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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 10,000 columns packed since 2007, OPUS® ValiChrom® Columns are uniquely suited for process validation. They are designed to match chromatographic efficiency 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 5 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 5~60
0.66 5~60
0.80 5~60
1.00 5~60
1.13 5~60
1.60 5~60
2.50 5~60
Convenient

Pre-packed columns provided ready to use

Flexible

Packed with user-specified process resin

高い再現性

Controlled bed height ensures replicate columns with similar product characteristics

スケーラブル

Ideal for precise scale down modelling

優れた費用対効果

Small diameter minimizes costly sample volume and viral spike volumes

Expertly packed

In an ISO 9001:2015 certified facility

 

Repligenは、ISO 9001品質管理システムに基づいて、バイオ医薬品業界向けの製品を開発・製造しています。高品質で安定した、堅牢な製品をタイムリーに提供し、お客様の事業継続性を保証することを重視しています。

Repligenの製造拠点について

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

0.66 cm

0.80 cm

1.00 cm

1.13 cm

1.60 cm

2.50 cm

Packed bed height

10 - 60 cm (customized)

Column volume range*

2-12 mL

3-20 mL

5-30 mL

8-45 mL

10-60 mL

20-120 mL

50-300 mL

Inner cross-sectional area

0.2 cm2

0.34 cm2

0.5 cm2

0.79 cm2

1.0 cm2

2.0 cm2

5.0 cm2

Connectors

1/16" Female (10-32)                                      

M6 female

Chemical stability

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

素材

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.