REPLIGEN OPUS 20 User Manual

REPLIGEN OPUS 20 User Manual

Pre-packed chromatography columns
Table of Contents

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OPUS® 5 - 80R
Pre-packed Chromatography Columns
USER GUIDE

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Table of Contents
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Summarization of Contents

Introduction
What is Open Platform User Specified (OPUS®)?
Defines OPUS® columns for chromatography purification in GMP or non-GMP applications.
Column Design
Details the design of the OPUS® platform for GMP manufacturing and campaign-use.
Platformable
Explains the configurability of OPUS® columns for various purification applications.
Materials of Construction
Lists the materials used in the construction of OPUS® columns, illustrated with diagrams.
OPUS® Physical Specifications
Provides detailed physical specifications, including dimensions and pressure ratings, for OPUS® columns.
Product Contact Materials
Identifies materials that come into contact with the product and their quality standards.
Solvent Compatibility
Details common solutions and their compatibility with OPUS® column materials.
Column Mass Table
Presents a table of approximate column weights based on bed height and diameter.
OPUS® Column Handling
Outlines features and recommendations for handling OPUS® columns, including handles and casters.
Preparing to Use Your OPUS® Column
Connecting and Operating Your OPUS® Column
Provides instructions on connecting and operating the OPUS® column with chromatography systems.
OPUS® Column Sanitization, Storage, and Disposal
Cleaning and Sanitization Notes
Offers guidance on cleaning and sanitization agents compatible with column materials.
Troubleshooting
Air in the column
Discusses causes and fixes for air bubbles appearing within the column.
High pressure during first use of column
Identifies reasons for high pressure upon initial column use and their resolutions.
Pressure increase during run
Explains factors contributing to pressure increases during a chromatography run.
Pressure drop during run
Details causes for unexpected pressure drops observed during a chromatography run.
Appendices
Appendix 1: Use of a 3-Way Valve for Inlet Connection and Air Purging
Step-by-step guide for using a 3-way valve to connect the column inlet and purge air.
Appendix 2: Connecting an OPUS® column to Chromatography Skids
Instructions for connecting OPUS® columns to chromatography skids.
Appendix 3: Column Performance Testing
Procedures for measuring and assessing column performance metrics like plate count.

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