FERMENTER BATCH No.

:-
Experiment :-

Lab inoculum Details Date of inoculation 12/30/1899 Date of seed transfer 12/30/1899 -

Seed transfer
Lab inoculum No. Culture No FM lot no Age PH PMV% Sterility
volume(ml)

Lab seed from Ballon flask pooled for desired volume

Total voume 0 Transfer 2%
Seed transfer
Pre-pre seed Date of inoculation Date of seed transfer Age pH PMV% Sterility
volume(Lit)/ %
12/30/1899 N
Seed transfer
Pre seed Date of inoculation Date of seed transfer Age pH PMV% Sterility
volume(Lit) / %
12/30/1899 12/30/1899 N

Production Batch details

B.NO 0 Vessel No. LF-11 Date of inoculation 12/30/1899 Date of Harvest 5/26/2023

Raw materials

Quantity Gm / lit.

Quantity Gm /16.5 lit. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

Q.C. Reference
Number / Batch No.

Remarks

Trace elements

Quantity Gm / lit.

Quantity Gm /16.5 lit.

QC Ref. Number

Lot no. of trace

element

Quantity of solution
used (ml)

Potable water used for Media charging

Batch charging observations

BI observed Volume 5 N NaOH quantity pH adjusted After Liquor ammonia quantity

Media pH pH adjusted to After sterilization pH AI pH
Lit. Required (ml) sterilization Required (ml)

Water added (L)

Batch Feeding events Antifoam Consumed (ml)

Feeding events Lot. No. Date of feed preparation feeding start age (hrs)

60% Dextrose
Solution

Sterile Antifoam T-
106

7.5% KNO3 Solution

FERMENTER BATCH No. :- 0

In-process analysis
Date &Time Age hrs. pH PMV% R.Dex. gm% Nitrate ppm Viscosity cps. Titre gm/kg. Rise gm/l. Wt. Sample gm.

5/19/2023 10:00
5/19/2023 10:00
5/19/2023 10:00
5/21/2023 16:00
5/21/2023 16:00
5/22/2023 16:00
5/23/2023 4:00
5/23/2023 4:00
5/23/2023 4:00
5/23/2023 4:00
5/23/2023 4:00
5/23/2023 4:00
5/23/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
5/26/2023 4:00
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5/26/2023 4:00
5/26/2023 4:00

12/30/1899 0:00

Before Inoculation 7.5% KNO3 Solution 10 % KOH Sol.

Seed Inoculum Vol Lit. Dextrose Feed Lit. Sterile water Lit. Antifoam Fed Lit. Calculated Volume (L) Total Sampling in kg Total Spillage in kg
vol. Lit added Lit. Added. L

0 1.65 0 0.000 0.000 0.000 1.7 0.00 0.00

0

Last Sample analysed Productivity Factor : gm Dextrose (Kg) /Rifa.B

Harvest Age Hrs Last Titer gms/Lit. Harvest Vol Lit. Broth Density (kg/Lit.) Harvested broth in Kg Total Rifa B kg.
at age of Rifa B/hr (Kg)
KNO3 Kg
288 #N/A #N/A 0.00 #N/A #N/A #N/A 0
Power Number 6 10.88
Dynamic viscosity (Pa.s) 0.0007331
Density (kg/m3) 1000
Impeller Diameter (m) 0.15
No of Impellers 3
Fermenter Volume 120

Power/volume (kW/m3) Power/Impeller (W) RPM (100L) RPM (10L)

0.544 10.88 172.8 300
0.864 17.27 201.6 350
1.289 25.78 230.3 400
1.835 36.71 259.1 450
2.518 50.35 287.9 500
3.351 67.02 316.7 550
4.351 87.01 345.5 600
5.531 110.63 374.3 650

Tip speed at
Power/volume (kW/m3) RPM (10L) 10 L RPM (100L)
0.5438232421875 300 1.18 231.66
0.863571166992187 350 1.37 270.26
1.2890625 400 1.57 308.87
1.83540344238281 450 1.77 347.48
2.5177001953125 500 1.96 386.09
3.35105895996094 550 2.16 424.70
4.3505859375 600 2.36 463.31
5.53138732910156 650 2.55 501.92
Current 100 L RPM RPM Difference
175.000 -2.2
205.000 -3.4
235.000 -4.7
265.000 -5.9
295.000 -7.1
325.000 -8.3
355.000 -9.5
385.000 -10.7

Proposed Tip Tip speed

Tip speed at 100 L speed for 10 L at 10 L
1.55 395.4 1.55
1.81 461.3 1.81
2.07 527.3 2.07
2.33 593.2 2.33
2.59 659.1 2.59
2.85 725.0 2.85
3.11 790.9 3.11
3.37 856.8 3.37
 Mfg R&D
Impeller Dia 0.128 0.075
Impeller Width 0.025 0.015
Ratio 0.20 0.2

Dynamic (Absolute) and Kinematic Viscosity of Water - SI Units

Temperat
Dynamic Viscosity
Kinematic Viscosity
ure
-t- -µ- -ν-

(oC)
(Pa s, N
(m2/s) x 10-6
Dynamic Viscosity
s/m2) x 10-3
1.6
0 1.787 1.787 1.4
f(x) = − 0.0212975342465753 x + 1.52118630136986
5 1.519 1.519 1.2 R² = 0.951498826530815
10 1.307 1.307 Dynamic Vi
1 N s/m2) x 1
20 1.002 1.004 Linear (Dyn
30 0.798 0.801 0.8 - (Pa s, N s/
40 0.653 0.658 0.6
50 0.547 0.553 0.4
60 0.467 0.475
0.2
70 0.404 0.413
0
80 0.355 0.365
0 10 20 30 40 50 60
90 0.315 0.326
100 0.282 0.29

1 cP = 0.01 poise = 0.01 gram per cm second = 0.001 Pascal second = 1 milliPascal second = 0.001 N.s/m 2
Viscosity

52118630136986

Dynamic Viscosity - µ - (Pa s,

N s/m2) x 10-3
Linear (Dynamic Viscosity - µ
- (Pa s, N s/m2) x 10-3 )

60

d = 0.001 N.s/m 2
Power Number 5.5
Dynamic viscosity (Pa.s) 0.000733
Density (kg/m3) 1000
Impeller Diameter (m) 0.128
No of Impellers 2
Fermenter Volume 6

RPM RPS (N) Power/Impeller (W)

300 5.00 23.62
350 5.83 37.51
400 6.67 55.99
450 7.50 79.73
500 8.33 109.36
550 9.17 145.56
600 10.00 188.98
650 10.83 240.27
600 10.00 188.98
Power/volume (kW/m3)
7.874
12.504
18.665
26.575
36.454
48.521
62.993
80.090
62.993
Power Number 5.5
Dynamic viscosity (Pa.s) 0.0007331
Density (kg/m3) 1000
Impeller Diameter (m) 0.128
No of Impellers 3
Fermenter Volume 60

650 11210019261382.7
10.8333333333333 895074.074074074

Power/volume (kW/m3) Power/Impeller (W) RPM (100L)

0.544 10.88 231.7
0.864 17.27 270.3
1.289 25.78 308.9
1.835 36.71 347.5
2.518 50.35 386.1
3.351 67.02 424.7
4.351 87.01 463.3
5.531 110.63 501.9

Tip speed at
Power/volume (kW/m3) RPM (10L) 10 L
0.5438232421875 300 1.18
0.863571166992187 350 1.37
1.2890625 400 1.57
1.83540344238281 450 1.77
2.5177001953125 500 1.96
3.35105895996094 550 2.16
4.3505859375 600 2.36
5.53138732910156 650 2.55
 10.88

RPM (10L) Current 100 L RPM RPM Difference

300 175.000 56.7
350 205.000 65.3
400 235.000 73.9
450 265.000 82.5
500 295.000 91.1
550 325.000 99.7
600 355.000 108.3
650 385.000 116.9

Proposed Tip Tip speed

RPM (100L) Tip speed at 100 L speed for 10 L at 10 L
231.66 1.55 395.4 1.55
270.26 1.81 461.3 1.81
308.87 2.07 527.3 2.07
347.48 2.33 593.2 2.33
386.09 2.59 659.1 2.59
424.70 2.85 725.0 2.85
463.31 3.11 790.9 3.11
501.92 3.37 856.8 3.37
 205 5500
91.125
3.435974E-05
17.220671373 287.0112

640 6510
9.966667 990.0332963
3.051758E-05
196.68935421 3278.156

3.051758E-05 0.00471
 0.315

3.4166666667 6.3809
0.015625 0.099225
861.0336 1000 1000
53.385416667 81754.08 633.1448 707424.4

5.833 6.3809
0.005625 0
9834.468 1000 1000
32.810625 50245.98 0 0

154.3242 5.363867 321.83200901

 350 5500
198.46134454
2.373047E-06
2.590269404 431.7116

650 6510
10.83333 1271.412037
2.373047E-06
19.641453552 3273.576
 0.315

5.833 6.3809
0.005625 0.099225
863.4231 1000 1000
32.810625 50245.98 633.1448 707424.4

5.833 6.3809
0.005625 0
6547.151 1000 1000
32.810625 50245.98 0 0
Power Number 5.5
Dynamic viscosity (Pa.s) 0.000733
Density (kg/m3) 1000
Impeller Diameter (m) 0.128
No of Impellers 3
Fermenter Volume 60

RPM RPS (N) Power/Impeller (W)

300 5.00 23.62
270 4.50 17.22
400 6.67 55.99
450 7.50 79.73
500 8.33 109.36
550 9.17 145.56
600 10.00 188.98
650 10.83 240.27
Power/volume (kW/m3)
1.181
0.861
2.800
3.986
5.468
7.278
9.449
12.013
0.1vvm Agitation Speed(RPM) :300
RPM Kla/h Airation (LPM):0.8
300 19.4 Time(min) PO2(%) C*-CL
350 26 0.5 34.5 65.5
650 74 1 44 56
1.5 68 32
2 71.8 28.2
2.5 67 33
3 65 35
3.5 74.9 25.1
1 vvm 4 83.8 16.2
RPM Kla/h 4.5 82.6 17.4
300 90.7 5 84 16
350 210 5.5 84.7 15.3
6 90.5 9.5
6.5 92 8
7 91 9
7.5 94.4 5.6
8 95.5 4.5
8.5 95.1 4.9
9 96.6 3.4
9.5 99 1
10 100 0

Time(min) PO2(%) C*-CL

1 44 56
2 71.8 28.2
3 65 35
4 83.8 16.2
5 84 16
6 90.5 9.5
7 91 9
8 95.5 4.5
9 96.6 3.4

Agitation Speed(RPM) :650

 Airation (LPM):0.8
Time(min) PO2(%) C*-CL
0.5 20 80
1 53 47
1.5 73.3 26.7
2 85 15
2.5 91.5 8.5
3 95.3 4.7
3.5 97.4 2.6
4 98.8 1.2
4.5 99.5 0.5

Agitation Speed(RPM) :350

Airation (LPM):0.8
Time(min) PO2(%) C*-CL
0.5 14.7 85.3
1 40.4 59.6
1.5 48.4 51.6
2 59.1 40.9
2.5 65.5 34.5
3 74 26
3.5 81.2 18.8
4 83.7 16.3
4.5 86 14
5 88.8 11.2
5.5 92.5 7.5
6 91.6 8.4
6.5 93.8 6.2
7 94.5 5.5
7.5 95.6 4.4
8 96 4
8.5 97 3
9 98.5 1.5
9.5 98.9 1.1
 Agitation Speed(RPM) :300
Airation (LPM):8.0
Time(min) PO2(%) C*-CL
0.5 27.5 72.5
1 55.1 44.9
1.5 78.9 21.1
2 88.2 11.8
2.5 95.8 4.2
3 98.3 1.7

Agitation Speed(RPM) :650

Airation (LPM):8.0
Time(sec) PO2(%) C*-CL
5 5 95
10 16 84
15 29 71
20 40 60
25 55.5 44.5
30 66 34
35 73 27
40 78.8 21.2
45 83 17
50 88.3 11.7
55 91.2 8.8
60 93.9 6.1
65 95.1 4.9
70 97.6 2.4
75 98.8 1.2
80 99.5 0.5
ln(C*-CL)
4.18 ln(C*-CL)
4.03
4.50
3.47
4.00
3.34 f(x) = − 0.324570106483254 x + 4.26375904641709
3.50
3.50
3.56 3.00
ln(C*-CL)
3.22 2.50 Linear (ln(C*-CL))
2.79 2.00
2.86 1.50
2.77 1.00
2.73 0.50
2.25 0.00
2.08 0 1 2 3 4 5 6 7 8 9 10
2.20
1.72
1.50 Kla/H 19.386
1.59
1.22
0.00
ln(C*-CL)
4.50
4.00
f(x) = − 0.332700086531562 x + 4.29172164365646
3.50
ln(C*-CL) 3.00
ln(C*-CL)
4.03 2.50 Linear (ln(C*-CL))
3.34
2.00
3.56
1.50
2.79
1.00
2.77
2.25 0.50
2.20 0.00
0 1 2 3 4 5 6 7 8 9 10
1.50
1.22
Kla/H 19.962

ln(C*-CL)
5.00

f(x) = − 1.23743217762758 x + 5.13326961033184

4.00
 ln(C*-CL)
ln(C*-CL) 5.00
4.38 f(x) = − 1.23743217762758 x + 5.13326961033184
4.00
3.85
3.28 3.00 ln(C*-CL)
2.71 Linear (ln(C*-CL))
2.14 2.00
1.55
0.96 1.00
0.18
-0.69 0.00
0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5
-1.00

Kla/H 74.244

ln(C*-CL)
4.45 ln(C*-CL)
4.09
5.00
3.94
4.50
3.71 f(x) = − 0.436023837344934 x + 4.5962902025686
4.00
3.54
3.50
3.26 ln(C*-CL)
3.00
2.93 Linear (ln(C*-CL))
2.50
2.79
2.00
2.64
1.50
2.42
1.00
2.01
0.50
2.13
0.00
1.82 0 1 2 3 4 5 6 7 8 9 10
1.70
1.48
1.39 Kla/H 26.16
1.10
0.41
0.10

ln(C*-CL)
4.50
f(x) = − 1.51165856407882 x + 5.24058743795693
4.00
3.50
 ln(C*-CL)
4.50
f(x) = − 1.51165856407882 x + 5.24058743795693
4.00
ln(C*-CL) 3.50
4.28 3.00
ln(C*-CL)
3.80 2.50 Linear (ln(C*-CL))
3.05
2.00
2.47
1.50
1.44
1.00
0.53
0.50
0.00
0 0.5 1 1.5 2 2.5 3 3.5

Kla/H 90.702

ln(C*-CL)
4.55 ln(C*-CL)
4.43 5.00
4.26 4.50 f(x) = − 0.0585020010907248 x + 5.20249831489337
4.09 4.00
3.80 3.50
3.53 3.00 ln(C*-CL)
Linear (ln(C*-CL))
3.30 2.50
3.05 2.00
2.83 1.50
2.46 1.00
2.17 0.50
1.81 0.00
1.59 0 10 20 30 40 50 60 70 80
0.88
0.18 3.51
-0.69 Kla/H 210.6
 Summary of geometrical dimensions of the 10 L (R&D) and 100 L (GMP) Satrorius Fermenters
10 L Fermenter
Total volume (L) 14
Maximum working volume (L) 10
Minimum Working volume (L) 5
Vessel diameter D (m) 0.19
Vessel height H (m) 0.47
Ratio H/D 2.47
Liquid height h1 (m) 0.36
Ratio h1/D 1.89
Impeller diameter d2 (m) 0.075
Number of Impellers 2.00
Ratio d2/D 0.39
Distance between impellers Δz (m) 0.09
Size holes ring sparger part (mm) 0.5
Number holes ring sparger part 16

Summary of Characterization results

Process Engineering Parameter N (rpm)
10 L scale (Batch start) 300
10 L scale (Though out the process) 650
Equal P/VL of 10 L for 100 L GMP Fermenter (Batch start) 230
Equal P/VL of 10L for 100 L GMP Fermenter (Through out the process) 500
Corrections based on mixing time for 100 L 600
(GMP) Satrorius Fermenters
100 L Fermenter
140
100
50
0.396
1.24
3.13
0.813
0.66
0.128
3.00
0.32
0.15
2
22

Tip Speed (m/s) Re P/VL (KW/m3) Mixing Time (sec) Kla/H

1.18 62989 0.54 14 19
2.55 136477.005 5.53 10 74
1.54 210990 0.54 27 24
3.35 458675 5.53 19 75
4.02 550410 9.45 15 74
 Jul-23
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Emp Code Name
Sat Sun Mon Tue Wed Thu Fri Sat Sun Mon Tue Wed Thu Fri Sat Sun Mon Tue Wed Thu Fri Sat Sun Mon Tue Wed Thu Fri Sat Sun Mon
1 215894 Nitin Panday GG WO GG GG GG GG GG GG WO GG GG GG GG GG HL WO GG GG GG GG GG GG WO GG GG GG GG GG GG WO GG
2 120258 Nitte Achuta Jaganatha GG WO GG GG GG GG GG GG WO GG GG GG GG GG HL WO GG GG GG GG GG GG WO GG GG GG GG GG GG WO GG
3 40008891 Sakshi Bhamare WO GG GG GG GG GG GG WO GG GG GG GG GG WO GG GG GG GG GG GG GG WO GG GG GG GG GG GG WO GG GG
4 40012192 Rahul Patil GG WO GG GG GG GG GG GG WO GG GG GG GG GG HL WO GG GG GG GG GG GG WO GG GG GG GG GG GG WO GG
5 Mayur Patil GG WO GG GG GG GG GG GG WO GG GG GG GG GG HL WO GG GG GG GG GG GG WO GG GG GG GG GG GG WO GG
6 40012979 Lakhan Yejare wO BB BB BB AA AA WO LL AA BB AA AA WO YY CC CC CC CC CC WO BB BB BB BB CC BB WO AA AA AA AA
7 40012989 Pratik Wani AA AA AA LL LL BB BB AA YY CC CC CC YY WO BB BB BB BB BB BB WO AA AA AA AA AA AA WO BB CC CC
8 40007564 Karthikeyan K BB CC CC CC BB BB AA BB GG AA WO BB CO XX AA WO AA AA GG GG GG WO CC CC BB CC CC CC CC WO BB
9 213163 Narendra Shyam Thorat CC WO GG AA CC CC CC CC YY WO BB GG XX AL AL AA WO GG AA CC WO GG GG GG GG GG BB BB BB BB WO

3 3 3 3 3 4 3 3 1 3 3 3 0 0 3 3 3 3 3 2 1 2 3 3 3 3 3 3 4 3 3
2 5 0 0 0 0 1 1 4 1 1 0 1 2 0 5 1 0 0 1 2 2 4 0 0 0 1 1 1 5 1

AA 1 1 1 1 1 1 1 1 1 1 1 1 0 0 1 1 1 1 1 0 0 1 1 1 1 1 1 1 1 1 1
BB 1 1 1 1 1 2 1 1 0 1 1 1 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1
CC 1 1 1 1 1 1 1 1 0 1 1 1 0 0 1 1 1 1 1 1 0 0 1 1 1 1 1 1 1 1 1
0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 1 1 0 0 0 0 0 0 0 0 0 0
0 0 0 0 0 0 0 0 2 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0