Sanitization of Purified Water Generation and Distribution System

Purified Water

Purified water is more than just a thirst-quenching beverage; it’s a cornerstone of health and well-being. In this blog, we explore the significance of purified water, the various purification methods, and why its consumption is essential for a healthy lifestyle.

Purification Methods: Purified water undergoes processes that eliminate impurities and contaminants, ensuring it meets stringent quality standards. Common purification methods include distillation, reverse osmosis, deionization, and filtration. Each method targets specific impurities, ranging from minerals and chemicals to bacteria and viruses.

Distillation: Distillation involves heating water to create steam, which is then condensed back into liquid form. This process effectively removes impurities with higher boiling points than water, leaving behind a purified product.

Reverse Osmosis: Reverse osmosis utilizes a semi-permeable membrane to filter out impurities. Water is forced through the membrane, trapping contaminants and allowing only pure water molecules to pass through.

Deionization: Deionization involves passing water through ion exchange resins to remove charged particles, such as ions and minerals. The result is highly pure water free of most dissolved impurities.

Filtration: Filtration methods range from activated carbon filters to micron filters, targeting particles and larger impurities. These filters are effective in improving taste and odor while removing visible contaminants.

Sanitization of Purified Water Generation and Distribution System

Objective: To lay down a procedure for the Sanitization of Purified Water Generation and Distribution system.

Scope: This Standard Operating Procedure applies to the formulation plant.

Responsibility

The Concerned Technician shall follow the Sanitization Procedure as per this SOP.

The Officer/Executive-Engineering shall be responsible for the implementation of the procedure as per this SOP.

The head-Engineering/Designee shall ensure compliance with the procedure as per this SOP.

Procedure

Sanitization of Purified Water Generation System

RO membranes are sanitized by using RO permeate which is filtered through MCF. The water in the tank is heated using an electrical heater which is installed inside the tank.

The sanitization procedure is as follows:

Make sure that the main supply to the panel is coming properly and turn “ON” all MCB switches.

For RO sanitization open pump suction valve and Discharge valve and all other valves are closed.

For EDI sanitization open the pump suction valve and discharge valve.

Start the pump and circulate warm water (NMT 45°C) with a maximum pump discharge of 2.5 kg/cm2.

Start the heater EHE. Set the temperature as 85oC and temperature rises at NMT 4°C per minute.

Continue the circulation till the temperature reaches to maximum of 85°C.

When temperature reaches 80°C switch “OFF” the heater EHE-001. Don’t stop circulation.

Maintain temperature for 60-90 minutes.

After completion of sanitization allow the system to cool to 45°C or below.

Flush the system with water at a maximum feed pressure of 2.5 kg/cm2.

Frequency: minimum twice a month.

Monitor and Record all the observations in a log sheet.

Sanitization Procedure For Distribution System

Switch “ON” the main power supply to the panel utilizing the starter switch at the side of the control panel.

Turn “ON” the MCB inside the control panel for powering the PLC and MMI.

Press the ‘ENTER’ button on the MMI to start the system.

Make sure the utilities (i.e. compressed air and steam) are available to the system at the required pressure and temperature respectively.

Make sure all the pump suction and discharge valves are kept open.

Make sure the MCB for the pumps is turned “ON” inside the control panel.

Put the system in ‘AUTO’ mode with the help of a selector switch (AUTO /OFF/ MANUAL) on the panel door.

Drain the water in a 2 KL storage tank till the water level reaches 750 ltrs for sanitization by opening the drain valve or feeding the water to reach 750 ltrs if the water level is low.

Press the SET button on the main screen to go to SET parameters for sanitization of the distribution system.

Enter the time for sanitization say 60 mins.

Enter the temperature for sanitization as 85º C at which the system is to be sanitized.

To put the system in sanitization mode turn “ON” the sanitization selector switch.

Ensure that all the drain/sampling valves are in closed condition.

The tank steam inlet valve will open and close depending on the temperature of the water for a pre-settable time. As soon as the temperature of water in the return line reaches above the specified value the actuated valve turns OFF.

During sanitization, all the valves and pumps will be operational with the help of Selector switches and push buttons on the main door.

After completion of the sanitization cycle, turn “OFF” the sanitization selector switch.

Empty the Distribution system by opening the drain valves. Also, open up all the sampling valves while draining off the system.

Let the tank be as it is for atmospheric cooling for 15-20 mins.

Fill in fresh water in the tank and recalculate for 30 mins.

Again drain the whole system and fill fresh UF water.

The distribution system is now ready for operation.

Forms and Records

Record of Sanitization of Purified Water System.

Distribution

Master Copy: Documentation Cell (QA)

Controlled Copies: Engineering, Production, Quality Assurance, Stores, Quality Control.

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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