Operational Qualification Protocol of Pillar Type Blender

The aim of developing the Operational Qualification Protocol of Pillar Type Blender is to collect enough details about the Pillar Type Blender. We want to set out the conditions needed for this machine and ensure that everything it does matches what it was designed for. We also want to ensure that the limits mentioned in the document are clear and accurate throughout the process.

Operational Qualification Protocol of Pillar Type Blender

Related: Blender Performance Qualification Protocol/ Annexures

SERIAL NO.ITEM DESCRIPTION
1.0PROTOCOL APPROVAL
2.0OVERVIEW:
2.1Objective
2.2Purpose
2.3Scope
2.4Responsibility
2.5Execution Team
3.0ACCEPTANCE CRITERIA
4.0REVALIDATION CRITERIA
5.0OPERATIONAL QUALIFICATION PROCEDURE
5.1Equipment Description
5.2Instruction for Filling the Checklist
5.3Test Instrument Details
5.4Verification of Functional Checks
5.5Verification of Key Functionality of Control Panel
5.6Verification of Safety Feature (S)
5.7Verification of Standard Operating Procedure
5.8Verification of Component to be calibrated
5.9Training Record Of Personnel (S)
5.10Deficiency And Corrective Action(s) Report(s)
6. 0OPERATIONAL QUALIFICATION FINAL REPORT
6.1Summary
6.2Conclusion
6.3Final Report Approval
1.0PROTOCOL APPROVAL:

This Operational Qualification Protocol of Pillar Type Blender has been reviewed and approved by the following signatories:

FUNCTIONNAMEDEPARTMENTSIGNATUREDATE
PREPARED BY QUALITY ASSURANCE  
REVIEWED BY PROJECTS / ENGINEERING  
REVIEWED BY PRODUCTION  
APPROVED BY QUALITY ASSURANCE  
2.0OVERVIEW :
2.1OBJECTIVE: 
 The objective of developing and executing this protocol is to collect sufficient data about the Pillar Type Blender and define the qualification requirements and acceptance criteria for the machine and prove that each operation proceeds as per design specification and the tolerances prescribed there in the document are the same at utmost transparency.
2.2PURPOSE: 
 The purpose of this protocol is to establish documentary evidence to ensure that the Pillar Type Blender received matches the Design specification and also to ensure that it is properly and safely installed.
2.3SCOPE: 
 The Scope of this protocol is limited to the Operational Qualification of Pillar Type Blender in XYZ Pharmaceuticals. Once the operational qualification of the Pillar Type Blender has been completed successfully, the equipment shall proceed with the performance qualification procedure.
2.4RESPONSIBILITY: 
 The following shall be responsible; Quality assurance officer/Executive  – For Preparation of Protocol /ExecutionProjects. Engineering Head – For execution. Production Head – For execution support. Quality Assurance Head – For adequacy and final approval.

Related: Auto Coater Operational Qualification Protocol/ Annexures

2.5EXECUTION TEAM:
 The satisfactory operation of the Pillar Type Blender shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Pillar Type Blender is operational and is satisfactorily working. The execution team is responsible for the execution of the installation of the Pillar Type Blender. The execution team comprises of:
DEPARTMENTDESIGNATIONNAMESIGNATUREDATE
PROJECTS    
PRODUCTION    
QUALITY ASSURANCE    
3.0ACCEPTANCE CRITERIA:
3.1The equipment shall be operational as per its specified operating instructions
3.2All SOPs for the equipment to be verified and checked
3.3Training shall be given to all the concerned personnel
3.4All the functionality of equipment components is to be checked.
4.0REVALIDATION CRITERIA:
 The machine shall be revalidated if:
 1. Any major changes affect the performance of the equipment.
2. After a major breakdown maintenance is carried out.
3. As per the revalidation date and schedule
5.0OPERATIONAL QUALIFICATION PROCEDURE
5.1EQUIPMENT DESCRIPTION:
Equipment NameContainer Blender (Pillar type)
Supplier / ManufacturerR. P. Products
Volumetric capacity (Gross)200 -100Ltrs.
Main motor HP1 HP.
Main motor RPM1440 RPM.
Power Pack Motor H.P2.0 HP
Power Pack Motor RPM1440 RPM

Pillar Type Blender comprises of following components:

  1. PLC
  2. MMI
  3. Power Pack
  4. Power Pack Motor
  5. Hydraulic Cylinder
  6. Reduction Gear Box – 2Nos.
  7. Drive Motors – 2nos
  8. Bearings.
  9. variable Frequency Drive
  10. Gear– Pinion Reduction Drive.
  11. Hydraulic Power Pack std. components
5.2INSTRUCTION FOR FILLING THE CHECKLIST
5.2.1In case of compliance of the test use the word ‘Complies’ otherwise use‘ Does not comply ‘ to indicate non-compliance.
5.2.2For identification of the components of the equipment and utilities use the word ‘’yes’’ to show its presence and use ‘No’ to indicate the absence of the identity
5.2.3Give detailed information in the summary and conclusion part of the Operational Qualification report.
5.2.4Whichever column is blank or not used ‘NA’ shall be used.

Related: Design Qualification Protocol for Vertical Laminar Reverse Flow

5.3TEST INSTRUMENT DETAILS
 Instrument/Equipment required: 1. Ammeter   2.  Tachometer
Sr. No.Name of InstrumentInst. ID. NumberCalibration valid up toChecked by/Date
     
     
     
5.4VERIFICATION OF FUNCTIONAL CHECKS:
NAME OF SYSTEM COMPONENTSPECIFIED FUNCTIONMATCHES WITH THE SPECIFIED FUNCTION(YES / NO)VERIFIED BY(SIGN)DATE
1. Drive assemblyTo provide the necessary torque to rotate the bin.   
2. Power Pack assemblyTo lift and hold the bin during the process   
3. VFDFor RPM setting and Soft start /Soft stop option   
4. Power Failure testThe process time elapsed should be in the PLC memory and the process shall continue from where the power interruption has occurred   
5. Fixed RPM12 RPM   
6. Volume check of BinTo check the volume   
7. Blender BinEasy movement of the bin in holding arms.   
5.5VERIFICATION OF KEY FUNCTIONALITY OF CONTROL PANEL:
OPERATING PANEL: 
MAKE: 
COMPONENT OF CONTROL PANELSPECIFIED FUNCTIONMATCHES WITH THE SPECIFIED FUNCTION(YES / NO)VERIFIED BY(SIGN)DATE
1. Programmable logic controlTo operate the equipment and to set the parameters as per the requirement.    
2. Emergency switch To stop the operation immediately at the time of emergency   
5.6VERIFICATION OF SAFETY FEATURES:
SAFETY FEATURES DESCRIPTIONFUNCTIONVERIFIED BY(SIGN)DATE
1. EarthingTo avoid electrical shocks due to leakage current.  
2. Emergency stop buttonTo stop the machine if the problem appears in running condition.  
3. Safety GuardFor the safety of the operator during operation.  
4. The bin is lifted to the set heightThe container / Bin does not rotate until the drive assembly with the Bin is lifted to a set height.   
5.7VERIFICATION OF STANDARD OPERATING PROCEDURE (SOP)

The following Standard Operating Procedures were verified as important for the effective performance of Pillar Type Blender.

Sr.No.SOP TITLESOP NUMBERVERIFIED BYDATE
1.    
2.    
3.    
4.    
5.8TRAINING RECORD OF PERSONNEL (S) :
Sr. No.Name of PersonnelDesignationSign. & DateTrained ByRemark
1.     
2.     
3.     
4.     
5.     
5.9DEFICIENCY AND CORRECTIVE ACTION (S) REPORT (S)
The following deficiency was verified and corrective actions were taken in consultation with the Engineering Department.
Description of deficiency:
 
 
 
 
 
 
 
Corrective action(s) taken:
 
 
 
 
 
 
 

Reviewed By:

Date:

6.0OPERATIONAL QUALIFICATION FINAL REPORT:
6.1SUMMARY:
 
 
 
 
 
 
 
6.2CONCLUSION:
 
 
 
 
 
 
 

6.3 FINAL REPORT APPROVAL

It has been checked and made sure that all the tests mentioned in the Operational Qualification Protocol of Pillar Type Blender are finished, matched up, and added to this plan or in the summary report. Also make sure that any changes or differences are noted down, authorized, and added to this Protocol.

The signature in the block below indicates that all items in this qualification report of Pillar Type Blender have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily resolved.

NAMEDESIGNATIONDEPARTMENTSIGNATUREDATE
  PROJECTS / ENGINEERING  
  PRODUCTION  
  QUALITY ASSURANCE  

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