Performance Qualification Protocol Vial sealing machine

Vial sealing machine

Vial sealing machine is installed in vial sealing room. The main action of vial sealing machine vials are accumulated on the turntable at the infeed of the machine and are carried towards the machine by a slats conveyor. A worm separates the vials are transfers them onto infeed star wheel. Vials and caps are accurately positioned by means of centering device. The crimping process is carried out gradually during the transport of the vials through the machine. Cam driven crimping process ensures proper synchronization between the crimping tool and vial. After the capping process is complete, vials are discharged by a star wheel and transferred in to inspection. Change over to different sizes of vials or flange caps (Seals) are affected by exchanging complete set of change parts.

Performance Qualification Protocol Vial sealing machine

OBJECTIVE

To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the Vial sealing Machine.

To demonstrate that the equipment / system is performing reproducibly and consistently within its operating range of operation and suitable for sealing of the different type of vials when operated as per standard operating procedure.

To demonstrate that the vial sealing process is capable of consistently and reliably producing appropriate sealing of the vials with flip off seals on different types of vials at different speeds encountered in the routine production operations.

To assure container integrity of the filled and sealed vials at different speeds with different sets of vials.

SCOPE

The scope of this protocol is limited to carry out the performance Qualification of Vial sealing Machine located in the Vial Sealing Room.

To be performed after the completion and authorization of Operational Qualification.

To be performed at the time of relocation or Re-qualification.

RESPONSIBILITIES AND IDENTIFICATION OF EXECUTION TEAM

Responsibilities: The group comprising of representatives from each of the following departments shall be responsible for the overall compliance with this protocol.

Department Responsibility
Production Execute the validation activity & provide necessary support
Engineering & Utility Participate & provide necessary support for the validation activity
Quality Control Testing of samples as per the test procedures
Quality Assurance Monitoring, sampling & reviewing the validation activities.

Identification of Executors: The personnel involved in the execution of this protocol shall be recorded- Name, Designation, Signature and Date.

TEST PROCEDURES

Following test procedures are followed to qualify the equipment for its performance.

Dye Ingress Method (Dye Inside Vial)

Material required: 5% Methylene blue solution, Vials, Rubber stoppers and seals.

Test Procedure:

The sterilized and depyrogenated vials (as required) are obtained on the scrambler of the vial-filling machine from the sterilizing tunnel.

The rubber stoppers (suitable to vial size) are obtained from the Steam sterilizer are charged into the respective hopper.

The vial size to be validated shall be decided based on the minimum, medium and maximum vial size, so as to get the effect of sealing integrity with different sizes of rubber stoppers / Aluminum seals, as there under.

Prepare 1 L of 5% Methylene Blue solution in WFI (DW) in a glass jar. Filter the solution through 0.2-micron filter to take it to the filling room. Connect the jar to the liquid filling assembly to fill required quantity of dye solution in each vial.

Operate the filling machine to fill the Methylene blue solution in the vial and to stopper with sterilized rubber stopper.

Required machine parts are assembled on the vial sealing machine.

Charge the required seals in to seal hopper of the sealing machine.

Filled and stoppered vials obtain on the scrambler of the Vial Sealing Machine from Vial Filling Machine.

Operate the sealing machine as per the standard operating procedure.

Sealing machine is operated as per the standard operating procedure at three different speeds i.e 40, 80 and 120 vials per minute.

At each speed collect 3 sets of 8 vials and test for Seal Integrity.

Follow the above procedure for each vial size and seal type used.

Dye Egress Method (Dye Outside Vial)

Material required: WFI water, Vials, Rubber stoppers and seals.

Test Procedure

The sterilized and depyrogenated vials (as required) are obtained on the scrambler of the vial-filling machine from the sterilizing tunnel.

The rubber stoppers (suitable to vial size) are obtained from the Steam sterilizer are charged into the respective hopper.

The vial size to be validated shall be decided based on the minimum, medium and maximum vial size, so as to get the effect of sealing integrity with different sizes of rubber stoppers / Aluminum seals, as there under.

Collect WFI water in vessel. Connect the vessel to the liquid filling assembly to fill required quantity of water in each vial.

Operate the filling machine to fill the WFI water in the vial and to stopper with sterilized rubber stopper.

Required machine parts are assembled on the Vial sealing machine.

Charge the required seals in to seal hopper of the sealing machine.

Filled and stoppered vials obtain on the scrambler of the Vial Sealing Machine from Vial Filling Machine.

Operate the sealing machine as per the standard operating procedure.

Sealing machine is operated as per the standard operating procedure at three different speeds i.e 40, 80 and 120 vials per minute.

At each speed collect 3 sets of 8 vials and test for Seal Integrity.

Follow the above procedure for each vial size and seal type used.

Acceptance criteria

Seal integrity test should comply.

No leak shall be observed in any vial.

No crack, damages on vials should found during sealing operation.

RECORDING OF OBSERVATIONS

Record the Equipment operation details after execution of each test procedures in the annexure – 1 (Recording of Observations For Performance Qualification).

Entry of Seal integrity test observations shall be followed.

DISCREPANCY AND CORRECTIVE ACTION REPORT

Document any discrepancies observed during the Performance qualification of the equipment in annexure -1. Include the corrective actions of the same. When all the discrepancies are satisfactorily resolved or an approved action plan is developed which ensures that the discrepancy will be resolved.

COMPILATION, REVIEW AND SUMMARY REPORT

Compile and review that all test procedures have been completed, reconciled and attached to this protocol. Verify that the approvals for deviations have been taken and are resolved appropriately to the satisfaction.

Performance Qualification shall be considered acceptable when all the conditions specified in the test procedures have been met.

Prepare the summary report and submit this for review, approval and authorization to Validation Core Team.

Annexure 1 (Recording Of Observations For Performance Qualification)

Details Of Operational Qualification Report : Report No./Date Of Authorization

Identification Of The Executors / Dye Ingress Method

EQUIPMENT OPERATION DETAILS
Vial size
Machine Set by name
Date of Vial Sealing
Type of Aluminum seal used
Number of Vials sealed / minute at Minimum, Medium and Maximum speed Medium speed (__________) Maximum speed (_______)
Sealing From
To
INSPECTION OF SEALED VIAL FOR DEFECTS
Speed Defects
Sealing defects Cracks /Vial damages Any other defects
Minimum speed (__________)
Medium speed  (___________)
Maximum speed(_________)

Dye Egress Method

VIAL SEALING RECORD – DYE EGRESS METHOD
Vial size
Machine Set by name
Date of Vial Sealing
Type of Aluminum seal used
Number of Vials sealed / minute at Minimum, Medium and Maximum speed Minimum speed (__________) Medium speed  (__________) Maximum speed (________)
Sealing From
To
INSPECTION OF SEALED VIAL FOR DEFECTS
Speed Defects
Sealing defects Cracks /Vial damages Any other defects
Minimum speed (__________)
Medium speed  (__________)
Maximum speed (__________)

REQUALIFICATION CRITERIA

Requalification criteria is as follows

  • If the machine is subjected for any major maintenance, up-gradation and/or modification that could directly or indirectly affect equipment performance and product quality.
  • Any change in the cleaning procedure and/or washing cycle.
  • Any change in the Vial, rubber stopper and Fip Off seal specification.
  • Major change/ modification in the facility
  • Relocation of the equipment.

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