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.
Verification of Key Functionality of Control Panel
5.6
Verification of Safety Feature (S)
5.7
Verification of Standard Operating Procedure
5.8
Verification of Component to be calibrated
5.9
Training Record Of Personnel (S)
5.10
Deficiency And Corrective Action(s) Report(s)
6. 0
OPERATIONAL QUALIFICATION FINAL REPORT
6.1
Summary
6.2
Conclusion
6.3
Final Report Approval
1.0
PROTOCOL APPROVAL:
This Operational Qualification Protocol of Pillar Type Blender has been reviewed and approved by the following signatories:
FUNCTION
NAME
DEPARTMENT
SIGNATURE
DATE
PREPARED BY
QUALITY ASSURANCE
REVIEWED BY
PROJECTS / ENGINEERING
REVIEWED BY
PRODUCTION
APPROVED BY
QUALITY ASSURANCE
2.0
OVERVIEW :
2.1
OBJECTIVE:
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.
2.2
PURPOSE:
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.
2.3
SCOPE:
TheScope 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.
2.4
RESPONSIBILITY:
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.
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:
DEPARTMENT
DESIGNATION
NAME
SIGNATURE
DATE
PROJECTS
PRODUCTION
QUALITY ASSURANCE
3.0
ACCEPTANCE CRITERIA:
3.1
The equipment shall be operational as per its specified operating instructions
3.2
All SOPs for the equipment to be verified and checked
3.3
Training shall be given to all the concerned personnel
3.4
All the functionality of equipment components is to be checked.
4.0
REVALIDATION 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
5.0
OPERATIONAL QUALIFICATION PROCEDURE
5.1
EQUIPMENT DESCRIPTION:
Equipment Name
Container Blender (Pillar type)
Supplier / Manufacturer
R. P. Products
Volumetric capacity (Gross)
200 -100Ltrs.
Main motor HP
1 HP.
Main motor RPM
1440 RPM.
Power Pack Motor H.P
2.0 HP
Power Pack Motor RPM
1440 RPM
Pillar Type Blender comprises of following components:
PLC
MMI
Power Pack
Power Pack Motor
Hydraulic Cylinder
Reduction Gear Box – 2Nos.
Drive Motors – 2nos
Bearings.
variable Frequency Drive
Gear– Pinion Reduction Drive.
Hydraulic Power Pack std. components
5.2
INSTRUCTION FOR FILLING THE CHECKLIST
5.2.1
In case of compliance of the test use the word ‘Complies’ otherwise use‘ Does not comply ‘ to indicate non-compliance.
5.2.2
For 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
5.2.3
Give detailed information in the summary and conclusion part of the Operational Qualification report.
5.2.4
Whichever column is blank or not used ‘NA’ shall be used.
To provide the necessary torque to rotate the bin.
2. Power Pack assembly
To lift and hold the bin during the process
3. VFD
For RPM setting and Soft start /Soft stop option
4. Power Failure test
The process time elapsed should be in the PLC memory and the process shall continue from where the power interruption has occurred
5. Fixed RPM
12 RPM
6. Volume check of Bin
To check the volume
7. Blender Bin
Easy movement of the bin in holding arms.
5.5
VERIFICATION OF KEY FUNCTIONALITY OF CONTROL PANEL:
OPERATING PANEL
:
MAKE
:
COMPONENT OF CONTROL PANEL
SPECIFIED FUNCTION
MATCHES WITH THE SPECIFIED FUNCTION(YES / NO)
VERIFIED BY(SIGN)
DATE
1. Programmable logic control
To 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
5.6
VERIFICATION OF SAFETY FEATURES:
SAFETY FEATURES DESCRIPTION
FUNCTION
VERIFIED BY(SIGN)
DATE
1. Earthing
To avoid electrical shocks due to leakage current.
2. Emergency stop button
To stop the machine if the problem appears in running condition.
3. Safety Guard
For the safety of the operator during operation.
4. The bin is lifted to the set height
The container / Bin does not rotate until the drive assembly with the Bin is lifted to a set height.
5.7
VERIFICATION 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 TITLE
SOP NUMBER
VERIFIED BY
DATE
1.
2.
3.
4.
5.8
TRAINING RECORD OF PERSONNEL (S) :
Sr. No.
Name of Personnel
Designation
Sign. & Date
Trained By
Remark
1.
2.
3.
4.
5.
5.9
DEFICIENCY 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:
6.0
OPERATIONAL QUALIFICATION FINAL REPORT:
6.1
SUMMARY:
6.2
CONCLUSION:
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.
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