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 Tube (70, 100, 140 mm) Acrylic MCS24 A

Column Tube (200, 250, 350 mm) Acrylic MCS25 B

Fixed flow tube

Pipe spool with ladish adaptor

Adjuster flow tube

Sanitary clamp adapters

Anti-jet disc

Flow tube seal (fixed and adjuster)

Sanitary clamp seals

Fixed flow cell

Adjuster flow cell

Bed Supports (Mesh)

Polypropylene (black) MCS40 C

Polypropylene Extruded Tube

20% Glass-filled polypropylene end connections

Polypropylene Extruded Tube

20% Glass-filled polypropylene end connections

MCS44 MCS21 D E

MCS13, MCS21 D E

20% Glass-filled polypropylene MCS21 E

20% Glass-filled polypropylene MCS21 E

Santoprene

Santoprene

MCS28 F

MCS28 F

Polypropylene (black) MCS38 MCS50 H C

Polypropylene (black) MCS38 MCS50 H C

Polypropylene

Fixed Bed Support Seal 70250mm columns) Santoprene

Adjuster bed support seal

Santoprene

Adjuster Seal (Wedge) Santoprene

MCS04 I

MCS29 G

MCS29 G

MCS29 G

Accessories used within Evolve® Process Column Range

Flexible Hose - Tubing

Flexible Hose – Ladish Ends

4 Port 2 Way Valve

2 Way Valve

90O pipework elbow

Pipework T piece

Tri-clamp to M6

Tri-clamp to 5/16 UNF

Bubble Trap

See separate Validation Guide

20% glass filled

Extruded Tube

Glass-filled polypropylene

See separate Validation Guide

Appendix

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

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

Appendix

Appendix

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

Appendix

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

Appendix

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

Appendix

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

Appendix

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

Appendix

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

Appendix

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

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

Appendix

Appendix

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

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

Appendix

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

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

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

Appendix

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

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

Appendix

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

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

Appendix

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

Appendix

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

Appendix

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

Appendix

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

Appendix

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

Appendix

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

Appendix

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

Appendix

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

Appendix

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

Appendix

Appendix D

D – Polypropylene Tube (Page 2 of 11)

Appendix

D – Polypropylene Tube (Page 3 of 11)

Appendix

D – Polypropylene Tube (Page 4 of 11)

Appendix

D – Polypropylene Tube (Page 5 of 11)

Appendix

D – Polypropylene Tube (Page 6 of 11)

Appendix

D – Polypropylene Tube (Page 7 of 11)

Appendix

D – Polypropylene Tube (Page 8 of 11)

Appendix

D – Polypropylene Tube (Page 9 of 11)

Appendix

D – Polypropylene Tube (Page 10 of 11)

Appendix

D – Polypropylene Tube (Page 11 of 11)

Appendix

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

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

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

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

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

H – Polypropylene (Page 1 of 1)

Appendix

I – Polypropylene Mesh (Page 2 of 6)

Appendix

Appendix I – Polypropylene Mesh (Page 3 of 6)

Appendix I – Polypropylene Mesh (Page 4 of 6)

Appendix I – Polypropylene Mesh (Page 5 of 6)

I – Polypropylene Mesh (Page 6 of 6)

Appendix

Appendix J – Braided Hose (Page 1 of 8)

Appendix J – Braided Hose (Page 2 of 8)

Appendix J – Braided Hose (Page 3 of 8)

Appendix J – Braided Hose (Page 4 of 8)

Appendix J – Braided Hose (Page 5 of 8)

Appendix J – Braided Hose (Page 6 of 8)

Appendix J – Braided Hose (Page 7 of 8)

Appendix J – Braided Hose (Page 8 of 8)

Appendix

K – Polyester (Page 1 of 5)

Appendix K

Appendix K – Polyester (Page 3 of 5)

Appendix K – Polyester (Page 4 of 5)

Appendix K

Appendix L – ADI Statement

Revision History

Revision

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