THE BEST LABORATORIES,PAK

STANDARD OPERATING PROCEDURE

DOCUMENT STATUS BLOCK
TITLE: Operating and cleaning Reverse
EFFECTIVE DATE: JAN- 2021 REVISION NO: 3
Osmosis System
DOCUMENT NO:
DEPARTMENT QC department Page 1 of 3
TBL/PRD/SOP/SYP/04

PURPOSE:

To lay down the procedure for the operation and Maintenance of Water Purification system.
SCOPE:

This is applicable to Quality Control Department

RESPONSIBILITIES:

 Section Pharmacist
 Machine Operator

PROCEDURE:

Put on the main switch, which is located at the backside of the Elix by this green indicator light indicates
that power supply is ON.

The system displays STANDBY and FLUSH.

Press continuously OPERATE / STANDBY button located on the front panel of the system.

The system displays OPERATE and FLUSH.

After the completion of the flush cycle the system produces purified water and is stored in the reservoir.

Once the tank is full the system displays TANK FULL and Elix system stops.

If the water level is decreases in the reservoir, Elix will operate to transfer water to the reservoir.

Operating procedure for Reservoir

Before collection of the water from the tap provided in the reservoir make sure that the reservoir tank
contains sufficient water by confirming with the display of Elix (minimum of 20%)

Operating procedure for Milli-Q A10 Gradient

WRITTEN BY: REVIEWED BY: APPROVED BY:

DESIGNATION: Section Incharge Production Manager Quality Control Manager

SIGNATURE:

DATE:
 THE BEST LABORATORIES,PAK
STANDARD OPERATING PROCEDURE
DOCUMENT STATUS BLOCK
TITLE: Operating and cleaning Reverse
EFFECTIVE DATE: JAN- 2021 REVISION NO: 3
Osmosis System
DOCUMENT NO:
DEPARTMENT QC department Page 2 of 3
TBL/PRD/SOP/SYP/04

Put on the main switch, which is located at the backside of the Milli-Q A10. Green indicator light glows,
indicates that power supply is ON.

The system will display PREOPERATE/STANDBY.

To change PREOPERATE/STANDBY mode press continuously OPERATE / STANDBY button, which

is located on the front side of the panel.

Make sure that system is in PREOPERATE mode.

To collect the water move the trigger on the dispenser towards the downward direction.

After collection of water from the system, push the trigger back to the upward direction to stop the water.

System Routine Maintenance

Cleaning Procedure of Reservoir:

Drain the water present in the reservoir tank by opening the tap provided to the reservoir. Opening the
knob of reservoir situated at the bottom, which is blue in color shall drain off the remaining water.

Completely drain the water from the reservoir.

Frequency: Weekly.

Again take 100 Liter of RO water in filling tank and give a trial run to wash the filling machine nozzles till all the tap
water is used in washing.

Then take 100 liter of RO water in the filling tank and give a trial run to wash the filling machine nozzles till all the
RO water is used in washing.

Again rinse the machine and tank with RO water before use.

Clean compressed air pipe with dry clean lint free duster.

Drench the duster with IPA and clean the control panel of machine including window and display screen.
WRITTEN BY: REVIEWED BY: APPROVED BY:
DESIGNATION: Section Incharge Production Manager Quality Control Manager

SIGNATURE:

DATE:
 THE BEST LABORATORIES,PAK
STANDARD OPERATING PROCEDURE
DOCUMENT STATUS BLOCK
TITLE: Operating and cleaning Reverse
EFFECTIVE DATE: JAN- 2021 REVISION NO: 3
Osmosis System
DOCUMENT NO:
DEPARTMENT QC department Page 3 of 3
TBL/PRD/SOP/SYP/04

Complete cleaning is essential to be carried out after each product change or after three consecutive batches of
same products.

After completion of cleaning inform your Section Incharge & QA officer to get Cleaned Tag of Liquid Filling
Machine.

Enter the activity in Machine Cleaning Log Book.

Chlorine Cycle Procedure
Put the system in standby mode by continuously pressing the OPERATE / STANDBY button located on front side
of the panel of Elix system.
Open the lid of the system and put one chlorine tablet in it and then close the lid.
Push the cleaning button for 10 seconds.
“Cl2 Clear” will appear on the screen. The instrument shows “15 mm” and subsequently it shows the time laps.
Cycle time is 15 minutes.
After the completion of the Chlorine cycle the system produces purified water and is stored in the reservoir.
Frequency for Chlorine cleaning cycle: Once in a month.

PRECAUTIONS:

 Wear gloves and dust mask during cleaning operation.

 Never clean the machine during running.

WRITTEN BY: REVIEWED BY: APPROVED BY:

DESIGNATION: Section Incharge Production Manager Quality Control Manager

SIGNATURE:

DATE: