Water For Injection ( WFI ) Water Estimation

Requirement per Requirement per Consumption time Pressure at use Temperature at use
Flow rate Peak user point Peak Load
Equipment No(s). of use No(s). of times Lot day per lot point point
Sr. No. User Points No. of Unit Remark
Capacity points per day Flow rate
Liter Liter (Minute) (Liter/hr) (Y/N) Nominal (bar) 0
C
(Liter/hr)
PROCESS REQUIREMENT

SVP

1 Wash - 1 1 5 50 250 10 300 Y 300 2-3 80-85

2 IPQC - 1 1 2 10 20 5 120 N 0 2-3 80-85

4 Compounding (Ampoule ) 1 500 500 60 500 Y 500 2-3 80-85

5 For Rinsing (mfg + storage tanks) 500 L 1 1 2 50 100 5 600 N 0 2-3 80-85

6 CIP of Manufacturing tanks 1 150 150 10 900 N 0 2-3 80-85

7 Rinsing For filtrartion(storage tanks) 2 50 100 5 600 N 0 2-3 80-85

500 L 1
8 CIP of filtrartion 1 150 150 10 900 N 0 2-3 80-85

2 IPQC - 1 1 4 10 40 5 120 Y 120 2-3 80-85

9 CIP of Filling 1 1 1 100 100 10 600 N 0 2-3 80-85

10 Terminal Sterilizer -Ampoule 1 1 5 240 1200 20 720 Y 720 2-3 80-85

LVP

11 Wash - 1 1 5 50 250 15 200 N 0 2-3 80-85

12 IPQC - 1 1 2 10 20 5 120 N 0 2-3 80-85

13 Compounding (Ampoule ) 1 3000 3000 60 3,000 Y 3000 2-3 80-85

14 For Rinsing (mfg + storage tanks) 3000 L 1 1 2 300 600 5 3,600 N 0 2-3 80-85

15 CIP of Manufacturing tanks 1 900 900 10 5,400 N 0 2-3 80-85

16 Rinsing For filtrartion(mfg + storage tanks) 2 300 600 5 3,600 N 0 2-3 80-85
3000 L 1
17 CIP of filtrartion 1 30 30 10 180 N 0 2-3 80-85

18 CIP of Filling 1 1 1 100 100 10 600 N 0 2-3 80-85

19 Water Spreay Terminal Sterilizer 1 1 5 750 3750 30 1500 Y 1500 2-3 80-85

TOTAL 13 6750 11860 23,560 6,140

Total Requirement of WFI Per Day 11860 Liter/day

No. of Working Hours / Day 10 Hours

Required WFI Generation Plant Capacity 1175 Liter/hr

Proposed WFI Generation Plant Capacity 1200 Liter/hr

Required Plant Steam Pressure For WFI Generation Plant 6 Kg

Total WFI User Points 13 Nos.

Peak Load flow rate of WFI 6140 Liter/hr

WFI Pump Capacity 14.0 CMH

WFI distribution Pipe Size 47.50 mm

WFI Tank Size 5,000 Liter