Evolve® 600 | Column Validation Support (Rev C | BP40055A)

Evolve® 600 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® 600 mm 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 Shield Ring

Adjuster flow cell

Adjuster cell inlet Liner

Fixed cell Inlet

Bed support retaining ring (adjuster)

Adjuster flow tube

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

Polypropylene (black) MCS38 MCS50 B

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 MCS31 MCS43 MCS48 MCS51 F

Flow tube flange gasket seal EPDM

F

Bed Supports (Sinter) Polypropylene MCS27 G

Sanitary clamp adapters Polypropylene MCS36 C

Bed support retaining bolt (adjuster and fixed) 20% Glass-filled polypropylene MCS21 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 Sheet Material (page 1 of 8)

Appendix

Appendix B – Polypropylene Sheet Material MCS50 (Black) (Page 2 of 8)

Appendix B – Polypropylene Sheet Material MCS50 (Black) (Page 3 of 8)

Appendix B – Polypropylene Sheet Material MCS50 (Black) (Page 4 of 8)

Appendix B – Polypropylene Sheet Material MCS50 (Black) (Page 5 of 8)

Appendix B – Polypropylene Sheet Material MCS50 (Black) (Page 6 of 8)

Appendix B – Polypropylene Sheet Material MCS50 (Black) (Page 7 of 8)

Appendix B – Polypropylene Sheet Material MCS50 (Black) (Page 8 of 8)

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

Revision

Comments Date

A Initial release 15/01/2022

B Additional Supplier added 19/04/2022

C Material Certification update and additional suppliers added 20/09/2022

E Material Certification and ADI Free statement updated 21/06/2023

F Rebranding 05/04/2024 Manual Revision Date F April 2024