TEST CERTIFICATE

* Air Borne Particle Count Test *

Client M/s Hetero Labs Ltd Date of Test
Location Unit-V,Jadcherla Equipment Name
Ref.No UL/PC/HLL/1463 Equipment ID No.
Area of Test Granulation - 3 Classification
Test Condition At Rest
Instrument Used
Name Air Borne Particle Counter Make
Model Cl-752x S.No
Flow Rate 75.5LPM
Calibration Done On 23.12.2013 Calibration Due On
Sampling Protocol Plan
Sample Volume 75 Liters No. of Locations
Sampling Time 00:01:00
Obtained Test Results
Sampling 0.5 /m
Room Name & No.
Location R1 R2 R3 Average R1
01 62586 37200 41066 46951.1 6693
02 100986 36520 29493 55666.7 10293
03 48160 26813 25373 33448.9 3666
04 64506 41573 38106 48062.2 8226
Granulation - 3(G1054) 05 45426 43160 28133 38906.7 4426
06 49853 40973 43813 44880.0 5040
07 64840 58066 55653 59520.0 7506
08 44986 50506 58093 51195.6 5173
09 70640 57413 79893 69315.6 8093
Mean Average 49771.9
Standard Deviation 10799.6
Standard Error 3599.9
95% UCL 56611.6
Maximum permitted number of particles/m 3 equal to or above
Class At Rest In Operation
0.5 /m 5.0 /m 0.5 /m
ISO-5 3520 29 3520
ISO-6 35200 293 352000
ISO-7 352000 2930 3520000
ISO-8 3520000 29300 Not Defined
INFERENCE: The above test results of room Confirms to ISO 14644-1 Class 8

Test Conducted By Test Witne

For Umed Laboratories For Hetero Lab

 3/9/2014
Air Handling Unit
ENE-1062
ISO-8

CLIMET
079431

22.12.2014

5.0 /m
R2 R3 Average
3906 3960 4853.3
3946 2906 5715.6
2306 2293 2755.6
4173 4906 5768.9
4640 3146 4071.1
3800 4386 4408.9
5853 5786 6382.2
5160 6413 5582.2
6480 8866 7813.3
5261.2
1454.5
484.8
6182.4
above
In Operation
5.0 /m
29
2930
29300
Not Defined
 Test Witnessed By

For Hetero Labs Ltd (Unit-V)

 TEST CERTIFICATE
* Air Borne Particle Count Tes
Client M/s AUROPEPTIDES LIMITED
Division IV Floor,APLRC2
Area of Test Production,Line-II
Test Condition In Operation

*Instrument Used*
Name Air Borne Particle Counter
Model Lasair-III(350L)
Flow Rate 50 LPM
Calibration Done On 29.07.2016
*Sampling Protocol Plan*
Sample Volume 50 Liters
Sampling Time 00:01:00
*Obtained Test Results*
Sampling 0.5 /m
Room Name & No.
Location R1 R2 R3
L1 56176 65520 68601
L2 77720 69489 61404
L3 63656 63160 49335
Glass Ware Stores-1
L4 39272 28219 22745
(P1-183)
L5 37779 42496 58940
L6 70552 64959 101537
L7 76884 60560 53493
Average Particles 58

Maximum permitted number of particles

EU-GMP
EU-GMP GRADE
GRADE/ISO
In Operation
0.5 /m 5.0 /m 0.5 /m
A 3520 20 ISO-5
B 352000 2900 ISO-6
C 3520000 29000 ISO-7
D Not Defined Not Defined ISO-8
ISO-9

INFERENCE: The above test results of room confirms to ISO 14644-1: 25-Dec-2015 EU-GMP Uncl

Test Conducted By
For Umed Laboratories
RTIFICATE
icle Count Test *
Date of Test 10.01.2017
Equipment Name Air Handling Unit
Equipment Id No AUE016
Classification Unclassified / ISO9

ent Used*
Make Lasair-III
S.No 101110

Calibration Due On 29.07.2017

rotocol Plan*
No. of Locations 07

Test Results*
5.0 /m
Average R1 R2 R3 Average
63432 6040 7580 7300 6973
69538 6660 5739 4380 5593
58717 5620 5320 3880 4940
30079 2539 2060 1380 1993
46405 2900 3460 4880 3747
79016 6941 5320 8201 6821
63646 6660 5240 4999 5633
58690 5100

number of particles/m3 equal to or below

ISO CLASS
In Operation
0.5 /m 5.0 /m
3520 29
352000 2930
3520000 29300
Not Defined Not Defined
35200000 293000

015 EU-GMP Unclassified/ISO9 (In Operation)

Test Witnessed By
For AURO PEPTIDES LIMITED
 TEST CERTIFICATE
* Air Borne Particle Count Tes
Client M/s AUROPEPTIDES LIMITED
Division IV Floor,APLRC2
Area of Test Production,Line-II
Test Condition In Operation

*Instrument Used*
Name Air Borne Particle Counter
Model Lasair-III(350L)
Flow Rate 50 LPM
Calibration Done On 29.07.2016
*Sampling Protocol Plan*
Sample Volume 50 Liters
Sampling Time 00:01:00
*Obtained Test Results*
Sampling 0.5 /m
Room Name & No.
Location R1 R2 R3
L1 38625 42810 45980
L2 44891 47691 71804
L3 57567 42696 73567
L4 51129 62163 67932
Equipment Hold-1 L5 66853 58365 54643
(P1-182) L6 67536 106585 84037
L7 87522 80262 81412
L8 105339 91306 74817
L9 64779 46441 38579
L10 36283 34268 52624
Average Particles 62

Maximum permitted number of particles

EU-GMP
EU-GMP GRADE
GRADE/ISO
In Operation
0.5 /m 5.0 /m 0.5 /m
A 3520 20 ISO-5
B 352000 2900 ISO-6
C 3520000 29000 ISO-7
D Not Defined Not Defined ISO-8
ISO-9
INFERENCE: The above test results of room confirms to ISO 14644-1: 25-Dec-2015 EU-GMP Uncl

Test Conducted By

For Umed Laboratories

RTIFICATE
icle Count Test *
Date of Test 10.01.2017
Equipment Name Air Handling Unit
Equipment Id No AUE016
Classification Unclassified / ISO9

ent Used*
Make Lasair-III
S.No 101110

Calibration Due On 29.07.2017

rotocol Plan*
No. of Locations 10

Test Results*
5.0 /m
Average R1 R2 R3 Average
42471 3520 4279 5160 4320
54795 4899 4599 7540 5680
57944 5839 4102 6142 5361
60408 4481 5642 6201 5441
59954 7179 5019 5520 5906
86053 7100 9279 7100 7826
83065 7240 6160 7059 6820
90487 9422 7282 6103 7602
49933 4800 3440 2620 3620
41059 2400 2341 4682 3141
62617 5572

number of particles/m3 equal to or below

ISO CLASS
In Operation
0.5 /m 5.0 /m
3520 29
352000 2930
3520000 29300
Not Defined Not Defined
35200000 293000
015 EU-GMP Unclassified/ISO9 (In Operation)

Test Witnessed By

For AURO PEPTIDES LIMITED

 TEST CERTIFICATE
* Air Borne Particle Count Tes
Client M/s AUROPEPTIDES LIMITED
Division IV Floor,APLRC2
Area of Test Production,Line-II
Test Condition In Operation

*Instrument Used*
Name Air Borne Particle Counter
Model Lasair-III(350L)
Flow Rate 50 LPM
Calibration Done On 29.07.2016
*Sampling Protocol Plan*
Sample Volume 50 Liters
Sampling Time 00:01:00
*Obtained Test Results*
Sampling 0.5 /m
Room Name & No.
Location R1 R2 R3
L1 72947 84936 72213
L2 60845 52032 79664
L3 118390 108265 119693
Analytical Reagents Room(P1- L4 92182 78736 72585
181) L5 95049 97473 85431
L6 81168 69602 56296
L7 46246 42897 49173
L8 47051 44393 49495
Average Particles 74

Maximum permitted number of particles

EU-GMP
EU-GMP GRADE
GRADE/ISO
In Operation
0.5 /m 5.0 /m 0.5 /m
A 3520 20 ISO-5
B 352000 2900 ISO-6
C 3520000 29000 ISO-7
D Not Defined Not Defined ISO-8
ISO-9

INFERENCE: The above test results of room confirms to ISO 14644-1: 25-Dec-2015 EU-GMP Uncl

Test Conducted By
For Umed Laboratories
RTIFICATE
icle Count Test *
Date of Test 10.01.2017
Equipment Name Air Handling Unit
Equipment Id No AUE016
Classification Unclassified / ISO9

ent Used*
Make Lasair-III
S.No 101110

Calibration Due On 29.07.2017

rotocol Plan*
No. of Locations 08

Test Results*
5.0 /m
Average R1 R2 R3 Average
76699 6201 6958 5238 6132
64180 3780 3699 5179 4220
115449 8601 7800 8799 8400
81168 6440 5681 5242 5788
92651 8201 8861 7201 8088
69022 7379 5182 4760 5773
46105 3500 4180 4479 4053
46980 4079 3200 4500 3926
74032 5798

number of particles/m3 equal to or below

ISO CLASS
In Operation
0.5 /m 5.0 /m
3520 29
352000 2930
3520000 29300
Not Defined Not Defined
35200000 293000

015 EU-GMP Unclassified/ISO9 (In Operation)

Test Witnessed By
For AURO PEPTIDES LIMITED
 TEST CERTIFICATE
* Air Borne Particle Count Tes
Client M/s AUROPEPTIDES LIMITED
Division IV Floor,APLRC2
Area of Test Production,Line-II
Test Condition In Operation

*Instrument Used*
Name Air Borne Particle Counter
Model Lasair-III(350L)
Flow Rate 50 LPM
Calibration Done On 29.07.2016
*Sampling Protocol Plan*
Sample Volume 50 Liters
Sampling Time 00:01:00
*Obtained Test Results*
Sampling 0.5 /m
Room Name & No.
Location R1 R2 R3
L1 37144 12821 82877
L2 59744 40340 62685
L3 59028 81561 71214
Spare Room-5 L4 77947 843530 110852
(P1-
180) L5 49704 71923 57965
L6 117023 78700 123070
L7 69548 41144 80450
L8 117922 153672 46891
Average Particles 106

Maximum permitted number of particles

EU-GMP
EU-GMP GRADE
GRADE/ISO
In Operation
0.5 /m 5.0 /m 0.5 /m
A 3520 20 ISO-5
B 352000 2900 ISO-6
C 3520000 29000 ISO-7
D Not Defined Not Defined ISO-8
ISO-9

INFERENCE: The above test results of room confirms to ISO 14644-1: 25-Dec-2015 EU-GMP Uncl

Test Conducted By
For Umed Laboratories
RTIFICATE
icle Count Test *
Date of Test 10.01.2017
Equipment Name Air Handling Unit
Equipment Id No AUE016
Classification Unclassified / ISO9

ent Used*
Make Lasair-III
S.No 101110

Calibration Due On 29.07.2017

rotocol Plan*
No. of Locations 08

Test Results*
5.0 /m
Average R1 R2 R3 Average
44281 8941 1880 5961 5594
54256 21301 2300 2360 8654
70601 2441 1500 4621 2854
344110 1500 6360 2020 3293
59864 3200 3120 1300 2540
106264 2340 2400 1800 2180
63714 3460 2440 2480 2794
106162 1680 1280 2701 1887
106157 3725

number of particles/m3 equal to or below

ISO CLASS
In Operation
0.5 /m 5.0 /m
3520 29
352000 2930
3520000 29300
Not Defined Not Defined
35200000 293000

015 EU-GMP Unclassified/ISO9 (In Operation)

Test Witnessed By
For AURO PEPTIDES LIMITED
 TEST CERTIFICATE
* Air Borne Particle Count Tes
Client M/s AUROPEPTIDES LIMITED
Division IV Floor,APLRC2
Area of Test Production,Line-II
Test Condition In Operation

*Instrument Used*
Name Air Borne Particle Counter
Model Lasair-III(350L)
Flow Rate 50 LPM
Calibration Done On 29.07.2016
*Sampling Protocol Plan*
Sample Volume 50 Liters
Sampling Time 00:01:00
*Obtained Test Results*
Sampling 0.5 /m
Room Name & No.
Location R1 R2 R3
L1 143616 193987 139664
L2 112770 89853 83582
L3 66608 55300 54794
L4 54847 157891 156944
L5 192714 135545 98248
Wash Area-1 (P1-179)
L6 85634 76195 77976
L7 92439 100274 97543
L8 86378 117672 144411
L9 126571 166254 140061
L10 120760 115034 100196
Average Particles 112

Maximum permitted number of particles

EU-GMP
EU-GMP GRADE
GRADE/ISO
In Operation
0.5 /m 5.0 /m 0.5 /m
A 3520 20 ISO-5
B 352000 2900 ISO-6
C 3520000 29000 ISO-7
D Not Defined Not Defined ISO-8
ISO-9
INFERENCE: The above test results of room confirms to ISO 14644-1: 25-Dec-2015 EU-GMP Uncl

Test Conducted By

For Umed Laboratories

RTIFICATE
icle Count Test *
Date of Test 10.01.2017
Equipment Name Air Handling Unit
Equipment Id No AUE016
Classification Unclassified / ISO9

ent Used*
Make Lasair-III
S.No 101110

Calibration Due On 29.07.2017

rotocol Plan*
No. of Locations 10

Test Results*
5.0 /m
Average R1 R2 R3 Average
159089 12000 16064 11242 13102
95402 10441 7761 7462 8555
58901 5941 4440 4520 4967
123228 4481 14497 14217 11065
142169 17443 11539 7199 12060
79935 7701 7260 6701 7221
96752 7418 7100 7020 7179
116154 5540 10181 13079 9600
144295 9841 13183 10302 11108
111997 8120 8320 7018 7819
112792 9268

number of particles/m3 equal to or below

ISO CLASS
In Operation
0.5 /m 5.0 /m
3520 29
352000 2930
3520000 29300
Not Defined Not Defined
35200000 293000
015 EU-GMP Unclassified/ISO9 (In Operation)

Test Witnessed By

For AURO PEPTIDES LIMITED