SOP for Passivation of Equipment

This Document describes (Standard Operating procedure) SOP for Passivation of Equipment

SOP for Passivation of Equipment

I. Purpose & Scope:

• The purpose of this SOP is to lay down the procedure for Passivation of Equipment.
• This Standard operating procedure shall be applicable for Passivation of equipment.

II. Responsibilities:

• All production and Quality control personnel shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part :

Introduction on Passivation of Equipment :

• Passivation:

Passivation is an activity by which activated ions on the contact surface of an equipment/its accessories is neutralized to make it non-reactive.

• Contact Surface:

The surface of Equipment/its accessories coming directly in Contact of materials being processed using the same equipment/its accessories.

• Rinse:

Volume of Solvent coming out from the equipment/it’s accessories during Spraying/flushing of the same on the surface of it’s finally cleaned contact surface.

Solution Preparation:

• 20% w/v Citric Acid:- Take 500 gm. of citric acid monohydrate & dissolve it in 1.5 liter of purified water with continuous stirring further dilute it up to 2.5 Liters with purified water mix by shaking for 5 minutes. (Volume of solution to be prepared will depend upon requirement).
• 0% w/v Sodium Hydroxide:-Take 125gm of NaOH & dissolve in 1.5 liter of purified water with continuous stirring further dilute it up to 2.5 Liters with purified water mix by shaking for 5 minutes. (Volume of solution to be prepared will depend upon requirement).

Procedure for Passivation of equipment  :

Step 1: Passivation with 20% Citric Acid.

• Wipe entire contact surface of the equipment /Change parts with above prepared 20% w/v citric acid solution and leave it idle for 30 minutes.
• Drain or decent the above solution from the said equipment/Change parts.
• Wash entire contact surface twice with potable water.
• Wash entire contact surface of said equipment/change parts with purified water.
• Finally rinse entire contact surface of said equipment/change parts with purified water.
• Record shall be maintained as per Annexure I.

Step 2 : Passivation with 5% NaOH Solution.

• Wipe entire contact surface of the equipment /Change parts with above prepared 5% NaOH w/v solution and leave it idle for 30 minutes.
• Drain or decent the above solution from the said equipment/Change parts.
• Wash entire contact surface twice with potable water.
• Wash entire contact surface of said equipment/change parts with purified water.
• Finally rinse entire contact surface of said equipment/change parts with purified
• Collect rinse water sample and send it to Q.C for analysis and Compliance for the same test.
• After Q.C. Release of wash water above passivated Equipment’s / accessories shall be used for commercial production.
• Frequency of Passivation : Before operation of new equipment and when judged by production manager or QA manager.
• Record shall be maintained as per Annexure I

IV : Annexure :

Annexure I : Passivation Record

Annexure I 

Passivation Record

Equipment/Accessories:                                                 ID. No. :

Area:                                                                                Date of Passivation:

1. After Passivation wash water shall be collect & sent to Q.C for wash water analysis as per current version of SOP

Volume of wash water specification:

Wash water sample collected By (QA) (Sign/Date/Time)

Q.C A.R. No.:    …………………                                Date:

Wash water sample Complies/Does not comply

Hence Equipment/Change parts released for commercial production from today onwards.

_________________

QA (Sign/Date/Time)