Introduction; General Introduction; Scope Of This Operating Instructions - GE AxiChrom 50 Operating Instructions Manual

1

Introduction

1.1

General introduction

AxiChrom column family has been designed to deliver reproducible results from process
development to production scales. This is facilitated by the innovative Intelligent Packing
where UNICORN™ software, ÄKTA™ systems and AxiChrom columns work together to
facilitate a convenient operation for packing of the bed via axial compression.
AxiChrom 50, 70 and 100 are designed to meet process development needs, such as
scale-up trials, and also be used in pilot scale production of biomolecules. The ÄKTA
systems ÄKTA avant, ÄKTAexplorer and ÄKTApilot can be used for the AxiChrom 50 col-
umn, the 70 column can be used with ÄKTA avant and ÄKTApilot, while the 100 column
is compatible with ÄKTApilot only. These columns are packed using internal hydraulic
axial compression. The 70 and 100 columns are mounted on a pivot stand, which allows
easy handling and unpacking. AxiChrom 50, 70 and 100 come in two column tube lengths
to allow bed heights between 10-30 cm and 30-50 cm. The columns are validatable and
use materials classified according to USP Class VI and FDA CFR 177. The material is free
from material of animal origin or has been produced under manufacturing conditions
complying with EMEA/410/01.
1.2

Scope of this Operating Instructions

This Operating Instructions is designed as a general introduction and guide to using
AxiChrom 50, 70 and 100. It is recommended that the user reads the complete Operating
Instructions before using the column. Information concerning safety precautions is
presented in this manual in conjunction with general information about the features
and operation of the column.
Specifically, the instructions cover:
Chapter 1
Chapter 2
Chapter 3
Chapter 4
Chapter 5
AxiChrom 50, 70 and 100 columns Operating instructions 28-9331-08 AG
General introduction, intended use of the columns, and labels.
Safety instructions.
AxiChrom 50, 70 and 100 specifications, including principles of
column function and column specifications.
Preparation of a column for use, including unpacking, installa-
tion, column and system setup, use of AxiChrom Master and
instructions for cleaning the column before use.
Preparations required before packing the column, including
slurry preparation and priming the column.
1 Introduction
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