SOP for Passivation of Stainless Steel Contact Parts of Production Equipments

OBJECTIVE

To provide a procedure for the passivation of Stainless steel contact parts of equipment located in the Production department. 

SCOPE

It applies to the SS product contact parts of the equipment used for manufacturing in the Production department. 

RESPONSIBILITY

• Operator / Engineering personnel: To passivate the SS product contact parts of the equipment as per this SOP. 
• Production Supervisor: To monitor and record the details of the passivation exercise as per this procedure. 
• QC personnel: To collect and analyze the rinse sample as per the pertinent procedure. 
• Production Manager / QA Manager: To ensure that the SOP is followed. 

PROCEDURE

• Clean the equipment using a lint-free dry cloth. 
• Prepare 20% citric acid solution in quantity sufficient to passivate the SS product contact parts of the equipment. 
• Soak a clean cloth in the prepared solution of citric acid and wipe the SS product contact surface of the equipment using the soaked cloth. 
• Then clean the product contact part of the equipment with Purified water. 
• After the purified water has been drained off, again wipe the contact surface with a cloth soaked in 20 % citric acid solution. 
• Ensure that the entire product contact surface of the equipment is in contact with 20 % citric acid solution.

• Hold the equipment in the same condition for around 14 – 16 hours. 
• Finally, flush the contact part of the equipment with Purified water till the rinse sample meets the specifications of Purified water (i.e. all the physical, chemical, and microbiological specifications of Purified water are complied with). 
• Q.C. personnel shall be intimated to collect and analyze the rinse sample. 
• Record the details of passivation activity as per Attachment-1: ‘Equipment Passivation Record’. 
• Frequency of Passivation: Before the operation of new equipment and when it is judged necessary by the Production Manager or QA Manager.

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ABBREVIATIONS

SOP: Standard Operating Procedure

QC: Quality Control

QA: Quality Assurance

SS: Stainless steel

Attachment-1: Equipment Passivation Record

Name of the Equipment: _____________

Department: _____________________

Equipment ID Number:______________

Sr. No.	Description of activity	Performed By/ Date	Checked By / Date
1	Equipment cleaning before Passivation
2	Preparation of 20 % citric acid solution (Quantity = ___________ L)
3	Contact time of 20 % citric acid solution with Equipment surface to be passivated = ____________ hours. (Time started:________       Time completed: ________)
4	Rinse sample collection
5	Rinse sample analysis

 

Rinse sample analysis result (Pass / Fail): ____________     

Sign / Date: _________________

 

Approved By: _________________ (QA Manager)

 

Authorized By: _________________ (Plant Manager)

REVISION HISTORY

Nil

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