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Performance Qualification Protocol. Vial washing machine

  • OBJECTIVE
  • To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the VERTICAL ROTARY VIAL WASHING MACHINE.
  • 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 inner surface of the unwashed vials.
  • Particulate matter contaminants, such as dust, lint, fibres etc.,
  • Endotoxins from endotoxins spiked vials
  • Soluble dye test (Ethylene blue test)
  • To establish washing cycle parameters under normal and worst-case conditions.
  • SCOPE
  • The scope of this protocol is limited to carry out the performance qualification of Automatic high-speed Vertical Rotary vial washing machine located in the Vial washing room of injectable section.
  • To be performed after the completion and authorization of Operational Qualification.
  • To be performed at the time of relocation or Requalification.
  • Abbreviations and definitions
    Abbreviation Definitions
    PQP Performance Qualification Protocol
    SOP Standard Operating Procedure
    QA Quality Assurance
    QC Quality Control
    NA Not Applicable
    No. Number
    µm Micro Meter
    ºC Degree Celsius
  • EQUIPMENT DESCRIPTION
  • Equipment Identification
  • The subjected equipment is identified as: Vial washing machine
  • Automatic high-speed rotary vial washing machine is located in Vial washing room for washing various types & sizes of vials.
  • Automatic rotary vial washing machine with 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.
  • Vials are fed on to an in feed turntable from where they are transferred on to an infeed star wheel and delivered to a revolving conveying system consisting of 26 gripper 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 degree 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 positions 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.
  • The cleaning media is collected in the top plate and recirculated. The sequence of washing 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 180o 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 gets distributed evenly in the tunnel-drying zone.
  • The washed vials are covered under Laminar airflow workstation fixed over the washing machine providing a class 100 environment there by protecting the washed vials from the particulate contamination from the environment.
  • Area description
  • Entry into the Vial washing room/ area is restricted to authorize personnel only and there is a requirement of protective gowning to enter into the room.
  • 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 respective 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.
  • Validation Matrix For Vial Washing
Run  SET OF PARAMETERS
Set Station-1 (RW) Station-2, 4 & 6 (CA) Station-3 (PW) Station-5 WFI)
Run-1 1 1.0 Kg/cm2 1.5 Kg/cm2 1.0 Kg/cm2 1.0 Kg/cm2
2 1.5 Kg/cm2 2.0 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2
Run-2 1 1.0 Kg/cm2 1.5 Kg/cm2 1.0 Kg/cm2 1.0 Kg/cm2
2 1.5 Kg/cm2 2.0 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2
Run-3 1 1.0 Kg/cm2 1.5 Kg/cm2 1.0 Kg/cm2 1.0 Kg/cm2
2 1.5 Kg/cm2 2.0 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2
  • Repeat the same procedure for each speed specified above for each vial size used.
  • Repeat two more runs on same speed (total three runs) to establish the consistency of the efficiency of the vial washing machine.
  • Record the observation in the Annexure-1 except Endotoxin details. Record the details of Endotoxin test in the annexure-2.
  • 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.
  • 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.
  • Now carefully collect the washed vials into a previously cleaned and departiculated closed container.
  • Allow the vials to wash and allow them to collect on the dead plate of the tunnel sterilizer.
  • Now load the spiked vials (sodium chloride/Particulate matter/Endotoxin) to be tested into the vial washer.
  • Ensure that the working of the laminar airflow workstation.
  • Verify and record the water for injection temperature and recirculation water temperature in the Annexure-1. Also record the machine speed in terms vials per minute by calculating from the number of strokes per minute. Record washing time at each wash similarly.
  • Switch on the vial washers for about 5 minutes to departiculate the nozzles and the pipelines.
  • Set the vial washer speed at minimum, medium and maximum as required.
  • Set the parameter as per the step 6.1 (Validation Matrix For Vial Washing).
  • Check and ensure the supply of the compressed air.
  • Ensure that the washing media is collected in to the surge tanks of the vial washers.
  • Ensure that the vial washing machine was set with suitable change parts for the size of the vial under test.
  • Test procedure:
  • Load details: Vials to be washed and spiked vials.
  • Vial washing
  • The spiked vial should contain 10000 EU.
  • Acceptance criteria
  • Record the observations in the annexure-2.
  • Mark the vials by numbering them with proper identification.
  • Prepare Endotoxin spiked vials as per the SOP No.
  • Test procedure:
  • Chemicals required: Endotoxin CSE
  • Preparation Procedure Of Endotoxin Spiked Vials
  • 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 conditi9ons also.
  • Acceptance criteria
  • Record the observations in the annexure-1.
  • Send 72 no’s of the dried spiked vials of each size to production department for conducting study.
  • The data generated shall be used for the estimation of the washing machine capacity to wash the vials when subjected to standard washing cycle.
  • Estimate the particulate matter in unspiked vial also as per the SOP No. QC224.
  • Repeat for two more vials for particulate matter estimation.
  • Subject the water for liquid particle counting as per respective SOP.
  • Make up to 50 ml using water for injection previously estimated for the particulate matter (i.e. blank) using liquid particle counter.
  • Sonicate and add the solution thus obtained into clean-stoppered conical flask. Rinse the vial several times to remove all the particulate matter adhered to the inner surface of the vial.
  • Take one vial and add 5 ml of water for injection.
  • Dry the vials at 60-700C to ensure that the spike dust is adhered to the vials.
  • Swirl each vial gently so that the particulate suspension is evenly distributed on the inner surface of each vial.
  • Add 0.2 ml of the dust suspension in each vial.
  • Mark the vials by numbering them with proper identification.
  • Take 75 nos. previously washed vials of each size.
  • Sonicate well on a sonicator.
  • Add 0.5 gm of standard dust, which is previously passed through 100 mesh.
  • Collect 100 ml of WFI in a 500 ml stoppered conical flask.
  • Test procedure:
  • Chemicals required: 5 gm of standard dust
  • Preparation Procedure Of Particulate Matter Spiked Vials
  • Acceptance Criteria: All the three vials should show opalescence.
  • Record the observations in the annexure-1.
  • Remaining 72 vials shall be used for study.
  • 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.
  • After drying unload the vials and store them in an airtight container.
  • Then load the spiked vials into an oven and dry them for 3 hours at 60- 700
  • Gently rotate each vial so that the total inner surface of the vials gets into contact with the solution.
  • Add 0.5 ml of saturated sodium chloride solution in each vial.
  • Mark the vials by numbering them with proper identification.
  • Take 75 nos. previously washed vials of each size.
  • Prepare 150 ml of saturated sodium chloride solution.
  • Test procedure:
  • Chemicals required: Sodium Chloride, Dilute nitric acid & Silver Nitrate
  • Preparation Procedure For Sodium Chloride Spiked Vials.
  • Procedure For Spiking of Vials
  • Water & Compressed air pressures should indicate as per the set parameters.
  • Water consumption for each run should be with in ± 10% of average consumption of all the three runs at specified speed.
  • Acceptance Criteria:
  • Record all the observation in the annexure-1.
  • Calculate the water consumption for each nozzle for each cycle of washing.
  • Measure the water by using measuring cylinder.
  • At each speed collect the water through silicon tubes into containers of respective, for 5 cycles/strokes of washing.
  • Operate the equipment as per the SOP with out loading of vials.
  • Set the equipment as per the step No. 6.1 (Validation Matrix For Vial Washing) as required.
  • Check and ensure the supply of the compressed air.
  • Ensure that the washing media is collected in to the surge tanks of the vial washers.
  • Other ends of silicon tubes are placed into container for water collection.
  • Connect the silicon tubes to each nozzle.
  • Remove the nozzles from the stations.
  • Test procedure:
  • Tools required: Measuring cylinder, Beaker/Container & Silicon tubes
  • Estimation of washing media (Recycled water, Purified water and WFI) consumption.
  • 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.
  • Acceptance criteria
  • No vial after subjected to washing cycle should show any opalescence when subjected for sodium chloride testing.
  • The normal unwashed vials and spiked vials (with particulate matter) after subjected to 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 subjected to washing cycle shall be tested and evaluated for information.
  • RECORDING OF OBSERVATIONS
  • Record the observations after execution of each test procedure, in the annexure –1 & 2 (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.
  • Prepare the summary report in the annexure-2 (Performance Qualification Report) and submit this for review, approval and authorisation to Validation Core Team.
  • Performance Qualification shall be considered acceptable when all the conditions specified in the test procedures have been met.
  • 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.
  • COMPILATION, REVIEW AND SUMMARY REPORT
  • References
    • Annexure – 1 (Recording Of Observations For Performance Qualification)
    • Annexure – 2 (Performance Qualification Report)

 

Annexure – 1 (Recording Of Observations For Performance Qualification)

Spiking of Endotoxin Vials

Vial Type/ Size:                                                              

Endotoxin Indicators
Lot No. Amount
Expiry Date Reconstitution on
LRW Details
LRW Lot No.: Expiry Date:
Date of Opening:
Spiking details
Micropipette ID: LAF ID:
Validation CSE Potency: Reconstitution:
Spiked volume: Number of Spiked vials:
Done By:

Reviewed by:                                                                                          Date:

Recovery of Spiked Endotoxin

 

Confirmation Of Labelled Claim Sensitivity Of The Lysate

LRW Details LAL Details Control Standard Endotoxin Details
LRW Lot No. LAL Lot No. Lot No.
Expiry Date Sensitivity Expiry Date
Date of Opening Date of Reconstitution Conc.
Expiry Date Reconstituted on
Endotoxin Indicators
Lot No. Amount
Expiry Date Reconstitution on

Control Standard Series

Tube No. LRW ( ml) Vol of CSE added from Tube Final CSE Concentration
01      
02      
03      
04      
05      
06      

Observation:

Time of Incubation:                                  Time of Observation:

  Temp. at Incubation:                              Temp. at Observation:

Replicate No. Observation at different concentrations End Point Log 10

End Point

– ve Control

(0.1 ml LRW + 0.1 ml lysate)

2 λ λ λ/2 λ/4
I              
II              
Mean of log  10 End Point      
Geometric Mean = Antilog 10 of Mean End Point    
  • Remarks:  The geometric Mean End Point concentration is within the / Not within the ± two fold of the labelled claim sensitivity of the lysate.
  • Done By:
  • RECOVERY OF ENDOTOXIN IN UNEXPOSED SPIKED VIALS
  •  No. of Unexposed vial used for determining the recovery =  01
  • Endotoxin Concentration Spiked on each vial = 10000 EU /vial
  • Volume of LRW required for dilution = 4.0 ml
  • Total concentration in vial will be 10000/4 =2500 EU/ ml
  • Dilutions:
Tube No. Volume of LRW added Volume of Endotoxin Concentrations Final Concentration Dilution
0.9 ml 0.1 ml of 2500 EU/ml 250 EU /ml 1: 40
0.9 ml 0.1 ml of Tube No.1 25 EU / ml 1: 400
0.9 ml 0.1 ml of Tube No.2 2.5 EU / ml 1: 4000
1.8 ml 0.2 ml of Tube No.3 0.25 EU / ml 1: 40000
1.0 ml 1.0 ml of Tube No.4 0.125 EU / ml 1: 80000
1.0 ml 1.0 ml of Tube No.5 0.06 EU / ml 1: 160000
  • Observation:
  • Time of Incubation:                                          Time of Observation:
  • Temp. at Incubation:                                        Temp. at Observation:
Dilution Sample Vol. of Sample Vol. of Lysate Result
·        – ve Control Test 100 µl of LRW 100 µl
Duplicate 100 µl of LRW 100 µl
·        1 : 40 000

 

Test 100 µl 100 µl
Duplicate 100 µl 100 µl
·        1 : 80 000

 

Test 100 µl 100 µl
Duplicate 100 µl 100 µl
·        1 : 160000

 

Test 100 µl 100 µl
Duplicate 100 µl 100 µl

 

  • Done By:
  • ENDOTOXIN CONTENT IN EXPOSED VIALS AFTER WASHING
  • Vial Size:____________Run No.:________     Machine Speed:____________              
  • Concentration of Endotoxin Spiked on each vial = 10000 EU / vial.
  • Assuming that after depyrogenation a three log reduction must have taken place, the total concentration on each vial will be = 10 EU / vial
  • Volume of LRW used for Dilution = 4.0 ml / vial
  • Therefore the total concentration in vial will be = 2.5 EU / ml
  • Dilutions:
Tube No. Volume of LRW added Volume of Endotoxin Concentrations Final Concentration Dilution
1. 1.8 ml of LRW 0.2 ml of 2.5 EU / ml 0.25 EU /ml 1: 40
2. 1.0 ml of LRW 1.0 ml of 0.25 EU / ml 0.125 EU /ml 1: 80

 

Dilution Sample Vol. of Sample Vol. of Lysate
·        1 : 40 Test 100 µl 100 µl
·        1 : 40 Duplicate 100 µl 100 µl
·        1 : 80 Test 100 µl 100 µl
·        1 : 80 Duplicate 100 µl 100 µl

 

Observation – Set1
Vial No. Dilution  1: 40 Dilution 1: 80 Vial No. Dilution  1: 40 Dilution 1: 80
Test Duplicate Test Duplicate Test Duplicate Test Duplicate
1 7
2 8
3 9
4 10
5 11
6 12
Time of Incubation Incubation Temp.  

 

Time of Observation Done By

 

Observation – Set2
Vial No. Dilution  1: 40 Dilution 1: 80 Vial No. Dilution  1: 40 Dilution 1: 80
Test Duplicate Test Duplicate Test Duplicate Test Duplicate
1 7
2 8
3 9
4 10
5 11
6 12
Time of Incubation Incubation Temp.  

 

Time of Observation Done By
  • ESTIMATION OF ENDOTOXIN REDUCTION
  • Set No.: 1; Vial Size:_________Run No.:____ Machine Speed:______________
  • Recovered endotoxin per            = Reciprocal of the last dilution which     Exposed vials                          was positive X lambda (Sensitivity of the Lysate).
  • Last Dilution which was positive =…………….
  • Therefore the reciprocal will be        =…………….
  • Sensitivity of the Lysate = 0.125 EU / ml

=  …………….  X 0.125 EU/ ml

=  ……………….. EU / vial

  • Recovered endotoxin per = Reciprocal of the last dilution which
  • Unexposed vial  was positive X lambda (Sensitivity of the Lysate).
  • Last Dilution which was positive =…………….
  • Therefore the reciprocal will be =…………….
  • Sensitivity of the Lysate = 0.125 EU / ml

=  ……………….  X 0.125 EU/ ml

=  ……………….. EU / vial

  • Therefore the amount of endotoxin reduced after depyrogenation

= log (b) -  log (a)

= log …………-  log ……. ….

= ……………….log reduction

  • Anti log of (log reduction) = ……………….fold reduction
  • INTERPRETATION:
  • There is greater / less than 3 log reduction in endotoxin in Depyrogenated vial. Hence washing cycle found satisfactory / not satisfactory.
  • Reviewed by:                                                                                          Date:
  • Set No.: 2; Vial Size:_________Run No.:____ Machine Speed:______________
  • Recovered endotoxin per = Reciprocal of the last dilution which     
  • Exposed vials was positive X lambda (Sensitivity of the Lysate).
  • Last Dilution which was positive =…………….
  • Therefore the reciprocal will be =…………….
  • Sensitivity of the Lysate = 0.125 EU / ml

=  …………….  X 0.125 EU/ ml

=  ……………….. EU / vial

  • Recovered endotoxin per = Reciprocal of the last dilution which
  • Unexposed vial was positive X lambda (Sensitivity of the Lysate).
  • Last Dilution which was positive =…………….
  • Therefore the reciprocal will be =…………….
  • Sensitivity of the Lysate = 0.125 EU / ml

=   ……………….  X 0.125 EU/ ml

=  ……………….. EU / vial

  • Therefore the amount of endotoxin reduced after depyrogenation

= log (b) -  log (a)

= log …………-  log ……. ….

=  ……………….log reduction

  • Anti log of (log reduction)  =   ……………….fold reduction
  • INTERPRETATION:
  • There is greater / less than 3 log reduction in endotoxin in Depyrogenated vial. Hence washing cycle found satisfactory / not satisfactory.

 

  • Reviewed by:                                                                                          Date:

 

Annexure – 2 (Performance Qualification Report)

 

Details Of Operational Qualification Report
Report No.   Date Of Authorisation  

 

Identification Of The Executors

 

S. No. Name Designation & Department  Sign & Date Training Details
       
  • Comments:
  • Reviewed by:                                                                                          Date:
Estimation of washing media (Recycled water, Purified water and WFI) consumption.

 

Machine speed Washing Media Pressures (Kg/Cm2) Washing media Nozzle Consumption (ml) Done by

Sign & Date

RW PW WFI CA Run-1 Run-2 Run-3 Avg./ Run/ 5 strokes Avg./ Stroke Total/2 nozzles/stroke
40 vials /minute 1.0 1.0 1.0 1.5 Re Cycled water Nozzle-1
Nozzle-2          
Nozzle-1            
Nozzle-2          
WFI Nozzle-1            
Nozzle-2          
2.0 Re Cycled water Nozzle-1
Nozzle-2
Nozzle-1
Nozzle-2
WFI Nozzle-1
Nozzle-2
  • Checked by:


Machine speed
Washing Media Pressures (Kg/Cm2) Washing media Nozzle Consumption (ml) Done by

Sign & Date

RW PW WFI CA Run-1 Run-2 Run-3 Avg./ Run/ 5 strokes Avg./ Stroke Total/2 nozzles/stroke
80 vials /minute 1.0 1.0 1.0 1.5 Re Cycled water Nozzle-1
Nozzle-2          
Nozzle-1            
Nozzle-2          
WFI Nozzle-1            
Nozzle-2          
2.0 Re Cycled water Nozzle-1
Nozzle-2
Nozzle-1
Nozzle-2
WFI Nozzle-1
Nozzle-2
  • Checked by:
Machine speed Washing Media Pressures (Kg/Cm2) Washing media Nozzle Consumption (ml) Done by

Sign & Date

RW PW WFI CA Run-1 Run-2 Run-3 Avg./ Run/ 5 strokes Avg./ Stroke Total/2 nozzles/stroke
120 vials /minute 1.0 1.0 1.0 1.5 Re Cycled water Nozzle-1
Nozzle-2          
Nozzle-1            
Nozzle-2          
WFI Nozzle-1            
Nozzle-2          
2.0 Re Cycled water Nozzle-1
Nozzle-2
Nozzle-1
Nozzle-2
WFI Nozzle-1
Nozzle-2
  • Checked by:
  • Comments:
  • Reviewed by:                                                                                           Date:
Preparation Procedure For Sodium Chloride Spiked Vials.

 Date:                                                                                             Vial size Used:

Procedure Observation/ Result
Quantity of saturated sodium chloride solution
0.5 ml of saturated sodium chloride solution spiked on the vials, and distributed evenly on the entire inner surface of the vial, and dried at 60- 700C in the oven
Number of vials spiked with the saturated sodium chloride solution
Estimation for the presence of sodium chloride in the vials: Three spiked vials filled with 1.0 ml of water for injection, sonicated, then 1ml of dilute Nitric acid was added followed by 1ml silver nitrate solution TS was added and observed for opalescence.
Remarks:
Name Signature Date
Done by
Checked by
Reviewed by
Preparation Procedure Of Particulate Matter Spiked Vials

 Date:                                                                                             Vial size Used:

Procedure Observation/ Result
Quantity of dust powder taken for the preparation of the particulate matter suspension.
0.2 ml of suspension spiked on the vials, the particulate suspension is distributed evenly on the entire inner surface of the vial, and dried at 60- 700C in the oven.
Number of vials spiked with the particulate matter suspension
Estimation Particles per spiked vial: Three vials filled with 10 ml of water for injection, sonicated, made up the volume to 50ml and subject to liquid particle counting. Such three consecutive readings shall be taken with three different vials and the average of the three- vials shall be used for further calculations.
Vial Particles greater than or equal to
10µm 25µm
Vial No. 1
Vial No. 2
Vial No. 3
Average/ vialà    
  • Note: Refer Attachment No.______
  • Remarks:
Name Signature Date
 

Done by

Checked by
 

Reviewed by

Estimation Particles In Unspiked Vial
Estimation Particles per unspiked vial: 12 vials each sonicated and particles extracted with 50 ml of water for injection and subject to liquid particle counting. Such three consecutive readings shall be taken with three different vial samples and the average of the twenty shall be used for further calculations. For each trial separate estimation shall be carried out.

 

Results
Particle size Particulate matter count/12 Vials Particulate matter count/Vial
10µm    
25µm    
Remarks:

Note: Refer Attachment No.______

Name Signature Date
Done by
Checked by
Verified by

 

Vial Washing
STUDY OF SODIUM CHLORIDE REMOVAL AFTER WASHING OF SPIKED VIALS
  • Vial Size used:
Machine speed Washing Media Pressures (Kg/Cm2) Results / Observations Meeting Requirement

Yes/No

Done by

Sign & Date

RW PW WFI CA Vial No
1 2 3 4 5 6 7 8 9 10 11 12
40 vials /minute 1.0 1.0 1.0 1.5
2.0
80 vials /minute 1.0 1.0 1.0 1.5
2.0
120 vials /minute 1.0 1.0 1.0 1.5
2.0
  • Note: +ve: Presence of Sodium chloride; -Ve; absence of Sodium chloride
  • Checked by:
  • Comments: 
  • Reviewed by:                                                                                                                                    Date:
STUDY OF PARTICULATE MATTER AFTER WASHING OF SPIKED AND UN SPIKED VIALS

Vial Size used:

Machine speed Washing Media Pressures (Kg/Cm2) Results / Observations Meeting Requirement

Yes/No

Done by

Sign & Date

RW PW WFI CA Spiked vials Un Spiked vials
Particles/12vials Particles/vial Particles/12vials Particles/vial
≥10 µm ≥25 µm ≥10 µm ≥25 µm ≥10 µm ≥25 µm ≥10 µm ≥25 µm
40 vials /minute 1.0 1.0 1.0 1.5
2.0
80 vials /minute 1.0 1.0 1.0 1.5
2.0
120 vials /minute 1.0 1.0 1.0 1.5
2.0
  • Note: Refer Attachment No.______
  • Checked by:
  • Comments:
  • Reviewed by:                                                                 Date:
Discrepancy And Corrective Action Report
Reference:

Discrepancy:

Corrective Action :

Satisfactorily completed? [Yes / No]:

Checked by / date:                                                  Reviewed and approved by / date:

Reference:

Discrepancy:

Corrective Action:

Satisfactorily completed? [Yes / No]:

Checked by / date:                                                  Reviewed and approved by / date:

Reference:

Discrepancy:

Corrective Action:

Satisfactorily completed? [Yes / No]:

Checked by / date:                                                  Reviewed and approved by / date:

  • REQUALIFICATION CRITERIA
  • Requalification criteria is as follows
  • If the machine is subjected for 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

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