|
Column Family |
Column IDs Tested |
Tube design |
Time period |
Status |
Study 1 |
OPUS® Pre-packed Chromatography |
OPUS® Pre-packed Chromatography |
Polypropylene |
18 months |
Complete |
Study 2 |
OPUS® Pre-packed Chromatography |
OPUS® Pre-packed Chromatography |
70% w/w |
60 months |
On-going 36-month time point complete |
Affinity Repligen CaptivA® and CaptivA® HF |
IEX/Mixed Mode Resin Purolite Praesto® (IEX) |
|
Component |
Material |
USP <88> class |
CFR 21 777 |
Animal origin |
Column Tube (OPUS® Pre-packed Chromatography Columns 2.5 - 30 cm ID) |
Polypropylene |
Class VI |
177.1520 |
Animal Free |
Column Tube (OPUS® Pre-packed Chromatography Columns 45/R, 60/R, 80R) |
70% w/w |
Class VI |
177.1520 |
Animal Free |
Flow Distributors |
Polypropylene |
Class VI |
177.1520 |
Animal Free |
Inlet and Outlet Ports for OPUS® Pre-packed Chromatography Columns |
Polypropylene |
Class VI |
177.1520 |
Animal Free |
Bed Support Screens |
Polypropylene |
Class VI |
177.1520 |
EMA 410/01 |
Flow Distributor O-Rings |
Platinum-cured medical grade silicone |
Class VI |
177.2600 |
Animal Free |
Return line |
Platinum-cured medical grade silicone, reinforced with strong polyester fiber |
Class VI |
177.2600 |
Animal Free |
OPUS® Pre-packed Chromatography Columns R Plug, and Inside Port |
Polypropylene |
Class VI |
177.1520 |
Animal Free |
OPUS® Pre-packed Chromatography Columns R Inner/ Outer Gaskets, and Plug O-ring |
Platinum-cured medical grade silicone |
Class VI |
177.2600 |
Animal Free |
Column diameter |
|||||||||
Physical Attributes |
2.5 cm |
5.1 cm |
8.1 cm |
10 cm |
12.6 cm |
14 cm |
20 cm |
25 cm |
30 cm |
Internal cross section |
4.91 cm2 |
20.4 cm2 |
51.5 cm2 |
78.5 cm2 |
125 cm2 |
154 cm2 |
314 cm2 |
491 cm2 |
707 cm2 |
Column hardware maximum pressure |
4 bar |
4 bar |
4 bar |
4 bar |
4 bar |
4 bar |
4 bar |
4 bar |
4 bar |
Bed height range |
5 - 30 cm |
5 - 30 cm |
5 - 30 cm |
5 - 30 cm |
5 - 30 cm |
5 - 30 cm |
5 - 30 cm |
5 - 30 cm |
5 - 30 cm |
Column volumes bed height 10 cm 20 cm 30 cm |
49 mL 98 mL 147 mL |
0.2 L 0.4 L 0.6 L |
0.5 L 1.0 L 1.5 L |
0.8 L 1.6 L 2.4 L |
1.3 L 2.5 L 3.8 L |
1.5 L 3.1 L 4.6 L |
3.1 L 6.3 L 9.4 L |
4.9 L 9.8 L 14.7 L |
7.1 L 14.1 L 21.2 L |
Assembled column bed height |
~25 + cm |
~20 + cm |
~20 + cm |
~20 + cm |
~28 + cm |
~30 + cm |
~30 + cm |
~33 + cm |
~35 + cm |
Outer diameter (including caps) |
6 cm |
7 cm |
10 cm |
16 cm |
20 cm |
21 cm |
27 cm |
33 cm |
38 cm |
Inlet/Outlet flow path internal diameter |
2.00 mm 5/64 in |
3.45 mm 5/32 in |
4.57 mm 3/16 in |
6.35 mm 1/4 in |
6.35 mm 1/4 in |
6.35 mm 1/4 in |
6.35 mm 1/4 in |
9.53 mm 3/8 in |
9.53 mm 3/8 in |
Inlet/Outlet port connectors |
3/4 inch mini Tri-clamp |
3/4 inch mini Tri-clamp |
3/4 inch mini Tri-clamp |
3/4 inch mini Tri-clamp |
3/4 inch mini Tri-clamp |
3/4 inch mini Tri-clamp |
3/4 inch mini Tri-clamp |
3/4 inch mini Tri-clamp |
3/4 inch mini Tri-clamp |
Column diameter |
|||
Physical Attributes |
45.7 cm |
59.9 cm |
79.9 cm |
Internal cross section |
1,640 cm2 |
2,818 cm2 |
5,014 cm2 |
Column hardware maximum pressure |
3 bar |
3 bar |
3 bar |
Bed height range |
10 - 30 cm |
10 - 30 cm |
10 - 30 cm |
Column volumes bed height 10 cm 20 cm 30 cm |
16 mL 33 mL 49 mL |
28 L 56 L 84 L |
50 L 100 L 150 L |
Assembled column height (CM)* |
≤ 22 cm BH: ~90 cm |
≤ 22 cm BH: ~93 cm |
≤ 20 cm BH: ~97 cm |
Outer diameter (including caps) |
54 cm |
68 cm |
91 cm |
Inlet/Outlet flow path internal diameter |
12.7 mm 1/2 in |
19.1 mm 3/4 in |
19.1 mm 3/4 in |
Inlet/Outlet port connectors |
3/4 inch mini Tri-clamp |
1 inch Tri-clamp |
1 inch Tri-clamp |
Each resin type is given a unique customer property (CP) number, establishing full traceability of customer supplied resin throughout the lifecycle of the OPUS order. Once received, the resin will be released and labeled with the unique CP number. All customer property is stored in a segregated cage in the warehouse until the column is ready for production and all movements throughout the facility are systematically tracked within Resource Planning System. After manufacturing is complete, the column is QA released, and any excess resin will be either disposed or returned based on customer designation.
Repligen uses Fourier Transform Infrared (FTIR) test analysis to identify each resin lot delivered for packing OPUS® Pre-packed Columns. The test correlates the unique IR absorbance trend of incoming resin against our library of trends representing > 200 resin types in our database. If the resin sample shows ≥95% correlation to a trend in our library, results will show a positive ID.
Yes. Unpacking of non-compressible media has not been studied and is not recommended. In general, these include Ceramic Hydroxyapatite, controlled pore glass, and silica based particles.
Yes. OPUS® Pre-packed Columns are compatible with conventional and disposable flow path chromatography systems. For more information about connecting and operating OPUS® Columns, please refer to the OPUS® Pre-packed Column User Guides.
Solvent compatibility list
|
|
|
Water |
2 M sodium hydroxide |
Sulfuric acid (<50%) |
20% Acetic acid |
Potassium hydroxide |
8 M urea or 6 M guanidine HCI |
20% Ethanol |
Benzyl alcohol |
Methanol |
10% Acetone |
Isopropyl alcohol (IPA) |
Phosphoric acid |
2% (w/v) Detergents |
Citric acid |
HCI (< 20%) |