DIAMETER DIAMETER DIAMETER DIAMETER

0.000 0.000 0.000 0.000

0.000 0.000 0.000 0.000
#DIV/0! #DIV/0! #DIV/0! #DIV/0!

DIAMETER

Moisture
Blank 1 2 3 SD
0.0518 0.0517 0.0519 0.000100 RSD=SD/avg.*100
Average 0.0518 RSD 0.19
Sample A B C Final
1 214.1 0.1 214.0 2140
2 223.8 0.1 223.7 2237
Average Moisture 2189

0.000
0.000
###
 VS Solution Preparation -- 0.1 Sodium Thiosulfate

1.016 1.004 1.017 Sum/3 Average SD %RSD

7.5864 7.5864 7.5864
0.1339239 0.1323421 0.1340557 0.4003216 0.3109512 0.1334405 0.0009536 1

0.0503 0.0508 0.0516 0.1527 0.1183 0.0509 0.0006557 1

 DIAMETER DIAMETER DIAMETER DIAMETER

0.000 0.000 0.000

0.000 0.000 0.000
#DIV/0! #DIV/0! #DIV/0!

DIAMETER DIAMETER DIAMETER

0.000 0.000
0.000 0.000
#DIV/0! #DIV/0!
DIAMETER
 SONALI KUSHAL
ADVALON SIZE-1 ADVALON SIZE-1
DIAMETER DIAMETER
0.489 0.523 0.520 0.488 0.521 0.520
0.522 0.479 0.480 0.494 0.528 0.515
0.507 0.478 0.459 0.451 0.455 0.471
0.480 0.525 0.530 0.477 0.487 0.521
0.451 0.448 0.475 0.449 0.461 0.446
0.473 0.511 0.528 0.476 0.498 0.458
0.499 0.462 0.448 0.489 0.465 0.474
0.489 0.514 0.524 0.448 0.465 0.518
0.526 0.499 0.444 0.448 0.456 0.469
0.468 0.472 0.468 0.524 0.517 0.490
Min 0.444 0.446
Max 0.530 0.528
avg 0.490 0.483

SONALI KUSHAL
ADVALON SIZE-1 ADVALON SIZE-1
DIAMETER DIAMETER
0.489 0.523 0.520 0.488 0.521 0.520
0.522 0.499 0.480 0.494 0.526 0.515
0.507 0.479 0.478 0.451 0.455 0.471
0.502 0.520 0.499 0.499 0.487 0.521
0.451 0.448 0.478 0.449 0.461 0.456
0.499 0.511 0.490 0.476 0.465 0.458
0.499 0.485 0.475 0.489 0.465 0.474
0.489 0.475 0.524 0.448 0.465 0.518
0.470 0.480 0.475 0.448 0.456 0.469
0.475 0.489 0.468 0.524 0.519 0.490
Min 0.448 0.448
Max 0.524 0.526
avg 0.490 0.483

SONALI KUSHAL
ADVACRYL SIZE-1 ADVACRYL SIZE-1
DIAMETER DIAMETER
0.497 0.522 0.490 0.480 0.482 0.484
0.449 0.467 0.468 0.473 0.470 0.475
0.482 0.485 0.499 0.460 0.462 0.465
0.475 0.478 0.480 0.480 0.475 0.472
0.490 0.492 0.489 0.472 0.475 0.470
0.486 0.487 0.486 0.485 0.482 0.480
0.475 0.478 0.479 0.460 0.465 0.463
0.495 0.496 0.492 0.473 0.472 0.470
 0.482 0.467 0.468 0.460 0.462 0.465
0.448 0.492 0.485 0.473 0.470 0.475
Min 0.448 0.460
Max 0.522 0.485
avg 0.483 0.472

SONALI KUSHAL
ADVACRYL SIZE-1 ADVACRYL SIZE-1
DIAMETER DIAMETER
0.486 0.522 0.485 0.521 0.475 0.485
0.449 0.467 0.468 0.473 0.470 0.475
0.482 0.485 0.485 0.460 0.462 0.465
0.475 0.448 0.480 0.480 0.475 0.472
0.446 0.465 0.489 0.472 0.475 0.470
0.485 0.499 0.495 0.485 0.475 0.480
0.475 0.485 0.486 0.460 0.465 0.463
0.495 0.485 0.531 0.473 0.462 0.470
0.465 0.485 0.486 0.468 0.462 0.465
0.448 0.485 0.485 0.473 0.470 0.475
0.446 0.460
0.531 0.521
0.481 0.473
 HETA SONALI KUSHAL
ADVALON SIZE-1 ADVAMRYL SIZE-3-0 ADVAMRYL SIZE-3-0
DIAMETER DIAMETER DIAMETER
0.457 0.467 0.482 0.296 0.286 0.291 0.289 0.289
0.459 0.451 0.471 0.299 0.292 0.289 0.291 0.299
0.462 0.469 0.464 0.292 0.294 0.310 0.291 0.283
0.487 0.472 0.469 0.287 0.289 0.298 0.290 0.294
0.488 0.472 0.480 0.290 0.291 0.294 0.298 0.298
0.482 0.481 0.482 0.289 0.282 0.287 0.298 0.293
0.464 0.485 0.481 0.294 0.298 0.292 0.290 0.290
0.472 0.488 0.488 0.293 0.287 0.284 0.290 0.292
0.476 0.492 0.459 0.293 0.293 0.294 0.294 0.294
0.482 0.490 0.459 0.292 0.294 0.296 0.295 0.295
0.451 0.282 0.283
0.492 0.310 0.302
0.474 0.292 0.293

HETA SONALI KUSHAL

ADVALON SIZE-1 ADVAMRYL SIZE-3-0 ADVAMRYL SIZE-3-0
DIAMETER DIAMETER DIAMETER
0.475 0.471 0.482 0.296 0.286 0.282 0.292 0.291
0.459 0.451 0.471 0.285 0.291 0.289 0.291 0.299
0.462 0.469 0.464 0.292 0.285 0.310 0.291 0.283
0.487 0.472 0.469 0.287 0.291 0.298 0.290 0.282
0.499 0.472 0.480 0.290 0.291 0.285 0.298 0.298
0.480 0.481 0.482 0.282 0.282 0.285 0.298 0.293
0.464 0.475 0.485 0.294 0.298 0.292 0.290 0.286
0.472 0.488 0.488 0.293 0.290 0.284 0.290 0.292
0.476 0.475 0.459 0.293 0.293 0.292 0.294 0.292
0.482 0.475 0.459 0.292 0.294 0.296 0.295 0.295
0.451 0.282 0.282
0.499 0.310 0.299
0.474 0.291 0.292

HETA SONALI KUSHAL

ADVACRYL SIZE-1 ADVACRYL SIZE-3-0 ADVACRYL SIZE-3-0
DIAMETER DIAMETER DIAMETER
0.490 0.492 0.492 0.242 0.246 0.245 0.241 0.240
0.492 0.496 0.496 0.243 0.245 0.240 0.234 0.242
0.495 0.497 0.492 0.246 0.232 0.236 0.264 0.260
0.498 0.492 0.492 0.236 0.242 0.241 0.235 0.242
0.495 0.495 0.498 0.244 0.248 0.247 0.260 0.245
0.496 0.492 0.496 0.245 0.242 0.245 0.270 0.260
0.498 0.494 0.499 0.230 0.232 0.234 0.235 0.240
0.497 0.494 0.492 0.242 0.245 0.246 0.250 0.242
0.492 0.496 0.496 0.248 0.242 0.241 0.245 0.240
0.495 0.498 0.498 0.229 0.230 0.232 0.263 0.255
0.490 0.229 0.234
0.499 0.248 0.270
0.495 0.241 0.248

HETA SONALI KUSHAL

ADVACRYL SIZE-1 ADVACRYL SIZE-3-0 ADVACRYL SIZE-3-0
DIAMETER DIAMETER DIAMETER
0.490 0.492 0.492 0.242 0.246 0.245 0.241 0.240
0.492 0.485 0.496 0.243 0.245 0.240 0.234 0.242
0.495 0.497 0.486 0.246 0.250 0.236 0.264 0.250
0.512 0.492 0.492 0.236 0.242 0.241 0.235 0.242
0.495 0.495 0.498 0.244 0.248 0.247 0.260 0.245
0.496 0.492 0.496 0.245 0.247 0.245 0.270 0.260
0.490 0.494 0.499 0.230 0.232 0.245 0.252 0.240
0.497 0.485 0.492 0.242 0.229 0.246 0.250 0.242
0.492 0.496 0.485 0.245 0.242 0.248 0.245 0.232
0.495 0.498 0.498 0.229 0.230 0.232 0.263 0.255
0.485 0.229 0.232
0.512 0.250 0.272
0.494 0.241 0.249
 KUSHAL HETA
VAMRYL SIZE-3-0 ADVAMRYL SIZE-3-0
DIAMETER DIAMETER
0.296 0.248 0.240 0.243
0.296 0.240 0.242 0.241
0.283 0.238 0.237 0.239
0.290 0.238 0.239 0.237
0.294 0.240 0.242 0.234
0.296 0.242 0.243 0.231
0.293 0.242 0.245 0.240
0.302 0.238 0.240 0.242
0.294 0.237 0.242 0.245
0.292 0.241 0.241 0.243
0.231
0.248
0.240

KUSHAL HETA
VAMRYL SIZE-3-0 ADVAMRYL SIZE-3-0
DIAMETER DIAMETER
0.296 0.248 0.240 0.243
0.296 0.253 0.242 0.241
0.283 0.238 0.245 0.239
0.292 0.238 0.239 0.237
0.294 0.240 0.242 0.234
0.296 0.242 0.242 0.242
0.293 0.242 0.245 0.240
0.293 0.242 0.240 0.242
0.294 0.237 0.241 0.242
0.292 0.241 0.241 0.243
0.234
0.253
0.241

KUSHAL HETA
VACRYL SIZE-3-0 ADVACRYL SIZE-3-0
DIAMETER DIAMETER
0.245 0.248 0.249 0.245
0.245 0.247 0.243 0.249
0.245 0.243 0.244 0.238
0.245 0.241 0.243 0.240
0.245 0.238 0.248 0.243
0.248 0.239 0.249 0.243
0.265 0.242 0.243 0.241
0.245 0.243 0.248 0.242
 0.242 0.243 0.248 0.245
0.258 0.245 0.249 0.243
0.238
0.249
0.244

KUSHAL HETA
VACRYL SIZE-3-0 ADVACRYL SIZE-3-0
DIAMETER DIAMETER
0.245 0.248 0.249 0.245
0.245 0.247 0.243 0.249
0.245 0.243 0.244 0.238
0.245 0.241 0.243 0.240
0.245 0.238 0.248 0.243
0.248 0.239 0.249 0.243
0.265 0.242 0.243 0.241
0.272 0.243 0.236 0.242
0.242 0.250 0.248 0.245
0.258 0.245 0.249 0.243
0.236
0.250
0.244
SR. NO. TEST EQUIPMENT NAME EQUIPMENT ID CALIBRATION DUE DATE
1 Suture Length Measuring scale QA/2015/020 5/10/2019
2 Suture Diameter Dial Gauge QA/2015/053 Next day of Testing
KPTS , NPTS & Seal
3 Instron QA/2015/003 14/11/2018
Strength
4 Extractable Color Weighing Balance QA/2015/012 15/07/2019

Moisture Content (Only

for ADVACRYL,
5 Moisture Meter QA/206/088 17/12/2018
ADVAMRYL, ADVAPD,
RAPID)

Residual EO & Ech (Only

6 GC QA/2015/034 18/11/2018
in EO sterilized Batches)

Dosimetry (Only in
7 Millivolt Meter QA/2016/087 5/4/2019
Gamma Batches)

STANDARD SOLUTIONS
For ADVALENE, PD, MRYL, CRYL, SYL & LON
Sr. No. Solution Name Reference No. Due Date
1 Cobaltous Chloride TS020
2 Cupric Sulfate TS021 17/12/2018
3 Ferric Chloride TS022
For ADVACAT Chromic
4 Potassium Dichromate TS023
17/12/2018
5 1% Diphenyl Carbazide TS024 17/12/2018
6 2N H2SO4 TS025
Criteria (For Size: 2-0) Criteria (For Size: 1)
KPTS 2.68 KgF KPTS 5.08 KgF
Moisture 1050 µg / Pack Moisture 1050 µg / Pack
ADVACRYL RAPID PILOT-I ADVACRYL (ADVA2347 - V17010)
Months & Test RT Accl. 55°C Months & Test RT Accl. 55°C
1M KPTS -- -- 3.77 FG KPTS 7.05
1M Moisture -- -- 533 FG Moisture 345.7
3M KPTS 3.59 3.78 3.69 3M KPTS 6.72 6.76 --
3M Moisture 822 746 579 3M Moisture 794 434 --
5M KPTS -- -- 3.52 6M KPTS 6.43 6.73 --
5M Moisture -- -- 753 6M Moisture 1487 1513 --
6M KPTS 3.43 3.51 -- 9M KPTS 6.62 6.59 --
6M Moisture 863 1157 -- 9M Moisture 1025 1482 --

Criteria (For Size: 1)

KPTS 5.08 KgF
Moisture 1050 µg / Pack
ADVACRYL (ADVA2347 - V17004)
Months & Test RT Accl. 55°C
FG KPTS 6.94
FG Moisture 236
1M KPTS -- -- 6.86
1M Moisture -- -- 534
3M KPTS 6.68 6.57 6.96
3M Moisture 633 458 317
6M KPTS 6.69 6.63 6.64
6M Moisture 845 669 729
9M KPTS 6.69 6.71 6.81
9M Moisture 968 746 938
DATE PRODUCT NAME DOE
7/5/2018 ADVALENE CURRENT & NEW SETUP
7/6/2018 ADVALON CURRENT & NEW SETUP
7/9/2018 ADVACAT CURRENT & NEW SETUP
8/1/2018 ADVASYL CURRENT & NEW SETUP
8/1/2018 ADVALENE NEW SETUP
8/2/2018 ADVALENE NEW SETUP
NEW DIE AND OLD ATTACHMENT MACHINE
NEW DIE AND OLD ATTACHMENT MACHINE
NEW DIE AND OLD ATTACHMENT MACHINE
NEW DIE AND OLD ATTACHMENT MACHINE
OLD DIE AND OLD ATTACHMENT MACHINE
OLD DIE AND OLD ATTACHMENT MACHINE
 Raw Material
Sr No. Document No. Version No.
1 RMS/0004 2
2 RMS/0008 5
3 RMS/0009 2
4 RMS/0013 1
5 RMS/0014 2
6 RMS/0016 0
7 RMS/0018 0

Packaging Material
1 PMS/0001 2
2 PMS/0003 3
3 PMS/0004 1
4 PMS/0005 3
5 PMS/0006 2
6 PMS/0007 4
7 PMS/0008 3
8 PMS/0009 3
9 PMS/0010 6
10 PMS/0011 1
11 PMS/0013 2
12 PMS/0014 3
13 PMS/0015 1
14 PMS/0017 3
15 PMS/0018 4
16 PMS/0019 4
17 PMS/0020 3
18 PMS/0021 3
19 PMS/0022 3
20 PMS/0023 3
21 PMS/0024 4
22 PMS/0025 2
23 PMS/0026 2
24 PMS/0029 0
25 PMS/0030 0

Standard Test Procedure

1 STP/0001 3
2 STP/0002 2
3 STP/0015 2
4 STP/0017 2
5 STP/0024 1
6 STP/0025 1
7 STP/0026 1
8 STP/0027 2
9 STP/0028 1
10 STP/0038 2
 FORM
1 FRM/0529 3
2 FRM/0530 2
3 FRM/0532 1
4 FRM/0534 1
5 FRM/0250 1
6 FRM/0251 5
7 FRM/0252 3
8 FRM/0253 3
9 FRM/0254 4
10 FRM/0255 5
11 FRM/0256 4
 Raw Material
Document Title
RM Specification For DEAE
RM Specification For surgical Suture Needle
RM Specification For Sodium benzoate
RM Specification For Araldite
RM Specification For Isopropyl Alcohol
RM Specification For LOCTITE 4014
RM Specification For Purified Water

Packaging Material
PM Specification For Nylon NLS
PM Specification For Tyvek 2FS
PM Specification For Polyester Poly
PM Specification For Grid Lacquer Pper
PM Specification For Nucrel Top
PM Specification For Nucrel Bottom
PM Specification For Peelable Top
PM Specification For Peelable Bottom
PM Specification For cartons (1dz)
PM Specification For Self Adhesive Tear Tape
PM Specification for BOPP Wrap Film For 1dz Cartons
PM Specification For IFU For Surgical Sutures
PM Specification For BOPP Wrap Film For 3dz Carton
PM Specification for Figure 8 Folder
PM Specification Of Printed Lid 2 For Suture Winding Tray
PM specification For Suture widing Tray
PM Specification For Shipper Box For 100dz Carton
PM Specification For Shipper Box for 120dz Carton
PM Specification For Printed Top Foil
PM Specification For Self Adhesive BOPP Tape (transparent) with AMS logo
PM Specification For figure 8 Folder With Flap
PM Specification For Shipper Box for 24 dz Carton
PM Specification for Shipper box for 50 dz Carton
PM Specification for SBF-ETO and SBF-FP
PM Specification for IFU For surgical Needle For Export

Standard Test Procedure

Suture Diameter Testing
Extractable Colour Of Dyed Suture
Determination Of Length of Suture
Tactile Test Of Monofilament Suture
STP For Surgical Suture Needle Ductility Testing
Detecting Silicone On Surgical Suture Needle
STP For Surgical Suture Needle Wire Diameter Testing
STP For Surgical Suture Needle Stiffness testing
STP For Surgical Suture Needle Bore Depth Testing
Procedure For Surgical Needle Profile measurement
 FORM
AMPIDB - ADVACRYL
AMPIDB - ADVAMRYL
AMPIDB - ADVAPD
AMPIDB - ADVASYL
FormAT For Product GTIN (GS1 Barcode) Details For ADVACAT
Format For Product GTIN (GS1 Barcode) Details For ADVACRYL
Format For Product GTIN (GS1 Barcode) Details For ADVALENe
Format for Product GTIN (GS1 barcode) Details For ADVALON
Format For Product GTIN (GS1 Barcode) Details For ADVAMRYL
Format For product GTIN (GS1 Barcode) Details For ADVAPD
Format For Product GTIN (GS1 Barcode) Details For ADVASYL
 0.32 0.324 0.326
0.335 0.337 0.323
0.322 0.32 0.327
0.33 0.324 0.325
0.321 0.315 0.316
0.334 0.332 0.325
0.32 0.337 0.327
0.326 0.321 0.323
0.328 0.333 0.335
0.325 0.326 0.334
0.318 0.324 0.329
0.328 0.331 0.335
0.325 0.332 0.328
0.326 0.335 0.336
0.332 0.336 0.334
0.321 0.33 0.328
0.322 0.325 0.33
0.328 0.323 0.315
0.321 0.338 0.331
0.325 0.321 0.317
0.319 0.332 0.329
0.322 0.328 0.335
0.321 0.327 0.326
0.326 0.318 0.328
0.329 0.331 0.332
0.328 0.324 0.334
0.321 0.327 0.333
0.335 0.328 0.326
0.32 0.317 0.324
0.318 0.326 0.327
Min 0.315
Max 0.338
Avg 0.327