Evolve® 450mm Chromatography Column Validation Support – Process-Wetted Materials
DELTA PRECISION LTD
Evolve® 450 Chromatography Column Validation Support – Process-Wetted Materials BP40047A
Revision History Revision A B C D
Comments
Date 20/01/2021 12/07/2021 19/4/2022 1/06/2022
Initial release Updated to reflect Evolve® Trademark status Addition of material suppliers Additional supplier added
Manual Revision
Date
D
June 2022
Evolve® is a registered trademark of Delta Precision Ltd. Evolve® is a registered trademark in the EU, UK and US.
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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® Chromatography Columns and Column refresh 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 only Column Component
Material
Certificate Reference
Appendix
Column Tube
Acrylic
A
Fixed flowcell Column Bottom flange Adjuster flowcell Adjuster cell inlet Liner Fixed cell Inlet Bed support retaining ring (adjuster) Adjuster flowtube Flowtube seal (fixed and adjuster) Sanitary clamp seals Adjuster Seal, Fixed flange seal, bed support seals and tube seals Flowtube flange gasket seal
Polypropylene (black) Polypropylene (black) Polypropylene (black) Polypropylene Polypropylene (black) Polypropylene (black) Polypropylene Santoprene Santoprene EPDM
Bed Supports (Sinter) Sanitary clamp adapters Bed support retaining bolt (adjuster and fixed) Pipe spool with ladish adaptor
Polyethylene Polypropylene 20% Glass-filled polypropylene
MCS25, MCS45, MCS47 MCS38 MCS38 MCS38 MCS36 MCS38 MCS38 MCS13 MCS28 MCS28 MCS31, MCS43, MCS48 MCS31, MCS43, MCS48 MCS27 MCS36 MCS21
EPDM
Polypropylene Extruded Tube 20% Glass-filled polypropylene end connections
B B B C B B D E E F F G C H
MCS13
E
MCS21
H
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Appendix A – Acrylic Tube (Page 1 of 5)
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Appendix A – Acrylic Tube (Page 2 of 5)
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Appendix A – Acrylic Tube (Page 3 of 5)
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Appendix A – Acrylic Tube (page 4 of 5)
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Appendix A – Acrylic Tube (page 5 of 5)
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Appendix B – Polypropylene (page 1 of 1)
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Appendix C – Polypropylene Bar (page 1 of 4)
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Appendix C – Polypropylene Bar (page 2 of 4)
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Appendix C – Polypropylene Bar (page 3 of 4)
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Appendix C – Polypropylene Bar (page 4 of 4)
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Appendix D – Polypropylene Tube (page 1 of 3)
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Appendix D – Polypropylene Tube (2 of 3)
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Appendix D – Polypropylene Tube (3 of 3)
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Appendix E –Santoprene Natural 8281 Med grade (page1 of 1)
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Appendix F – EPDM (page 1 of 4)
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Appendix F – EPDM (page 2 of 4)
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Appendix F – EPDM (page 3 of 4)
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Appendix F – EPDM (page 4 of 4)
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Appendix G – Polyethylene sinter (page 1 of 5)
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Appendix G – Polyethylene sinter (page 2 of 5)
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Appendix G – Polyethylene sinter (page 3 of 5)
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Appendix G – Polyethylene sinter (page 4 of 5)
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Appendix G – Polyethylene sinter (page 5 of 5)
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Appendix H – 20% Glass Filled Polypropylene (page 1 of 2)
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Appendix H – 20% Glass Filled Polypropylene (page 2 of 2)
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Appendix I – ADI Statement
DELTA PRECISION LTD ANIMAL FREE STATEMENT. Delta Precision Limited hereby declare that the EVOLVE® Column products do not contain animal derived materials. The thermoplastics used in Delta Precision Ltd. EVOLVE® Column’s process stream, are limited to Acrylic, Hytrel Polyester, Santoprene, braided PVC and Polypropylene. Some of these materials are known to contain trace level additives which may possibly be of animal origin, e.g., tallow derivatives (calcium stearates). Components such as fatty acids, fatty alcohols, metallic soaps, fatty amines, fatty amides, fatty acid esters, glycerine are incorporated into plastics as lubricants, slip agents, anti-static agents, as well as emulsifiers, antioxidants, or corrosion inhibitors. These additives are primarily extracted from tissues of ovine or bovine origin. The tallow derivatives used for the production of our plastic components undergo a series of severe process steps during manufacture such as those described in directive EMEA 410/01. Due to this manufacturing process (temperature, high pressure, use of acids) we estimate the BSE risk from our plastic products to be negligible, as the prions which pass on BSE are: a) totally immobilised. b) have no survival opportunity in thermoplastics. c) are ultimately damaged by thermal processing. Raw material supplier’s products are free from animal derived substances either through total exclusion or as a result of the processing conditions described in EMEA 410/01. In addition, tallow derivatives are not considered specified BSE risk materials according to the current revision of the U.S. Code of Federal Regulations Title 21 of part 189.5 which specifies risk materials obtained from cattle. Herewith we confirm that the Evolve® Column product range is suitable for use in applications where animal derived materials are to be avoided. Delta Precision Limited. Technical Support Services.
Mr. G Parnell. Director. UNITS 4 & 5 STONEDALE ROAD, OLDENDS INDUSTRIAL ESTATE, STONEHOUSE, GLOUCESTERSHIRE ENGLAND GL10 3RQ. TEL:+44 (0)1453 707500 . E-mail:- enquiries@delta-precision.co.uk . COMPANY REG.NO. 05253517
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