- 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
Provides essential guidance for ensuring microbial control and system integrity in pharmaceutical applications. It rightly emphasizes the importance of thorough cleaning, validated disinfection procedures, and documentation to maintain compliance and product safety.
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