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OPUS® 5 - 80R

Pre-packed Chromatography Columns

USER GUIDE

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Summary of Contents for OPUS 14

Page 1: ...OPUS 5 80R Pre packed Chromatography Columns USER GUIDE ...

Page 2: ...he furnishing performance or use of this material No part of this document may be photocopied reproduced or translated to another language without the prior written consent of Repligen Corporation For further information please contact Repligen Corporation at www repligen com 2018 Repligen Corporation All rights reserved The trademarks mentioned herein are the property of Repligen Corporation and ...

Page 3: ...dling 10 3 Preparing to Use Your OPUS Column 10 4 OPUS Column Sanitization Storage and Disposal 13 4 1 Cleaning and Sanitization Notes 13 5 Troubleshooting 13 5 1 Air in the column 13 5 2 High pressure during first use of column 13 5 3 Pressure increase during run 14 5 4 Pressure drop during run 14 6 Appendices 15 6 1 Appendix 1 Use of a 3 Way Valve for Inlet Connection and Air Purging 15 6 2 Appe...

Page 4: ...n Weight 10 Table 7 Column Handling Features 10 List of Figures Figure 1 Materials of Construction Summary OPUS 5 and 8 Columns 5 Figure 2 Materials of Construction Summary OPUS 10 30 Columns 6 Figure 3 Materials of Construction Summary OPUS 45R 60R and 80R Columns 7 Figure 4 SaniSure Clamp Removal 11 Figure 5 Stainless Steel Valve Connection to OPUS Column 11 Figure 6 Position of 3 way valve for ...

Page 5: ...n platform offers an alternative to conventional pack in place glass or stainless steel columns and can be reliably packed with virtually any resin from any source To accommodate a wide range of biopharmaceutical applications OPUS Columns are configurable for nearly any bed height and industry standard internal diameters 2 2 Column Design The OPUS platform has been designed to meet the requirement...

Page 6: ...ly available bioprocessing resins Available in a wide range of bed heights and industry standard column diameters Configurable for specific packing procedures release tests and storage solutions Regulatory Support File For additional details into supporting data for the design of the OPUS product line and testing of qualified processes refer to the Regulatory Support File RSF The RSF may be access...

Page 7: ...OPUS 10 30 Columns Inlet Port Polypropylene Top Cap ABS Plastic Outlet Port Polypropylene Column Tube Polypropylene Flow Distributors with 12μm Mesh Polypropylene Column Outlet Polypropylene Bottom Cap ABS Plastics Return Line Platinum Cured Silicone Side Guard ABS Plastic O rings Platinum Cured Silicone ...

Page 8: ...cm 2 154 cm 2 314 cm 2 491 cm 2 707 cm 2 Column Body Pressure Rating 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 Column Volumes 10 cm Bed Height 20 cm Bed Height 30 cm Bed Height 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 ...

Page 9: ...0 cm 2 2 818 cm 2 5 014 cm 2 Column Body Pressure Rating 3 Bar 3 Bar 3 Bar Bed Height Range 5 30 cm 5 30 cm 10 30 cm Column Volumes 10 cm Bed Height 20 cm Bed Height 30 cm Bed Height 16 L 33 L 49 L 28 L 56 L 84 L 50 L 100 L 150 L Assembled Column Height cm 22 cm BH 90 cm 22 cm BH 116 cm 22 cm BH 93 cm 22 cm BH 120 cm 20 cm BH 97 cm 20 cm BH 123 cm Outer Diameter including caps 54 cm 68 cm 91 cm In...

Page 10: ...ibutor O Rings OPUS R Plug O Ring OPUS R Inner Outer Gaskets Platinum Cured Silicone PCS O rings Class VI 177 2600 Animal Free Return Line Tube OPUS 10 80R Platinum Cured Silicone PCS braided tubing Class VI 177 2600 Animal Free PP Polypropylene PCS Platinum Cured Silicone 2 7 Solvent Compatibility The product contact materials of construction consist of polypropylene and silicone parts Table 5 li...

Page 11: ...rocessing a Minimum Packing Pressure i Chromatography skid pressure alarms should be set based on the packing pressure for your particular OPUS column b Temperature i Column construction is designed to support a working temperature range of 2o 40 C 2 Upon receipt of the box crate a Inspect the outside of the heavy duty cardboard carton for OPUS 5 30 Columns or wooden crate for OPUS 45R 60R and 80R...

Page 12: ...ped down prior to use with Ethanol or Isopropyl Alcohol solution if necessary a If storing the column in 2 8o C allow the column to equilibrate to room temperature overnight prior to use of the column b Using a wire cutter or sharp scissors remove the white cable tie on the SaniSure clamp sealing the inlet port See Figure 4 Figure 4 SaniSure Clamp Removal Connecting and Operating Your OPUS Column ...

Page 13: ...connected under low flow immediately stop the flow of liquid into the column Column outlet may now be opened via same instruction as Step 1 2 1 3 1 If both the inlet and outlet port are open the column may drain out and draw air into the column flow path 2 Connect outlet tubing to the outlet port and flush the storage solution from the column with 3 5 column volumes of RO DI water or mild buffer e...

Page 14: ...mn Potential Fixes If air entered the inlet port and did not reached the column to the best assessment of the operator follow the air purge procedure described in Appendix 1 If air entered the packed chromatography bed recondition the column by running a solution with low surface tension in reverse flow for 2 3 CVs Increased backpressure on the column effluent may aid in forcing air bubbles out fr...

Page 15: ...ct load concentrations Fouled chromatography resin Temperature shifts between buffers used in the column Potential Fixes Clean the column with the appropriate cleaning method for the residue that clogged the mesh and or resin Running in reverse flow or up flow mode is recommended Flow 5CV of equilibration buffer through the column in reverse flow Recheck pressure and column performance Efficiency ...

Page 16: ...urge line while pumping the mobile phase at low flow rate i e 50 cm hr and draw the plunger to create negative pressure Air bubbles will be drawn into the syringe and mobile phase will immediately fill the space created 4 OPUS 20 80R Columns begin pumping mobile phase at a slow flow rate i e 50 cm hr The mobile phase will travel into the column inlet and out of the purge line This path will engage...

Page 17: ...he column outlet is closed with the pinch valve or outlet cap thus creating a stop barrier for the flow The fraction of the flow that enters the inlet line will dislodge the trapped air in the tube and connector 3 With the flow split to the bypass and inlet lines air bubbles will begin to travel upward in the inlet tube and will be evacuated through the column bypass line into the system outlet To...

Page 18: ...he Injection Solution and Injection Volume used by Repligen 6 Elute with mobile phase for 1 2 CV at the same test flow rate while monitoring UV or conductivity depending on the Injection Solution 6 1 Salt injection solutions are typically analyzed with a conductivity meter while acetone injection solutions are analyzed with an UV meter 6 2 Calculate number of theoretical plates and asymmetry of th...

Page 19: ...oretical plates HETP Height of an equivalent theoretical plate expressed in units of cm N Smaller values indicate a sharper peak Plates meter N m Number of theoretical plates per meter Larger values indicate a sharper peak Formula N m 100 HETP Example Given an HETP specification of 0 05 cm N the conversion follows as below 1 0 05 𝑐𝑐𝑐𝑐 𝑁𝑁 20 𝑁𝑁 𝑐𝑐𝑐𝑐 20 𝑁𝑁 𝑐𝑐𝑐𝑐 100 𝑐𝑐𝑐𝑐 1 𝑚𝑚 2000 𝑁𝑁 𝑚𝑚 Since the for...

Page 20: ...mns Index A Air 14 17 C Certificate of Analysis 4 11 Connect 17 19 Connecting 13 14 19 G GMP Run Ready 11 H Handling 11 M Materials of Construction 6 7 O Operating 13 14 15 P Pressure 7 8 11 15 Q Quality 4 S Sanitization 14 Shipping 11 Storage 14 W Warranty 1 ...

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