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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:

Installation Qualification Protocol for Automatic four head Vial Sealing Machine
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
5.0INSTALLATION QUALIFICATION PROCEDURE
5.1System Description
5.2Instruction for Filling the Checklist
5.3Installation Check-List
5.4Identification of Major Components
5.5Verification of Material of Construction
5.6Identification of Supporting Utilities
5.7Identification of Safety And Interlock System
5.8Identification of Standard Operating Procedure (SOP)
5.9Identification of component to be calibrated
5.10Verification of Drawings and Documents
5.11Abbreviations
5.12Deficiency And Corrective Action(s) Report(s)
5.13Annexure(s)
6.0INSTALLATION QUALIFICATION FINAL REPORT
6.1Summary
6.2Conclusion
6.3Final report approval

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

1.0PROTOCOL 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:

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 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.
2.2PURPOSE: 
 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.
2.3SCOPE: 
 This Protocol is applicable to the installation of an Automatic four-head Vial Sealing Machine at the tablet manufacturing facility XYZ Pharmaceutical.
2.4RESPONSIBILITY: 
 The following shall be responsible:
Department Head: Write their Responsibilities.
2.5EXECUTION 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:
DEPARTMENTDESIGNATIONNAMESIGNATUREDATE
PROJECTS/ ENGINEERING    
PRODUCTION    
QUALITY ASSURANCE    
3.0ACCEPTANCE CRITERIA:
3.1The equipment shall fulfill all the selection criteria and its individual application
3.2The equipment shall comply with the specification mentioned in the user requirement specification.
3.3It shall be complying with all the designed specifications.
3.4The Material Of Construction (MOC) shall comply with the specification.
3.5All supporting electric and non-electric utilities of specified capacities are to be near the place of installation.
4.0REVALIDATION 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.
5.0INSTALLATION QUALIFICATION PROCEDURE: 
5.1SYSTEM 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

5.2INSTRUCTION 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 Installation Qualification report.
5.2.4Whichever column is blank or not used ‘NA’ shall be used.
5.3INSTALLATION CHECKLIST:
5.3.1Verification Of Major Components And Accessories.
Sr. NO.STATEMENTYES / NOCHECKED 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)   
5.4IDENTIFICATION OF MAJOR COMPONENTS:
 Describe each critical component and check them and fill out the inspection checklist.
System ComponentsDesign SpecificationComplies / Does Not ComplyChecked By(Sign)Date
Main Gear Box with MotorMake: Make Name
Model: Model Name
Electric Motor: 0.5HP, 1Phase, 230VAC, 50Hz.
A.C. Frequency DriveMake: Make Name
H.P: 1.0
Fibre Optic SensorsMake: Make Name
Model: Model Name
Voltage: 10-30 V DC.
Vibrator ControllerMake: Make Name
Amp: 5 to 15 Amp.
Digital CounterMake: Make Name
Supply: 230 V A.C.
Model: CT56G
Conveyor Gear Box with MotorMake: 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 ComponentsDesign SpecificationComplies / Does Not ComplyChecked By(Sign)Date
Contactor (Vibrator)Make: Make Name
Sr. No.: LC1D09A.
M.P.: 25
   
Vibrator RelayMake: Make Name
Sr. No.:LRD10
   
On/Off Delay TimerMake: Make Name
EnterpriseVolt: 230V AC
   
Clutch ProxyMake: Make Name
Type: PNPSize: M12
   
Push Button, On/Off Actuator, Emergency StopMake: Make Name   
% Speed PotMake: Make Name   
Counting SensorMake: Make Name, Size: M12   
TransformerMake: Make Name EnterpriseA.M.P.: 1.5   
Relay CardMake: Make Name, Supply: 24V D.C.   
5.5VERIFICATION OF MATERIAL OF CONSTRUCTION:
 Verify the material of construction from test certificates.
Sr. No.ComponentMOCMethod Of VerificationVerified By (Sign)Date
1.Vibrator BowlSS 304Visually with test certificate  
2.Vibrator ChuteSS 304Visually with test certificate  
3.Star wheel and back guide setDelrine/HylumVisually with test certificate  
4.Feed wormDelrine/NylonVisually with test certificate  
5.6IDENTIFICATION OF SUPPORTING UTILITIES:
UTILITYPROPERLY IDENTIFIED & CONNECTED (YES/NO)CHECKED BY (SIGN)DATE
1) Electricity: Specification: 415 VAC, 3 Ph. 50 Hz   
5.7IDENTIFICATION 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/interlockSpecified FunctionIdentified by (Sign.)Date
Chute Fiber Optic sensorChute 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 switchIf 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 sensorA 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.  
5.8IDENTIFICATION 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
5.9IDENTIFICATION OF COMPONENT TO BE CALIBRATED:
Sr.No.Name of the InstrumentLocationSpecificationIdentified by (sign)Date
      
      
      
      
5.10VERIFICATION OF DRAWING AND DOCUMENTS:
The following documents are reviewed and attached as listed below:
Sr. No.DRAWING AND DOCUMENT DETAILCHECKED 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.
5.12DEFICIENCY 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.
6.1SUMMARY:
 
 
 
 
 
 
 
6.2CONCLUSION:
 
 
 
 
 
 
 

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.

NAMEDESIGNATIONDEPARTMENTSIGNATUREDATE
  PROJECTS / ENGINEERING  
  PRODUCTION  
  QUALITY ASSURANCE  
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