Performance Qualification Protocol. Bung washer

November 5, 2016January 16, 2024 Pharma Editor

OBJECTIVE
To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the BUNG WASHING MACHINE.
To verify the Rubber stopper washing process is capable of consistently and reliably removing
Particulate matter contaminants, such as dust, lint, fibres etc.,
Bacterial Endotoxins, from the spiked rubber stoppers, and to establish the washing and equipment operation parameters.
SCOPE

The scope of this protocol is limited to carry out the performance Qualification of 20mm Grey/Bromo butyl rubber stopper washing process by using Rubber stopper washer located in the Preparation and Sterilization Zone of injectable section.
Note: The protocol is not applicable for pre-washed and/or siliconized rubber stoppers received in Ready for sterilization (RFS) bags.
To be performed at the time of relocation or Requalification.
To be performed after the completion and authorization of Operational Qualification.
EQUIPMENT DESCRIPTION
Bung washer is installed in unit preparation room.
Purpose of the equipment:
Purpose of this Bung washer is for washing & Siliconization of the various types of rubber stoppers.
Basic mode of operation:
The equipment as suggested by names, washes the bungs with detergent and rinses with Purified water & WFI automatically through PLC. There is one vessel for washing the bungs having capacity of 10,000 bungs. The entire process is time dependent and hence has to be checked the cleanliness of the bungs.
The vessel have inputs of compressed air, Purified water & WFI inlets and heaters perforated basket which hold the bungs during the process are placed inside the vessel. The vessel is covered with transparent lids to view the bungs in washing process. The bungs have a totally enclosed environment and are controlled by a PLC automated system.
Abbreviations and definitions

Abbreviation	Definitions
PQP	Performance Qualification Protocol
SOP	Standard Operating Procedure
Abbreviation	Definitions
QA	Quality Assurance
QC	Quality Control
NA	Not Applicable
No.	Number
ÂºC	Degree Centigrade
SLT	Standard Laboratory Technique

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 test procedures
Quality Assurance	Monitoring, sampling & reviewing the validation activities.

After completion of each load wash cycle, collect the spiked red butyl rubber stoppers with the help of clean forceps in to previously cleaned stoppered conical flask and close the flask.
Operate the bung washer as per the SOP and record the details in the annexure-1.
Randomly add 10 nos. of dust spiked rubber stoppers for each trial of previously estimated for the quantity of the particulate matter load on each stopper and Close the drum.
Charge cleaned bung washer with the minimum / maximum load of 20mm butyl rubber stoppers.
Rubber Stopper Washing
Use 60 noâ€™s of the spiked and dried plugs to carry out performance qualification test.
The data generated shall be used for the estimation of the washing machine capacity to wash the test load of rubber stoppers as per the standard washing cycle.
Record the observations in the annexure-1.
Collect the water from the conical flask into a clean beaker and send to microbiology laboratory for estimation of particulate matter present in the water.
Add 50 ml of WFI to the stoppered conical flask and sonicate the flask for 5 minutes.
Place 10 rubber stoppers in previously cleaned stoppered conical flask for estimation of particulate count.
Dry the plugs at 60-70⁰C to ensure that the spike dust is adhered to the plugs.
Add 0.2 ml of the dust suspension to each rubber stopper on the concave portion of the rubber plug.
Take 70 rubber stoppers with different colour of the load rubber stoppers for easy identification (for minimum and maximum loads and each load having three trials).
Sonicate well on a sonicator.
Add 5 gm of standard dust, which is previously passed through 100 mesh.
Collect 100 ml of WFI in a 500 ml stoppered conical flask.
Spiking Of Rubber Stoppers with Particulate matter
Following test procedures are followed to qualify the equipment for its performance.
Load details: Selected load sizes are 5000 and 10000 nos. of 20mm grey/ butyl rubber stoppers to evaluate bung washer efficiency with the minimum and maximum load sizes.
TEST PROCEDURES
Identification of Executors: The personnel involved in the execution of this protocol shall be recorded- Name, Designation, Signature and Date.
NOTE: The particulate count of the dust spiked rubber stoppers shall be estimated prior to conducting the study.
The above procedure shall be performed for each load size.
Repeat the above procedure for another two runs.
Record the observations in the annexure-1.
Raise the sample request form for the estimation of bio burden level of washed rubber stoppers.
Collect the water from the conical flask into a clean beaker and send to microbiology laboratory for estimation of particulate matter present in the water.
Add 50 ml of WFI water to the stoppered conical flask and sonicate the flask for 5 minutes.
Acceptance Criteria
The rubber stoppers after the standard washing cycle should not show any visible particles.
â‰¥10 Âµm size particles should not exceed 25 per ml and â‰¥25 Âµm size particles should not exceed 3 per ml. (or) As per In-house specifications.
Bioburden level is for information.
RECORDING OF OBSERVATIONS
Record the observations of after execution of each test procedures, in the annexure â€“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 â€“2 (Performance Qualification Report) and submit this for review, approval and authorisation to Validation Core Team.
Annexures
Annexure â€“ 1 (Recording Of Observations For Performance Qualification)

Annexure â€“ 1 (Recording Of Observations For Performance Qualification)

Details Of Operational Qualification Report
Report No.	Â	Date Of Authorisation	Â

Identification Of The Executors

S. No.	Name	Designation & Department	Sign & Date	Training Details
	Â	Â	Â	Â

Reviewed by:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Date:

Spiking of Rubber Stoppers

Â Date of spiking:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Done by:
Â Date of testing for particulate matter:

Results of Particulate count
Particle size	Count
Â	Â

Test Done by:

Â Reviewed by:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Date:

Washing of Rubber Stoppers

Load Size:Â (Minimum)_____________Nos Rubber stoppers Â Â Â Â Â Â Â Â Â

S. No.	Operation	Time		Done by Sign & Date	Supervised by Sign & Date
S. No.	Operation	From	To	Done by Sign & Date	Supervised by Sign & Date
1	Load Rubber stoppers into bung washer. Randomly add 10 nos. of dust spiked rubber stoppers in to the load. Start the operation as per the SOP. Record the quantity:________Nos.				Â
2	First wash: Wash the rubber stoppers with detergent solution (______ ml) and purified water for 30 minutes. Record the temperature of Purified water: __________ÂºC.				Â
3	Second wash: Wash the rubber stoppers with Purified water for 30 minutes. Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
4	Third wash: Wash the rubber stoppers with water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
4	Check the clarity of rinse water. Clarity: OK / Not OK				Â
6	Fourth wash: Wash the rubber stoppers with Silicone oil (_______ ml) and Water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
7	Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
8	If clarity is not achieved, repeat the cycle and check the clarity.				Â
9	Unload the rubber stoppers in to baskets after completion of all washings.				Â
10	Follow as per the step No. 6.2.4 to 6.2.8 in the protocol.				Â

Load Size:Â (Minimum)_____________Nos Rubber stoppersÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Run No. 2 of 3

S. No.	Operation	Time		Done by Sign & Date	Supervised by Sign & Date
S. No.	Operation	From	To	Done by Sign & Date	Supervised by Sign & Date
1	Load Rubber stoppers into bung washer. Randomly add 10 nos. of dust spiked rubber stoppers in to the load. Start the operation as per the SOP. Record the quantity:________Nos.				Â
2	First wash: Wash the rubber stoppers with detergent solution (______ ml) and purified water for 30 minutes. Record the temperature of Purified water: __________ÂºC.				Â
3	Second wash: Wash the rubber stoppers with Purified water for 30 minutes. Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
4	Third wash: Wash the rubber stoppers with water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
4	Check the clarity of rinse water. Clarity: OK / Not OK				Â
6	Fourth wash: Wash the rubber stoppers with Silicone oil (_______ ml) and Water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
7	Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
8	If clarity is not achieved, repeat the cycle and check the clarity.				Â
9	Unload the rubber stoppers in to baskets after completion of all washings.				Â
10	Follow as per the step No. 6.2.4 to 6.2.8 in the protocol.				Â

Load Size:Â (Minimum)_____________Nos Rubber stoppersÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Run No. 3 of 3

S. No.	Operation	Time		Done by Sign & Date	Supervised by Sign & Date
S. No.	Operation	From	To	Done by Sign & Date	Supervised by Sign & Date
1	Load Rubber stoppers into bung washer. Randomly add 10 nos. of dust spiked rubber stoppers in to the load. Start the operation as per the SOP. Record the quantity:________Nos.				Â
2	First wash: Wash the rubber stoppers with detergent solution (______ ml) and purified water for 30 minutes. Record the temperature of Purified water: __________ÂºC.				Â
3	Second wash: Wash the rubber stoppers with Purified water for 30 minutes. Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
4	Third wash: Wash the rubber stoppers with water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
4	Check the clarity of rinse water. Clarity: OK / Not OK				Â
6	Fourth wash: Wash the rubber stoppers with Silicone oil (_______ ml) and Water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
7	Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
8	If clarity is not achieved, repeat the cycle and check the clarity.				Â
9	Unload the rubber stoppers in to baskets after completion of all washings.				Â
10	Follow as per the step No. 6.2.4 to 6.2.8 in the protocol.				Â

Â Load Size:Â (Maximum)_____________Nos Rubber stoppersÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Run No. 1 of 3

S. No.	Operation	Time		Done by Sign & Date	Supervised by Sign & Date
S. No.	Operation	From	To	Done by Sign & Date	Supervised by Sign & Date
1	Load Rubber stoppers into bung washer. Randomly add 10 nos. of dust spiked rubber stoppers in to the load. Start the operation as per the SOP. Record the quantity:________Nos.				Â
2	First wash: Wash the rubber stoppers with detergent solution (______ ml) and purified water for 30 minutes. Record the temperature of Purified water: __________ÂºC.				Â
3	Second wash: Wash the rubber stoppers with Purified water for 30 minutes. Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
4	Third wash: Wash the rubber stoppers with water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
4	Check the clarity of rinse water. Clarity: OK / Not OK				Â
6	Fourth wash: Wash the rubber stoppers with Silicone oil (_______ ml) and Water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
7	Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
8	If clarity is not achieved, repeat the cycle and check the clarity.				Â
9	Unload the rubber stoppers in to baskets after completion of all washings.				Â
10	Follow as per the step No. 6.2.4 to 6.2.8 in the protocol.				Â

Â Load Size:Â (Maximum)_____________Nos Rubber stoppersÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Run No. 2 of 3

S. No.	Operation	Time		Done by Sign & Date	Supervised by Sign & Date
S. No.	Operation	From	To	Done by Sign & Date	Supervised by Sign & Date
1	Load Rubber stoppers into bung washer. Randomly add 10 nos. of dust spiked rubber stoppers in to the load. Start the operation as per the SOP. Record the quantity:________Nos.				Â
2	First wash: Wash the rubber stoppers with detergent solution (______ ml) and purified water for 30 minutes. Record the temperature of Purified water: __________ÂºC.				Â
3	Second wash: Wash the rubber stoppers with Purified water for 30 minutes. Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
4	Third wash: Wash the rubber stoppers with water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
4	Check the clarity of rinse water. Clarity: OK / Not OK				Â
6	Fourth wash: Wash the rubber stoppers with Silicone oil (_______ ml) and Water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
7	Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
8	If clarity is not achieved, repeat the cycle and check the clarity.				Â
9	Unload the rubber stoppers in to baskets after completion of all washings.				Â
10	Follow as per the step No. 6.2.4 to 6.2.8 in the protocol.				Â

Â Load Size:Â (Maximum)_____________Nos Rubber stoppersÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Run No. 3 of 3

S. No.	Operation	Time		Done by Sign & Date	Supervised by Sign & Date
S. No.	Operation	From	To	Done by Sign & Date	Supervised by Sign & Date
1	Load Rubber stoppers into bung washer. Randomly add 10 nos. of dust spiked rubber stoppers in to the load. Start the operation as per the SOP. Record the quantity:________Nos.				Â
2	First wash: Wash the rubber stoppers with detergent solution (______ ml) and purified water for 30 minutes. Record the temperature of Purified water: __________ÂºC.				Â
3	Second wash: Wash the rubber stoppers with Purified water for 30 minutes. Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
4	Third wash: Wash the rubber stoppers with water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
4	Check the clarity of rinse water. Clarity: OK / Not OK				Â
6	Fourth wash: Wash the rubber stoppers with Silicone oil (_______ ml) and Water for injection for 30 minutes. Record the temperature of the WFI: __________ÂºC.				Â
7	Check the clarity of rinse water as per the SOP. Clarity: OK / Not OK				Â
8	If clarity is not achieved, repeat the cycle and check the clarity.				Â
9	Unload the rubber stoppers in to baskets after completion of all washings.				Â
10	Follow as per the step No. 6.2.4 to 6.2.8 in the protocol.				Â

OBSERVATIONS
Particulate MatterÂ

Load Size	Run No.	Particulate matter		Done by Sign & Date	Verified by Sign & Date
Load Size	Run No.	â‰¥10 Âµm particles	â‰¥25 Âµm particles	Â	Â
Minimum	1 of 3			Â	Â
	2 of 3			Â	Â
	3 of 3			Â	Â
Maximum	1 of 3			Â	Â
	2 of 3			Â	Â
	3 of 3			Â	Â

Bio burden results
Date of test: Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Date of Report:
Media used for TABC:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Auto clave Load No.:
Media used for Fungi:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Auto clave Load No.:

Load Size	Run No.	Cfu/10 rubber stoppers		Done by Sign & Date	Verified by Sign & Date
Load Size	Run No.	TABC	Fungi	Â	Â
Minimum	1 of 3			Â	Â
	2 of 3			Â	Â
	3 of 3			Â	Â
Maximum	1 of 3			Â	Â
	2 of 3			Â	Â
	3 of 3			Â	Â

Remarks:

Discrepancy And Corrective Action Report

Reference :

Discrepancy :

Corrective ActionÂ Â Â Â Â :

Satisfactorily completed? [Yes / No]:

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

Reference :

Discrepancy :

Corrective Action :

Satisfactorily completed? [Yes / No]:

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

Reference :

Discrepancy :

Corrective Action :

Satisfactorily completed? [Yes / No]:

Checked by / date:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 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 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 rubber stopper specification.
Major change/ modification in the facility
Relocation of the equipment.

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kuwait, KUWAIT CITY, KYRGYZSTAN, L'Aquila, La Spezia, Laghouat, Lancashire, Lancaster, LAOS, Latina, LATVIA, Launceston, Leabaib, Lebanon, Lebday, Lecce, Lecco, Leeds, Leicester, Leicestershire, Lejbailat, Lekhwair, Leningrad, Leqtaifiya (West Bay Lagoon), LESOTHO, Lexington, LIBERIA, LIBREVILLE, LIBYA, Lichfield, LIECHTENSTEIN, Lijmiliya, Lille–Kortrijk–Tournai France/ Belgium, LILONGWE, LIMA, Lincoln, Lincolnshire, Lipetsk, Lisbon, Lisburn, Lisburn and Castlereagh, LITHUANIA, Liverpool, Livorno, LJUBLJANA, LOMÉ, london, Loni, Looe, Lossiemouth, Lostwithiel, Luaib, LUANDA, Lucca, Lucknow, Ludhian, Lusail, LUSAKA, Luton, LUXEMBOURG, M'Sila, Macclesfield, Macerata, MADAGASCAR, Madinat Al Kaaban, Madinat ash Shamal, Madinat Khalifa North, Madinat Khalifa South, Madison, Madrid, Madurai, Magadan Moscow, Maghnia, MAJURO, MALABO, malawi, Malaysia, MALDIVES MALE, MALI, MALTA, MANAGUA, MANAMA, Manchester, MANILA, Manitoba, Mantua, Maranhao, Marlborough, Marlow, Marseille, Mascara, MASERU, Massa and Carrara, Matera, Matlock, Mato Grosso, Mato Grosso do Sul, MAURITANIA, mauritius, MBABANE, Mebaireek, Médéa, Medway, Meerut, Mehairja, Melbourne, Merseyside, Merthyr Tydfil, Mesaieed, Mesaimeer, Messina, Mexico, MEXICO CITY, Mid and East Antrim, Mid Ulster, Middlesbrough, Midlothian, Milan, Milford, Milngavie, Milton, Milton Keynes, Minas Gerais, Minsk, Modena, MOGADISHU, Monmouthshire, MONROVIA, MONTEVIDEO, Monza and Brianza, Moradabad, Moray, MORONI, Moscow, Mostaganem, Motherwell and Wishaw, Mount Vernon, Mourne, Muaither, Mumbai, Muraikh, Murmansk, MUSCAT, Mushayrib, Myaanmar (Burma), Mysore, N'DJAMENA, Nagpur, NAIROBI, Najma, NAMIBIA WINDHOEK, Nanded Kolapur, Nantwich, Naples, Nashik, NASSAU, NAURU, Navi Mumbai, Neath Port Talbot, Nellore, Nelson, Nepal, Netherlands, New Al Hitmi, New Al Mirqab, New Al Rayyan, New Brunswick, New Fereej Al Ghanim, New Fereej Al Khulaifat, New Plymouth, New Salata, New South Wales, new Zealand, Newfoundland and Labrador, Newport, NewportAuburn, Newquay, Newry, NGERULMUD, NIAMEY, NICARAGUA, NICOSIA, NIGER, Nigeria, Nizhniy Novgorod, Nizhny, Noida, Norfolk, Norfolk Island, North, North Ayrshire, North East Derbyshire, North East Lincolnshire, NORTH KOREA, North Lanarkshire, North Lincolnshire, NORTH MACEDONIA, North Somerset, North West, North Yorkshire, Northamptonshire, Northern, Northern Ireland, Northern Territory, Northumberland, Northwest Territories, Northwich, Norway, Norwich, Nottingham, Nottinghamshire, NOUAKCHOTT, Nova Scotia, Novara, Novgorod, Novosibirsk, Nu`ayjah, Nunavut, Nuoro, NUR-SULTAN, Nuremberg, Oakland, Old Al Ghanim, Old Al Hitmi, Old Al Rayyan, oman, Omsk, Onaiza, ontario canada, OntarioToronto, Oran, Orenburg, Oristano, Orkney Islands, Oryol, OSLO, Otago, Ottawa, OUAGADOUGOU, Ouargla, Oxford, Oxfordshire, Padua, Paisley, Pakistan, PALAU, Palermo, PALESTINE, PANAMA, PANAMA CITY, PAPUA NEW GUINEA, Para, PARAGUAY, Paraiba, PARAMARIBO, Parana, Paris, Parma, Patna, Pavia, Pembrokeshire, Penrith, Penryn, Penza, Penzance, Pernambuco, Perth, Perth and Kinross, peru, Perugia, Pesaro and Urbino, Pescara, Peterborough, Philippines, PHNOM PENH, Piacenza, Piaui, Pimpri, Pisa, Pistoia, Plymouth, Poland, Poole, Pordenone, PORT LOUIS, PORT MORESBY, PORT OF SPAIN, PORT VILA, PORT-AU-PRINCE, Porto Portugal, PORTO-NOVO, Portsmouth, portugal, Potenza, Powys, Prague, PRAIA, Prato, Preston, PRETORIA, Prince Edward Island, PRISTINA, Pskov, Pune, PYONGYANG, Qatar, Quebec City, Queensland, QUITO, Ragusa, Raipur, Rajkot, Ramsey, Ranchi, Ras Abu Aboud, Ras Al Khaimah, Ras Lafan, Ravenna, Rawdat Al Hamama, Rawdat Al Khail, Rawdat Egdaim, Rawdat Rashed, Reading, Redcar and Cleveland, Reggio Calabria, Reggio Emilia, Regina, Relizane, Renfrew, Renfrewshire, Repton, REYKJAVIK, Rhondda Cynon Taf, Rieti, RIGA, Rimini, Rio de Janeiro, Rio Grande, Ripon, Riverside, RIYADH, Romania, Rome, ROSEAU, Rostov, Rotterdam, Rovigo, Rumeilah, Russia, Rutland, RWANDA, Ryazan, Saharanpur, Saïda, SAINT GEORGE'S, SAINT JOHN'S, SAINT KITTS & NEVIS, SAINT LUCIA, Saint Petersburg, SAINT VINCENT & THE GRENADINES, Sakhalin, Salem, Salerno, Salford, Salisbury, Saltash, Samara, SAMOA, SAN JOSE, SAN MARINO, SAN SALVADOR, Sandhurst, SANTIAGO, SANTO DOMINGO, SÃO TOMÉ & PRÍNCIPE, SÃO TOMÉ SAUDI ARABIA, SARAJEVO, Saratov, Saskatchewan, Sassari, Savona, Sawda Natheel, Saxony, Scotland, Scottish Borders, SENEGAL, SEOUL, Serbia, Sétif, Seville, SEYCHELLES, Shagra, Sharjah, Sheffield, Shetland Islands, Shropshire, Sidi bel Abbès, Siena, SIERRA LEONE, Siliguri, Simaisma, singular, Skikda, SKOPJE, Slough, SLOVAKIA, SLOVENIA, Smolensk, Sofia, Solapur, SOLOMON ISLANDS, SOMALIA, Somerset, Sondrio, Souk Ahras, SOUTH AFRICA, South Australia, South Ayrshire, South Bucks, South Cambridgeshire, South Derbyshire, South East, South Gloucestershire, SOUTH KOREA, South Lakeland, South Lanarkshire, South Sardinia, SOUTH SUDAN, SOUTH TARAWA, South Tyrol, South West, South Yorkshire, Southampton, Southend-on-Sea, Southland, spain, Springfield, SRI JAYAWARDENEPURA KOTTE, Sri Lanka, Srinagar, St Albans, St Asaph, St Davids, St. Austell, St. Ives, St. John's, Staffordshire, Stirling, STOCKHOLM, Stockton-on-Tees, Stoke Poges, Stoke-on-Trent, Stuttgart, SUCRE, sudan, Suffolk, Sunderland, Surat, SURINAME, Surrey, SUVA, Sverdlovsk, Swansea, Sweden, Swindon, switzerland, Sydney, Syracuse, SYRIA, TAJIKISTAN, TALLINN, Tambov, TANZANIA, Taranto, TASHKENT, Tasmania, TBILISI, Tébessa, TEGUCIGALPA, TEHRAN, Telford, Telford and Wrekin, Teramo, Terni, Thailand, Thane, The Hague, The Pearl, THIMPHU, Thiruvananthapuram, Thuringia, Thurrock, Thurso, Tiaret, TIMOR-LESTE DILI, Tintagel, TIRANA, Tiruchirappalli, Tizi Ouzou, Tlemcen, TOGO, TOKYO, Tomsk, TONGA NUKUʻALOFA, Torbay, Trapani, Trento, Treviso, Trieste, TRINIDAD & TOBAGO, TRIPOLI, Truro, Tula, TUNIS, TUNISIA, Turin, turkey, TURKMENISTAN, TUVALU, Tver, Tyne and Wear, Tyumen, Udine, UGANDA, Ujjain, Ukraine, Ukraine. Dnipropetrovsk, Ulhasnagar, Ulyanovsk, Umm al-Qaiwain, Umm al-Quwain, Umm Bab, Umm Birka, Umm Ghuwailina, Umm Lekhba, Umm Qarn, Umm Salal Ali, Umm Salal Mohammed, United arab emirates, UNITED ARAB EMIRATES (UAE), united Kingdom, UNITED KINGDOM* (UK), united state, United States, UNITED STATES OF AMERICA (USA), URUGUAY, UZBEKISTAN, Vadodara, VADUZ, Vale of Glamorgan, Valencia, VALLETTA MARSHALL ISLANDS, VANUATU, Varanasi, Varese, Vasai Virar, VATICAN CITY, VATICAN CITY (Holy See), VENEZUELA CARACAS, Venice, Verbano-Cusio-Ossola, Vercelli, Verona, Vibo Valentia, Vicenza, Victoria, Vienna, VIENTIANE, VIETNAM HANOI, Vijayawada, VILNIUS, Visakhapatnam, Viterbo, Vladimir, Volgograd, Vologda, Voronezh, Wadi Al Banat, Wadi Al Sail, Wadi Al Wasaah, Wadi Lusail, Wakefield, Wales, Warrington, Warsaw, Warwickshire, Washington, Wellington, Wells, West Berkshire, West Dunbartonshire, West Lothian, West Midlands, West Sussex, West Yorkshire, West Yorkshire (Bradford–Leeds), Western Australia, Western Isles, Westland, Whitehaven, Whitehorse, Wick, Wiltshire, Winchester, Windsor and Maidenhead, Winnipeg, Wisbech, Wokingham, Wolverhampton, Worcester, Worcestershire, Workington, Wrexham, Wrexham Qatar, Wycombe, YAMOUSSOUKRO, YAOUNDE, YAREN DISTRICT, Yaroslavl, Yellowknife, YEMEN SANA'A ZAMBIA, YEREVAN, York, Yorkshire and the Humber, Yukon, ZAGREB, ZIMBABWE, Zürich

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