Cleaning and Disinfection of a Newly Purified Water System Before Start Up : Pharmaceutical Guidelines

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Cleaning and Disinfection of a Newly Purified Water System Before Start Up

Learn the cleaning and disinfection process for a new Purified Water System.
  • WHO require any newly installed pharmaceutical water distribution system to be degreased, passivated and periodically sanitized.
  • The purpose of degreasing is to remove any greasy materials produced from the welding process
  • The purpose of passivation of the interior surfaces of the loop is to form a barrier between the water and free ion and to re-establish the protective layer on the surface of the steel, which was removed by welding. (It is also good if you have a rouging problem).
  • The purpose of sanitization is to control the microbial contamination and biofilm

1. Degreasing

  • After the wedding, you will have to degrease it. As you know, pipes are quite dirty and also welding releases some "greasy" material. You can do this with a caustic based solution
  • Charge the tank around 600 liters of PW and then add 15 Kgs of sodium hydroxide (100%). Mix with a rod, don’t use detergents to avoid foaming.
  • Re-circulate the solution through the entire loop for 30 minutes: one hour, discharge and rinse the tank and loop with fresh water several times.

2. Passivation

  • You need to Passivate the tank and the distribution loop. As you know, PW has a pH slightly acidic (about 6.5) so you need to Passivate the stainless steel to increase its resistance.
  • Collect the storage tank about 600 liters of PW, add 20 liters of nitric acid (69%)Then recirculate the solution 30 minutes, drain the solution from the user points
  • Collect the storage tank about 600 liters of PW, add 25 Kgs of citric acid (100%)Then recirculate the solution 30 minutes, drain the solution from the user points.
  • Flush the circulation loop with purified water till the PH = 7.0 is achieved, use pH paper indicator and no traces of nitric acid or NaOH are present.

3. Sanitization

  • Usually, you have two types of thermal sanitization: one at 80°C that is recirculating for 2 hours, and other at 121°C (a kind of sterilization) that recirculates for 30 minutes (For both you have to have the PW level in the tank of about 15%) then cool down.

Submitted By:
Mr. Ibrahim Hashim

Microbiology Manager-Sabaa Pharma Group-Egypt
002-0122635047
E- mail: ibrahimhashim71@yahoo.com





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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