Evolve® 450 | Validation Support (Rev D | BP40047A)

Evolve® 450 mm Process Columns

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 Evolve® 450 mm Process Chromatography Columns.

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

Materials of Construction – Process Wetted Parts

Column Tube

Fixed flow cell

Column Bottom flange

Adjuster flow cell

Adjuster cell inlet Liner

Fixed cell Inlet

MCS25, MCS45, MCS47 A

Polypropylene (black) MCS38 MCS50 B

Polypropylene (black) MCS38 MCS50 B

Polypropylene (black) MCS38 MCS50 B

Polypropylene MCS36 C

Polypropylene (black) MCS38 MCS50 B

Bed support retaining ring (adjuster) Polypropylene (black) MCS38 MCS50 B

Adjuster flow tube Polypropylene MCS13 D

Flow tube seal (fixed and adjuster) Santoprene MCS28 E

Sanitary clamp seals Santoprene MCS28 E

Adjuster Seal, Fixed flange seal, bed support seals and tube seals EPDM

Flow tube flange gasket seal

Bed Supports (Sinter)

Sanitary clamp adapters

Bed support retaining bolt (adjuster and fixed)

Pipe spool with 2addish adaptor

F

F

G

C

Glass-filled polypropylene MCS21 H

Polypropylene Extruded Tube 20% Glass-filled polypropylene end connections MCS13 MCS21 E H

A – Acrylic Tube (Page 1 of 5)

Appendix

A – Acrylic Tube (Page 2 of 5)

Appendix

Appendix A – Acrylic Tube (Page 3 of 5)

Appendix

A – Acrylic Tube (Page 4 of 5)

A – Acrylic Tube (Page 5 of 5)

Appendix

B – Polypropylene (page 1 of 8)

Appendix

B – Polypropylene

(Black) (Page 2 of 8)

Appendix

MCS50

B – Polypropylene MCS50 (Black) (Page 3 of 8)

Appendix

B – Polypropylene MCS50 (Black) (Page 4 of 8)

Appendix

B – Polypropylene MCS50 (Black) (Page 5 of 8)

Appendix

B – Polypropylene MCS50 (Black) (Page 6 of 8)

Appendix

B – Polypropylene MCS50 (Black) (Page 7 of 8)

Appendix

B – Polypropylene MCS50 (Black) (Page 8 of 8)

Appendix

C – Polypropylene Bar (page 1 of 4)

Appendix

C – Polypropylene Bar (page 2 of 4)

Appendix

C – Polypropylene Bar (page 3 of 4)

Appendix

C – Polypropylene Bar (page 4 of 4)

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 –Santoprene Natural 8281 Med grade (page1 of 1)

Appendix F – EPDM (page 1 of 5)

Appendix F – EPDM (page 2 of 5)

Appendix F – EPDM (page 3 of 5)

Appendix F – EPDM (page 4 of 5)

Appendix F – EPDM (page 5 of 5)

G – Polyethylene sinter (page 1 of 5)

Appendix

Appendix G – Polyethylene sinter (page 2 of 5)

Appendix G – Polyethylene sinter (page 3 of 5)

Appendix G – Polyethylene sinter (page 4 of 5)

G – Polyethylene sinter (page 5 of 5)

Appendix

H – 20% Glass Filled Polypropylene (page 1 of 2)

Appendix

H – 20% Glass Filled Polypropylene (page 2 of 2)

Appendix

Appendix I – ADI Statement

Revision History

A Initial release 20/01/2021

B Updated to reflect Evolve® Trademark status 12/07/2021

C Addition of material suppliers 19/04/2022

D Update material certificate and add further material grade 20/09/2022

E Update Material Certification 21/06/2023

F Rebranding 05/04/2024