SOP for Passivation of Purified Water Storage Tank and Distribution Piping : Pharmaguideline

Online GMP Courses with Certificate

ENROLL

SOP for Passivation of Purified Water Storage Tank and Distribution Piping

Standard operating procedure of passivation of purified water storage tank and distribution system with nitric acid and hot waterto decontaminate.

1.0 OBJECTIVE

To lay down the procedure for the passivation of purified water storage tank and distribution piping.

2.0 SCOPE

This SOP shall be applicable for the purified water storage tank and distribution piping.

3.0 RESPONSIBILITY

Operator /Engineer/ Executive

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Collect the Reverse Osmosis (RO) product water in the purified water storage tank.
5.2 Flush the storage tank with RO water by filling and draining the tank twice.
5.3 Again take the fresh RO water in the storage tank and flush the interconnecting piping in the open loop and then in the closed loop.
5.4 Drain out the storage Tank.
5.5 Prepare the Nitric acid solution (about 10 % solution) in the purified water storage tank. Take about 350 liters of RO product Water; add 35 liters of Nitric acid.
5.6 Circulate the above Nitric acid solution in the interconnecting piping in the closed loop distribution system for 2.0 hours.
5.7 Stop the distribution pump and drain all the Nitric acid solution.
5.8 Collect the RO water into purified water storage tank and flush the distribution system till the pH is in between 7-8 and then drain the water.
5.9 Collect the RO water into the purified water storage tank and heat it to 80ºC to 85ºC and circulate through distribution loop system for a minimum of 1 hour to sanitize the loop system.
5.10 Check the pH values of RO water and outlet of the storage tank.
5.11 If the pH values of RO water and outlet of storage tank differ by more than +/- 0.5, again flush the distribution system till traces of Nitric acid are removed. pH should be within +/- 0.5 of the RO outlet water.
5.12 Use proper hand gloves duly disinfected with IPA or chlorinated water while preparing the solution.
5.13 Use safety goggle and mask while preparing the solution.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 RO: Reverse Osmosis
6.3 IPA: Iso Propyle Alcohol
Also see: How to Remove Pathogenic Bacteria from Water Systems
Get ready to use editable documents in MS-Word FormatView List





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


1 comment: Post Yours! Read Comment Policy ▼

  1. sir is any guideline for passiavtion of PWS, please reply

    ReplyDelete

Please don't spam. Comments having links would not be published.


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Online Courses


Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg


Recent Posts