Installation Qualification Protocol for Automatic four head Vial Sealing Machine

Installation Qualification protocol for the Automatic four head Vial Sealing Machine has the following contents:

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	INSTALLATION QUALIFICATION PROCEDURE
5.1	System Description
5.2	Instruction for Filling the Checklist
5.3	Installation Check-List
5.4	Identification of Major Components
5.5	Verification of Material of Construction
5.6	Identification of Supporting Utilities
5.7	Identification of Safety And Interlock System
5.8	Identification of Standard Operating Procedure (SOP)
5.9	Identification of component to be calibrated
5.10	Verification of Drawings and Documents
5.11	Abbreviations
5.12	Deficiency And Corrective Action(s) Report(s)
5.13	Annexure(s)
6.0	INSTALLATION QUALIFICATION FINAL REPORT
6.1	Summary
6.2	Conclusion
6.3	Final report approval

Related: Operational Qualification of Automatic High-Speed Linear Vial Washing Machine (Protocol)

1.0	PROTOCOL APPROVAL:

The signing of this approval page of the Protocol indicates agreement with the qualification approach described in this document. If a modification to the qualification approach becomes necessary, an addendum shall be prepared and approved. The protocol cannot be used for execution unless approved by the following authorities.

This Installation Qualification protocol for the Automatic four head Vial Sealing Machine has been reviewed and approved by the following persons:

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 pertaining to the Automatic four-head Vial Sealing Machine and define the qualification requirements and acceptance criteria for the unit. Successful completion of these qualification requirements will provide assurance that the Automatic four-head Vial Sealing Machine was installed as required in the manufacturing area.
2.2	PURPOSE:
	The purpose of this protocol is to establish documentary evidence to ensure that the Automatic four-head Vial Sealing Machine received matches the Design specification and also to ensure that it is properly and safely installed.
2.3	SCOPE:
	This Protocol is applicable to the installation of an Automatic four-head Vial Sealing Machine at the tablet manufacturing facility XYZ Pharmaceutical.
2.4	RESPONSIBILITY:
	The following shall be responsible: Department Head: Write their Responsibilities.

2.5

EXECUTION TEAM:

The satisfactory installation of the Automatic four-head Vial Sealing Machine shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Automatic four-head Vial Sealing Machine is installed and is satisfactorily integrated. The execution team is responsible for the execution of the installation of the Automatic four-head Vial Sealing Machine. The execution team comprises of:

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
PROJECTS/ ENGINEERING
PRODUCTION
QUALITY ASSURANCE

3.0	ACCEPTANCE CRITERIA:
3.1	The equipment shall fulfill all the selection criteria and its individual application
3.2	The equipment shall comply with the specification mentioned in the user requirement specification.
3.3	It shall be complying with all the designed specifications.
3.4	The Material Of Construction (MOC) shall comply with the specification.
3.5	All supporting electric and non-electric utilities of specified capacities are to be near the place of installation.

4.0	REVALIDATION CRITERIA:
	The machine has to be revalidated if
	✔There are any major changes in system components, which affect the performance of the system. ✔After a major breakdown maintenance is carried out. ✔As per the revalidation date and schedule.

5.0		INSTALLATION QUALIFICATION PROCEDURE:
5.1		SYSTEM DESCRIPTION

The automatic four-head sealing machine is a compact versatile machine. The machine is precision built on the sturdy welded frame of either M.S. or S.S.304 Completely enclosed in a stainless steel sheet. This machine can be used to seal the duly rubber stopper vial which is either filled with liquid or powder.

It works on the basic principle of sealing the duly stopper vial, when the vial is rotating in between the chuck and lifting assembly and the sealing roller starts to move towards the vial neck and with rotary movement of the vial, sealing roller skirts and seal the vial and duly sealed vial transfer from turret to conveyor through the exit star wheel.

Machine Frame Structure:

The machine frame is made of M.S. (Powder coated) duly welded and grinded surfaces and fully covered with the S.S.304 sheet. Suitable SS covers cover the entire body from the sides. The main motor, main gearbox, pinion shaft assembly, star wheel assembly, feed worm assembly, etc. are assembled inside the stand frame.

Main Drive Mechanism:

The main drive gear motor assembly is mounted on the bottom side of the machine frame. It contains the main gear motor, main drive gearbox is coupled with the Muff coupling which drives the pinion shaft.

Conveyor Belt:

The conveyor is mounted on the top plate of the machine and the main purpose of the conveyor is to feed the duly stopper vial to the in-feed star wheel and to transfer the duly sealed vial either to the inspection machine. The conveyor is a 2” width S.S.304 material. Moving on a S.S. “C” type channel and its drive is taken from the pinion shaft chain wheel. A nylon chain sprocket is fitted at the two ends of the conveyor for driving the conveyor belt on the “C” channel. S.S. guides are provided on the conveyor to adjust according to the vial diameter and height.

Turret Assembly:

It is the main part of the machine, where actual sealing is going to be done. It is located at the center of the machine and it is made of aluminum casting. The turret has two parts one is an upper turret another is a lower turret; it is equipped with a chuck assembly, crimping roller assembly, and lifter assembly. Turrets will pick up the vial from the in-feed star wheel and sealing will be done and then again it will deliver the vial to the exit star wheel.

Star Wheel Clutch Assembly:

The star wheel is located at the top side of the machine and the star wheel clutch assembly is located below the top plate. Its application is to operate the clutch when there is jamming because of the over diameter of the vial. When the clutch is get operated. The micro switch, which is fitted below the clutch plate will be operated and the machine will be in the OFF position.

Feed Worm Clutch Assembly:

Feed worm clutch also does the same function as the star wheel clutch when the vial is oversized or vial falls on the conveyor during the movement.

Vibrator Assembly:

The vibrator assembly is located at the topmost position of the machine, it has having vibrator unit with a magnetic coil with spring steel vibrator strips to transfer the vibration to the cap bowl. The vibrator unit is covered with an SS 304 sheet. The vibrator bowl delivers the aluminium seal to the chute, which delivers the same to the exit end of the chute. Then vial will pick up the seal during the rotary movement of the vial with the infeed star wheel.

Lifter Assembly:  Lifter assembly is fitted on the lower turret. Which moves on the lifter cam provided at the top plate and bottom side of the lower turret. It picks up the vial from the infeed star wheel and holds it between the lifter bowl and chuck, And after sealing operation it delivers the vial to the exit star wheel.

Chuck Assembly: Chuck assembly is located at the upper turret. It has a chuck shaft; the spur gear mounted on the top of the shaft rotates the shaft for the sealing operation and the bottom side of the shaft has a sealing chuck, sealing chuck has a cap groove either for plain seal or for flip-off seal. 

Crimping Assembly:

The crimping assembly is located in the upper turret, it has a crimping cam and sealing roller block with roller. The crimping roller moves towards the vial neck with the help of the crimping cam, when the vial is held by a chuck and gradually pressure of the roller increase as it moves on the crimping cam, and sealing pressure can be adjusted by spring tension provision is provided in crimping block.

Equipment Details:

Equipment Name: Automatic Four-Head Vial Sealing Machine

Make: Make Name

Model No.: Modal No.

Capacity: 120 vials/Minute

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 Installation Qualification report.
5.2.4	Whichever column is blank or not used ‘NA’ shall be used.

5.3	INSTALLATION CHECKLIST:
5.3.1	Verification Of Major Components And Accessories.

Sr. NO.	STATEMENT	YES / NO	CHECKED BY(SIGN)	DATE
	Verify that the “As Built” drawing is complete and represents the design concept.
	Verify that major components are securely anchored and shockproof.
	Verify that there is no observable physical damage.
	Verify that there is sufficient room provided for servicing.
	All-access ports are examined and cleared of any debris.
	Equipment identification nameplate visible.
	Verify that all piping and electrical connections are done according to the drawings.
	Safe electrical connections are fitted.
	Wiring diagram affixed to inside section of the control panel.
	Units installed on the foundation are secure in place as per the manufacturer’s recommendations.
	Check the dimensions for the infeed conveyor: —– mm (L) X —–mm (W)
	Check the dimensions for the outfeed conveyor: —–mm (L) X —–mm (W)

5.4	IDENTIFICATION OF MAJOR COMPONENTS:
	Describe each critical component and check them and fill out the inspection checklist.

System Components	Design Specification	Complies / Does Not Comply	Checked By(Sign)	Date
Main Gear Box with Motor	Make: Make Name Model: Model Name Electric Motor: 0.5HP, 1Phase, 230VAC, 50Hz.
A.C. Frequency Drive	Make: Make Name H.P: 1.0
Fibre Optic Sensors	Make: Make Name Model: Model Name Voltage: 10-30 V DC.
Vibrator Controller	Make: Make Name Amp: 5 to 15 Amp.
Digital Counter	Make: Make Name Supply: 230 V A.C. Model: CT56G
Conveyor Gear Box with Motor	Make: Make Name Model: Model Name Motor: 0.25HP, 1Phase, 230V, 50Hz.
M.C.B. (Main & Drive)	Make: Make Name Supply: 230V ACNo. of pole: 2 pole A.M.P:16 (Main) & 6 (Drive)
Contactor (Main)	Make: Make Name A.M.P.: 30

System Components	Design Specification	Complies / Does Not Comply	Checked By(Sign)	Date
Contactor (Vibrator)	Make: Make Name Sr. No.: LC1D09A. M.P.: 25
Vibrator Relay	Make: Make Name Sr. No.:LRD10
On/Off Delay Timer	Make: Make Name EnterpriseVolt: 230V AC
Clutch Proxy	Make: Make Name Type: PNPSize: M12
Push Button, On/Off Actuator, Emergency Stop	Make: Make Name
% Speed Pot	Make: Make Name
Counting Sensor	Make: Make Name, Size: M12
Transformer	Make: Make Name EnterpriseA.M.P.: 1.5
Relay Card	Make: Make Name, Supply: 24V D.C.

5.5	VERIFICATION OF MATERIAL OF CONSTRUCTION:
	Verify the material of construction from test certificates.

Sr. No.	Component	MOC	Method Of Verification	Verified By (Sign)	Date
1.	Vibrator Bowl	SS 304	Visually with test certificate
2.	Vibrator Chute	SS 304	Visually with test certificate
3.	Star wheel and back guide set	Delrine/Hylum	Visually with test certificate
4.	Feed worm	Delrine/Nylon	Visually with test certificate

5.6	IDENTIFICATION OF SUPPORTING UTILITIES:

UTILITY	PROPERLY IDENTIFIED & CONNECTED (YES/NO)	CHECKED BY (SIGN)	DATE
1) Electricity: Specification: 415 VAC, 3 Ph. 50 Hz

5.7	IDENTIFICATION OF SAFETY AND INTERLOCK SYSTEM:
	Identify and record the safety and interlock features (if any) and their function in the following tables:

Name of the safety feature/interlock	Specified Function	Identified by (Sign.)	Date
Chute Fiber Optic sensor	Chute Sensor is fitted in the center of the chute, if the level of the seal goes below the sensor, then it gives a signal and makes the machine OFF.
Infeed, Outfeed star wheel, and feed worm clutch 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, the machine gets OFF.
No stopper on vial before sealing machine stop sensor	A sensor is fitted at the infeed end this sensor ensures that if there is no rubber stopper present on the vial then the machine will stop.

5.8		IDENTIFICATION OF STANDARD OPERATING PROCEDURE (SOP)
The following Standard Operating Procedures were identified as important for the effective performance of the Automatic Four Head Vial sealing Machine.
1.	Operation and cleaning of Automatic Four Head Vial sealing Machine
2.	Preventive maintenance of Automatic Four Head Vial sealing Machine

5.9	IDENTIFICATION OF COMPONENT TO BE CALIBRATED:

Sr.No.	Name of the Instrument	Location	Specification	Identified by (sign)	Date

5.10	VERIFICATION OF DRAWING AND DOCUMENTS:
The following documents are reviewed and attached as listed below:

Sr. No.	DRAWING AND DOCUMENT DETAIL	CHECKED BY (SIGN)	DATE

5.11	ABBREVIATIONS
The following Abbreviations are used in the installation qualification protocol for Automatic four-head Vial Sealing Machine.
P & I: Piping and instrumentation. VSM: Vial Sealing Machine.

5.12	DEFICIENCY AND CORRECTIVE ACTION (S) REPORT (S)
The following deficiency was identified and corrective actions were taken in consultation with the validation team.

Description of deficiency:

Corrective action(s) taken:

 Reviewed By:

 Date

5.13 Annexure(s):

Sr.No.	Annexure No.	Title of Annexure

6.0	INSTALLATION QUALIFICATION FINAL REPORT:

All the IQ data sheets and discrepancy reports shall be reviewed by the validation team to prepare a summary report. The summary of IQ shall be used to draw conclusion for approval of the installation qualification of the Automatic four-head Vial Sealing Machine report.

6.1	SUMMARY:
6.2	CONCLUSION:

6.3 FINAL REPORT APPROVAL

It has been verified that all tests required by the Automatic four-head Vial Sealing Machine protocol are completed, reconciled, and attached to this protocol or included in the qualification summary report. Verified that all amendments and discrepancies are documented, approved, and attached to this protocol.

The signature in the block below indicates that all items in this qualification report of the Automatic four head Vial Sealing Machine have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily resolved.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PROJECTS / ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE