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Filter Integrity Test Certificate Purpose: To Determine The Integrity of Installed Hepa Filters

The document reports the results of filter integrity tests conducted on HEPA filters installed in laminar airflow equipment and air handling units at a medical supplies manufacturing facility. Filters were tested using an aerosol photometer to measure upstream and downstream aerosol concentrations. All filters tested showed upstream concentrations between 20-80 μg/ltr and downstream concentrations less than 0.01%, indicating the filters passed the integrity test.

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831 views2 pages

Filter Integrity Test Certificate Purpose: To Determine The Integrity of Installed Hepa Filters

The document reports the results of filter integrity tests conducted on HEPA filters installed in laminar airflow equipment and air handling units at a medical supplies manufacturing facility. Filters were tested using an aerosol photometer to measure upstream and downstream aerosol concentrations. All filters tested showed upstream concentrations between 20-80 μg/ltr and downstream concentrations less than 0.01%, indicating the filters passed the integrity test.

Uploaded by

balajichandrakant
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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FILTER INTEGRITY TEST CERTIFICATE

PURPOSE: TO DETERMINE THE INTEGRITY OF INSTALLED HEPA FILTERS


Client M/[Link] Medical Stores (MFG) Reference No GMPLCS/SMS/FIT/21-22/B001
3,Sardar Ghat Lane,Bhadreshwar,Hooghly. Test Reference ISO 14644-3
West Bengal. Date of Test 13/09/2021
Area of Test Microbilogy Next Due Date 12/09/2022
Equipement ID No. SML/LAF/01 Equipement Name Laminar Air Flow
INSTRUMENT USED FOR TESTING
Instrument Name Aerosol Photometer Make TSI
Serial No 2975 Model PH-5
Calibrated on 03/06/2021 Calibration Due On 03/06/2022
Genarator Details
Instrument Name Aerosol Generator Make ATI
[Link] SEC/ASG-05 Model TDA-4B
OBTAINED TEST RESULTS
Upstream aerosol Upstream aerosol Downstream aerosol
Sr. Supply Filter Concentration
Room /Equipement Name Concentration in (µg/ltr) concentration in (%) Results
No. [Link] in (%) NLT 100%
20 to 80 (µg/ltr) (LT 0.01%)

laminar Air Flow


1 F1 32 100 0.0001 Passed
(SML/LAF/01)

REMARK : The HEPA filters installed in the above specified were Passed / Failed filter integrity test by
using PAO.
Conducted By Witnessed By Approved By

Balaji Bobade ENGINEERING QA


M/[Link] laboratories And Clean Room Solutions M/[Link] Medical Stores (MFG)
FILTER INTEGRITY TEST CERTIFICATE

PURPOSE: TO DETERMINE THE INTEGRITY OF INSTALLED HEPA FILTERS


Client M/[Link] Medical Stores (MFG) Reference No GMPLCS/SMS/FIT/21-22/B002
3,Sardar Ghat Lane,Bhadreshwar,Hooghly. Test Reference ISO 14644-3
West Bengal. Date of Test 13/09/2021
Area of Test Microbilogy Next Due Date 12/09/2022
AHU No. AHU-01 Area Second Floore
INSTRUMENT USED FOR TESTING
Instrument Name Aerosol Photometer Make TSI
Serial No 2975 Model PH-5
Calibrated on 03/06/2021 Calibration Due On 03/06/2022
Genarator Details
Instrument Name Aerosol Generator Make ATI
[Link] SEC/ASG-05 Model TDA-4B
OBTAINED TEST RESULTS
Upstream aerosol Upstream aerosol Downstream aerosol
Sr. Supply Filter Concentration
Room Name Concentration in (µg/ltr) concentration in (%) Results
No. [Link] in (%) NLT 100%
20 to 80 (µg/ltr) (LT 0.01%)

1 LAF ROOM F1 32 100 0.0001 Passed

2 AIR LOCK-1 F1 35 100 0.0040 Passed

3 INCUBATOR ROOM F1 30 100 0.0020 Passed

REMARK : The HEPA filters installed in the above specified were Passed / Failed filter integrity test by
using PAO.
Conducted By Witnessed By Approved By

Balaji Bobade ENGINEERING QA


M/[Link] laboratories And Clean Room Solutions M/[Link] Medical Stores (MFG)

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