Alfa Laval LKH UltraPure Equipment documentation Doc. ID No.: Alfa Laval Q-doc LKH-UP US version 1.2 Order information

Serial No.: 866409

P&ID reference:

Item No: 9634094167 Order No.: 82491 Shop Order No.: 160064

Item Description: LKHU10M160D4VS18BINNC005B36WSP

Product history:

Equipment Documentation LKH UltraPure Page 2 of 5

Serial No.: 866409

Doc. ID No.: Alfa Laval Q-doc LKH UltraPure US 1.2

Declaration of Compliance Supplier

Alfa Laval Inc. 5400 International Trade Drive, Richmond VA 23231, United States Phone: +1 804 222 5300 E-mail: [email protected] Traceability We as supplier hereby guarantee and certify that the materials and/or equipment have been manufactured in accordance to and comply with ASME BPE, 2007 Edition and FDA CGMP. Compliance to EN 10204 type 3.1 (MTR) * We as supplier hereby guarantee and certify that our steel parts, stated in the Product wetted steel parts table in this document, complies with the European Standard EN 10204 of October 2004, Inspection certificate 3.1. Compliance to the U.S. Food & Drug Administration CFR 21 §177.2600 We as supplier hereby guarantee and certify that our compound(s), stated in the Product wetted elastomer parts table in this document, complies with the U.S. Food & Drug Administration (FDA) Code of Federal Regulations, Title 21, part 177.2600. FDA Declarations from our suppliers can be forwarded upon request. Compliance to the U.S. Food & Drug Administration We as supplier hereby guarantee and certify that our Silicon Carbide compound(s), stated in the Product wetted elastomer parts table in this document, are accepted by U.S. Food & Drug Administration (FDA) Code of Federal Regulations to be used in contact with food. Compliance to the United Stated Pharmacopeia (USP)** We as supplier hereby guarantee and certify that our compound(s), stated in the Product wetted elastomer parts table below, has been tested and certified by an independent laboratory to be in compliance with the criteria of the U.S. Pharmacopeia, Class VI chapter 87 and 88 (version 22 or higher). Test reports can be forwarded upon request. TSE (Transmissible Spongiform Encephalopathy) Declaration We as supplier hereby declare, under our sole responsibility, that the above stated equipment has never been in contact with any compound derived from animal sources. Consequently this equipment does not contain Specific Risk Materials ( SRM`s ) associated with risk of TSE. TSE Declarations from our suppliers can be forwarded upon request. Surface finish Declaration In accordance with Alfa Laval quality procedures we as supplier hereby declare that the equipment wetted surfaces finish have a surface finish characteristics in accordance with the specification of the equipment.

* 3.1 certificates (MTR’s) are attached to this document ** EPDM only

Equipment Documentation LKH UltraPure Page 3 of 5

Serial No.: 866409

Doc. ID No.: Alfa Laval Q-doc LKH UltraPure US 1.2

Order information Item No.: 9634094167 Shop Order No.160064

Item Description: LKHU10M160D4VS18BINNC005B36WSP

Pump Qty..: 1 Ra. Cert. Incl. N/A Surface finish : 20ra Electro Polishing option : X

Low ferrite option : N/A Passivation option : X

Product wetted steel parts, 3.1 acc. To EN10204 (MTR) traceability Pos.

Part Name

Item No.

Qty

Material

Heat No.

1.4404 ASTM A743 Gr. CF3M 316L 1.4404 1.4435 1.4404 1.4404

FF-1392

25

Back Plate

9612138410

1

37

Impeller

9612131204

1

9612139602 1 Impeller Screw 9612128801 1 Casing ( 2545890 ) N/A - Outlet 1 N/A - Fitting outlet 1 29 N/A - Fitting inlet 1 N/A - Cone outlet N/A N/A - Cone inlet N/A 9634004801 - Drain 1 Product wetted elastomer parts, Compound ID tracking 36

Pos.

Part Name

Service kit No.

Qty

11 11.1

1

Stationary seal ring

14 14.1

O-ring stationary seal Rotating Seal ring

1 9634069137

1

HS6638 FF-1199 518065 S-98794 S-11092 N/A N/A 11F693

Material

Compound ID / Heat No.

N/A

294333

1.4462

426406

SIC

11.2 12

N/A N/A 316L

0479B

R37-1

EPDM

R47-1

N/A

1318748

SIC

R37-1

15

O-ring rotating seal

1

EPDM

R47-1

26

O-ring for pump casing

1

EPDM

68065

38

O-ring for impeller screw

1

EPDM

70 EPDM 291

Responsibilities (for internal use only) The responsible person from Quality department who has performed test and/or entered data to this document must approve and sign. By signing this document the responsible person hereby declares that the instructions are followed and the requirements are in the appropriate SOP’s of this document.

QC Date + Name

05/27/2015

Equipment Documentation LKH UltraPure Page 4 of 5

Serial No.: 866409

Product specification list Complete parts overview:

Doc. ID No.: Alfa Laval Q-doc LKH UltraPure US 1.2

Equipment Documentation LKH UltraPure Page 5 of 5

Serial No.: 866409

Doc. ID No.: Alfa Laval Q-doc LKH UltraPure US 1.2

Procedures (available upon request)

Polishing

Welding

Cleaning

Passiv ti

Markin

Quality i ti

Packin

PM FH1

Pump Performance certificate Attached to this document.

Instruction manual and spare parts Packed in box with pump

Other documentation attached (if option is ordered with pump): -

Specific surface finish certificate Low delta ferrite certificate Passivation certificate Hydrostatic certificate Certified print

Declaration of compliance to Alfa Laval internal quality system We as supplier hereby declares, under our sole responsibility, that the above stated unique equipment is manufactured, tested and inspected under controlled conditions established by our ISO 9001:2000 Quality System, and complies to the above selected documents and procedures. Richmond, United States, 05/27/2015

Stacey Flynn, Quality Manager, Alfa Laval

CERTIFICATE LKH 10 WET SETS USA Product

: LKH-10 wet sets Quality Department Alfa Laval (India) Ltd..

Item no.

:

9613415002

Gat no ;30/33 & 74/82 Sarole, veer Road Tq: Bhor, Dt: Pune Maharastra state

Casing No.

:

2545890

Tel: +91 2113 282367-70 Fax: +91 2113 282301 www.alfalaval.com

Contents

1

Collection list / List for FDA declarations

Test certificate Misc. Material certificates Misc. FDA declarations

Collection list for LKH 10 Wet sets Manufacturer

: Alfa Laval (India)Ltd sarole

Product :-

: LKH 10 WET SETS :

Item no. : -

: 9613415002

USA Richmond PO no

: US - 156713

Description

Art no 9612131204

Impeller

9612138410 Backplate 9612139602 Impeller Screw a) Casing b) Inlet Ferrule 9612128801 c) Outlet Ferrule d) Outlet pipe

Material ASTM A743 Gr. CF3M 1.4404 316L 1.4404 1.4404 1.4404 1.4435

Lot No. ------------2545890 --------------------

Heat no 0479B FF-1392 HS6638 FF-1199 S-11092 S-8794 518065

Remark 72 3378 IA/MTC/196/500 3293 65564 50139 A/08-783327

This certificate is made according to EN 10204:2004 § 3.1. As far we can determine, material is free from mercury and low melting alloy contamination. We certify the chemical analysis and/or physical tests were determined by standard methods and are correct as contained in the records of the company are a true copy of the data furnished to us.

Part O-ring for pump casing O-ring for impeller screw

Material EPDM EPDM - -

Supplier AB Industrigummi Freudenberg Simrit

We hereby certify that seal rings/ o-rings correspond to the attached FDA approvements from our Principal AL Kolding

Sarole

14/02/2015

Sign : Mangesh Kuchekar Sr. Engineer, Quality Control

Material Test Report ABFTM

MTR Serial ID: ABFTM Part Number: 9634004801 BS14AM TYPE A-1/2-316L-PL -- B-P FERRULE

Alfa Laval Inc. 9560 58th Place Suite 300 Kenosha, WI 53144 Tel: +1 800 558 4060 Tel: +1 262 605 2600 Fax: +1 262 605 2664 www.alfalaval.us

Date Issued: 8/13/2014 Manufacturing Ref: ASME BPE 2012 Finish Code

ID Finish (m-inch Ra-Max)

OD Finish

ASME BPE SFF CODE

PC

20 Ra Max Mechanical Polish

Unpolished

SFF1

PL

20 Ra Max Mechanical Polish

Polished 32 Ra

SFF1

PD

15 Ra Max Electropolish

Unpolished

SFF4

PM

15 Ra Max Electropolish

Polished 32 Ra

SFF4

PJ

10 Ra Max Electropolish

Unpolished

SFF4

PR

10 Ra Max Electropolish

Polished 32 Ra

SFF4

Heat #

Alt #

11F693

Heat #

11F693

Alt #

Material

Type

C

Mn

P

S

Si

Cr

Ni

Mo

bar

316L

0.019

1.80

0.028

0.012

0.38

16.85

10.17

2.13

Raw Material Size(s)

Hardness

Yield Strength (KSI)

Tensile Strength (KSI)

Elongation (%)

Raw Material Specification

30.000 mm bar 316L

77.00 (RB)

36.25

82.66

67.00

ASTM A-479/ASME SA-479

We certify that the chemical analysis and/or physical tests were determined by standard methods and are correct as contained in the records of the company and are a true copy of the data furnished to us. As far as we can determine, this material is free from mercury and low melting alloy contamination. Note: "N/A" in any field indicates that the particular datum was not available in the documentation furnished to us. This Certified Mill Test Report is computer generated and meets EN10204(3.1).

Electropolishing Advanced Metal Improvement Technologie

May 06, 2015

Alfa Laval Inc (Richmond, VA) P.O. Box 50391 Accounts Payable Richmond, VA 23250-0361 This is to certify that the following parts were processed according to standard process and your purchase order specifications:

PART NO.

9634080521OSO

PART DESCRIPTION

Wet Seg

PURCHASE ORDER NO.

US-163383

QUANTITY SHIPPED

8 PCS.

OPERATION PERFORMED

Electropolish and Passivate

ORDER NO.

477308-00

SHIPMENT NO.

16942

LOT NUMBER SPEC NUMBER REMARKS

CERT DESCRIPTION

EP & Passivate

ABLE ELECTROPOLISHING COMPAN

Thomas Glass President

Marcia

[email protected]

Phone: 1.888.868.2900 ● Fax: 773.277.1655 ● www.ableelectropolishing.com CHICAGO Corporate Headquarters Production Facility: 2001 S. Kilbourn Ave. ● Chicago, IL 60623

05/26/2015 Alphabio, Inc. Rancho Santa Margarita, Calif. 92688

REF: Your Purchase Order: 33006 Alfa Laval Order No.: 0030352842 Serial No.: 866409 Mfg Po # 7874236 Mfg Order #160064 Afal Laval Model:LKHU10M160D4VS18BINNC005B36WSP

Alfa Laval Inc. 9560 58th Place, Suite 300 Kenosha, WI 53144-7805 USA Tel: +1 800-558-4060 Tel: +1 262-605-2600 Fax:+1 262-605-2664 www.alfalaval.com

Hydrostatic Testing To Whom It May Concern: This will certify that a hydrostatic test was performed on the referenced pump. The pressure of 80 Psi was maintained in the wetted portion of the pump for five minutes. There was no fluid leakage or damage to any of the pump components.

Very truly yours, Alfa Laval Inc.

Jeffery Jenkins Fluid Handling Team Manager

Pump Test Certificate Customer

Alfa Laval Order No. 160064

Serial No.

Date 5/27/2015 12:06:52 PM

866409 Pump Type LKHU-10

Impeller Size 6.299

Special Notes HP Size

Voltage 5

460

Frequency

RPM

Total Head in Feet

60

Frame Size 182TC/184TC Phases

3520

3

Pump Performance Curve

155.6 155.4 155.2

Test Data Flow in USGPM

155 154.8 154.6 154.4 154.2 154 153.8

Total Head in Feet

0.0

155.5

12.0 25.8

155.0 155.1

39.9

153.8

153.6 0

10

20 30 Flow in USGPM

40

50

Power in HP

Power Consumption (Measured Motor Input) 5 4.5 4 3.5

Test Data Flow in USGPM

3 2.5 2 1.5 1 0.5 0 0

10

20 30 Flow in USGPM

40

Power (HP)

0.0

3.3

12.0

3.9

25.8

4.1

39.9

4.7

50

Alfa Lava hereby certifies that the above-mentioned pump has been manufactured, tested and inspected under controlled conditions established by our quality system and conforms to the specifications stated in the Alfa Laval performance chart.

Authorized Signature Jeffery Jenkins Fluid Handling Manufacturing Assembly Supervisor