Evolve® 70 - 250 | Validation Support (Rev E | BP40030A)

Evolve® Process Chromatography Columns (70 - 250 mm) Validation Support – Process-Wetted Materials

Validation Support: Process Wetted Materials Introduction All materials in contact with the process stream have been selected for their suitability for use in equipment utilised in biopharmaceutical applications, and either conform to relevant sections of FDA code of Federal Regulations Vol. 21, 170-199 and/or have passed the USP Class VI test for in vivo toxicity.

This document provides generic certification statements for the process-wetted materials used in the construction of the range of Evolve® Process Chromatography Columns, specifically columns within the diameter range 70-250 mm.

In addition, a statement is provided in Appendix L, which further clarifies details of ADI (Animal Derived Ingredient) status.

Materials of Construction- Process Wetted Parts Common components across Evolve® Process Column range 70-250 mm diameter.

Column Component

Material

Certificate Reference

Appendix

Column Tube (70, 100, 140 mm)

Acrylic

MCS24

A

Column Tube (200, 250, 350 mm)

Acrylic

MCS25

B

Fixed flow tube

Polypropylene (black)

MCS40

C

Pipe spool with ladish adaptor

Polypropylene Extruded Tube 20% Glass-filled polypropylene end connections

MCS13 MCS44 MCS21

D

Polypropylene Extruded Tube 20% Glass-filled polypropylene end connections

MCS13,

D

MCS21

E

Sanitary clamp adapters

20% Glass-filled polypropylene

MCS21

E

Anti-jet disc

20% Glass-filled polypropylene

MCS21

E

Flow tube seal (fixed and adjuster)

Santoprene

MCS28

F

Sanitary clamp seals

Santoprene

MCS28

F

Fixed flow cell

Polypropylene (black)

MCS38 MCS50

H C

Adjuster flow cell

Polypropylene (black)

MCS38 MCS50

H C

Bed Supports (Mesh)

Polypropylene

MCS04

I

Fixed Bed Support Seal 70250mm columns)

Santoprene

MCS29

G

Adjuster bed support seal

Santoprene

MCS29

G

Adjuster Seal (Wedge)

Santoprene

MCS29

G

Adjuster flow tube

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Accessories used within Evolve® Process Column Range Column Component

Material

Certificate Reference

Appendix

Flexible Hose - Tubing

Braided PVC

MCS11 MCS49 MCS52

J

Flexible Hose – Ladish Ends

Polyester

MCS05

K

4 Port 2 Way Valve

See separate Validation Guide

2 Way Valve

Santoprene/Polypropylene

MCS29 MCS13 MCS21

G D E

90O pipework elbow

Polypropylene 20% glass filled

MCS21

E

Pipework T piece

Polypropylene Extruded Tube Polypropylene 20% glass filled

MCS13 MCS21

D E

Tri-clamp to M6

20% Glass-filled polypropylene

MCS21

Tri-clamp to 5/16 UNF

20% Glass-filled polypropylene

MCS21

Bubble Trap

See separate Validation Guide

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Appendix A – Plexiglas XT Acrylic Tube (Page 1 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 2 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 3 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 4 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 5 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 6 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 7 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 8 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 9 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 10 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 11 of 12)

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Appendix A – Plexiglas XT Acrylic Tube (Page 12 of 12)

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Appendix B – Transpalite Acrylic Tube (Page 1 of 2)

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Appendix B – Transpalite Acrylic Tube (Page 2 of 2)

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Appendix C – Polypropylene (Black) MCS40 (Page 1 of 7)

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Appendix C – Polypropylene (Black) MCS40 (Page 2 of 7)

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Appendix C – Polypropylene (Black) MCS40 (Page 3 of 7)

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Appendix C – Polypropylene (Black) MCS40 (Page 4 of 7)

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Appendix C – Polypropylene (Black) MCS40 (Page 5 of 7)

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Appendix C – Polypropylene (Black) MCS40 (Page 6 of 7)

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Appendix C – Polypropylene (Black) MCS40 (Page 7 of 7)

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Appendix C – Polypropylene MCS50 (Black) (Page 8 of 14)

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Appendix C – Polypropylene MCS50 (Black) (Page 9 of 14)

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Appendix C – Polypropylene MCS50 (Black) (Page 10 of 14)

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Appendix C – Polypropylene MCS50 (Black) (Page 11 of 14)

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Appendix C – Polypropylene MCS50 (Black) (Page 12 of 14)

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Appendix C – Polypropylene MCS50 (Black) (Page 13 of 14)

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Appendix C – Polypropylene MCS50 (Black) (Page 14 of 14)

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Appendix D – Polypropylene Tube (Page 1 of 11)

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Appendix D – Polypropylene Tube (Page 2 of 11)

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Appendix D – Polypropylene Tube (Page 3 of 11)

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Appendix D – Polypropylene Tube (Page 4 of 11)

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Appendix D – Polypropylene Tube (Page 5 of 11)

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Appendix D – Polypropylene Tube (Page 6 of 11)

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Appendix D – Polypropylene Tube (Page 7 of 11)

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Appendix D – Polypropylene Tube (Page 8 of 11)

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Appendix D – Polypropylene Tube (Page 9 of 11)

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Appendix D – Polypropylene Tube (Page 10 of 11)

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Appendix D – Polypropylene Tube (Page 11 of 11)

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Appendix E – 20% Glass Filled Polypropylene (Page 1 of 2)

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Appendix E – 20% Glass Filled Polypropylene (Page 2 of 2)

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Appendix F –Santoprene Natural 8281-MED Grade (Page 1 of 1)

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Appendix G –Santoprene 8281 Med Grade compounded Black (Page 1 of 2)

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Appendix G –Santoprene 8281 Med Grade compounded Black (Page 2 of 2)

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Appendix H – Polypropylene (Page 1 of 1)

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Appendix I – Polypropylene Mesh (Page 1 of 6)

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Appendix I – Polypropylene Mesh (Page 2 of 6)

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Appendix I – Polypropylene Mesh (Page 3 of 6)

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Appendix I – Polypropylene Mesh (Page 4 of 6)

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Appendix I – Polypropylene Mesh (Page 5 of 6)

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Appendix I – Polypropylene Mesh (Page 6 of 6)

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Appendix J – Braided Hose (Page 1 of 8)

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Appendix J – Braided Hose (Page 2 of 8)

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Appendix J – Braided Hose (Page 3 of 8)

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Appendix J – Braided Hose (Page 4 of 8)

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Appendix J – Braided Hose (Page 5 of 8)

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Appendix J – Braided Hose (Page 6 of 8)

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Appendix J – Braided Hose (Page 7 of 8)

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Appendix J – Braided Hose (Page 8 of 8)

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Appendix K – Polyester (Page 1 of 5)

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Appendix K – Polyester (Page 2 of 5)

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Appendix K – Polyester (Page 3 of 5)

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Appendix K – Polyester (Page 4 of 5)

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Appendix K – Polyester (Page 5 of 5)

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Appendix L – ADI Statement

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Revision History Revision

Comments

Date

A

Initial release

11/06/18

B

Photo updated, Document Number and Revision History Added

25/02/19

C

ADI Statement Added, Document revised after review by NM

04/03/19

D

Reviewed - Document updated, new material certification added.

350mm column removed to improve clarity now in separate Guide

20/1/2021

E

Updated to reflect Evolve® Trademark status

12/07/2021

F

Material supplier updates

20/90/2022

G

Updates to Animal Free Statement and material certificates

21/06/2023

H

Rebranding

05/04/2024

Manual Revision

Date

H

April 2024

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Issue Date: 05 April 2024 Author Name: L Pepperell QA Reviewer Name: T Moore This product is covered by or for use under one or more patents: https://www.astreabioseparations.com/legal/patents/ All trademarks, trade names, trade dress, product names and logos are the property of Astrea UK Services Ltd. Copyright © 2023 Astrea Bioseparations Ltd. All rights reserved.