Table of Contents
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Table of Contents
Summary of Contents for REPLIGEN OPUS 14
- Page 1 OPUS® 5 - 80R Pre-packed Chromatography Columns USER GUIDE...
- Page 2 The information contained in this document is subject to change without notice. Repligen Corporation makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose.
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Page 3: Table Of Contents
Table of Contents Safety Notices ........................4 Introduction ......................... 4 2.1 What is Open Platform User Specified (OPUS®)? ..............4 2.2 Column Design ........................... 4 2.3 Platformable ..........................5 2.4 Materials of Construction ......................5 2.5 OPUS® Physical Specifications ....................7 2.6 Product Contact Materials ...................... - Page 4 List of Tables Table 1. Removal of OPUS® Pre-packed Columns from Packaging ............4 Table 2. Physical Specifications Summary (OPUS® 5 – 30 Columns) ............7 Table 3. Physical Specifications Summary (OPUS® 5 – 30 Columns) ............8 Table 4. Product Materials and Quality Standards ................. 9 Table 5.
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Page 5: Safety Notices
OPUS® 5-80R Pre-packed Chromatography Columns Safety Notices Please abide by the following movement and handling recommendations according to uncrating guide based on column internal diameter. Do not pull or strain the white inlet and outlet ports protruding from the top of the OPUS® column. Table 1. -
Page 6: Platformable
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 accessed via Repligen website. Materials of Construction Figure 1. Materials of Construction Summary: OPUS® 5 and 8 Columns... -
Page 7: Figure 2. Materials Of Construction Summary: Opus® 10 - 30 Columns
OPUS® 5-80R Pre-packed Chromatography Columns Figure 2. Materials of Construction Summary: OPUS® 10 – 30 Columns Top Cap (ABS Plastic) Outlet Port (Polypropylene) Inlet Port (Polypropylene) Side Guard Column Tube (ABS Plastic) (Polypropylene) O-rings Flow (Platinum Distributors Cured Silicone) with 12μm Mesh (Polypropylene) Return Line... -
Page 8: Opus® Physical Specifications
OPUS® 5-80R Pre-packed Chromatography Columns Figure 3. Materials of Construction Summary: OPUS® 45R, 60R, and 80R Columns OPUS® Physical Specifications Table 2. Physical Specifications Summary (OPUS 5 – 30 Columns) ® Column Diameter Physical 5.1 cm 8.1 cm 10 cm 12.6 cm 14 cm 20 cm... -
Page 9: Product Contact Materials
OPUS® 5-80R Pre-packed Chromatography Columns Column Diameter Outer Diameter 7 cm 10 cm 16 cm 20 cm 21 cm 27 cm 33 cm 38 cm (including caps) Inlet/Outlet 3.45 mm 4.57 mm 6.35 mm 6.35 mm 6.35 mm 6.35 mm 9.53 mm 9.53 mm Flow Path... -
Page 10: Solvent Compatibility
OPUS® 5-80R Pre-packed Chromatography Columns Table 4. Product Materials and Quality Standards Component Material CFR 21 177 BSE/TSE Composite tube 70% w/w E-Glass Class VI OPUS® 45R, 60R, 80R cm IDs / PP* 177.1520 Animal Free USP <88> Homopolymer Column Tubes Extruded PP Class VI 177.1520... -
Page 11: Column Mass Table
Inspect the outside of the heavy-duty cardboard carton (for OPUS® 5 – 30 Columns) or wooden crate (for OPUS® 45R, 60R and 80R Columns) for any unusual signs of damage. If significant damage has occurred, please contact Repligen immediately. b. Locate the shipping delivery documents attached to the outside of the box. -
Page 12: Figure 4. Sanisure Clamp Removal
OPUS® 5-80R Pre-packed Chromatography Columns b. Reference Table 1 and Table 7 in this User Guide for handling suggestions and features. c. Do not pull or strain the white inlet and outlet ports protruding from the top of the OPUS® column. 4. - Page 13 Appendix 2 1. Connect the column to the chromatography skid while limiting the entry of air to the inlet port connection. Repligen suggests the following sequence for reducing air introduction to the column: 1.1. The column may have off-gassed during shipment which leaves the ports dry; however, the packed bed will remain hydrated in its storage solution.
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Page 14: Opus® Column Sanitization, Storage, And Disposal
Examples of low surface tension solutions include 1% surfactant (e.g. Tween) and 20% Ethanol for normal phase resins o Contact Repligen Customer Support for specific troubleshooting tactics specified to column dimension and packed resin •... -
Page 15: Pressure Increase During Run
OPUS® 5-80R Pre-packed Chromatography Columns • Reduce the flow rate of solution through the column to abide by pressure limit of the packed resin bed • Confirm that high viscosity solutions are not being used during pressure evaluation • Flow of alcohols through the column is known to increase column pressure •... -
Page 16: Appendices
OPUS® 5-80R Pre-packed Chromatography Columns Appendices Appendix 1: Use of a 3-Way Valve for Inlet Connection and Air Purging To purge air when the column is first connected to the chromatography system: 1. Connect one end of the 3-way valve to the column inlet and the other end to the chromatography system pump. -
Page 17: Appendix 2: Connecting An Opus® Column To Chromatography Skids
OPUS® 5-80R Pre-packed Chromatography Columns 7. Introduce flow to the column at a low flow rate (i.e. 50 cm/hr) to flush trapped air from the column outlet. In the absence of a 3-way valve: 1. A “T” line can be connected between the column and chromatography system. 2. -
Page 18: Figure 8. Absorbance / Conductivity Graph
4. Proceed to testing the column: 4.1. Note: refer to your column’s CoA or CoQ for the test “Mobile Phase” and “Testing Flow Rate” used by Repligen. 5. Conduct a pulse injection with 1-2% CV of the Injection Solution. 5.1. Note: refer to your column’s CoA or CoQ for the “Injection Solution” and “Injection Volume”... - Page 19 OPUS® 5-80R Pre-packed Chromatography Columns Efficiency Definitions: Purpose: This section describes the conversion of HETP values expressed in centimeters to Efficiency values expressed in Plates/meter. Both HETP and Efficiency may be used to quantitatively describe the quality of a chromatography column’s packed bed. N: Number of theoretical plates HETP: Height of an equivalent theoretical plate, expressed in units of cm/N.
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Page 20: Index
OPUS® 5-80R Pre-packed Chromatography Columns Index Air ................14, 17 Operating ............13, 14, 15 Certificate of Analysis ..........4, 11 Pressure ............7, 8, 11, 15 Connect ..............17, 19 Connecting ............13, 14, 19 Quality ................4 GMP Run Ready ............11 Sanitization ..............
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