SOP Guide for Pharma

SOP for Cleaning of Nebulizer Solution Mixing Equipment

SOP for Cleaning of Nebulizer Solution Mixing Equipment

Standard Operating Procedure for Cleaning Nebulizer Solution Mixing Equipment

1) Purpose

The purpose of this SOP is to define the process for cleaning nebulizer solution mixing equipment to ensure compliance with hygiene standards, avoid cross-contamination, and maintain product quality.

2) Scope

This SOP applies to all mixing tanks, agitators, pipelines, and associated equipment used for preparing nebulizer solutions within the facility.

3) Responsibilities

Operators: Perform routine cleaning activities as per the defined procedure.
Maintenance Team: Inspect and repair equipment if required during cleaning activities.
Quality Assurance (QA): Validate and approve cleaning records.
Supervisors: Ensure cleaning is conducted as per schedule and procedures.

4) Procedure

4.1 Pre-Cleaning Activities

4.2 Cleaning Steps

4.2.1 Cleaning the Mixing Tank

4.2.2 Cleaning the Agitator

4.2.3 Cleaning Pipelines and Valves

4.3 Post-Cleaning Activities

4.4 Frequency of Cleaning

4.5 Handling Cleaning Failures

4.6 Safety Precautions

5) Abbreviations

6) Documents

The following documents should be maintained:

7) References

Relevant regulatory guidelines and references include:

8) SOP Version

Version: 1.0

Annexure

Annexure Title: Cleaning Log

 
Date Equipment ID Cleaning Method Performed By QA Approval Remarks
DD/MM/YYYY Equipment Identifier Details of cleaning Technician Name QA Name Details of activity
           

Annexure Title: Cleaning Schedule

 
Equipment ID Cleaning Type Frequency Last Cleaned Date Next Due Date
Equipment Identifier Routine/Deep Daily/Weekly DD/MM/YYYY DD/MM/YYYY
         

Annexure Title: Cleaning Failure Report

 
Date Equipment ID Issue Identified Corrective Action Performed By QA Approval
DD/MM/YYYY Equipment Identifier Description of issue Details of corrective action Technician Name QA Name
           
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