Evolve® Process Chromatography Column Kits | Validation Support- Process-Wetted Materials | BP40058A

Evolve® Process Chromatography Column Kits

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 Evolve® Process Chromatography Column Kits.

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

Below are tables of the components within the available kits range. Only components that are regarded as process wetted are listed; this is not a full list of kit components.

Connection kit

COMPONENT

Flow tube Adaptor 20% Glass-filled polypropylene

Flow Tube Seal, Ladish Santoprene

Flow Tube Seal, Santoprene

Adjuster Flow Tube

Spares Kit

Polypropylene Tube, 20% Glass-filled polypropylene

Bed Support Assembly, Fixed,

Bed Support Assembly, Adjuster,

Adjuster seal

Flow Tube Seal

Flow Tube Seal, Ladish

Mesh, Santoprene

Mesh, Santoprene

Bed Support Kit

Bed Support Assembly, Fixed,

Bed Support Assembly, Adjuster,

Elastomer Seal Kit

Adjuster Cell Kit

Fixed Cell Kit

Fixed Cell

Wetted Flow Path Kit

Flow Tube Adaptor

Adjuster Flow Tube

Bottom Flow Tube

Pipe spool Elbow

Polypropylene Tube, 20% Glass-filled polypropylene

Bed Support Assembly, Fixed, Polypropylene Mesh, Santoprene

Bed Support Assembly, Adjuster, Polypropylene Mesh, Santoprene

Adjuster seal

Flow Tube Seal

Flow Tube Seal, Ladish Santoprene

Tube Replacement Kit

Spare parts and kits cont. KIT COMPONENT

Flow Tube Adaptor

Adjuster Flow Tube

Bottom Flow Tube

Pipe spool Elbow

Bed Support Assembly, Fixed,

20% Glass-filled

Polypropylene Tube, 20% Glass-filled polypropylene

Polypropylene Tube, 20% Glass-filled polypropylene

Polypropylene Mesh, Santoprene

Bed Support Assembly, Adjuster, Polypropylene Mesh, Santoprene

Adjuster seal

Adjuster Cell

Fixed Cell

Glass-filled

Flow Tube Seal

Flow Tube Seal, Ladish

Fluid Connection Kit

2-way Sanitary Pinch Valve

Flexible Hose

6 mm Tee

Flow Tube Seal, Ladish

Flexible Hose Kit

Santoprene Polypropylene

20% Glass filled Polypropylene

Braided PVC Polyester ends

Polypropylene Tube, 20% Glass-filled polypropylene

Flexible Hose Braided PVC Polyester ends

Flow Tube Seal, Ladish

Column Reversal Kit

4 Port 2-way Valve

Flexible Hose

PVDF Valve Body PTFE Ball Santoprene See separate 4 port 2 way valve validation guide

Braided PVC Polyester ends

Flow Tube Seal, Ladish Santoprene

Column Isolation Kit

4 Port 2-way Valve

Flexible Hose

PVDF Valve Body PTFE Ball Santoprene

Braided PVC Polyester ends

Flow Tube Seal, Ladish Santoprene

See separate 4 port 2 way valve validation guide

1 of 12)

Appendix A – Plexiglas XT Acrylic Tube (Page

A –

2 of 12)

Appendix

Plexiglas XT Acrylic Tube (Page

A –

XT

Tube (Page 3 of 12)

Appendix

Plexiglas

Acrylic

A –

XT

Tube (Page 4 of 12)

Appendix

Plexiglas

Acrylic

A –

XT

Tube (Page 5 of 12)

Appendix

Plexiglas

Acrylic

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

Appendix

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

Appendix

A – Plexiglas XT

Tube (Page 8 of 12)

Appendix

Acrylic

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

Appendix

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

Appendix

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

Appendix

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

Appendix

1 of 2)

Appendix B – Transpalite Acrylic Tube (Page

2 of 2)

Appendix B – Transpalite Acrylic Tube (Page

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

Appendix

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

Appendix

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

Appendix

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

Appendix

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

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

Appendix

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

Appendix

Appendix F –Santoprene Natural 828Page 1-MED Grade (Page 1 of 1)

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

Appendix G–Santoprene 8281 MED compound (Black) (Page 2 of 2)

H – Polypropylene (Page 1 of 1)

Appendix

I – Polypropylene Mesh (Page 2 of 6)

Appendix

I – Polypropylene Mesh (Page 3 of 6)

Appendix

I – Polypropylene Mesh (Page 4 of 6)

Appendix

I – Polypropylene Mesh (Page 5 of 6)

Appendix

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)

K – Polyester (Page 1 of 5)

Appendix

Appendix K

Appendix K – Polyester (Page 3 of 5)

Appendix K – Polyester (Page 4 of 5)

Appendix K

Appendix l – ADI Statement

Revision History