sop for Operation and Cleaning of Purified Water Generation System
1.0 OBJECTIVE :
1.1 To lay down a procedure for operation and cleaning of Purified water Generation System.
2.0. SCOPE :
2.1 This procedure is applicable for operation and cleaning of Purified water Generation System situated
3.0. RESPONSIBILITY :
3.1 Operator Engineering Department shall be responsible for operation and cleaning of Purified water Generation System and maintaining it records.
3.2 Officer/Executive Engineering Department shall be responsible for to verify the proper operation and cleaning of Purified water Generation System and to take corrective action if any operational deviation.
4.0. ACCOUNTABILITY :
4.1 Head Engineering Department
5.0. PROCEDURE :
5.1 Operation of Purified Water Generation System:
5.1.1 Check the level of SMBS Antiscalant and NaOH dosing tank, If required make 2% fresh solution (200gm with 10 Ltr P.W) after cleaning the dosing tank. Dosing pump stroke setting will be 30% (1.2LPH) for SMBS and Antiscalant; 20% (0.8 LPH) for NaOH.( If conductivity and ORP valve exceeds its limit; adjust dosing strokes accordingly and record in Annex-II.
5.1.2 Switch “ON” main.
5.1.3 “SELECT THE PLANT TO OPERATE” shall be appeared on PLC screen.
5.1.4 Touch to the PLC Screen, ““AUTO / MANUAL” shall be appeared on the PLC Screen.
5.1.5 Press the “AUTO” key on PLC Screen, “LOGIN / LOGOUT” shall be appeared on the PLC Screen.
5.1.6 Press the Login key and enter the password of the system and press it.
5.1.7 PLC screen shall be shown “AUTO MODE ON”
5.1.8 Press “SET PARA” key, for setting of the operating parameters
5.1.9 Set the operating parameters as below:
Delay to RWP : 00010 sec
Delay to SV3- SV5 open : 00002 sec
Delay to ROHP : 00010 sec
Delay to SOV-3 OFF : 00010 sec
Delay to SOV-4 OFF : 00030 sec
Delay to EDI ON : 00010 sec
Delay to SOV-5 OFF : 00030 sec
Flushing OFF time : 03600 sec
Flushing ON time : 00300 sec
speed in Auto Mode : 080%
Print interval : 120 min
5.1.10 Press the “PROCESS PARA”, for setting of Process parameters
5.1.11 Set the process parameters as below:
ORP Valve : 00400
EDI outlet conductivity : 1.25 µs/cm
RO outlet conductivity : 20 µs/cm
5.1.12 Press “START” key and operation shall be started.
5.1.13 Press “OVER VIEW” for process view.
5.1.14 Press “AUTO FLUSH” for auto flushing of purified water whenever required.
5.1.15 If any alarm shall be appeared during the process, press “ALARM” on main menu
5.1.15.1 ON PLC screen shall be shown the unusual observation for which Alarm appears, press the “SELECT” key and the press ESC key for disappear the alarm
5.1.15.2 Again press the “RETURN” key for return to main menu.
5.1.16 Press the “STOP’ key for stop the operation
5.1.17 Whenever conductivity of Purified Water goes out of set limit, FDV shall be ON.
5.1.17.1 Press “START’ key to start the operation.
5.1.17.2 Press “STOP” key whenever system shall be shut down.
5.1.18 Take reading of purified water generation at every 02hours as per annexure-II.
5.2 Cleaning and sanitization of Purified Water Generation System :-
5.2.1 Set the CIP parameters as below:
Temp : 80 0C
Time : 60 Min
5.2.2 Connect the CIP to RO system.
5.2.3 Press “CIP” key for CIP of the system.
5.2.4 Frequency of cleaning : Monthly.
5.2.5 Fill the cleaning record as per Annex-I.
5.2.6 If microbial load increase, use chemical sanitization by citric acid (2% solution) 3 kg in 150 liters of purified water and add buffer ammonium hydroxide solution .Adjust the pH of the solution to 4 pH. Prepare the chemical sanitization solution in CIP tank.
5.2.7 Run the CIP pump for the 1 hour.
5.2.8 Stop the CIP pump for the 1 hour and again start for 1 hour.
5.2.9 Drain the CIP solution and flush the RO with purified water till pH comes in the range of 6.5 to 7.0 through CIP pump.
5.2.10 Fill the cleaning record of PW generation system as per annexure- I.
5.2.11 Maintain the dosing chemicals consumption record on daily bases as par annexure –III.
6.0. ABBREVIATION :
Sr. No. | Abbreviation used | Full form of abbreviation used |
1 | WFI | Water for injection |
2 | SOP | Standard operating procedure |
3 | PLC | Programmable Logic Controller |
6 | PLP | Process Loop Pump |
7 | FDV | Fluid Diaphragm Valve |
8 | CIP | Clean In Place |
ATTACHMENTS (ANNEXES) :
Annex-I: Cleaning /Sanitization record for Purified Water Generation System.
Annex-II: Operation log sheet of Purified Water Generation System
Annex-III: Dosing chemical consumption record
8.0. REFERENCE :
Sr. No. | Reference Title | Author Name | Edition | Page No. |
— | — | — | — | — |
ANNEX – I
CLEANING / SANITIZATION RECORD OF PURIFIED WATER GENERATION SYSTEM
FREQUENCY: MONTHLY
Sr. No.
|
Date |
Hot Water Temp. (NLT 80ºC) |
Chemical Used |
CIP Time (Hrs) | Done By | Checked by | Remarks | |||
From |
To |
|||||||||
Chemical | Quantity | |||||||||
|
ANNEX – II
OPERATION LOG SHEET OF PURIFIED WATER GENERATION SYSTEM
FREQUENCY: Every Two Hours
Sr. No. | Time | ORP Value (NMT 400 mv) | Cartridge Filter Pressure (Kg/cm²) | HPP Dis charge Pressure (kg/cm²)
(5-8) |
RO pump | Conduc tivity of RO water (NMT 20 µs/cm) | EDI | Done
by |
Remark | ||||||||
permeate flow (max 3000 ltr) | reject flow rate
250-300 LPH |
voltage (NMT 150 V DC) | current (NMT 3 amp DC) | Conduc tivity (NMT 1.25 µs/cm | |||||||||||||
Start time | Stop time | ||||||||||||||||
Inlet NLT 3.0kg/cm2 | Out let | Diff. NMT 1.0 | |||||||||||||||
|
ANNEX – III
DOSING CHEMICALS CONSUMPTION RECORD
FREQUENCY: DAILY
|
NaoH Qty. (Kg) |
SMBS Qty. (Kg) |
Antiscalent Qty. (Kg) |
Done by |
Remarks |
||||||
Date |
Qty. Recd |
Qty. Used |
Balance Qty. |
Qty. Recd |
Qty. Used |
Balance Qty. |
Qty. Recd |
Qty. Used |
Balance Qty. |
||
process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipment
concurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System