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OPUS® ValiChrom Columns are glass pre-packed columns that are exact scale-down models of full-scale columns, ideal for process validation, including viral clearance.

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OPUS® ValiChrom Columns are high performance glass pre-packed columns designed to be exact scale-down models of corresponding full-scale chromatography columns.  Each column is individually flow-packed according to validated packing protocols with the precision of 1 mm bed height.

OPUS® ValiChrom Columns are ideal for parameter evaluation and optimization, as well as for process validation.

  • Pre-packed with user-specified chromatography resin
  • Flow-packed with correct resin compression factor to simulate performance of process columns
  • Proven reproducibility between packed columns
  • Jacketed glass column with fixed bed height to match process column or user‘s special needs

OPUS® ValiChrom Columns can be packed to any desired bed height between 10 and 60 cm and are available in the following formats:

Internal Diameter Bed Height
cm cm
   
0.50 10-60
0.80 10-60
1.13 10-60
1.60 10-60
2.50 10-60

 

Each column comes with individual column performance data summarized in a Certificate of Analysis (CoA) that includes:

  • Efficiency (Plate/m)
  • Asymmetry
  • Pressure flow rate
  • Convenient, pre-packed columns provided ready to use
  • Flexible, packed with user-specified process resin
  • Robust design, jacketed biocompatible precision bore borosilicate glass allows visualization of resin across the full bed height, convenient diameter tubing simplifies calculations, fixed bed height standardizes adaptor constructions
  • Matched diameter, bed height and compression with full-scale process column
  • Proven, with over 2500 columns packed worldwide
  • Reproducible, controlled bed height ensure replicate columns with similar product characteristics
  • Cost-effective, small diameter minimizes costly sample volume and viral spike volumes
  • Scalable, ideal for precise scale down modelling
  • Certified, with individual performance Certificate of Analysis (CoA)
  • Expertly packed in an ISO 9001:2008 certified facility and ISO Class 7 manufacturing clean room

OPUS® ValiChrom Columns are designed for qualitative resin screening experiments, small scale methods development work, small scale separation (e.g. by size exclusion chromatography). They are unique in their ability to provide a reliably packed and valid evaluation system for comparisons of dissimilar resin types.

  • Virus clearance studies
  • Functional scale down modelling (scale down validation)
  • Resin lifetime evaluation
  • Resin lot-to-lot validation
  • CIP method validation
  • Process robustness studies

Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system.  We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.

LEARN MORE ABOUT REPLIGEN MANUFACTURING

Column inner diameter

0.50 cm

0.80 cm

1.13 cm

1.60 cm

2.50 cm

Packed bed height

10 - 60 cm (customized)

Column volume range*

2-12 mL

5-30 mL

10-60 mL

20-120 mL

50-300 mL

Inner cross-sectional area

0.2 cm2

0.5 cm2

1.0 cm2

2.0 cm2

5.0 cm2

Connectors

1/16" female (10-32)

1/16" female (10-32)

M6 female

M6 female

M6 female

Chemical stability

All commonly used aqueous buffers, pH 1 – 14, organic solvents**.  Avoid the use of halogenated organic solvents, hexane

Column storage solution

  • AIEC and CIEC Columns: 20 % ethanol + 150 mM sodium chloride
  • HIC, SEC, Affinity and MMC Columns: 20 % ethanol
  • CHT, CFT Columns (Bio-Rad): 20 % ethanol + 10 mM sodium phosphate, pH 6.8
  • ProSep® Columns(Millipore):1 % benzyl alcohol + 0.1 M sodium acetate, pH 5.1

Recommended storage temperature

  • AIEC, CIEC, HIC, SEC and MMC: +4°C to +30°C
  • Affinity Columns: +2°C to +8°C

Working temperature

+4°C to +30°C

Maximum working pressure

Up to 30 bar

Materials of construction

Outer tube: PMMA; Inner tube: Boresilica glass; Frit: Freudenberg PE/PP 7 - 12 µm pore size


* The actual column volume of the packed bed is specified by the selected bed height.  Customized bed heights < 10 cm are available upon request.
** The chemical stability of the packed chromatography resin also has to be taken into consideration. For more information, please refer to the manufacture’s resin specification.
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