Thermo Fisher Scientific EvolveD Columns User guide

Brand
Thermo Fisher Scientific
Model
EvolveD Columns
Type
User guide
EvolveD™ Columns
Pub. No. MAN0018737 Rev. A.0
WARNING! Read the Safety Data Sheets (SDSs) and
follow the handling instructions. Wear appropriate
protective eyewear, clothing, and gloves. Safety Data Sheets
(SDSs) are available from thermosher.com/support.
This user manual describes the properties and use of EvolveD™
columns pre-packed with chromatography resin available from
Thermo Fisher Scientic. For the use of EvolveD™ columns
packed with dierent resin, please refer to the manufacturer’s
instructions.
Product description
The EvolveD™ Column range is a ready-to-use format column
designed specically for use in Biopharmaceutical applications.
These columns are supplied pre-packed and ready to use, and
feature an entirely non-metallic ow path which has the following
advantages:
• Eliminates the corrosion risk and contamination of the
process
• Allows the use of high concentration sodium chloride
solutions and guanidine hydrochloride (if suitable)
• Prevents any product inactivation through metal contact
The columns are qualied in terms of performance and pressure
ow characteristics.
5
2
1
21
2
4
6
73
6
7
7
5
5
4
4
6
1
3
3
1Inlet
2Outlet
3Column handle
4Column tube
5Tubing guard
6Column stand
7Pipe spool
Quality Standards
The columns are available as ready-to-use products suitable for
cGMP processes. These columns are packed in a classied ISO7
environment, and suitably sanitized to allow direct
implementation into processes without the need for pre-
preparation by the user. All materials in contact with the process
stream have been selected for their suitability for use in equipment
utilized in biopharmaceutical applications, and so either conform
to relevant sections of FDA code of Federal Regulations vol. 21
170–199 and/or passed USP class VI testing for in vivo toxicity.
Pressure Equipment Directive (PED)
European Pressure Directive 97/23/EC relates to regulations that
are mandatory and govern a wide range of pressure containing
vessels. The design and manufacture of chromatography columns,
including EvolveD™ Columns, are aected by these regulations.
EvolveD™ Columns have been assessed to fall within the Sound
Engineering Practice (SEP) category of these regulations. The
foundation of the assessment is based on the following:
• EvolveD™ Columns are liquid chromatography columns,
which when used in accordance within their Operating
Instructions should have no gas (e.g., air) present within the
columns.
• The substances that are used within the column remain in
liquid form during the entire operation at the maximum
stated operating temperature.
Pressurization
• The maximum pressure is less than 6 bar.
• The product pressure x volume is equal to or less than 200 bar
litres.
The maximum pressure rating is 6 bar in line with the pressure
equipment directive. The maximum recommended operating
pressure is 4 bar. Users of these chromatography columns must
ensure that the maximum recommended operating pressure is not
exceeded. It is recommended that an over-pressurization
protection device such as a pressure relief valve or equipment is
used.
USER GUIDE
For Research Use or Further Manufacturing. Not for diagnostic use or direct administration in to humans or
animals.
General guidelines
• Review the Regulatory Support File for additional
information regarding the product.
• EvolveD™ Columns are shipped in a preservative. This
solution will be ushed from the column during equilibration
and preparation for use.
• Take care when moving or handling the columns as they
weigh up to 17 kg (for the 20 cm D x 20 cm L). Mechanical
handling equipment or manual handling aids should be used
where personnel cannot safely lift or move the column or its
subassemblies.
Install the column
EvolveD™ Columns are designed as disposable, ready-to-use units.
1. Remove the column from the external packaging (cardboard
box).
The column is double-bagged. Keep the column in the bag
until transferred to a suitable qualied area.
2. Remove the plastic bagging, then place the column on a level
surface. Perform a visual inspection of the column to ensure
no damage occurred during transit.
3. Use proper PPE when making all connections and
disconnections. Remove the protective end caps by
unclipping the sanitary clamps on both the inlet and outlet.
The sanitary clamps are re-useable and are removed by
pushing one of the ratchet ends perpendicular to the other
ratchet end (the ratchet ends are one directional).
4. Fill the inlet and/or outlet ports with equilibration buer
prior to connecting the lines to avoid air.
The inlet port is the central port in the middle of the column,
and the outlet port is aached to the side of the column by
means of a pipe spool.
5. Connect the inlet of the column to a chromatography system
with 25 mm (3/4 inch) TC sanitary ings (which are
cleaned, primed, and set at a slow ow rate to minimize any
risk of air entering the column).
A 4-way two port valve can also be used to create this
connection. The Santoprene™ gaskets can be re-used to form
a seal with the 25 mm TC sanitary ing from the
chromatography system.
a. With the column outlet closed, connect the column inlet
under low ow and clamp tight to avoid air being
introduced into the system.
b. Immediately stop the ow of liquid into the column
once the inlet has been connected to avoid
pressurization.
c. Secure the ing using a sanitary clamp. Fit the
sanitary clamp around the two sanitary ing anges
and secure rmly.
6. Connect the outlet of the column to the chromatography
system with 25 mm (3/4 inch) TC sanitary ings.
a. With the column outlet closed, connect the column
outlet.
b. Secure the ing using a sanitary clamp. Fit the
sanitary clamp around the two sanitary ing anges
and secure rmly.
7. Open the column outlet and ush the storage solution
(preservative) from the column using an appropriate/resin
recommended equilibration buer at a ow rate equal to 50%
of the operational ow rate (e.g., if the operational ow rate
is 120 cm/h, set the initial ush ow rate at 60 cm/h). Allow
at least 3 column volumes of the buer to ow through the
column, or until the eluent matches the pH and conductivity
of the buer entering the column before using the column.
8. If there is a requirement to evaluate the column eciency,
follow the instructions as described in “Column eciency
test“ on page 8.
2
EvolveD
™
Column User Guide
Column operation guidelines
The following guidelines are general recommendations to follow when operating EvolveD™ Columns. Refer to the individual user guide of
the packed resin for the appropriate solutions and conditions to carry out column chromatography.
• Filter/clarify all buers and feedstock through an appropriate lter prior to running the columns.
• The maximum operating pressure for the column is 4 bar. Do not exceed this pressure limit. Refer to the individual user guide of the
packed resin with respect to ow rates, pressure recommendations, and other process conditions.
• The column inlet is located on the top and in the centre of the column, and the column outlet is located on the top of the column to the
side via a pipe spool from the boom of the column.
The following table provides a quick reference guide to determine the linear to volumetric ow rates of the respective column sizes. Refer
to the appropriate resin user guide for the recommended ow rates.
Table 1 Flow rates for the different EvolveD™ Columns
Linear Flow Rate (cm/h)
7 cm (D) x 10 cm (L)
7 cm (D) x 20 cm (L)
10 cm (D) x 10 cm (L)
10 cm (D) x 20 cm (L)
20 cm (D) x 10 cm (L)
20 cm (D) x 20 cm (L)
Volumetric Flow Rate (mL/min)
25 16 33 131
50 32 65 262
75 48 98 393
100 64 131 524
120 77 157 628
150 96 196 785
200 128 262 1,047
250 160 327 1,309
300 193 393 1,571
Cleaning and storage
Clean-in-place
Refer to the individual user guide of the packed resin for the
appropriate solutions and conditions in order to carry out a clean-
in-place (CIP).
Cleaning agents, like Isopropyl alcohol (IPA) can be used to clean
and disinfect the outside of the column.
Storage
After usage, the column should be stored or disposed.
Refer to the individual user guide of the packed resin for the
appropriate solutions and conditions in order to store the column.
Follow all appropriate cleaning instructions before disposal. If
disposing of the column, ush with water for 3 CVs. Follow all
regulatory requirements when disposing of columns.
EvolveD
™
Column User Guide
3
Product specifications
Column properties
Table 2 EvolveD™ Column technical data (10-cm bed height columns)
Column dimension 7 cm (D) x 10 cm (L) 10 cm (D) x 10 cm (L) 20 cm (D) x 10 cm (L)
Cross-sectional area (cm2) 38.5 78.5 314.2
Bed height (mm) 100 100 100
Column volume (L) 0.385 0.785 3.14
Pressure rating (bar) (psi) 4 (58) 4 (58) 4 (58)
Operating temperature[1] 2 to 30°C 2 to 30°C 2 to 30°C
Bed support pore size (µm) 8 8 8
Inlet/outlet internal diameter
(mm) 3 mm 3 mm 6 mm
Inlet/outlet port connections 25-mm TC sanitary fitting
[1] The operating temperature is dependent on the resin packed.
Table 3 Weights and Dimensions (10-cm bed height columns)
Column dimension 7 cm (D) x 10 cm (L) 10 cm (D) x 10 cm (L) 20 cm (D) x 10 cm (L)
Total weight[1] (kg) 3.1 3.4 11.8
Max external diameter (mm) 180 180 340
Max external height (mm) 280 285 310
[1] Total weight based on a packed column.
Table 4 EvolveD™ Column technical data (20-cm bed height columns)
Column dimension 7 cm (D) x 20 cm (L) 10 cm (D) x 20 cm (L) 20 cm (D) x 20 cm (L)
Cross-sectional area (cm2) 38.5 78.5 314.2
Bed height (mm) 200 200 200
Column volume (L) 0.77 1.57 6.28
Pressure rating (bar) (psi) 4 (58) 4 (58) 4 (58)
Operating temperature[1] 2 to 30°C 2 to 30°C 2 to 30°C
Bed support pore size (µm) 8 8 8
Inlet/outlet internal diameter
(mm) 3 mm 3 mm 6 mm
Inlet/outlet port connections 25-mm TC sanitary fitting
[1] The operating temperature is dependent on the resin packed.
Table 5 Weights and Dimensions (20-cm bed height columns)
Column dimension 7 cm (D) x 20 cm (L) 10 cm (D) x 20 cm (L) 20 cm (D) x 20 cm (L)
Total weight[1] (kg) 4.0 4.6 16.7
Max external diameter (mm) 180 190 340
Max external height (mm) 380 390 410
[1] Total weight based on a packed column.
4
EvolveD
™
Column User Guide
Material Conformity
All materials in contact with the process stream have been selected for their suitability for use in equipment utilized in Biopharmaceutical
applications and so either conform to relevant sections of FDA code of Federal Regulations vol. 21 170–199 and/or passed USP class VI
testing for in vivo toxicity.
Table 6 Materials of construction - process wetted parts
Column component Material
Column tube Polypropylene
Sanitary clamp adapters 20% Glass-filled polypropylene
Bed supports Polypropylene
Adjuster bed support seal Santoprene™ elastomer
Adjuster seal EPDM
Fixed bed support seal Santoprene™ elastomer
Fixed flow cell Polypropylene (white)
Adjuster flow cell Polypropylene (white)
Anti-jet disc 20% Glass-filled polypropylene
Sanitary clamp seals Santoprene™ elastomer
Pipe spool Polypropylene
Table 7 Materials of construction - process non-wetted parts
Column component Material
Column cap and Column base unit Acetal white
Column Base unit Acetal white
Pipe spool support ring/Column handle Acetal white
Flow cell spacer EPDM
Bolts/lock pins Stainless steel 316
EvolveD
™
Column User Guide
5
Chemical Compatibility
EvolveD™ Columns are ideally suited for aqueous-based applications. For detailed compatibility information, see the following table.
Note:
·All solvents are at 100% concentration unless noted otherwise
·Concentrations: % refer to w/w
·All data is referenced to room temperature (15°C to 25°C)
·For compatibility with the resin packed in the column, use the guidelines in the manual for the resin.
·If using substances not listed, you must consider their eect as the integrity and safety of the column could be compromised. Where
stated, the concentrations of identied chemicals are maximum levels determined suitable (or detrimental) to the column construction
materials.
Table 8
Chemical Wetted Components[1] Non-Wetted[1]
Acetic acid 25% ++ ++
Benzyl alcohol up to 2% ++ ++
Citric acid 20% ++ ++
Disodium phosphate ++ ++
Ethanol 20% ++ ++
Ethylene glycol (1,2-ethanediol) ++ ++
Glycerol (Glycerine) ++ ++
Guanidine hydrochloride 2M ++ --
Sodium acetate ++ ++
Sodium chloride 2 M ++ ++
Triton ® X-100 surfactant up to 1% ++ ++
Urea 6 M ++ ++
[1] Resistence: ++ is Resistant and suitable for continuous use, -- is Not resistant and not recommended.
6
EvolveD
™
Column User Guide
Related products
Product name Catalog No.
380 ML 770 ML 780 ML 1.6 L 3.1 L 6.3 L
CaptureSelect™ IgG-CH1
EvolveD™ Column 6943200071 6943200072 6943200101 6943200102 6943200201 6943200202
CaptureSelect™ KappaXL
EvolveD™ Column 6943210071 6943210072 6943210101 6943210102 6943210201 6943210202
CaptureSelect™ KappaXP
EvolveD™ Column 6943212071 6943212072 6943212101 6943212102 6943212201 6943212202
CaptureSelect™ FcXL
EvolveD™ Column 6943280071 6943280072 6943280101 6943280102 6943280201 6943280202
CaptureSelect™ CH1-XL
EvolveD™ Column 6943462071 6943462072 6943462101 6943462102 6943462201 6943462202
CaptureSelect™ HSA
EvolveD™ Column 6942970071 6942970072 6942970101 6942970102 6942970201 6942970202
CaptureSelect™ HGH
EvolveD™ Column 6943160071 6943160072 6943160101 6943160102 6943160201 6943160202
CaptureSelect™ TSH
EvolveD™ Column 6943562071 6943562072 6943562101 6943562102 6943562201 6943562202
CaptureSelect™ FSH
EvolveD™ Column 6943180071 6943180072 6943180101 6943180102 6943180201 6943180202
CaptureSelect™ hCG
EvolveD™ Column 6943410071 6943410072 6943410101 6943410102 6943410201 6943410202
CaptureSelect™ tPA
EvolveD™ Column 6943430071 6943430072 6943430101 6943430102 6943430201 6943430202
CaptureSelect™ C-tagXL
EvolveD™ Column 6943072071 6943072072 6943072101 6943072102 6943072201 6943072202
EvolveD
™
Column User Guide
7
Column efficiency test
1. Aach the column to an equilibrated chromatography
system.
2. Test the column at the recommended ow rate for the resin
being used.
If no ow rate for testing is available, use a ow rate of
120 cm/h or the recommended resin operational ow rate.
3. Commence ow for 1 column volume (CV) to equilibrate and
obtain baseline using either the equilibration buer (low
ionic strength buer) or a saline solution as the mobile phase.
4. Inject 2–4% CV of a tracer solution (as recommended by the
resin manufacturer).
Commonly used tracer solutions include 1–2 M NaCl
solution or a dilute acetone solution (up to 5%), dependant
on detection method preference (or recommendation from
the resin manufacturer).
5. Continue ow until a conductivity (or UV) peak is observed,
and the trace has returned to baseline (~ 2 CV).
6. End the run, then determine the asymmetry factor and plate
count:
Figure 1 Example UV chromatogram of a 3% acetone
sample during a column efficiency test
• L = bed height (cm)
• N = number of theoretical plates.
• VR = volume eluted from the start of the sample
application to the peak maximum.
• Wh = The width of the recorded peak at half of the peak
height.
VR and Wh have the same units.
The peak corresponding to the acetone or NaCl sample
should be symmetrical with an asymmetry factor as close to
1 as possible.
• a = ascending part of the peak width at 10 % peak
height.
• b = descending part of the peak width at 10 % of peak
height.
7. Refer to the associated documentation for the resin with
regards to the recommended specication for asymmetry
and plate count/HETP.
8. Packing factors for CaptureSelect agarose resins are typically
in the range of 1.1–1.3.
Limited product warranty
Life Technologies Corporation and/or its aliate(s) warrant their
products as set forth in the Life Technologies' General Terms and
Conditions of Sale at www.thermosher.com/us/en/home/global/
terms-and-conditions.html. If you have any questions, please
contact Life Technologies at www.thermosher.com/support.
BAC BV | Huizerstraatweg 28 | 1411 GP Naarden | The Netherlands
For descriptions of symbols on product labels or product documents, go to thermofisher.com/symbols-definition.
The information in this guide is subject to change without notice.
DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT,
PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.
Revision history: Pub. No. MAN0018737
Revision Date Description
A.0 16 December 2019 New instructions for EvolveD™ Columns.
Important Licensing Information: This product may be covered by one or more Limited Use Label Licenses. By use of this product, you accept the terms and conditions of all
applicable Limited Use Label Licenses.
©2019 Thermo Fisher Scientific Inc. All rights reserved. EvolveD is a trademark of Delta Precision Ltd. and is used under license. All trademarks are the property of Thermo
Fisher Scientific and its subsidiaries unless otherwise specified.
thermofisher.com/support | thermofisher.com/askaquestion
thermofisher.com
16 December 2019
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Thermo Fisher Scientific EvolveD Columns User guide

Brand
Thermo Fisher Scientific
Model
EvolveD Columns
Type
User guide
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