VIAL WASHING MACHINE

January 27, 2024July 17, 2022 by Abha Maurya

VIAL WASHING MACHINE

An automatic rotary vial washing machine with an integral washing tank for recycled water, with multiple washing stations, is designed to clean the glass vials internally and externally with different washing media in six stages at the rated output of 120 vials per minute. Operation by the rotary travel system and Control through PLC.

Intensive 6-stage internal cleaning with multi-stage external cleaning
Surround interject cleaning of containers in continuous motion
Optimal and configurable media consumption
A sampling at various points
Quick changeovers
Special transportation of thin-walled & unstable containers
Synchronized with de-pyrogenating tunnels
HiJet Air management stations for water removal from containers before entry into the tunnel

Vials are fed onto an in-feed turntable from where they are transferred onto an infeed star wheel and delivered to a revolving conveying system consisting of 26 grippers equally spaced V-gripper are mounted on the circumference of the gripper ring which rotates around a vertical axis.

The horizontal rotation of the vial through 180 degrees during the infeed as well as the opening and closing of the grippers is cam controlled.

Vials are passed through the cleaning station upside down. At the individual station spray tubes travel is synchronism with vials then position the vials, with orifices exactly centered. The spray tubes follow the continuously moving grippers from start to the finish of a working station and retract. As long as spray tubes are inside the vials spraying with cleaning media takes place.

An automatic high-speed rotary vial washing machine is located in the Vial washing room for washing various types & sizes of vials.

Name of the Supplier: M/s. PETALS INNOVATIVE MACHINE Pvt. Ltd Mumbai/ Klenzaids Contamination
Controls Pvt. Ltd Mumbai.

The cleaning media is collected in the top plate and recirculated. The sequence of washing is as follows.

Station – 1: Internal & External recycled water.
Station – 2: Internal compressed air.
Station – 3: Internal Purified water.
Station – 4: Internal compressed air.
Station – 5: Internal WFI.
Station – 6: Internal & External Compressed air.

The vials are withdrawn in a process similar to the entry. The vials are reversed by 180^o up & engaged in the slots of an out-feed star wheel from where the vials are pushed back to back to the down line machine.

These washed vials are pushed via the dead plate of the vial washing machine onto the tunnel conveyor belt and get distributed evenly in the tunnel-drying zone.

The washed vials are covered under a Laminar airflow workstation fixed over the washing machine providing a class 100 environment thereby protecting the washed vials from particulate contamination from the environment.

To establish documented evidence that will provide a high degree of assurance and reliability about the performance of the ROTARY VIAL WASHING MACHINE.

Objective:

To verify the vial washing process is capable of consistently and reliably producing appropriate washing of different types of vials at different speeds encountered in the routine production operations.

The Vial washing process is capable of consistently and reliably removing

Any chemical traces that may present on the inner surface of the unwashed vials.
Particulate matter contaminants, such as dust, lint, fibers, etc.,
Endotoxins from endotoxins spiked vials
Soluble dye test (Ethylene blue test)
To establish washing cycle parameters under normal and worst-case conditions.

CHALLANGE TEST PROCEDURES

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

Estimation of washing media (Recycled water, Purified water, and WFI) consumption.
Procedure For Spiking of Vials
Preparation Procedure Of Particulate Matter Spiked Vials
Preparation Procedure Of Endotoxin Spiked Vials
Vial washing

Validation Matrix For Vial Washing

Run	SET OF PARAMETERS
Run	Set	Station-1 (RW)	Station-2, 4 & 6 (CA)	Station-3 (PW)	Station-5 WFI)
Run I	1	1.0 Kg/cm²	1.2 Kg/cm²	1.0 Kg/cm²	1.0 Kg/cm²
Run I	2	1.5 Kg/cm²	2.0 Kg/cm²	1.5 Kg/cm²	1.5 Kg/cm²
Run II	1	1.0 Kg/cm²	1.5 Kg/cm²	1.0 Kg/cm²	1.0 Kg/cm²
Run II	2	1.5 Kg/cm²	2.0 Kg/cm²	1.5 Kg/cm²	1.5 Kg/cm²
Run III	1	1.0 Kg/cm²	1.5 Kg/cm²	1.0 Kg/cm²	1.0 Kg/cm²
Run III	2	1.5 Kg/cm²	2.0 Kg/cm²	1.5 Kg/cm²	1.5 Kg/cm²

The above set parameters shall be selected keeping the machine speed as standard in three Runs and changing the other parameters (air pressure & Water pressure) to verify the performance of the washing machine at that particular speed against the simulated variables and the effect on the performance of the vial washing.

The same set parameters shall be verified at low (40 vials/minute), medium (80 vials/minute), and high speed (120 vials/minute) of the machine for each vial size used.

Estimation of washing media (Recycled water, Purified water, and WFI) consumption.

Tools required: Measuring cylinder, Beaker/Container & Silicon tubes

Test procedure:

Remove the nozzles from the stations.
Connect the silicone tubes to each nozzle.
Other ends of silicon tubes are placed into containers for water collection.
Ensure that the washing media is collected into the surge tanks of the vial washers.
Check and ensure the supply of compressed air.
Set the equipment as per the step mentioned in Validation Matrix For Vial Washing as required.
Operate the equipment as per the SOP without loading vials.
At each speed collect the water through silicon tubes into containers of respective, for 5 cycles/strokes of washing.
Measure the water by using a measuring cylinder.
Calculate the water consumption for each nozzle for each cycle of washing.
Record all the observations.

Acceptance Criteria:

Water consumption for each run should be within ± 10% of the average consumption of all three runs at the specified speeds.
Water & Compressed air pressures should indicate as per the set parameters.

Procedure For Spiking of Vials by Sodium Chloride

Preparation Procedure For Sodium Chloride Spiked Vials.

Chemicals required: Sodium Chloride, Dilute nitric acid & Silver Nitrate

Test procedure:

Prepare 150 ml of saturated sodium chloride solution.
Take 75 nos. previously washed vials of each size.
Mark the vials by numbering them with proper identification.
Add 0.5 ml of saturated sodium chloride solution in each vial.
Gently rotate each vial so that the total inner surface of the vials gets into contact with the solution.
Then load the spiked vials into an oven and dry them for 3 hours at 60- 70^{0 C}
After drying unload the vials and store them in an airtight container.
Collect at least 3 vials from the dried spiked vials and test each vial for the presence of sodium chloride by adding 1.0 ml of water for injection, sonicate, then add 1 ml of dilute nitric acid followed by the addition of 1ml silver nitrate solution TS and observe for opalescence.
The remaining 72 vials shall be used for the study.
Record the observations

Acceptance Criteria: All three vials should show opalescence.

Preparation Procedure Of Particulate Matter Spiked Vials

Chemicals required: 5 gm of standard dust

Test procedure:

Collect 100 ml of WFI in a 500 ml stoppered conical flask.
Add 0.5 gm of standard dust, which is previously passed through 100 mesh.
Sonicate well on a sonicator.
Take 75 nos. previously washed vials of each size.
Mark the vials by numbering them with proper identification.
Add 0.2 ml of the dust suspension to each vial.
Swirl each vial gently so that the particulate suspension is evenly distributed on the inner surface of each vial.
Dry the vials at 60-70⁰C to ensure that the spike dust adheres to the vials.
Take one vial and add 5 ml of water for injection.
Sonicate and add the solution thus obtained into a clean-stoppered conical flask. Rinse the vial several times to remove all the particulate matter adhered to the inner surface of the vial.
Makeup to 50 ml using water for injection previously estimated for the particulate matter (i.e. blank) using a liquid particle counter.
Subject the water for liquid particle counting as per respective SOP.
Repeat for two more vials for particulate matter estimation.
Estimate the particulate matter in the un-spiked vial.
The data generated shall be used for the estimation of the washing machine’s capacity to wash the vials when subjected to a standard washing cycle.
Send 72 no’s of the dried spiked vials of each size to the production department for conducting the study.
Record the observations.

Acceptance criteria

This procedure shall be considered acceptable when the vials when spiked with dust are having at least 7500 No. of particles per vial i.e. at least ten times more than the particulate level present on the normal unwashed vial to ensure that the vial washing process is capable of performing in worst-case conditions also.

Preparation Procedure Of Endotoxin Spiked Vials

Chemicals required: Endotoxin CSE

Test procedure:

Prepare Endotoxin spiked vials.
Mark the vials by numbering them with proper identification.
Record the observations.

Acceptance criteria

The spiked vial should contain 10000 EU.

Vial washing

Load details: Vials to be washed and spiked vials.

Test procedure:

Ensure that the vial washing machine was set with suitable change parts for the size of the vial under test.
Ensure that the washing media is collected into the surge tanks of the vial washers.
Check and ensure the supply of compressed air.
Set the parameter as per step Validation Matrix For Vial Washing.
Set the vial washer speed at minimum, medium, and maximum as required.
Switch on the vial washers for about 5 minutes to de-particulate the nozzles and the pipelines.
Verify and record the water for injection temperature and recirculation water temperature.
Also, record the machine speed in terms of vials per minute by calculating the number of strokes per minute.
Record washing time at each wash similarly.
Ensure that the working of the laminar airflow workstation.
Now load the spiked vials (sodium chloride/Particulate matter/Endotoxin) to be tested into the vial washer.
Allow the vials to wash and allow them to collect on the dead plate of the tunnel sterilizer.
Now carefully collect the washed vials into a previously cleaned and de-particulated closed container.
Transfer the washed spiked vials (sodium chloride/Particulate matter/Endotoxin) to Quality control for the estimation/identification of the spiking material/traces present in the washed vials if any.
Transfer 12 nos unspiked washed vials (sodium chloride/Particulate matter/Endotoxin) to Quality control for the estimation/identification of the spiking material/traces present in the washed vials if any.
Record the observation with Endotoxin details. Record the details of the Endotoxin test.
Repeat two more runs at the same speed (a total of three runs) to establish the consistency of the efficiency of the vial washing machine.
Repeat the same procedure for each speed specified above for each vial size used.

Acceptance criteria

No vial after being subjected to the washing cycle should show any opalescence when subjected to sodium chloride testing.
The normal unwashed vials and spiked vials (with particulate matter) after being subjected to the washing cycle should have a particle count of not more the 600 particles of 10µm and 60 particles of 25µm per washed vial.
Endotoxin spiked vials after being subjected to the washing cycle shall be tested and evaluated for information.

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 and submit this for review, approval, and authorization to Validation Core Team.

REQUALIFICATION CRITERIA

Requalification criteria are as follows

If the machine is subjected to any major maintenance, up-gradation, and/or modification/relocation 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 specification.
Periodic monitoring