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OPUS® ValiChrom™ Pre-packed Columns
Process Validation

 

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

Pre-packed columns for process validation

OPUS ValiChrom

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 Pre-packed Columns

With over 2500 columns packed since 2007, OPUS® ValiChrom™ Columns are uniquely suited for process validation. Because they are designed to match the diameter, bed height and compression of the production scale column with a precision of 1mm, they are ideal for parameter evaluation and process validation, including virus clearance studies.

  • Pre-packed with user-specified chromatography resin - over 300 resins
  • Can be packed to any desired bed height between 10 and 60 cm
  • Flow-packed with correct resin compression factor to simulate performance of process columns
  • Convenient diameter tubing simplifies calculations
  • Fixed bed height standardizes adaptor constructions
  • Jacketed biocompatible precision bore borosilicate glass column allows visualization of resin across the fullbed height
  • Certificate of Analysis (CoA) includes efficiency (Plate/m), asymmetry, and pressure flow rate.

    See resin list

Available 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
Convenient

Pre-packed columns provided ready to use

Flexible

Packed with user-specified process resin

Reproducible

Controlled bed height ensures replicate columns with similar product characteristics

Scalable

Ideal for precise scale down modelling

Cost-effective

Small diameter minimizes costly sample volume and viral spike volumes

Expertly packed

In an ISO 9001:2008 certified facility and ISO Class 7 manufacturing clean room

 

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.

about Repligen Manufacturing

process validation and virus clearance Applications

Process validation

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

OPUS® ValiChrom™ Columns demonstrate reproducible packed bed performance for robust validation, as shown in the superimposition of HETP curves from 16 different units.

 

Because OPUS® ValiChrom™ Columns match the bed height of the production scale column with a precision of 1mm, they are ideal for scale-down process validation.

Virus clearance studies

Clearance of virus during chromatographic steps is necessary in case of contamination of the used cell bank. OPUS® ValiChrom™ Columns are ideal for testing multiple and identical packed columns to proof log-reduction.

specifications

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 manufacturer’s resin specification.