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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. They are designed to match chromatographic effiency and bed height of production scale columns with a precision of 1mm, making them ideal for parameter evaluation, process validation, and viral 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
便利性

Pre-packed columns provided ready to use

灵活性

Packed with user-specified process resin

可重复性

Controlled bed height ensures replicate columns with similar product characteristics

可放大性

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在ISO 9001质量管理体系下开发和生产用于生物制药行业的产品。我们专注于及时交付高质量、一致且稳健的产品,以确保我们客户的业务连续性。

关于Repligen生产

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 prove 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.