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Water Treatment in Pharmaceuticals Plant SOPs

Water Treatment in Pharmaceuticals Plant is for describe all the procedure of Water Treatement in Pharmaceuticals plants.

1.0 OBJECTIVE

1.1 To describe the procedure for water treatment plant operation.

2.0 SCOPE

2.1 The scope of this SOP pertains to the water treatment plant (Reverse osmosis plant)

Water Treatment

3.0 RESPONSIBILITIES

3.1 It is the responsibility of Operator and section Supervisor (tablet and capsule) to follow this SOP as it is written.

3.2 It is the responsibility of Production Pharmacist (Tablet and Capsule) to ensure that this procedure is followed as it is written.

3.3 It is the responsibility of production manager to make certain that this SOP is followed in its entirety, reviewed and updated as necessary.

4.0 DEFINITIONS & ABBREVIATIONS

4.1 SOP: Standard Operating Procedure

4.2 WTS:Water treatment section.

5.0 MATERIALS & EQUIPMENTS

5.1 Reverse Osmosis Plant.

4.0 INTRODUCTION.

The water treatment plant consist of raw water storage tank, chlorine dosing system, sand filter, 5 micron jumbo cartridge filter, carbon filter, water softener, brine tank, 5 micron slim cartridge filter, anti scalent dosing system, double pass reverse osmosis system, intermediate water storage tank and ultra violet sterilizer.
The raw water is first chlorinated to disinfect, passed through a sand filter to get rid of suspended particles if any, passed through a 5 micron jumbo size cartridge filter, passed through a carbon filter to eliminate any foul odour, passed through a water softener to remove its hardness, passed through a 5 micron slim cartridge filter, passed through 1st RO system (lower 3 membranes) & product water is collected in SS intermediate buffer tank, passed through 2nd RO system (top 2 membranes), product water is passed through UV lamp for sterilization and finally collected in SS RO water storage tank of solution preparation area.

 

6.0 PROCEDURES.

6.1 Open the inlet valve # 1 of raw water supply to storage tank.
6.2 Ensure that raw water storage tank is full.
6.3 Ensure that chlorine solution is present in the tank of chlorine dosing system.
6.4 Ensure that dosing knob of chlorine dosing system is at 10%.
6.5 Switch on the electrical supply of chlorine dosing system and ensure that dosing of chlorine solution into the raw water storage tank has started.
6.6 Open the out let valve # 2 of storage tank.
6.7 Take a sample of chlorinated raw water from valve # 3 and check the amount of chlorine in the sample.
6.8 specification: 0.5 ppm
6.9 Switch on the electrical power supply of feed pump from the main control panel.
6.10 Check the primary feed water pressure from its gauge at main control panel.
6.11 Specification: 30-40 psi.
6.12 Set the primary feed water pressure from feed pump bypass valve # 4.
6.13 If its pressure is high then open this valve and if low then close the valve accordingly to maintain the pressure between 30-40 psi.
6.14 Ensure that operating control valve of sand filter is on “service (filter)” position.
6.15 check that 5 micron cartridge filter is present & properly placed in the housing of jumbo cartridge filter # 1
6.16 Ensure that operating control valve of carbon filter is on “service (filter)” position.
6.17 Check the feed water pressure from its gauge at main control panel.
6.18 Specification: 30-40 psi.
6.19 Ensure that operating control valve of water softener is on “service (filter)” position.
6.20 check that 5 micron cartridge filter is present & properly placed in the housing of slim cartridge filter # 2
6.21 Collect the sample of soft water from valve # 5 and check the hardness.
6.22 Specification: total hardness should be less than 10 ppm.
6.23 Switch on the electrical power supply of high pressure pump of 1st pass ro.
6.24 Set the product water flow from “concentrate control valve” of 1st pass ro.
6.25 specifications: product water flow 12-16 lpm
6.26 concentrate water flow 6-8 lpm
6.27 check the pressure of 1st pass ro from high pressure gauge
6.28 Specification: 130-150 psi.
6.29 Now the water will pass through the lower 3 membranes of 1st pass and product water will be collected in ss intermediate buffer tank while the concentrate water will be drained off from system.
6.30 Collect the samples of product water of each individual membrane of 1st pass from their respective sampling valves # 6, 7 & 8 if required.
6.31 Collect the sample of combined product water of all the 3 membranes of 1st pass ro from the sampling valve # 9 and check its tds.
6.32 specifications: less than 15 ppm
6.33 When the intermediate buffer tank will be full then 1st pass ro system will be automatically off.
6.34 Ensure that anti-scalent solution is present in the tank of anti-scalent chemical dosing system.
6.35 Ensure that dosing knob of anti-scalent chemical dosing system is between 30-40%.
6.36 Switch on the electrical power supply of high pressure pump of 2nd pass system from its main control panel.
6.37 Ensure that out let valve # 10 of intermediate tank is open.
6.38 Set the product water flow from “concentrate control valve” of 2nd pass.
6.39 specifications: product water flow 8-12 lpm
6.40 concentrate water flow 4-6 lpm
6.41 check the pressure of 2nd pass ro from its high pressure gauge
6.42 Specification: 130-150 psi.
6.43 Now the product water of 1st pass will flow through the top 2 membranes of 2nd pass and product water of 2nd pass will pass through uv sterilizer and will be collected in ss storage tank of solution preparation area while the concentrate water will be drained off from system.
6.44 Collect the samples of product water of each individual membrane of 2nd pass from their respective sampling valves # 12 & 13 if required.
6.45 Switch on the electrical power supply of uv sterilizer.
6.46 Collect the sample of combined product water of both membranes of 2nd pass (double pass) from the sampling valve # 14 installed before uv sterilizer and check for tds.
6.47 Specifications: less than 5 ppm.
6.48 Collect the sample of finished double pass ro water from sampling valve # 15 installed after the uv sterilizer to check the final microbial count in finished product water to be used in drug manufacturing.

NOTE:
Once the water treatment plant is operational then run it as per following frequency to avoid their choking and to keep them fit for production & maintain the record accordingly.
1. Daily basis: 15 minutes at least.
2. Thrice a week: 30 minutes at least.
3. Twice a week: 45 minutes at least.

NUMBERING OF OPERATING VALVES OF WATER TREATMENT PLANT.

Valve # Description
1 Inlet valve of raw water supply to storage tank.
2 Outlet valve of raw water storage tank.
3 Sampling point for chlorinated raw water.
4 By-pass valve of feed pump.
5 Sampling point for soft water & cleaning of 1st pass membranes.
6 Sampling point for product water of 1st membrane of 1st pass.
7 Sampling point for product water of 2nd membrane of 1st pass.
8 Sampling point for product water of 3rd membrane of 1st pass.
9 Sampling point for combined product water of all 3 membranes of 1st pass.
10 Outlet valve of intermediate storage tank.
11 Cleaning valve for 2nd pass membranes.
12 Sampling point for product water of 1st membrane of 2nd pass.
13 Sampling point for product water of 2nd membrane of 2nd pass.
14 Sampling point for combined product water of 2nd pass before UV sterilizer.
15 Sampling point for combined product water of 2nd pass after UV sterilizer.
BACK WASHING & REGENERATION OF WATER TREATMENT PLANT.

SAND FILTER:

01 Ensure that operating control valve of sand filter is on “Back Wash” position.
02 Switch on the electrical power supply of feed pump from the main control panel.
03 Run the feed pump for 10 minutes.
04 Switch off the feed pump.
05 Change position of operating control valve to “Fast Rinse” position.
06 Switch on the feed pump.
07 Run the feed pump for 5 minutes.
08 Switch off the feed pump.
09 Change the position of operating control valve to “Service (Filter)” position.
Carbon Filter:
1 Ensure that operating control valve of carbon filter is on “Back Wash” position.
2 Switch on the electrical power supply of feed pump from the main control panel.
3 Run the feed pump for 10 minutes.
4 Switch off the feed pump.
5 Change position of operating control valve to “Fast Rinse” position.
6 Switch on the feed pump.
7 Run the feed pump for 5 minutes.
8 Switch off the feed pump.
9 Change the position of operating control valve to “Service (Filter)” position.
Water Softener:
1 Prepare the Brine solution as per its SOP.
2 Dip the filter of water softener into brine solution.
3 Change the operating control valve to “Brine & Slow Rinse” position.
4 Switch on the feed pump
5 Consume the whole 30 liter solution in approximately 30 minutes.
6 Remove the brine container from the area.
7 Switch off the feed pump.
8 Change the operating control valve to “Fast Rinse” position.
9 Switch on the feed pump.
10 Run it for 10 minutes.
11 Switch off the feed pump.
12 Change the operating control valve to “Service (Filter) position.
13 Run the water softener and take the sample from valve # 5 and check it for hardness.
Specifications: Total hardness should be less than 10 ppm.

PREPARATION OF ANTI-SCALENT SOLUTION FOR R.O PLANT

PROCEDURE:

1 Ensure the cleanliness of polyethylene container.
2 Open the cap of PE container.
3 Completely fill this container with R.O water (approximately 80 liters).
4 Add one liter (1000 ml) anti-scalent chemical (Flowcon-260) into this container and mix it thoroughly.
5 Adjust the dose from its adjustment knob between 30-40%.
6 Its pump will be energized (on-off) automatically with high pressure pump of 1st pass RO system.

PREPARATION OF CHLORINE SOLUTION FOR R.O PLANT.

PROCEDURE:

1 Ensure the cleanliness of polyethylene container.
2 Open the cap of PE container.
3 Completely fill this container with R.O water (approximately 80 liters).
4 Add half liter (500 ml) chlorine (Liquid bleach) into this container and mix.
5 Adjust the dose from its adjustment knob at 10%.

PREPARATION OF BRINE SOLUTION FOR WATER TREATMENT PLANT

PROCEDURE:

1 Take a polyethylene container of 50 Kg capacity and ensure its cleanliness.
2 Add 30 liters R.O water in it.
3 Add 10 kg Sodium Chloride (Natural Salt) in it.
4 Mix to dissolve the salt completely in water.

7.0 REFERENCES

NA

8.0 REQUIRED DOCUMENT

NA

9.0 ATTACHED DOCUMENT

NA

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