Vial Filling Machine Performance Qualification, Purpose
[][] Vial Filling Machine Performance Qualification, The purpose of this protocol is to provide an outline for the Performance Qualification of Vial/Vial 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 various running speed.
=>To check the stoppering of vials.
=>To check the presence of any particulate matter visually.
Vial 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:
=>Equipment Name
=>Machine No.
=>Location
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Responsibility
[][]Protocol preparation as per the guideline of Validation Master Plan
=>Validation Dept.
[][]Check & review of the protocol
=>Validation & Technical Expert*
[][]Approval of protocol prior to execution
=>Head of Validation, QA, Engg., Plant
[][]M/C operation , testing and data processing
=>Validation team
[][]Microbiology challenge test
=>Microbiology
[][]Preparation of report
=>Validation Dept.
[][]Check & review of the report
=>Validation & Technical Expert*
[][]Approval of the qualification report
=>Head of Validation/QA/Engg./Plant
[][]Authorization of the report
=>Director, Technical Operations
[][]Protocol preparation as per the guideline of Validation Master Plan
=>Validation Dept.
System and process Description
The Vial filling and stoppering machine is used to fill and stopper the vials. The machine consists of following parts:
Line 1:
[][]This line is a compact filling line with capacity to fill around 6000 Vials/ hr. This machine can fill from 0.3 ml to 2.1 ml. In brief its function is as follows:
[][]The vials are fed upright from a depyrogenation tunnel connected to upstream on to an in feed rotary table.
[][]This table rotates continuously and guides the vials with various deflectors through two infeed lanes into the walking beam transport system.
[][]There are two sensors attached in each lane to detect fallen containers, which after detection goes to bin.
[][]These containers are stopped by two infeed gates.
[][]If there are enough containers in the in feed tracks the container feed sensors at the in feed are actuated and infeed gates open.
[][]The walking beam advances the containers intermittently to various work station where two containers are processed at each machine cycle as per following sequence:
Nitrogen flushing=>Filling=>Nitrogen flushing =>Stoppering=>Discharge=>stopper Checking =>Visual Inspection=>Confirmation
Machine consists of following parts:.
Infeed Rotary Table —
[][]The containers are placed upright on the infeed rotary table by the machine upstream- The containers are conveyed continuously until they are stopped by infeed gates.
[][]There is ultrasonic sensor on table which detects Quantity of containers on the table.
[][]If too many containers accumulate on table then sensor give message to tunnel to reduce the speed of tunnel automatically.
[][]When Quantity is reduced , automatically tunnel increase its speed.
Container feed tracks and monitoring –
[][]The containers from above table are feed into two tracks, where they pass an outlet in the rim of table where fallen containers roll out into a bin beneath the rotary table.
[][]A sensor is located in each feed track. If the container supply in one of the track is very much low , then infeed gates closes, so no further container enter the machine from this track.
[][]When the supply replenish the gates reopen.
Infeed gates
[][]The containers arriving in the infeed tracks are stopped by the infeed gates and are prevented from entering the walking beam.
[][]When the infeed gates are switched on at the operating panel, each gate opens to let containers into transport system provided that the respective container feed sensor detect sufficient containers in the track.
Container Registration sensor
[][]This detect the containers in walking beam and transform information to machine cycle to start the process.
[][]If no container is detected then work station is blocked automatically.
Walking beam transport System –
[][]This system transport the vials through the machine.
[][]They are conveyed upright on a base guide between walking beam and the counterguide.
[][]This walking beam consist of two parts : one part centers the vials and the other one transport them.
Liquid dosing unit –
[][]The product is filled by 2(two) rotary piston pump. The amount dispensed is virtually proportional to the pump stroke.
[][]As the pump piston rise. Product is drawn from the manifold to the pump via hoses.
[][]The piston then turns through 180°, so that the grooves are directed towards the filling needle.
[][]As the pistons are lowered, the product is discharged through dosing hoses and filling needle in to the vials.
[][]This dose can be adjusted by altering the pump stroke.
Gas-flushing Equipment –
[][]Two needles for pre flushing and two needle for post flushing are provided in this system.
[][]The gas flushing needles are lowered in containers with the filling needle movement and flush the container interior with 0.2µ filtered Nitrogen, thereby displacing the ambient air from the container.
Stopper insertion station –
[][]At this station the rubber stoppers are placed on the neck of containers and then pressed in.
[][]The vacuum required for the insertion station is provided by inbuilt vacuum pump.
[][]This station consists of Stopper feed, sorting bowl filling level monitor, Feed track monitoring, stopper check sensors, discharge wheel and tray loading unit.
Line-2:
[][]This line is a compact filling line with capacity to fill around 12000 ampoules/ hr. It has ampoule sealing machine also. This machine can fill from 0.3 ml to 2.1ml. In brief its function is as follows:
[][]The Ampoules are fed upright from a Depyrogenation tunnel connected to upstream on to a in feed belt.
[][]At the end of belt the ampoules are picked by the feed scroll, spaced by the recesses of the scroll and pushed into the individual transport recesses around the periphery of star wheel.
[][]The star wheel conveys the ampoules in a continuous movement and present to individual work stations.
[][]The rotation discs located at the work stations rotate the ampoules during all the work process to ensure smooth functioning of each step.
[][]All the work stations move forward synchronously with the containers during ampoule processing and swivel back to initial position after end of process.
[][]Four ampoules are processed at each machine cycle with following sequence:
Nitrogen flushing=> Filling =>Nitrogen flushing =>Heating of tips of Ampoules =>Sealing by Fusing =>Pulling of Ampoule tips=>Discharge
Machine consist of following parts:.
Infeed belt
[][]The containers are placed upright on the infeed belt by the machine upstream.
[][]If too many containers accumulate on belt then sensor give message to tunnel to reduce the speed of tunnel automatically.
[][]When Quantity is reduced, automatically tunnel increase its speed.
[][]If no container arrive from tunnel, then infeed scroll of AFV stops, preventing any further ampoules from entering the star wheel.
Container Registration sensor
[][]Before each transport recess on the star wheel reaches the first work station, a light sensor checks for the presence of Ampoule.
[][]If ampoule is detected, the pulse emitted by the photoelectric sensor is memorized in electronic control and this information is transferred for running all machine cycles.
[][]If no ampoule is detected then work stations are blocked automatically..
Liquid dosing unit
[][]The product is filled by 4(Four) rotary piston pump. The amount dispensed is virtually proportional to the pump stroke. As the pump piston rise.
[][]Product is drawn from the manifold to the pump via hoses.
[][]The piston then turns through 180°, so that the grooves are directed towards the filling needle.
[][]As the pistons are lowered, the product is discharged through dosing hoses and filling needles in the ampoules.
[][]This dose can be adjusted by altering the pump stroke.
Gas-flushing Equipment
[][]Four needles for pre flushing and Four needle for post flushing are provided in this system.
[][]The gas flushing needles are lowered in Ampoules with the filling needle movement and flush inside the Ampoule interior with 0.2µ filtered Nitrogen, thereby displacing the ambient air from the Ampoule.
Line 3 :
[][]This line is a compact filling line with capacity to fill around 6000 vials/ hr.
[][]It is also set for full stoppering as this line is only for liquid filling.
[][]This machine can fill from 0.3 ml to 2.1 ml. This machine is same as line 1.
Line 4:
[][]This line is a standalone filling line with capacity to fill around 6000 vials/ hr.
[][]It is also set for full stoppering as this line is for liquid filling.
[][]This machine can fill from 0.7 ml to 5.5 ml and 8 ml to 50 ml.
[][]In this machine the vials are sterilized in Dry Heat sterilizer in trays and are feed manually to machine.
Tests To Be Performed and Planned
| Sl.No | Test | Plan/Frequency |
|---|---|---|
| 01 | Consistency in fill volume at various speed | Consecutive 3 runs |
| 02 | Proper Stoppering | Consecutive 3 runs |
| 03 | Check of presence of any particulate matter | Consecutive 3 runs |
Test Details and Records
Consistency of Filled Volume
[][]The vial filling machine is started at a main drive motor speed of 100% and after 15 minutes 10 vials 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
=>Media used for filling
=>Vial Size
| Particulars | Run 1 Date: | Run 2 Date: | Run 3 Date: |
|---|---|---|---|
| No. of 3ml vials to fill at main drive motor speed of 100% | |||
| Average volume of 10 Vials at 15 Minutes after start | |||
| No. of 3ml vials to fill at main drive motor speed of 90% | |||
| Average volume of 10 Vials at 15 Minutes after start | |||
| No. of 3ml vials to fill at main drive motor speed of 80% | |||
| Average volume of 10 Vials at 15 Minutes after start |
Acceptance Criteria: The filled volume has to be within 10ml ± 0.5ml.
Check of Stoppering
[][]In each run 20 vials are collected to visually check the stoppering.
Result of checking stoppering
| Run no. | Date | No. of properly stroppered vials | No. of not properly stroppered vials | Percentage of rejected vials |
|---|---|---|---|---|
Acceptance Criteria: The number of rejected vials has to be less than 1.0%.
Check of presence of any particulate matter
[][]In each run 20 vials are collected to check the presence of any visible particulate matter.
Result of checking presence of any particulate matter
| Run no. | Date | No. of total filled vials | No. of rejected vials | Percentage of rejected vials |
|---|---|---|---|---|
[][]Acceptance Criteria: The number of rejected vials has to be less than 1.0%.
Report Summary
[][]The Performance Qualification study for Vial/Vial 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) |
|---|---|---|---|---|---|
| 01 | Consistency in fill volume at various speed | NMT 0.5ml Variation from adjusted Limit | |||
| 02 | Proper Stoppering | 99% Complies | |||
| 03 | Check of presence of any particulate matter. | 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 vial 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/Vial 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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Vial Filling Machine Performance Qualification Protocol