ITT PureFlo

Assembled at Tecnik Fluid Controls Pvt. Ltd.

ITT under license from ITT Engineered Valves LLC

W-124, 1 Floor MIDC Tarapur, Boisar
Dist - Palghar, Maharashtra 401506, INDIA

Customer: Reliance Life Sciences Pvt. Ltd. Quantity: 04

Int. Surface Finish: RA 15 Microinch Max
Customer Order Number: LSO/6302095
Pureflo Order Number: 2200117 Ext.Surface Finish: No Mechanical Polish, as forged
Pureflo Line Number: 500 Electropolish Finish: Internal Electropolish Only

3.1 CERTIFICATE OF CONFORMITY

Date Issued: August 30, 2022

Item Number (Description): (A) 1.0-F-428L-7-0-4-TME-970

B D
Serial Number
2200117-500-1
2200117-500-2
2200117-500-3
2200117-500-4

Heat Number Information: Heat /Code (Number) Description Material Size

316L- Stainless Steel 1.0"
PAK/21L1430 Forging
316L - Stainless Steel 1.0"
PAO/21L2205 Forging

Acopyof the Certified Material Test Report or the Certificate of Compliance is attached for
the Item(s) listed above.

Pneumatic Test Report: 2.2 Pneumatic-Test Report is attached for the Item(s) listed above.

Surface Roughness Report: 2.2 Surface Roughness Report is attached for the Item(s) listed above

Part No. Description Qty Date Code Cure Date Lot No Exp. Date
Additional Information:
04 N/A 07/2022 1-349578 07/2036
47093A Diaphragm WR
01.00 MC C2 TFM

Extra Description:
Grade TM diaphragms (modified PTFE) have a LIMITED SHELF LIFE of 14 years.
Regulations
Grade TM diaphragms (modified PTFE) Comply with the FDA Code of Federal
successfully passed
Title 21 Section 177-1550 and have been tested in accordance with and
the U.S.
Pharmacopeia 40 Class VI @250°F (121°c) for 60 mins & 158°F(70°c) for 24 hrs
Biologically Reactivity test, Section 87 and Section 88.
PTFE) is
The maximum temperature rating for Grade TM diaphragms (modified
329°F (165°c).
Grade TM diaphragms (modified PTFE) are in compliance to:
10993-5:"Tests for Cytotoxicity- In Vitro Methods"
10993-10: "Tests for Irritation and Sensitization."
10993-11:" Tests for Systematic Toxicity."
(modified
We hereby confirm that for production of ITT Grade TM diaphragms
PTFE) no material of animal origin has been used during the whole production
process. Grade TM materials is of synthetic (PTFE resin) origin.
Grade TM (PTFE) complies with EMEA/410/01 Rev. 3 July 2011.
Section 3.3 & 3.4
Grade TM diaphragms (modified PTFE) meets ASME BPE Part SG,
are not made with natural rubber latex
Grade TM diaphragms (modified PTFE)

Cont.......
Page 1 of 6

Sallhs
 ITT PureFlo

ITT Assembled at Tecnik Fluid Controls Pvt. Ltd.

under license from ITT Engineered Valves LLC
W-124, 1" Floor MIDC Tarapur, Boisar
Dist - Palghar, Maharashtra - 401506, INDIA

Customer: Reliance Life Sciences Pvt. Ltd.

Customer Order Number: LSO/6302095 Quantity: 04
Pureflo Order Number: 2200117 Int. Surface Finish: RA 15 Microinch Max
Pureflo Line Number: 500 Ext.Surface Finish: No Mechanical Polish, as forged
Electropolish Finish: Internal Electropolish Only
...2...

Part No., Description Oty Date Code Cure Date Lot No Exp. Date
48039 CUSHION BACKING 04 N/A 06/2022 8741640 06/2028
WR 01,00 FDA B1

Extra Description Grade B1: Grade B1 (EPDM) backing cushions have a LIMITED SHELF LIFE
of 6 years.
Grade B1 (EPDM) backing cushions comply with the FDA Code of Federal Regulations Title 21
Section 177.2600 and have been tested in accordance with and successfully passed the U.S.
Pharmacopeia 40 Class VI @250°F(121°c) for 60mins &158°F (70°C) for 24 hrs Biologically
Reactivity test, Section 87 and Section 88.
The maximum temperature rating for Grade B1 (EPDM) backing cushions is 302°F (150°c).
Grade B1 (EPDM) backing cushions are in compliance to:
10993-5:" Tests for Cytotoxicity---In Vitro Methods"
10993-10:"Tests for Irritation and Sensitization."
10993-11:"Tests for Systematic Toxicity."
Grade B1 (EPDM) complies with 21CFR 177.2600 (e) "Rubber articles intended for repeated
use in contact with aqueous food." Exception: Grade B1 (EPDM) does not comply with
177.2600 (f)
"Rubber articles intended for repeated use in contact with fatty food".
Grade B1 (EPDM) is animal derived ingredient free.
Grade B1 (EPDM)complies with EMEA/410/01 Rev. 3 July 2011.
Grade B1 (EPDM) meets ASME BPE Part SG,Section 3.3 &3.4.
Grade B1 (EPDM) is peroxide cured.
Grade B1 (EPDM) is not made with natural rubber latex.

EP ASME BPE InternalSurface Electropolish is compliant with ASME BPE 2014 - NONMANDATORY APPENDIX H
ELECTROPOLISHING PROCEDURE QUALIFICATION

Comments:

We certify that the components on the above referenced purchase order meet the requirements of the purchase order,
applicable drawing(s),and our ISO 9001:2015 manufacturing, testing and inspection procedures to assure an acceptable quality
level applicable to the pracese items are supplied in accordance with QMS Manual Rev 25 dated March 29,2018

BOISAR

Manager, Quality Assurance (or representative)

Page 2 of 6
 ITT PureFlo
Assembled at Tecnik Fluid Controls Pvt. Ltd.

ITT under license from ITT Engineered Valves LLC

W-124,1* Floor MIDC Tarapur, Boisar
Dist - Palghar, Maharashtra 401506, INDIA

Customer: Reliance Life Sciences Pvt. Ltd. Quantity: 04

Customer Order Number: LSo/6302095 Int. Surface Finish: RA 15 Microinch Max
Pureflo Order Number: 2200117 Ext.Surface Finish: No Mechanical Polish, as forged
Pureflo Line Number: 500 Electropolish Finish: Internal Electropolish Only
2.2 PNEUMATIC-TEST REPORT
Date Issued: August 30, 2022

The Valves Seat &Shell has been tested as per MSS SP-88
Shell
Seat Test Result
Sr. No. Size Item Description Test
Pressure
Pressure
1.0-F-428L-7-0-4-TME-970 196 PSI 236 PSI OK
2200117-500-1 1.0"
1.0-F-428L-7-0-4-TME-970 196 PSI 236 PSI OK
2200117-500-2 1.0"
1.0-F-428L-7-0-4-TME-970 196 PSI 236 PSI OK
2200117-500-3 1.0"
1.0-F-428L-7-0-4-TME-970 196 PSI 236 PSI OK
2200117-500-4 1.0"

Comments:

We certify that the components on the above referenced purchase

order meet the requirements of the purchase order,
applicable drawing(s), and our ISO 9001:2015 manufacturing, testing and inspection procedures to assure an acceptable quality
accordance with OMS Manual Rev 25 dated March 29,2018
level applicable to the product, these itemns are supplied in

Manager, Quality Assurance (or representative)

Page 3 of 6
 ITT PureFlo

ITT Assembled at Tecnik Fluid Controls Pvt. Ltd.

under license from ITT Engineered Valves LLC
W-124, 1" Floor MIDC Tarapur, Boisar
Dist - Palghar, Maharashtra -401506, INDIA
Customer: Reliance Life Sciences Pvt. Ltd.
Customer Order Number: LSO/6302095 Quantity: 04
Pureflo Order Number: 2200117 Int. Surface Finish: RA 15 Microinch Max
Pureflo Line Number: 500 Ext.Surface Finish: No Mechanical Polish, as forged
2.2 SURFACE Electropolish Finish: Internal Electropolish Only
ROUGHNESS
Date Issued: August 30, 2022
REPORT

Measuring Equipment :Mitutoyo Surface Tester

Probe Type :SJ 210
Measuring Standard :ISO 1997
Measured Length :0.8mm
Measurement Point :4 Points

Measurement :Ra<0.4um (15uin)- Internal Surface Finish

Result :OK

Comments:

We certify that the components on the above referenced purchase order meet the requirements of the purchase order,
applicable drawingls), and our I50 9001:2015 manufacturing, testing and inspection procedures to assure an acceptable quality
level applicable to the product, these items are supplied inaccordance with QMS Manual Rev 25 dated March 29,2018

Manager, Quality Assurance (or representative)

Page 4 of 6
 ITT PureFlo

ITT Assembled at Tecnik Fluid Controls Pvt. Ltd.

under license from ITT Engineered Valves LLC
W-124, 1" Floor MIDC Tarapur, Boisar
Dist - Palghar, Maharashtra - 401506, INDIA

Customer: Reliance Life Sciences Pvt. Ltd. Quantity: 04

Customer Order Number: LSO/6302095 Int. Surface Finish: RA15 Microinch Max
Pureflo Order Number: 2200117 Ext.Surface Finish: No Mechanical Polish, as forged
Pureflo Line Number: 500 Electropolish Finish: Internal Electropolish Only
VALVE BODY (FORGING) HEAT # 21L1430 FORGING CODE: PAK

Pradeep Metals Limited

Manufacturers of Closed Die Forgings
Regd.Office/Wor ks : R-205, M.LD.C, RABALE,
NAVI MUMBAI-400 701, INDIA
Phone: 91-22-2769 1026
Email: [email protected]
CIN No.: L99999 MH1982 PLCO26191
MATERIAL TEST CERTIFICATE EN10204 - 3.1 (LABFM/03/02)

Cert.No. 0030
TECNIK FLUID CONTROLS PVT.LTD.
PLOT NO. W-124, 1*t FLOOR, Date 29/04/2022
MIDC TARAPUR,
BOISAR EIF-A0D-CCM- Rolled
& ES-A-0143 REV.A
EN10222-5 Grade X2CrNiMo18-14-3 (DIN 1.4435)/ BASEL
Melting
Material ASTM A182 F316L S9 / Spec ESA-195 Rev.NIL NORM 2(BN2) Pr'ocess Fully KIlled
Client Ref Date Qty Steel Mill
Invoice No. Invoice Date Client Ref no. LAXCON STEELS LTD
TFCPLPO2201/075 30-01-2022 283
0309 29-04-2022

Drg. No. Drg.Rev. Lot code Heat No.

PM No. Part Name Part Number
BODY WRFRG 01.00 AK 21L1430
50434-P 124061 NIL
360400XG-F UNV TSS
Chemical Composition (%) Ti
Ferrite
Ni Mo Cu
Mn Si P Cr
0.005 17.00 12.50 2.50
Min 0.050 0.10 0.50
0.0450.017 18.00 14.00 3.00
Max 0.030 2.00 1.00
Mill 0.003 0.0735 0.45
0.037 0.006 17.27 12.60 2.55
Actual 0.024 1.59 0.33
Mechanical / Metallurgical Properties ISO 148-1
6892-1 Charpy Impact Testing Done as per EN
Tensile Testig Done as per EN ISO 6y" Notch size (mnm) 10x10x55
Impact (T) Impact (Long)
YS YS RA Elong. At 200C
RT UTS At 20°C (RT) 100 Joules Mlin.
N/mm N/mm² %
+20°c N'mm A5
Joules Min.
(Long) 0.2% 1.0% 2 3 Avg
45 1 2 3 Avg
200 235 50.0
Min S20
670 286 292 288 288.66
Max
242.93 271.58 76.97 54.60
Actual 552.07 Actual
149,152,156
Hardness(HBw Min. Max.:
10/3000(6506-1) Microstructure
Heat Treatment Absent
Water, Soaking Grain Boundary Carbide Precipitation
Solution Annealed at 1060°C QUenched in
2Hrs, Cooled below 260°C ASTN 182, ENI0204, EN ISO
148-1.
DIN EN10222-1. EN10222-5,
Technical Technical Standards EN ISO 6892-1, EN6506-1,
Requirement As per Drawing.
Inspection & Control of Dimension 1.4435/F316L
Material Identification
Marking Details P AK Pradeep Metals Ltd.
For
Remarks P
9cturer mark
Manufac
customer Spec ESA-19s RevNIL
Material conforns to as per
E112 : 5
Average Grain Size as per ASTM
Material free fom Radia tion
part.
No Welding performed on the contaminntion
Steel free from Lead, MIercury Rev.A Method 4 :0.12,0.12,0.10 = Avg.
0.119%
ES-A-0143
Ferrite content as perBASELNORMI 2(BN2) Calcula tion method : 6.02
Ferrite content as per
per ES-A-0027 Rev.B
PICKLING & PASSIVATION DONE as SUD INDUSTRIE SERVICE GmbH (FEBRUARY 2010)
TUW
ISSUED IN AGREEMENT WITH intended use must be disposed as per local enviionmental D.K.PATIL
after
The product & waste generated (Authorised Works Inspector)
protectton lnws.
the contract or PO
and confor1 to the reguirements of
herein has been inspected and tested,
Certífied that the material des cribed

Page 5 of 6
 ITT PureFlo

ITT Assembled at Tecnik Fluid Controls Pvt. Ltd.

under license from ITT Engineered Valves LLC
W-124, 1 Floor MIDC Tarapur, Boisar
Dist - Palghar, Maharashtra 401506, INDIA

Customer: Reliance Life Sciences Pvt. Ltd.

Customer Order Number: LSo/6302095 Quantity: 04
Pureflo Order Number: 2200117 Int. Surface Finish: RA 15 Microinch Max
Pureflo Line Number: 500 Ext.Surface Finish: No MechanicalPolish, as forged
Electropolish Finish: Internal Electropolish Only
VALVE BODY (FORGING) HEAT # 21L2205 FORGING CODE: PAO

Pradeep Metals Limited

Manufacturers of Closed Die Forgings
Regd.Office/Works : R-205, M.ID.C, RABALE,
NAVI MUMBAI-400 701, INDIA
Phone: 91-22-2769 1026
Email: [email protected]
CIN No.: L99999MH1982PLCO26191
MATERIAL TEST CERTIFICATE- EN0204 -3.1 (LAB/FM/03/02)

|TECNIK FLUID CONTROLS PVT.LTD. Cert.No. 0035

PLOT NO. W-124,1 t FLOOR,

MIDC TARAPUR, Date 29/06/2022

BOISAR
EN10222-5 Grade X2CrNiMo 18-14-3 (DIN 1.4435) & ES-A-0143 REV.A EIF-AOD-CCM - Rolled
Mateial Melting
ASTM A182 F316L S9 /Spec ESA-195 Rev.NIL/ BASEL NORM 2(BN2) Process Fully Kiled
Steel Mill
Invoice No. Invoice Date Client Ref no. Client Ref Date Qty
LAXCON STEELS LTD
TFCPLPO2205/o04 04-05-2022 110
1154/2022-23 29-06-2022
Lot code Heat No.
PM No. Part Name Part Number Drg. No. Drg.Rev.
BODY WR FRG 01.00 NIL AO 21L220O5
36040OXG-F 50434-P 124061
UNV TSS
Chemical Composition(%) Cu Ii Ferrite
Si P Cr Ni Mo
Mn
0.005 17.00 12.50 2.50
Mim 0.50
18.00 14.00 0.050 0.10
Max 0.030 2.00 1.00 0.045 o.017 3.00

Ml 0.006 0.030 0.34

0.037 0.012 17.57 12.65 2.52
Actual 0.019 1.54 0.46
Mechanic al / Metallurgical Properties
Charpy Impact Testing Done as per EN ISO 148-1
Tensile Testing Done as per EN ISO 6892-1
«y» Notch size (mm) 10x10x55
Impact (T) Impact (Long)
RT UTS YS YS RA Elong. At 20°C (RT)
At 20oc
+20°c N/mm N/mm N/mm² Joules Min. 100 Joules Min.
ng 0.2% 1.0% A5
2 3 Avg 1 2 3 Avg
Min 520 200 235 50.0 1
-

Max 670 294 298 290 294

Actual 550.38 238.76 284.89 76.36 53.25
Actual 149,152,156
Hardness(HBW Min. Max.:
10/3000(6506-1) Mic1ostructure
Heat Treatment
Solution Annealed at 1060°C Quenched in Water, Soaking Grain Boundary Carbide Precipitation Absent
2Hrs, Cooled below 260°C
EN10204, EN ISO 148-1,
Technical Standards DIN EN10222-1, EN10222-5, ASTM 182,
Technical EN ISO 6892-1,:EN6506-1,
Requirement Inspection & Control of Dimension As per Drawing.
Material Identification 1.4435/F316L
Marking Details P AO
For Pradeep Metals Ltd.
Remarks
Manufacturer nark
Rev.NIL
Material confoIns to as per customer Spec ESA-195
Avernge Grain Size as per ASTMI E112 : 5
Material îree îrom Radia tion
g performed on the part.
No
Steel Welaims
free fronPTend.
contaminntion
Mercuiy
tent ns per ES-A-0143 Rev.A Method 4 :0.15.0.12.0.14
Ferrite content
= AvR. 0.130%
Ferrite content as per BASELNORM 2(BN2) Calculatdon method : 7.24
PICKILING & PASSIVATION DONE as per ES-A-0027 Rev.
SERYICE GubH (FEBRUARY 2010)
ISSUED IN AGREEMENT WITH TUY SUD INDUSTRIE
The pro dåct & Waste generated after ntended use
must be disposed as per local environnental D.KPATIL
protection laws. (Authorised Vor ks In spector)

teste d, and con form to the requirenents of the contract or PO

Certified thatthe material described herein has been inspected nnd

Page 6 of 6