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Foresight Pro Chromatography Columns, CHT Ceramic Hydroxyapatite

Foresight Pro Chromatography Columns, CHT Ceramic Hydroxyapatite

Foresight Pro CHT prepacked columns are GMP ready and specifically designed to be used for all biopharmaceutical purification workflows. This includes a wide variety of purification and polishing applications for vaccines, monoclonal antibodies, and recombinant proteins.

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Overview

foresight pro chromatography 1

5–33 cm ID Columns


foresight pro chromatography 2

45 cm ID Columns

Foresight Pro Chromatography Columns are good manufacturing practice (GMP) ready columns specifically designed to be used for all biopharmaceutical manufacturing applications. The columns have a sanitary design with minimal dead space and effective cleanability, and connections to pumping systems are made via standard 3/4" Tri-Clamp Fittings. CHT prepacked columns are available in a range of column diameters and bed heights. CHT prepacked columns are shipped in 0.1 N NaOH.

Features and Benefits

  • GMP ready columns — validated and ready to use
  • Excellent performance — data include asymmetry, HETP, endotoxin, and bioburden
  • Patented and robust column hardware design maintains CHT packed bed
  • Columns maintain performance criteria after shipping and cycling
  • Columns maintain performance criteria post shipping and post cycling
  • All wetted parts meet USP Class VI requirements of USP <88>
  • Standard Tri-Clamp connections — plug and play
  • Columns are packed in a controlled ISO Class 7 cleanroom
  • Range of column diameters and bed heights — 5–45 cm ID and 10 or 20 cm bed height
  • Resin reference sample included with each column
  • Regulatory support file available

Packing Quality

The performance of the Foresight Pro Columns was evaluated before and after International Safe Transit Association (ISTA). As shown in Figures 1 and 2 the columns maintained performance criteria indicating excellent stability during shipping. For more details see Bulletin 3291.

  • Packing Quality Figure 3

    Figure 1: Evaluation of N/m, comparing pre- and post-ISTA tests. Pre-ISTA test (); Post-ISTA test(); ISTA, International Safe Transit Association; N/m, number of theoretical plates per meter.

  • Packing Quality Figure 4

    Figure 2: Evaluation of As, comparing pre- and post-ISTA tests. Pre-ISTA test (); Post-ISTA test(); As, asymmetry factor; ID, inner diameter; ISTA, International Safe Transit Association.

Cycling Data

The performance of the Foresight Pro Columns was evaluated for flow stability. The columns went through a series of cycles. Figures 3 and 4 show that the columns maintained performance criteria indicating a robust packed CHT bed. For more details see Bulletin 3291.

  • Cycling Figure 5

    Figure 3: Evaluation of N/m, comparing the first and tenth cycle of Foresight Pro Columns.
    First cycle (); Tenth cycle ()

  • Cycling Figure 6

    Figure 4: Evaluation of As, comparing the first and tenth cycle of Foresight Pro Columns.
    Pre-ISTA 2A (); Post-ISTA 2A()

Non-Product Contact Material Summary

Element Material
Top and bottom supporting plates Polypropylene
Holding bars Polyamide or 304 stainless steel
Wheels Rubber wheel with stainless steel support plate and 2 locking casters

Product Contact Material Summary

Element Material USP <88> Class CFR 21 177 Animal Origin
Column body Glass (5 cm ID columns) N/A N/A N/A
Column body

Acrylic (8, 10, 13, 20, 24, 33, 45 cm ID columns)

Class VI 177.1010 Animal-free
Flow distributors Polypropylene Class VI 177.1520 Animal-free
Inlet and outlet connectors Polypropylene Class VI 177.1520 Animal-free
Tubing connections Reinforced elastomer tubing Class VI 177.2600 Animal-free
Tri-Clamp Gasket and O-rings Ethylene propylene diene monomer (EPDM) Class VI 177.2600 Animal-free
Bed support screens Polyamide

Note: The polyamide bed support screen is welded
to the polypropylene flow distributor without using any extra chemicals

Class VI 177.1500 Animal-free

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Specifications

Column efficiency, plates/meter
≥ 4,800
Column asymmetry
0.80 ≤ As ≤ 2.2
Microbial bioburden, CFU/ml
< 10
Endotoxin level, EU/ml
< 0.25
Column shipping solution
0.1 N NaOH

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