Astrea Evolve AB070505 Manual

Technical User Guide
Evolve™Process Columns
(70, 100 & 140mm diameter columns)

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Contents
Table of Figures .........................................................................................4
1. Column Hardware....................................................................................5
Mechanical Description: .............................................................................5
Design features: ......................................................................................5
Technical data........................................................................................6
Weights and Dimensions.............................................................................6
Pressure Drop .........................................................................................7
Material Conformity..................................................................................9
Materials of Construction – Process-Wetted Parts ............................................9
Materials of Construction – Non Process-Wetted Parts.......................................9
Chemical Compatibility.............................................................................10
2. Safety Guidelines ...................................................................................12
Safety considerations ...............................................................................12
Pressure Equipment Directive (PED)..............................................................12
Over-Pressurization .................................................................................12
Handling ..............................................................................................12
Chemical compatibility.............................................................................12
3. Column Installation and Operation...............................................................13
Column Installation..................................................................................13
(1) Installation of bed supports.................................................................13
(2) Installation of Fixed Bed Support ..........................................................13
(3) Levelling the Evolve™ Process Columns ...................................................14
(4) Installation of Adjuster Bed Support.......................................................14
(5) Setting the Bed Height.......................................................................15
4. Column Operation...................................................................................16
Hydrostatic Leak Test...............................................................................16
Column Packing (Constant Flow Rate Method)..................................................17
Unpacking ............................................................................................20
Cleaning...............................................................................................20
Storage................................................................................................20
5. Maintenance .........................................................................................21
Routine Maintenance Procedures and General Guidelines ....................................21
Disassembly of Evolve™ Process Columns ........................................................22
Adjuster Assembly ................................................................................22
Fixed Assembly....................................................................................23
Tube Assembly ....................................................................................23
Reassembly of Evolve™ Process Columns.........................................................24

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Fixed Assembly....................................................................................24
Adjuster Assembly ................................................................................25
6. Troubleshooting.....................................................................................28
Leakage from Adjuster Seal........................................................................28
Leakage from Fixed Bed Support Seal............................................................28
Leakage from Inlet or Outlet ......................................................................28
Excessive Column Back Pressure ..................................................................28
Media Leakage .......................................................................................29
7. Ready to Use.........................................................................................30
Kits supplied with Column..........................................................................30
Tool kit................................................................................................30
Connection kit .......................................................................................30
Spares Kit.............................................................................................31
8. Spare Parts, Kits & Accessories.................................................................32
Column Refresh Kit..................................................................................32
Wetted Flow path Kit...............................................................................34
Bed Support Kit ......................................................................................34
Elastomer Seal Kit...................................................................................35
Adjuster Cell Kit.....................................................................................35
Tube Replacement Kits.............................................................................35
Fixed Cell Kit.........................................................................................36
Fluid Connection Kit (70- & 100 mm diameter columns) ......................................36
Fluid Connection Kit (140, 200 & 250 mm diameter columns)................................36
Flexible Hose (70 & 100 mm diameter columns)................................................36
Flexible Hose (140, 200 & 250 mm diameter columns) ........................................37
Torque Wrench Kit (70, 100 & 140 mm diameter columns) ...................................37
9. Chromatography Performance ..................................................................38

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Table of Figures
Figure 1 Pressure Drop Evolve™ 70 mm Process Column 7
Figure 2 Pressure Drop Evolve™ 100 mm Process Column 7
Figure 3 Pressure Drop Evolve™ 140 mm Process Column 8
Figure 4 Diagram showing the location of the fixed bed support 13
Figure 5 Photograph showing the installation of the fixed bed support 14
Figure 6 Diagram showing the location of the adjuster bed support 14
Figure 7 Photograph showing the location of the adjuster bed support 15
Figure 8 Schematic of the column with part identification 19
Figure 9 Adjuster Assembly for EvolveTM 100 Process Column 22
Figure 10 Fixed Assembly for EvolveTM 100 Process Column 23
Figure 11 Diagram showing the location of the fixed bed support 24
Figure 12 Photograph showing the installation of the fixed bed support 24
Figure 13 Photograph showing the location of the adjuster bed support 25
Figure 14 Diagram showing the location of the adjuster bed support 26
Figure 15 Photograph showing the final location of the adjuster bed support 26
Figure 16 Photograph showing the alignment of markings on flow tube and
sanitary clamp adapter to ensure component is correctly tightened 27
Figure 17 Description of Column Efficiency Calculations 38

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1. Column Hardware
Mechanical Description:
Evolve™ Process Columns are designed specifically for use in
biopharmaceutical applications and can be used in both pilot and
production scale chromatographic processes.
A pressure rating of 4 bar, operating temperature range of 2-30°C
and adjustable bed height makes this column suitable for a wide
range of chromatography media types and chromatographic
techniques.
Design features:
1. The entire flow path is non-metallic, which has the following advantages;
a. Eliminates the corrosion risk and contamination of the process.
b. Allows the use of high concentration sodium chloride and guanidine hydrochloride
solutions.
c. Prevents any product inactivation through metal contact.
2. Unlike other columns available on the market the Evolve™ Process Columns have an integral
bed support and seal assembly. The polypropylene mesh and seal are manufactured as a
single unit and fits directly on the flow cell without any fixings, which has the following
advantages;
a. Ensures the maximum area is available to flow, promoting good chromatographic
performance and clean ability.
b. Eliminates use of fixings to secure the bed support to the flow cell, removing the
potential for leak paths or dead flow zones.
c. Reduces number of components in the column assembly, leading to easy operation
and maintenance.
3. Sealing of the adjuster flow cell to the tube wall is achieved by a moulded Santoprene®
seal. Central activation of this seal ensures that compression is even. The mechanism to
energise and de-energise the seal is simple and easy to operate.
4. Positioning of the adjuster assembly within the acrylic tube is easy and simple using the
central adjustment mechanism.
5. The column is composed of three main sub-assemblies –
a. Adjuster assembly - which consists of the adjuster flow cell assembly, adjuster seal
components, adjuster flange and a central height adjust rod. This allows the
position of the adjuster to be varied using the height adjust rods over the range 20-
520 mm.
b. Tube unit - which consists of the acrylic column tube, flanges and column stand or
support legs.
c. Fixed assembly - which consists of the bottom flow cell assembly and flow tube.

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Technical data
Column:
70 100 140
Product Code AB070505 AB100505 AB140505
Tube i.d. (mm) 70 100 140
Cross sectional area (cm2) 38.5 78.5 154
Maximum bed height (cm) 520 520 520
Minimum bed height (cm) 20 20 20
Max. column volume (L) 2 4 8
Adjustable capacity (L)
1.9 3.9 7.7
Pressure rating (bar/psi) 4/ 58 4/ 58 4/ 58
Operating temperature
2 to 30°C
Bed support size 8µm
Weights and Dimensions
Column: 70 100 140
Product Code AB070505 AB100505 AB200505
Adjuster Weight (kg) 4 5 7.5
Total weight empty (kg) 11.5 12.5 19
Total Weight Full* (kg) 13 16 26
Maximum diameter excluding
casters (mm)
226 226 282
Maximum diameter including
casters (mm)
226 226 282
Maximum height (mm) 1523 1543 1545
Minimum clearance** (mm) 1620 1620 1620
*based on bed height of 520 mm and specific gravity 1.05
**minimum height required to remove adjuster from acrylic tube unit

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Pressure Drop
The pipework and column contribute to the pressure drop of the chromatographic system.
Measuring the pressure drop from the column inlet to the column outlet shows the contribution
made by the column hardware. The tests were performed at ambient temperature 15-20°C using RO
water.
Figure 1 Pressure Drop Evolve™ 70 mm Process Column
Figure 2 Pressure Drop Evolve™ 100 mm Process Column
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0200 400 600 800 1000 1200
Linear Velocity cm/hr
Pressure bar
00.2 0.4 0.6 0.8 11.2 1.4 1.6
Volumetric flowrate L/min
Evolve 100

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Figure 3 Pressure Drop Evolve™ 140 mm Process Column

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Material Conformity
All materials in contact with the process stream have been selected for their suitability for use in
equipment utilised in biopharmaceutical applications and so either conform to relevant sections of
FDA code of Federal Regulations vol. 21 170-199 and/or have passed USP class VI test for in vivo
toxicity.
Materials of Construction – Process-Wetted Parts
Column Component
Material
Column tube Acrylic
Fixed flow tube Polypropylene
Adjuster flow tube Polypropylene
Sanitary clamp adapters 20% glass filled polypropylene
Bed supports Polypropylene
Fixed bed support seal Santoprene®
Adjuster seal Santoprene®
Flow tube seal (fixed and adjuster) Santoprene®
Adjuster bed support seal Santoprene®
Fixed flow cell Polypropylene (black)
Adjuster flow cell Polypropylene (black)
Anti-jet disc 20% glass-filled polypropylene
Sanitary clamp seals Santoprene® elastomer
Pipe spool Polypropylene
Materials of Construction – Non Process-Wetted Parts
Column Component
Material
Adjuster flange, tube flange and fixed flange, fixed flow cell
back plate (200 & 250 mm only) Acetal black
Seal adjust boss, seal adjust tube Stainless steel
Threaded central adjust rod Acetal black
Seal adjust handles (70 mm and100 mm), pipework clamp Acetal blue
Seal adjust handles (140 mm, 200 mm and 250 mm) Stainless steel/Acetal blue
Lifting eye (200 mm and 250 mm only) Stainless steel 316
Support Leg Stainless steel 316
Foot (200 mm and 250mm only) Stainless steel with rubber
Bolts, screws, washers Stainless steel type 316