG 0 05.05.2022 21.05.2022
90 CO2 Gas Distribution System MMBF/ENG/URS/006 ENG 0 05.05.2022 21.05.2022
91 O2 Gas Distribution System MMBF/ENG/URS/007 ENG 0 05.05.2022 21.05.2022
92 Biosafety Cabinet MMBF/USP/URS/024 USP 0 09.05.2022 28.05.2022
93 Water Bath MMBF/USP/URS/025 USP 0 09.05.2022 28.05.2022

47
14 Typical
47 61
47