Operational Qualification of Automatic Injectable Powder Filling With Rubber Stopping Machine

Operational Qualification of Automatic Injectable Powder Filling With Rubber Stopping Machine protocol shall define the test procedures, documentation, references, and acceptance criteria to establish that the machine operates and performs as intended in accordance with the design qualification.

Related: Installation Qualification of Automatic Injectable Powder Filling With Rubber Stoppering Machine

SERIAL NO.	ITEM DESCRIPTION
1.0	PROTOCOL APPROVAL
2.0	OVERVIEW:
2.1	Objective
2.2	Purpose
2.3	Scope
2.4	Responsibility
2.5	Execution Team
3.0	ACCEPTANCE CRITERIA
4.0	REVALIDATION CRITERIA:
5.0	OPERATIONAL QUALIFICATION PROCEDURE
5.1	Equipment Description
5.2	Instruction for Filling the Checklist
5.3	Calibration of Process Control Instruments
5.4	Verification of Functional keys
5.5	Verification of Design parameters
5.6	Verification of Safety Features
5.7	Verification of Standard Operating Procedure
5.8	Training Record of Personnel (S)
5.9	Verification of Sequential Operation of The Equipment
5.10	Verification of Effect Of Power Failure on The Equipment
5.11	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:

Signing to Operational Qualification of Automatic Injectable Powder Filling With Rubber Stopping Machine Protocol indicates agreement with the operational qualification approach described in this document. Read More by Downloading this Protocol (See Below)

FUNCTION	NAME	DEPARTMENT	SIGNATURE	DATE
PREPARED BY		QUALITY ASSURANCE
REVIEWED BY		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 pertaining to the Automatic Single Head Injectable Powder Filling with Rubber Stoppering Machine Model (Modal Name). Read More by Downloading this Protocol (See Below)
2.2	PURPOSE:
	The purpose of this protocol is to establish documentary evidence to ensure that the installed Automatic Single Head Injectable Powder Filling with Rubber stoppering Machine Model (Modal Name) will operate reproducibly and consistently within its full dynamic range of operation according to manufacturer’s specifications and to demonstrate that the control panel and other manual operation of Automatic Single Head Injectable Powder Filling with Rubber stoppering Machine Model (Modal Name) provides the proper functionality as specified in the design qualification.

2.3

SCOPE:

The Scope of this protocol is limited to the operational qualification of Automatic Single Head Injectable Powder Filling with Rubber stoppering Machine Model (Modal Name) in XYZ Pharmaceuticals. The objective of developing and executing this protocol is to collect sufficient data pertaining to the Automatic Single Head Injectable Powder Filling with Rubber Stoppering Machine Model (Modal Name) and define the qualification requirements and acceptance criteria for the machine. This protocol shall define the test procedures, documentation, references, and acceptance criteria to establish that the Automatic Single Head Injectable Powder Filling with Rubber Stoppering Machine Model (Modal Name) operates and performs as intended in accordance with the design qualification.

2.4	RESPONSIBILITY:
	The following shall be responsible; Departmental Head: Responsibility

2.5

EXECUTION TEAM:

The satisfactory operation of the Automatic Single Head Injectable Powder Filling with Rubber Stoppering Machine Model (Modal Name) shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Automatic Single Head Injectable Powder Filling with Rubber stoppering Machine Model (Modal Name) is operational and is satisfactorily working. The execution team is responsible for operating Automatic Single Head Injectable Powder Filling with a Rubber Stoppering Machine Model (Modal Name). All executors involved with this protocol shall sign within the prescribed format given below:

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
PROJECTS/ENGINEERING
PRODUCTION
QUALITY ASSURANCE

3.0	ACCEPTANCE CRITERIA:
3.1	Read More by Downloading this Protocol (See Below)
3.2	Read More by Downloading this Protocol (See Below)
3.3	All construction materials of the contact parts are to be checked as per the specifications.
3.4	All the functionality of equipment components is to be checked.
3.5	All the safety features of the equipment shall be verified and utilities shall be available near the equipment.
3.6	The validity of the calibration of test instruments shall be checked and all the required calibration of the components of the equipment shall be performed.

4.0	REVALIDATION CRITERIA:
	The machine has to be revalidated if:
	✔ Any major changes affect the equipment’s performance. ✔After a major breakdown maintenance is carried out. ✔As per the revalidation date and schedule.

5.0	OPERATIONAL QUALIFICATION PROCEDURE :
5.1	EQUIPMENT DESCRIPTION

Equipment Name	Automatic Single Head Injectable Powder Filling with Rubber stoppering Machine Model (Modal Name)
Supplier / Manufacturer	Manufacturer Name
Overall Dimension (LXW)	1525(W) x 2340(H) x  3960(L) mm
Output	120  Vials/Min
Model	(Modal Name)
Service it offers	Filling and Rubber stoppering of vials
Location	XYZ

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.

5.3	CALIBRATION OF PROCESS CONTROL INSTRUMENTS:

Objective	To verify that the process control instruments identified during the installation of the automatic injectable powder filling with rubber stoppering machine are calibrated.
Test Procedure	Verify the calibration certificate and calibration status label on the instrument and ensure that the same are calibrated and record the details in the table below. Also, record the details of the instruments used for the calibration in the table below.
Acceptance criteria	All the critical process control instruments should be calibrated.

Instrument Details				Calibration Details
Name	Location	Id. No.	Range	Done On	Next Due	SOP No.	Certificate No.

REFERENCE INSTRUMENTS DETAILS:

Instrument Details		Calibration Details			Checked By/date
Name	Range	Done On	Next Due	Certificate No

Comments:

Reviewed By/Date:

Related: Operation Qualification of Sterilizing and Depyrogenation Tunnel

5.4	VERIFICATION OF FUNCTIONAL KEYS:

Objective	To check and identify the individual functional keys and verify that the function of the individual key is as per the manufacturer’s specifications.
Test Procedure	Identify each functional key listed below, operate and verify its function against the specified function, and record the observations.
Acceptance criteria	Each functional key should perform the specified function when activated.

Functional Key / Procedure	Specified Function	Observation	DiscrepancyYes/No	CheckedBy/Date
Main ON / OFF key switch	To connect/disconnect the power supply to the control panel/machine.
Emergency Stop Switch	To stop the machine in case of an emergency
Start Button	To start the machine
Stop Button	To stop the machine

Comments:

Reviewed By/Date:

5.5	VERIFICATION OF DESIGN PARAMETERS:

Objective	To measure and verify that the automatic injectable powder filling with rubber stoppering machine supplied is as per the standard/design parameters.
Test Procedure	Verify the automatic injectable powder filling with the rubber stoppering machine by verifying the filling time by physically checking the No. of vials filled and record the actual results in the table below. A minimum of three observations to be made.
Acceptance criteria	The observations made for different parameters should be the same as the specification.

S.No.	Description	Specification	Observation / Output			DiscrepancyYes/No	Checked By/Date
			Trial 1	Trial 2	Trial 3
	Vial filled per minute
	Vial size
	Acquired speed

Comments:

Reviewed By/Date:

5.6	VERIFICATION OF SAFETY FEATURES:

Objective	To verify the safety features present in the automatic injectable powder filling with rubber stoppering machine are performing as per the specification when activated.
Test Procedure	Verify the response of each safety feature listed below against the specified function by activating the same as per the procedure given. Record the observations.
Acceptance criteria	The safety features when activated should produce desired results.

Alarm / Interlock	Specified Function	Activation Procedure	Observation	DiscrepancyYes/No	Checked By/Date
No Vial No Filling Sensor	No vial no filling system is provided to avoid the wastage of costly powder, while the machine is running in ideal condition and the vial is not present below the powder wheel.	Try to run the machine keep the minimum vials then see when the vials are over the dosing is still in operation or not.
Vial Separator Proximity Switch	If during production any vial comes with an over diameter or over height then any of the three clutches will get operated and through that signal machine will get OFF.	Try to put some vials, which are of over diameter, and see the results.

Alarm / Interlock	Specified Function	Activation Procedure	Observation	DiscrepancyYes/No	Checked By/Date
No stopper in the chute machine stop sensor.	This sensor is used to sense the presence of a rubber stopper in the chute. In case during the production time if there is no rubber stopper present in the chute then it will stop the machine.	Try to run the machine with a minimum amount of rubber stoppers in the chute. You will see that once the rubber stoppers are over in the chute, the sensors indicate and stop the machine.

Comments:

Reviewed By/Date:

5.7	VERIFICATION OF STANDARD OPERATING PROCEDURE (SOP)

The following Standard Operating Procedures were verified as important for the effective performance of Automatic four head vial sealing machine operation.

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	VERIFICATION OF SEQUENTIAL OPERATION OF THE EQUIPMENT:

Objective	To demonstrate that the automatic injectable powder filling with rubber stoppering machine is capable of achieving the desired results when operated as per the set parameters.
Test Procedure	Operate the automatic injectable powder filling with a rubber stoppering machine as per the SOP. Verify that the machine is operating in safe and normal conditions; record the results and discrepancies observed if any.
Acceptance criteria	The automatic injectable powder filling with a rubber stoppering machine should produce the expected results when operated as per the procedure.

Procedure / Parameter	Expected Result	Observation / Results
		Trial – 1	Trial – 2	Trial – 3
Switch “ON” the machine by pressing the ON / OFF switch.	The machine is ready for operation.
Operated By Name:
Signature and Date:

Comments:

Reviewed By/Date:

Related: Installation Qualification of Sterilizing and Depyrogenation Tunnel (Protocol)

5.10	VERIFICATION OF EFFECT OF POWER FAILURE ON THE EQUIPMENT:

Objective	To verify that the automatic four-head vial sealing machine reverts to a failsafe condition in the event of power failure and that it returns to a specified state when power is restored and can be restarted.
Test Procedure	Start the operation of the machine in auto mode as per the SOP for a set time duration of 10 minutes. Approximately midway through the set operation time (4-6 minutes), switch OFF the total power supply to the equipment for 3 minutes. Restore the power supply and restart the machine by pressing the start button (the equipment should not be reset) to record whether the equipment starts normally. Measure the total operational in the table below.
Acceptance criteria	The machine stops in safe and secure conditions in the event of power failure. When the power supply is restored the machine should not start till the operator intervenes and restarts the equipment. The machine should restart normally, without any problems. The total elapsed time (total run time + power failure duration) should be equal to the total time duration on the stopwatch. The timer should start operating from the time just before the power failure.

Parameter	Observation / Results
	Trial – 1	Trial – 2	Trial – 3
Set time duration
Elapsed time values Initial (a)At power failure (b)Run time (c= a-b) After power failure (d) Final (e) Run time (f = e-d)
Total run time (g=c+f)
Power failure duration (h)
Total time duration On stopwatch
Actual (g+h)

Parameter	Observation / Results
	Trial – 1	Trial – 2	Trial – 3
Observations when a power failure occurs.
Equipment stops in safe and secure condition. (Yes/No)
Observations when the power supply is restored.
Operator intervention is required to restart the equipment. (Yes/No)
The equipment restarts in normal condition. (Yes/No)
Operated By Name:
Signature and Date:

Comments:

Reviewed By/Date:

5.11	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 verified that Read More by Downloading this Protocol (See Below)…

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE

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