Passivation and Cleaning Procedure Purified Water Distribution Loop

  • Objective : To ensure that the Purified Water Distribution System is Chemically cleaned.
  • Scope :Applicable for Passivation and Cleaning of Purified Water Distribution Loop
  • Procedure :
  • Fill the Purified Water Storage Tank till the Half Level.
  •  Ensure Suction & Discharge valve of pump are open and all user points & sampling valves are closed.
  • Start the recirculation pump & circulate water for 25 – 30 min.
  • Then drain the water from the tank & piping via user points & sampling points.
  •  Prepare Cleaning chemical by diluting Nitric acid (HNO3) of 2% concentration in Purified Water.
  • Start the recirculation pump and circulate the cleaning chemical for 45-60 min.
  • Then drain the cleaning chemical from the tank & piping via user points & sampling points.
  • Prepare Passivation chemical by diluting Sodium Hydroxide (NaOH) (of 100% purity) with water with 1% of concentration.
  • Start recirculation pump and circulate the Passivation chemical for not less than
    1 hr.
  •  Drain the Passivation chemical from equipments and recirculation loops via each user points.
  •  Transfer fresh water to Purified Water Storage Tank.
  •  Flush the equipment and recirculation loops with purified water till the pH is neutral (6 to 7) or to the in feed water quality.
  • Observation should be filled in Cleaning & Passivfdaation Report Sheet.


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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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