DIAMETER DIAMETER DIAMETER DIAMETER

0.569 0.582 0.554 0.488 0.492 0.478 0.498 0.479 0.484 0.487
0.565 0.567 0.580 0.493 0.475 0.484 0.483 0.482 0.496 0.498
0.577 0.576 0.571 0.501 0.477 0.480 0.504 0.499 0.472 0.478
0.568 0.579 0.582 0.498 0.483 0.489 0.484 0.492 0.478 0.495
0.552 0.590 0.592 0.501 0.475 0.481 0.495 0.490 0.486 0.492
0.585 0.582 0.568 0.494 0.486 0.481 0.481 0.489 0.483 0.495
0.554 0.560 0.554 0.488 0.482 0.476 0.507 0.498 0.489 0.478
0.565 0.572 0.559 0.499 0.491 0.478 0.501 0.497 0.504 0.477
0.569 0.592 0.572 0.498 0.479 0.492 0.476 0.493 0.498 0.499
0.577 0.583 0.589 0.491 0.480 0.492 0.476 0.479 0.492 0.495
0.552 0.475 0.472 0.477
0.592 0.501 0.507 0.507
0.573 0.487 0.490 0.489

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
 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
0.489 0.481
0.491 0.480
0.490 0.488
0.491 0.485
0.484 0.480
0.483 0.483
0.507 0.504
0.499 0.485
0.490 0.491
0.489 0.483
0.000
0.000
#DIV/0!
SR. NO. TEST EQUIPMENT NAME EQUIPMENT ID
1 Suture Length Measuring scale QA/2015/020
2 Suture Diameter Dial Gauge QA/2015/053

3 KPTS , NPTS & Seal Strength Instron QA/2015/003

4 Extractable Color Weighing Balance QA/2015/012

Moisture Content (Only for

5 ADVACRYL, ADVAMRYL, Moisture Meter QA/206/088
ADVAPD, RAPID)

Residual EO & Ech (Only in

6 GC QA/2015/034
EO sterilized Batches)

Dosimetry (Only in Gamma

7 Millivolt Meter QA/2016/087
Batches)

STANDARD SOLUTIONS
For ADVALENE, PD, MRYL, CRYL, SYL & LON
Sr. No. Solution Name Reference No. Due Date
1 Cobaltous Chloride TS017
2 Cupric Sulfate TS018 9/18/2018
3 Ferric Chloride TS019
For ADVACAT Chromic
4 Potassium Dichromate TS014
8/31/2018
 5 1% Diphenyl Carbazide TS015 8/31/2018
6 2N H2SO4 TS016

Sr. No. RM / PM Material Re-validation / Release Valide Upto Date

Name

1 LID 3 Years
2 SBF / SBF-FP 3 Years
3 CARTON 3 Years
4 PEELABLE TOP FOIL 2 years
5 NUCREL TOP FOIL 2 years
6 Absorbable Suture As per supplier CoA
7 Non Absorbable Suture 2 Years
8 Needle 3 Years

Document No. Document Title

FRM/0328 Format for COA Of Printed Top Foil
FRM/0272 Format For COA Of Cartons (1dz)
FRM/0273 Format For Raw Data Sheet Of Cartons (1dz)
CALIBRATION DUE DATE
10/5/2019
Next day of Testing

11/14/2018

7/16/2018

9/18/2018

5/10/2018

4/5/2019
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