Performance Qualification Protocol for Vial Filling Machine

Vial Filling Machine

Automatic single Head Injectable Powder Filling Machine is a compact versatile machine. The Machine is precision built on sturdy welded frame of S.S. 304 completely enclosed in stainless steel sheet. This machine can be used to fill sterile powder in vials received from the Sterilizing tunnel. Then vial will be transferred to the next operation of Rubber Stoppering and transferred to sealing. This Machine will handle glass vials ranging from 5 ml to 20 ml. Vial filling machine is installed in vial filling room.

Powder Filling Unit:

Powder from the powder hopper, will be sucked by the powder wheel, which is located just below the powder hopper. The powder wheel will be having a continuous vacuum suction, which sucks the powder from the powder hopper to the predetermined level of the piston length and then the doctor blade inside the powder hopper will doctor off excess powder. During the indexing movement of the powder wheel powder will be held by the vacuum till powder-filling port comes just above the vial. The vial sensor will sense the vial and it passes the signal to the solenoid valve and vacuum will get off and the compressed gas will flush the powder into the vial. During the filling operation vial will be held to the position by the vial separators. To achieve filling into 5ml to 20ml vials. If required single vial can also be filled with multiple doses to get the desired fill weight. Then vial further moves on conveyor for rubber stoppering operation.

Media Filling Unit:

Media filling unit is required for process simulation study, which works on the basic principal of simple piston mechanism. Media will be sucked from the liquid media holding tank with the aid of the syringe during the down ward movement of the piston. And it delivers the liquid media during its upward movement into the vial. The bottom end of the syringe is fitted with eccentric shaft. The provided mechanical setting will vary its volume. The volume of the deliverable media will be from 4ml to 80ml.

Rubber Stoppering Unit:

The filled vials will be held with the aid of gripper belts at rubber-stoppering station. The rubber stoppers from the vibratory bowl will be dispensed through chute. and places stopper on the vials. No rubber stopper – machine stop and no vial -no rubber stopper – machine stop, mechanism will ensure perfect closing of the vial on – line.

Pre And Post Gassing Mechanism:

The filling machine will be provided with appropriate pre and post gassing mechanism to provide inert environment in the empty vial as well as in the powder filled vial to avoid degradation as per the product requirement.

Performance Qualification Protocol for Vial Filling Machine

OBJECTIVE

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

To Demonstrate that the equipment / system is performing reproducibly and consistently within its operating range of operation and fill weight according to manufacturers specifications.

SCOPE

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

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

To be performed at the time of relocation or Requalification.

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 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.

Qualification Matrix

Six fill weights are selected ranging from minimum to maximum based on the product list proposed (used in production) to evaluate the performance range of the filling machine. Fill weight, Fill volume, Vial size and Rubber stoppers are mentioned in the table below.

Vial Size Target Fill Weight in mg Machine Speed Rubber stopper
5 ml 125 Minimum 20 mm

Bromo Butyl

Medium
Maximum
250 Minimum
Medium
Maximum
10 ml 500 Minimum
Medium
Maximum
1000 Minimum
Medium
Maximum
20 ml 2000 Minimum
Medium
Maximum
3000 Minimum
Medium
Maximum

The drug considered for filling machine performance qualification is Calcium Carbonate.

Before Tap density 0.43gm/cc

After Tap density 0.55gm/cc

It is worthy that the other Cephalosporins, which will be filled by machine, would also be in the similar range of Bulk Density.

Verification Of The Impact Of Machine Speed On The Fill Weight

Tools required: Change parts, Analytical balance.

Material required: Calcium Carbonate, Vials & Rubber stoppers as required.

Test procedure:

Required machine parts are assembled on the vial filling and stoppering machine.

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

Indent and receive the Calcium Carbonate and charged into the respective hopper.

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

The Calcium Carbonate is filled into the vials as per the fill weight criteria (Refer qualification matrix).

Operate the machine as per the SOP and adjust the Vacuum and Nitrogen gas pressures as required.

For each fill weight, machine shall be operated at three different speeds i.e minimum, medium and maximum and at each speed for a period of 10 minutes.

Collect 20 vials at initial, middle and at the end of the filling operation of the particular speed and test for physical parameters such as Appearance, Weight variation, Average weight and Rubber stopper fixing.

Follow the above procedure for each vial size as per the qualification matrix.

Verification Of The Impact Of Powder Level In The Hopper On Fill Weight.

Tools required: Change parts, Analytical balance.

Material required: Calcium Carbonate, Vials & Rubber stoppers as required.

Test procedure:

This study can be performed during above trials by checking the powder level in the hopper. Or

Filling will be carried out at three different levels i.e Full, Half and 1/4th level of powder in the hopper at normal operating range (i.e 80 – 100 vials/minute).

Collect 3 sets of vials at each level and test for physical parameters such as Appearance, Weight variation, Average weight and Rubber stopper fixing.

Follow the above procedure for each vial size as per the qualification matrix.

Acceptance criteria

Powder spillage should not be found during filling.

No vial should damage.

Weight variation :± 5% of target fill weight

Average weight :± 2% of target fill weight

Rubber stoppers should be fixed properly to the vials.

RECORDING OF OBSERVATIONS

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

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 functions 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 in the annexure –2 (Performance Qualification Report) and submit this for review, approval and authorization to Validation Core Team.

References

  • Annexure (Recording Of Observations For Performance Qualification)

Details Of Operational Qualification Report

Verification Of The Impact Of Machine Speed On The Fill Weight.

Vial size 5 ml

Type & Size of Rubber stopper used

Number of Vials sealed / minute at Minimum, Medium and Maximum speed.

Date of Vial Filling & Stoppering ,Details of Filling & Stoppering

Target Fill Weight :125 mg

INSPECTION OF FILLED & STOPPERED VIALS FOR DEFECTS

Defects :Spillages, Cracks /Vial damages , Any other defects

WEIGHT VARIATION

Acceptance Criteria for 125 mg  Average Fill in 5 ml:

1. Uniformity of Weight ± 5 % of average weight

2. Average weight ± 2 % of target fill weight (122.5 to 127.5 mg)

Acceptance Criteria for 250 mg Average Fill in 5 ml:

1. Uniformity of Weight ± 5 % of average weight

2. Average weight ± 2 % of target fill weight (490.00 to 510.00 mg)

Acceptance Criteria for 1000 mg Average Fill in10 ml:

1. Uniformity of Weight ± 5 % of average weight

2. Average weight ± 2 % of target fill weight (1960.00 to 2040.00 mg)

Vial Size :5 ml ,Target Fill weight :125 mg ,250 mg

Vial size : 10  ,ml ,Target Fill Weight : 1000 mg

Vial size : 20  ,ml ,Target Fill Weight : 2000 mg

Vial size : 20  ,ml ,Target Fill Weight : 3000 mg

Vial No. , Weight in mg ,Minimum Speed (Initial ,Middle, End ) ,Medium Speed (Initial ,Middle, End ),Maximum Speed (Initial ,Middle, End ).

Verification Of The Impact Of Powder Level In The Hopper On Fill Weight

WEIGHT VARIATION : Hopper Full ,Hopper Half, Hopper 1/4th

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 fill weight and equipment performance.

Any change in the fill weight range , vial and rubber stopper specification

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