Cartridge Filling Machine Performance Qualification, Purpose
[][]Cartridge Filling Machine Performance Qualification, The purpose of this protocol is to provide an outline for the Performance Qualification of Vial/Cartridge Filling Machine to:
[][]Demonstrate that the system performs as intended by repeatedly running the system on its intended schedules under normal operating conditions and worst-case conditions, where appropriate.
[][]To assess the machine capability to fill consistent volumes at maximum and minimum running speed.
[][]To verify the gliding force of filled cartridges.
[][]To ensure proper stoppering.
[][]To check the air bubble size with respect to glass bead size.
Cartridge Filling Machine Performance Qualification, Scope
[][]The aim of this qualification is to perform the performance qualification of the following machine. It is documented evidence that the machine installed properly and functions correctly in accordance with the desired specification as well as manufacturer’s information.
[][]It also certifies that the machine operates reliably and within prescribed or specified operating limit. This protocol covers the following machine:
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Responsibility
[][]Validation Dept.
Protocol preparation as per the guideline of Validation Master Plan
[][]Validation & Technical Expert*
Check & review of the protocol
[][]Head of Validation, QA, Engg., Plant
Approval of protocol prior to execution
[][]Validation team
M/C operation , testing and data processing
[][]Microbiology
Microbiology challenge test
[][]Validation Dept.
Preparation of report
[][]Validation & Technical Expert*
Check & review of the report
[][]Head of Validation/QA/Engg./Plant
Approval of the qualification report
[][]Director, Technical Operations
Authorization of the report
[][]Validation Dept.
Protocol preparation as per the guideline of Validation Master Plan
System and process Description
[][]The Cartridge filling and stoppering machine is used to fill and stopper the Cartridges. The machine consists of following parts:
[][]This line is a compact filling line with capacity to fill around 2500 cartridges/ hr. The cartridges are fed upright from a depyrogenation tunnel connected to upstream on to an in feed rotary table.
[][]There is a vibrator by which this table is vibrated continuously and guides the cartridges with various deflectors through infeed lanes into the filling portion. There is a sensor to detect fallen containers.
[][] If there is any fallen cartridge, it shows alarms on the display and the machine is stopped. If there are enough containers in the in feed tracks the container feed sensors at the in feed are actuated and infeed gates open. After coming through the in feed rotary screw the glass beads are inserted into the cartridges.
[][]There are two rotary piston pumps for transferring the filling media from vessel to the two filling nozzles. First nozzle is for filling half of the required volume and second one is for remaining half.
[][] There is a nozzle for sucking the access media at the 2nd filling nozzle. The filling volume is virtually proportional to the stroke of the piston pumps.
After filling, the flip off seals are attached at the top of the cartridges.
[][]There is a container for flip off seals and these are transferred by using the vibration. A proximity sensor detects the presence of flip off seals.
[][]The whole process occurs under a Laminar Air Flow Unit which ensures a clean area of Class A (ISO Class 5). The flow diagram of filling machine is as follows:
Tests To Be Performed and Planned
| SR./NO. | Test | Plan/Frequency |
|---|---|---|
| 01 | Consistency in fill volume at various speed | Consecutive 3 runs |
| 02 | Gliding force measurement for filled cartridges. | Consecutive 3 runs |
| 03 | To check the bubble size with respect to size of Glass beads. | Consecutive 3 runs |
| 04 | To check proper stoppering. | Consecutive 3 runs |
Test Details and Records
Consistency of Filled Volume
[][]The cartridge filling machine is started at a main drive motor speed of 100% and after 15 minutes 10 cartridges are collected to check the consistency of filled volume.
[][]The same procedure is repeated for 90% and 80% main drive motor speed.
[][]Result is recorded in the result sheet form.
Record of consistency of filled volume
| Cartridge Size | Run 1 Date: | Run 2 Date: | Run 3 Date: |
|---|---|---|---|
| No. of 3ml cartridges to fill at main drive motor speed of 100% | |||
| Average volume of 10 Cartridges at 15 Minutes after start | |||
| No. of 3ml cartridges to fill at main drive motor speed of 90% | |||
| Average volume of 10 Cartridges at 15 Minutes after start | |||
| No. of 3ml cartridges to fill at main drive motor speed of 80% | |||
| Average volume of 10 Cartridges at 15 Minutes after start |
Acceptance Criteria: The filled volume has to be within 3ml ± 0.3ml.
Gliding Force for Filled Cartridges
[][]10 cartridges are marked and loaded with the cartridges of total batch.
[][]After filling and stoppering 10 filled cartridges are collected at 15 minutes after starting the machine at a speed of 100% of main motor.
[][]The procedure is repeated twice by varying the speed to 90% and 80% of the main motor.
Record of Gliding Force for Filled Cartridges
| Run no. | Gliding Force Measuring Machine Specification | Date | Average Gliding Force (Newton) | Met Acceptance Criteria (Y/N) |
|---|---|---|---|---|
| 01 | ||||
| 02 | ||||
| 03 |
Acceptance Criteria: The gliding force has to be less than 20N.
Bubble Size
[][]In each run 20 cartridges are collected to visually check the presence of glass beads and the bubble size with respect to glass bead size.
[][]Result of checking bubble size
| Run no. | Date | Glass bead present (Y/N) | Bubble present (Y/N) | Bubble size is smaller than glass bead size (Y/N) | Percentage of rejected cartridges |
|---|---|---|---|---|---|
Check of Stoppering
In each run 20 cartridges are collected to visually check the stoppering.
Result of checking stoppering
| Run no. | Date | No. of properly stroppered cartridges | No. of not properly stroppered cartridges | Percentage of rejected cartridges |
|---|---|---|---|---|
Acceptance Criteria: The number of rejected cartridges has to be less than 10%.
[][]List of Reference Involved in Validation Study
[][]Details Of Attachments To Validation Report
Report Summary
The Performance Qualification study for Vial/Cartridge Filling machine was carried out for 3 consecutive date and following result summary was obtained.
| No. | Tests | Acceptance limits | Run 1 Passed (Y/N) | Run 2 Passed (Y/N) | Run 3 Passed (Y/N) |
|---|---|---|---|---|---|
| Consistency in fill volume at various speed | NMT 0.3ml Variation from adjusted Limit | ||||
| Gliding force for filled cartridges | Gliding Force for filled cartridges has to be less than 20 Newton. | ||||
| Bubble Size | Bubble size has to be less than glass beads size. | ||||
| Proper Stoppering | 99% Complies |
[][]The Result of this Performance Qualification study was recorded, summarized and analyzed. The observed parameters/tests and subsequent analytical results show that the cartridge filling machine perform as per predetermined acceptance criteria. Hence, the machine successfully qualifies the performance Qualification test.
Conclusion
[][]The performance qualification complies with the acceptance criteria taken above and the results obtained are attached to the protocol.
[][]Vial/Cartridge Filling Machine bearing Equipment ID No. ……….………….Is / Is Not qualifying the Performance Qualification test as per the guideline described in this Protocol No. ————- and Can Be / Cannot Be use for production.
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Performance Qualification of Cartridge Filling Machine Protocol