Report No:-
N EXTECH
NEXTECH SDN BHD
(NEBB Certified Firm Registration No. 3144)
Procedure for
Airflow Velocity Test
Purpose
To determine the average filter face velocity and uniformity of filters installed in the cleanroom
Instrumentation
Multifunction Micromanometer / AirData Multimeter
Specifications
Testing Condition : S As Built At Rest In Operation
Average Velocity : Refer to summary of test result
Procedure
References : International Organization for Standardization, ISO 14644-1:2015
NEBB Procedural Standards for Certified Testing of Cleanrooms, 2009-3rd Edition
IEST-RP-CC-006.3 Testing Cleanroom
EU Guideline to Good Manufacturing Practice Medicinal Product
• PICS -Annex 1 Manufacture Of Sterile Medicinal Products 1 July 2018
1. Every 2'x4' filter was divided into 2 test grids (1 test grid for 2' x 2')
2. The manometer was set up on the testing fixture, which are designed to suit the
above grids. The probe was then positioned at the center of each 2 feet by 2 feet grid.
3. Measure the airflow velocity at each test position. Allow 10 seconds for each measurement
and record the average reading during the period
Computation Method
k
v i, p
Average Face Velocity for Filter i, Vi
p =1
k
n k
v i, p
V
i =1 p =1
Room Average Velocity,
nk
where,
k = 4, is the number of velocity readings taken per filter
n = total number of filters in the room/zone
n k = total number of velocity readings taken for the room/zone
vi, p = is the p th velocity reading for the i th filter
Doc No. NT/APC/ISO/03
Date : 31.12.2015 (Revision 01) Compiled by Nextech Sdn Bhd
Report No:-
N EXTECH
NEXTECH SDN BHD
(NEBB Certified Firm Registration No. 3144)
Procedure for
Filter Installation Leak Test
(Ambient Scan Method)
Purpose
To verify the absence of bypass leakage (between filter frame and ceiling frame and ceiling grid system)
in the installation of the filters and confirm that the installed filters are free of defect and small leaks.
Instrumentation
Airborne Particle Counter with Isokinetic Sampling Proble
Specifications
Testing Condition : S As Built At Rest In Operation
Procedure
References : International Organization for Standardization, ISO 14644-1:2015
NEBB Procedural Standards for Certified Testing of Cleanrooms, 2009-3rd Edition
IEST-RP-CC-006.3 Testing Cleanroom
IEST-RP-CC001.6 HEPA and ULPA Filter
1. The filter's face velocities were determined to ensure that they are within the general
design range
2. The upstream concentration was taken, at particle size 0.3 micron and greater. This was
taken for information only
3. Airborne Particle Counters with a resolution of 0.3 micron or greater was used for the leak
test. The sampling flow rate of the counters was at 13m/min.
4. A rectangular handheld Isokinetic Sampling Probes was used to scan the filters. The probe
dimension was selected to achieve isokinetic sampling. The scanning rate not to exceed
1ft2/min with overlapping motion.
5. The probe was held at 1" from the frame and filter surface during scanning. A count of 1 or
more will force a sustained residence time of the probe at the location to assess the source
of the detected counts.
6. All confirmed or suspected leaks was indentified and recorded. Re-test were conducted after
remedial action had been taken.
Doc No. NT/APC/ISO/03
Date : 31.12.2015 (Revision 01) Compiled by Nextech Sdn Bhd
Report No:-
N EXTECH
NEXTECH SDN BHD
(NEBB Certified Firm Registration No. 3144)
Procedure for
Airborne Particle Count Test
Purpose
To measure the airborne particulate level in the cleanroom and to determine the room cleanliness
classification as per ISO 14644-1: 2015
Instrumentation : Airborne Particle Counter
Testing Condition : S As Built At Rest In Operation
Acceptance Criteria :
Airborne Particulate Cleanliness classes for cleanrooms and clean zones
TABLE 1: ISO 14644-1 : 2015 NEW MAXIMUM CONCENTRATION LIMITS
Maximum concentration limits (particle/m3 of air) for particles equal to
and larger than the considered sizes below
Cleanliness Class Number 0.1 µm 0.2 µm 0.3 µm 0.5 µm 1.0 µm 5.0 µm
ISO Class 1 10 N/A N/A N/A N/A N/A
ISO Class 2 100 24 10 N/A N/A N/A
ISO Class 3 1 000 237 102 35 N/A N/A
ISO Class 4 10 000 2 370 1 020 352 83 N/A
ISO Class 5 100 000 23 700 10 200 3 520 832 N/A
ISO Class 6 1 000 000 237 000 102 000 35 200 8 320 293
ISO Class 7 N/A N/A N/A 352 000 83 200 2 930
ISO Class 8 N/A N/A N/A 3 520 000 832 000 29 300
ISO Class 9 N/A N/A N/A 35 200 000 8 320 000 293 000
Test Procedure
References : International Organization for Standardization, ISO 14644-1:2015
NEBB Procedural Standards for Certified Testing of Cleanrooms, 2009-3rd Edition
IEST-RP-CC-006.3 Testing Cleanroom
1. This test was conducted after all the other test had been completed.
2. The Cleanroom were purged for at least 12 hours before testing commences.
3. The rooms were divided into test grids using the Table 2:-
TABLE 2 : SAMPLING LOCATIONS RELATED TO CLEANROOM AREA
Area of cleanroom Minimum number of Area of cleanroom Minimum number of
(m2) less than or sampling location to be (m2) less than or sampling location to be
equal to tested (NL) equal to tested (NL)
2 1 76 15
4 2 104 16
6 3 108 17
8 4 116 18
10 5 148 19
24 6 156 20
28 7 192 21
32 8 232 22
36 9 276 23
52 10 352 24
56 11 436 25
64 12 636 26
68 13 1 000 27
72 14 > 1 000 See Formula (A.1)
Formula (A.1) 𝐴
𝐴 ≥ 1000 𝑚2 , 𝑁𝐿 = 27
1000
Doc No. NT/APC/ISO/03
Date : 31.12.2015 (Revision 01) Compiled by Nextech Sdn Bhd
Report No:-
N EXTECH
NEXTECH SDN BHD
(NEBB Certified Firm Registration No. 3144)
Procedure for
Airborne Particle Count Test
4. The counter's sampling time was set to 1 minute.
5. A minimum of 1 sample was taken at the centre of each grid, at a height of 1 meter above
the floor.
6. When an obstruction was encountered, the sample was taken at 1ft above the obstruction.
Computation Method
2.08
𝐾𝑁
𝐶2 = 10 𝑥
𝐷
C 2 is the maximum permitted concentration (particle per cubic meter) of airborne
particles that are equal to and greater than the considered particle size
N is the ISO classification number, which shall not exceed a value of 9 or less than 1
D is the considered particle size, in micrometers, that is not listed in Table 1
K is the constant, 0.1, expressed in micrometer
Doc No. NT/APC/ISO/03
Date : 31.12.2015 (Revision 01) Compiled by Nextech Sdn Bhd
Report No:-
N EXTECH
NEXTECH SDN BHD
(NEBB Certified Firm Registration No. 3144)
Procedure for
Temperature & Relative Humidity Test
Purpose
To determine the capability of the Cleanroom air handling system to maintain the air temperature
and relative humidity within the specified limits.
Instrumentation
Temperature Humidity Meter
Specifications
Testing Condition : S As Built At Rest 0 In Operation
Average : Temperature - Please refer to Summary of Test Results
Relative Humidity - Please refer to Summary of Test Results
Procedure
References : International Organization for Standardization, ISO 14644-1:2015
NEBB Procedural Standards for Certified Testing of Cleanrooms, 2009-3rd Edition
IEST-RP-CC-006.3 Testing Cleanroom
EU Guideline to Good Manufacturing Practice Medicinal Product
• PICS -Annex 1 Manufacture Of Sterile Medicinal Products 1 July 2018
1. All airflow balancing was successfully completed prior to this test
2. The air conditioning system was operated continuously for at least 24 hours prior to the
commencement of the test.
3. The probe of the anemometer was positioned at the center of the sampling grid at a height of
1 meter from the floor.
4. When an obstruction was encountered, measurement was taken at 6 inches above the
obstruction.
5. Readings were recorded after stabilization.
6. The average temperature and relative humidity of the cleanroom were computed from the data.
Doc No. NT/APC/ISO/03
Date : 31.12.2015 (Revision 01) Compiled by Nextech Sdn Bhd
Report No:-
N EXTECH
NEXTECH SDN BHD
(NEBB Certified Firm Registration No. 3144)
Procedure for
Light Intensity Test
Purpose
To determine the light intensity level at working height level within the Cleanrooms
Instrumentation
Lux Meter
Specifications
Testing Condition : S As Built At Rest In Operation
Average lighting intensity : Please refer to summary of test result
Procedure
References : International Organization for Standardization, ISO 14644-1:2015
NEBB Procedural Standards for Certified Testing of Cleanrooms, 2009-3rd Edition
IEST-RP-CC-006.3 Testing Cleanroom
EU Guideline to Good Manufacturing Practice Medicinal Product
• PICS -Annex 1 Manufacture Of Sterile Medicinal Products 1 July 2018
1. All fluorescent lighting were operated for at least 100 hours to ensure "proper seasoning".
2. The lighting were operated continuously for at least 2 hours to allow for temperature
stabilization prior to the actual commencement of the test.
3. One reading was taken at the centre of each grid and at a height of 1 meter above the floor.
4. If there were obstructing equipment or furniture, the measurement was taken at 6 inches
above the obstruction.
Doc No. NT/APC/ISO/03
Date : 31.12.2015 (Revision 01) Compiled by Nextech Sdn Bhd
Report No:-
N EXTECH
NEXTECH SDN BHD
(NEBB Certified Firm Registration No. 3144)
Procedure for
Room Differential Pressure Test
Purpose
To determine the capability of the Cleanroom system to maintain the specified pressure
differential
Instrumentation
Multifunction Micromanometer / Airdata Multimeter
Specifications
Testing Condition : S As Built At Rest In Operation
Differential Pressure : Please refer to Summary of Test Result
Procedure
References : International Organization for Standardization, ISO 14644-1:2015
NEBB Procedural Standards for Certified Testing of Cleanrooms, 2009-3rd Edition
IEST-RP-CC-006.3 Testing Cleanroom
EU Guideline to Good Manufacturing Practice Medicinal Product
• PICS -Annex 1 Manufacture Of Sterile Medicinal Products 1 July 2018
1. All airflow balancing was successfully completed prior to this test
2. All doors into the Cleanroom and the reference areas were closed throughout the duration
of the test
3. Differential pressure between the Cleanroom and the reference area were measured
and recorded with manometer
Doc No. NT/APC/ISO/03
Date : 31.12.2015 (Revision 01) Compiled by Nextech Sdn Bhd
