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M/s.Sabui Medical Stores (MFG) 3, Sardar Ghat Lane, Bhadreshwar, Hooghly

The document provides the results of particle count tests conducted in three clean rooms - a laminar air flow room, a filling and sealing room, and a bulk filling room - at a medical equipment manufacturing facility. The tests found that the laminar air flow room met the requirements for ISO Class "A", the filling and sealing room met requirements for ISO Class "D", and the bulk filling room met requirements for ISO Class "C". The purpose was to determine the actual airborne particle count cleanliness levels in the rooms at rest.

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balajichandrakant
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64 views

M/s.Sabui Medical Stores (MFG) 3, Sardar Ghat Lane, Bhadreshwar, Hooghly

The document provides the results of particle count tests conducted in three clean rooms - a laminar air flow room, a filling and sealing room, and a bulk filling room - at a medical equipment manufacturing facility. The tests found that the laminar air flow room met the requirements for ISO Class "A", the filling and sealing room met requirements for ISO Class "D", and the bulk filling room met requirements for ISO Class "C". The purpose was to determine the actual airborne particle count cleanliness levels in the rooms at rest.

Uploaded by

balajichandrakant
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 6

PARTICLE COUNT TEST CERTIFICATE

PURPOSE
To the determine the actual Airborne Particle count Cleanliness Level in a clean room "At Rest" Occupancy State
CUSTOMER DETAILS
Client M/s.Sabui Medical Stores (MFG) Document No GMPLCS/SML/PCT/21-22/B001
3,Sardar Ghat Lane,Bhadreshwar,Hooghly. Test Reference EUGMP-ISO:2015
telangana-503102 Date of Test 13/09/2021
Equipment Name Laminar Air Flow Next Due Date 12/09/2022
Equipment Id RLS/WH/RLAF/003 Area of test Microbiology
INSTRUMENT USED FOR TESTING
Instrument Name Airborne Particle counter Make TSI
Model 9350-03 Serial No 93501922002
Flow Rate 50.0 lpm Sampling Time 01 Minute
Calibrated On 14/07/2021 Calibration Due On 14/07/2022
OBTAINED TEST RESULT ACCEPTANCE CRITERIA
ISO Accepatance Accepatance
Obtained No.of Particles ≥ 0.5 μm³ Obtained No.of Particles ≥ 5.0 μm³ Result
Classification Location Criteria for the Criteria for the
Number Particle size ≥ Particle size ≥
S1 S1 0.5 µm /ft³ 5.0 µm / ft³

1 0 0 100 0 Pass
2 0 0 100 0 Pass
3 0 0 100 0 Pass
4 0 0 100 0 Pass
5 0 0 100 0 Pass
ISO Class "5"
6 0 0 100 0 Pass
7 0 0 100 0 Pass
8 0 0 100 0 Pass
9 0 0 100 0 Pass
10 0 0 100 0 Pass
Mean of the average 0 0 100 0 Pass

INFERENCE The above Specified Confirms to ISO Class "A" for Particle Count Test as per -ISO:2015

Conducted By Checked By Approved By

Mr.Balaji ENGINEERING QA
M/s.GMP laboratories And Clean Room Solutions M/s.Sabui Medical Stores (MFG)

Page 1 of 6
PARTICLE COUNT TEST CERTIFICATE

PURPOSE
To the determine the actual Airborne Particle count Cleanliness Level in a clean room "At Rest" Occupancy State
CUSTOMER DETAILS
Client M/s.Sabui Medical Stores (MFG) Document No GMPLCS/SML/PCT/21-22/B002
3,Sardar Ghat Lane,Bhadreshwar,Hooghly. Test Reference EUGMP-ISO:2015
telangana-503102 Date of Test 13/09/2021
Room Name Filling Sealing Next Due Date 12/09/2022
Room ID Filling sealing Room Area of test Filling Area
INSTRUMENT USED FOR TESTING
Instrument Name Airborne Particle counter Make TSI
Model 9350-03 Serial No 93501922002
Flow Rate 50.0 lpm Sampling Time 01 Minute
Calibrated On 14/07/2021 Calibration Due On 14/07/2022
OBTAINED TEST RESULT ACCEPTANCE CRITERIA
ISO Accepatance Accepatance
Obtained No.of Particles ≥ 0.5 μm³ Obtained No.of Particles ≥ 5.0 μm³ Result
Classification Location Criteria for the Criteria for the
Number Particle size ≥ Particle size ≥
S1 S1 0.5 µm /ft³ 5.0 µm / ft³

1 11266 277 100,000 700 Pass


2 20201 151 100,000 700 Pass
ISO Class "5" 3 24009 251 100,000 700 Pass
4 15411 628 100,000 700 Pass
5 23318 194 100,000 700 Pass
Mean of the average 18841 300 100,000 700 Pass

INFERENCE The above Specified Confirms to ISO Class "D" for Particle Count Test as per -ISO:2015

Conducted By Checked By Approved By

Mr.Balaji ENGINEERING QA
M/s.GMP laboratories And Clean Room Solutions M/s.Sabui Medical Stores (MFG)

Page 2 of 6
PARTICLE COUNT TEST CERTIFICATE

PURPOSE
To the determine the actual Airborne Particle count Cleanliness Level in a clean room "At Rest" Occupancy State
CUSTOMER DETAILS
Client M/s.Sabui Medical Stores (MFG) Document No GMPLCS/SML/PCT/21-22/B003
3,Sardar Ghat Lane,Bhadreshwar,Hooghly. Test Reference EUGMP-ISO:2015
telangana-503102 Date of Test 13/09/2021
Room Name Bulk Filling Next Due Date 12/09/2022
Room ID Bulk Filling Room Area of test Filling Area
INSTRUMENT USED FOR TESTING
Instrument Name Airborne Particle counter Make TSI
Model 9350-03 Serial No 93501922002
Flow Rate 50.0 lpm Sampling Time 01 Minute
Calibrated On 14/07/2021 Calibration Due On 14/07/2022
OBTAINED TEST RESULT ACCEPTANCE CRITERIA
ISO Accepatance Accepatance
Obtained No.of Particles ≥ 0.5 μm³ Obtained No.of Particles ≥ 5.0 μm³ Result
Classification Location Criteria for the Criteria for the
Number Particle size ≥ Particle size ≥
S1 S1 0.5 µm /ft³ 5.0 µm / ft³

1 10644 101 100,000 700 Pass


2 20109 199 100,000 700 Pass
ISO Class "5" 3 11902 215 100,000 700 Pass
4 1340 428 100,000 700 Pass
5 19809 458 100,000 700 Pass
Mean of the average 12761 280 100,000 700 Pass

INFERENCE The above Specified Confirms to ISO Class "D" for Particle Count Test as per -ISO:2015

Conducted By Checked By Approved By

Mr.Balaji ENGINEERING QA
M/s.GMP laboratories And Clean Room Solutions M/s.Sabui Medical Stores (MFG)

Page 3 of 6
PARTICLE COUNT TEST CERTIFICATE

PURPOSE
To the determine the actual Airborne Particle count Cleanliness Level in a clean room "At Rest" Occupancy State
CUSTOMER DETAILS
Client M/s.Sabui Medical Stores (MFG) Document No GMPLCS/SML/PCT/21-22/B004
3,Sardar Ghat Lane,Bhadreshwar,Hooghly. Test Reference EUGMP-ISO:2015
telangana-503102 Date of Test 13/09/2021
Room Name LAF Room Next Due Date 12/09/2022
Room ID LAF Room Area of test Microbiology
INSTRUMENT USED FOR TESTING
Instrument Name Airborne Particle counter Make TSI
Model 9350-03 Serial No 93501922002
Flow Rate 50.0 lpm Sampling Time 01 Minute
Calibrated On 14/07/2021 Calibration Due On 14/07/2022
OBTAINED TEST RESULT ACCEPTANCE CRITERIA
ISO Accepatance Accepatance
Obtained No.of Particles ≥ 0.5 μm³ Obtained No.of Particles ≥ 5.0 μm³ Result
Classification Location Criteria for the Criteria for the
Number Particle size ≥ Particle size ≥
S1 S1 0.5 µm /ft³ 5.0 µm / ft³

1 2438 19 100,000 700 Pass


2 3541 29 100,000 700 Pass
ISO Class "5"
3 2569 134 100,000 700 Pass
4 8424 105 100,000 700 Pass
Mean of the average 4243 72 100,000 700 Pass

INFERENCE The above Specified Confirms to ISO Class "D" for Particle Count Test as per -ISO:2015

Conducted By Checked By Approved By

Mr.Balaji ENGINEERING QA
M/s.GMP laboratories And Clean Room Solutions M/s.Sabui Medical Stores (MFG)

Page 4 of 6
PARTICLE COUNT TEST CERTIFICATE

PURPOSE
To the determine the actual Airborne Particle count Cleanliness Level in a clean room "At Rest" Occupancy State
CUSTOMER DETAILS
Client M/s.Sabui Medical Stores (MFG) Document No GMPLCS/SML/PCT/21-22/B005
3,Sardar Ghat Lane,Bhadreshwar,Hooghly. Test Reference EUGMP-ISO:2015
telangana-503102 Date of Test 13/09/2021
Room Name Air Lock Next Due Date 12/09/2022
Room ID Air Lock Room Area of test Microbiology
INSTRUMENT USED FOR TESTING
Instrument Name Airborne Particle counter Make TSI
Model 9350-03 Serial No 93501922002
Flow Rate 50.0 lpm Sampling Time 01 Minute
Calibrated On 14/07/2021 Calibration Due On 14/07/2022
OBTAINED TEST RESULT ACCEPTANCE CRITERIA
ISO Accepatance Accepatance
Obtained No.of Particles ≥ 0.5 μm³ Obtained No.of Particles ≥ 5.0 μm³ Result
Classification Location Criteria for the Criteria for the
Number Particle size ≥ Particle size ≥
S1 S1 0.5 µm /ft³ 5.0 µm / ft³

1 3084 38 100,000 700 Pass


ISO Class "5" 2 5946 77 100,000 700 Pass
3 3662 57 100,000 700 Pass
Mean of the average 4231 57 100,000 700 Pass

INFERENCE The above Specified Confirms to ISO Class "D" for Particle Count Test as per -ISO:2015

Conducted By Checked By Approved By

Mr.Balaji ENGINEERING QA
M/s.GMP laboratories And Clean Room Solutions M/s.Sabui Medical Stores (MFG)

Page 5 of 6
PARTICLE COUNT TEST CERTIFICATE

PURPOSE
To the determine the actual Airborne Particle count Cleanliness Level in a clean room "At Rest" Occupancy State
CUSTOMER DETAILS
Client M/s.Sabui Medical Stores (MFG) Document No GMPLCS/SML/PCT/21-22/B006
3,Sardar Ghat Lane,Bhadreshwar,Hooghly. Test Reference EUGMP-ISO:2015
telangana-503102 Date of Test 13/09/2021
Room Name Incubator Next Due Date 12/09/2022
Room ID Incubator Room Area of test Microbiology
INSTRUMENT USED FOR TESTING
Instrument Name Airborne Particle counter Make TSI
Model 9350-03 Serial No 93501922002
Flow Rate 50.0 lpm Sampling Time 01 Minute
Calibrated On 14/07/2021 Calibration Due On 14/07/2022
OBTAINED TEST RESULT ACCEPTANCE CRITERIA
ISO Accepatance Accepatance
Obtained No.of Particles ≥ 0.5 μm³ Obtained No.of Particles ≥ 5.0 μm³ Result
Classification Location Criteria for the Criteria for the
Number Particle size ≥ Particle size ≥
S1 S1 0.5 µm /ft³ 5.0 µm / ft³

1 3706 53 100,000 700 Pass


2 4276 48 100,000 700 Pass
ISO Class "5"
3 3831 45 100,000 700 Pass
4 857 35 100,000 700 Pass
Mean of the average 3168 45 100,000 700 Pass

INFERENCE The above Specified Confirms to ISO Class "D" for Particle Count Test as per -ISO:2015

Conducted By Checked By Approved By

Mr.Balaji ENGINEERING QA
M/s.GMP laboratories And Clean Room Solutions M/s.Sabui Medical Stores (MFG)

Page 6 of 6

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