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Chromatography Column Bubble Trap Kit Installation and Instruction Guide

DELTA PRECISION LTD

Chromatography Column

Bubble Trap Kit Installation and Instruction Guide

Table of Contents Bubble Trap Kit ......................................................................................................... 2 Kit Contents............................................................................................................... 2 Technical Specifications ............................................................................................ 3 Materials Conformity ................................................................................................. 3 Chemical Compatibility ............................................................................................. 4 Installation and Bubble Trap Connections ................................................................ 6 General Guidelines ........................................................................................................................... 6 Fitting the Bubble trap onto the column .............................................................................................. 6 Pipework Connections ....................................................................................................................... 6 Operating Instructions............................................................................................... 8 Bubble Trap Priming ........................................................................................................................ 8 Sample loading ................................................................................................................................. 8 Maintenance .............................................................................................................. 9 Cleaning and Storage ........................................................................................................................ 9 Contact Us ................................................................................................................ 10 Revision History Revision A B C

Comments Initial release Updated address Updated. AABTK3 added. Evolve® Logo Change to reflect trademark registration Address removal

Date 28/1/2016 21/06/2018 07/07/2021

Evolve® is a registered trademark of Delta Precision Ltd. Evolve® is a registered trademark in the EU, UK and US.

Manual Revision

Date

July 2021

Bubble Trap Kit This kit enables the integration and installation of a bubble trap to an Evolve® Column. Bubble traps remove air from the system protecting the column from air ingress which can lead to the drying out of media, loss of packed bed integrity and loss of chromatographic performance. Bubble traps also act as pulse dampeners, provide an equal and smooth flow which prevents excessive sample dilution and poor flow distribution. There are three bubble trap kits AABTK1 for Evolve® 70mm and 100mm columns, AABTK3 for Evolve® 140mm and AABTK2 for Evolve® 200mm and 250mm columns.

Kit Contents Kit Contents 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 passed USP class VI test for in vivo toxicity.

QTY 1 1 1 1 1 1 1 1 1 1 1 1 2 10 10 10

X X X

X X

X X X X X X X X X X X

Table 1 Contents of Bubble trap Kits

AABTK3

DESCRIPTION Bubble Trap 30mm Bubble Trap 60mm T Piece Shut off valve Flexible hoses 3mm od, 1.2m Flexible hoses 6mm od, 1.5m Flexible hose 3mm od, 0.3m Flexible hose 6mm od, 0.3m Bracket small Bracket large 4 port 2 way valve small 4 port 2 way valve large Blanking Cap Ladish Seal 6mm id Ladish Seal 3mm id Click clamps

AABTK2

BUBBLE TRAP KIT

AABTK1

Product Ref.

X X X

Technical Specifications Product. No AABTK1 AABTK2 Maximum working pressure 4 bar 4 bar Internal Diameter 30mm 60mm Full volume 140mls 560mls O Operational Temperature Range 2-30 C 2-30OC For Column Diameters mm 70,100 200,250 AABTK3 features bracket to attach bubble trap to Evolve® 140mm column

AABTK3 4 bar 60mm 560mls 2-30OC 140 only

Materials 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 passed USP class VI test for in vivo toxicity. Materials of construction – process-wetted parts Bubble Trap Kit Component Bubble Trap body Flowtube Ladish adaptors T Piece (3mm id and 6mm id) 4 port 2 way valve small 4 port 2 way valve large Shut off valve

Material Acrylic Polypropylene/Santoprene seal Glass filled Polypropylene Polypropylene tube/ GF PP ends PVDF valve Body/PTFE Ball/EPDM seals PVDF valve Body/PTFE Ball/EPDM seals Polypropylene/Santoprene/ GF Polypropylene ends Santoprene® Braided PVC hose/ Hytrel ends Glass filled Polypropylene Nylon

Ladish TC Seals Flexible hoses (3mm id and 6mm id) all lengths Blanking Cap Clamps

Materials of construction – non process-wetted parts Bubble Trap Kit Component Bracket small (for Evolve® 70mm,100mm and 140mm column) Bracket. Large (for Evolve® 200mm and 250mm column) Bolts

Material Acetal Acetal Stainless steel type 316

Chemical Compatibility The Evolve® columns and Bubble Trap are ideally suited for aqueous-based applications. See the table below for detailed compatibility information. Resistance

Notes

    General

Resistant; suitable for continuous use Not resistant; not recommended Limited resistance No information available All solvents are at 100% concentration unless noted otherwise Concentrations: % refer to w/w All data is referenced to room temperature (15º – 25ºC)

Wetted Components

Non Wetted

                            

Chemical 1,2-dichloroethane Acetic acid 25% Acetone 5% Acetonitrile Ammonia aqueous<25% Ammonium Sulphate 10-40% Benzyl alcohol 1% Benzyl alcohol 2% Butanol Calcium chloride 2 Calcium hydroxide 30% Calcium hypochlorite Chloracetic acid 50% Chloroform Chromic acid 10% Citric acid Copper sulphate Dichloromethane Dimethyl formamide Dimethyl sulfoxide 10% Disodium phosphate Ethanol 20% Ethanol 70% Ethylene glycol (1,2-ethanediol) Formaldehyde 50% Glycerol (Glycerine) Guanidine hydrochloride 6M Hydrochloric acid 10% Hydrofluoric acid

Chemical Compatibility cont. Resistance

Notes

    General

Wetted

Non Wetted Stainless Steel 316L

Chemical Hydrogen peroxide Industrial methylated spirit (IMS) Methanol 20% Methanol 50% Methyl chloride (Chloromethane) Methyl ethyl ketone (MEK) Methylene chloride Nitric acid 10% Nitric acid 70% Peracetic acid 300 ppm Phosphoric acid Potassium hydroxide 2M Iso-propanol 20% Iso-propanol 40% n-propanol 20% Sodium acetate Sodium bicarbonate 20% Sodium carbonate Sodium chlorate Sodium chloride 2M Sodium chloride 6M Sodium hydroxide 0.5M Sodium hydroxide 2M Sodium hypochlorite 200 ppm Sodium nitrate Sodium sulphate Trichloroethene (Trichloroethylene) Triton® X-100 surfactant Urea 6M Zinc chloride

                             

          < 55%                   

Installation and Bubble Trap Connections General Guidelines To disassemble and assemble the bubble trap follow the instructions below. When assembling/dissembling attention should be paid to: 1. Always use the correct size tools. A comprehensive tool kit is provided with the columns. 2. Do not over-tighten components and use correct torque settings as given in this guide. 3. Good engineering practices should be followed at all times and operations carried out in an approved and safe manner.

Fitting the Bubble trap onto the column The Bubble trap is attached to the column using a bracket which is located on the tie bars of the column. It is recommended that the bracket is firstly attached to the bubble trap and then attached to the column. Ensure that the bolts are tight and the bracket is firmly attached.

Pipework Connections 1. Connect the pipework and valve as shown in Figure 1 below. 2. The flow from the pump or chromatography system is connected to the 4 port valve

Figure 1 Bubble Trap fitted to Evolve® columns

Bubble Trap Online Column Top

Process In

Column Out

Figure 2a Flow diagram for Bubble trap Kit. Showing bubble trap online and position of 4 port 2way valve.

Bubble Trap Bypass Column Top

Process In

Column Out

Figure 2b Flow diagram for Bubble trap Kit. Showing bubble trap bypassed and position of 4 port 2way valve.

Operating Instructions Bubble Trap Priming 1. After installation the bubble trap and pipework must be primed before use. 2. With the bubble trap bypassed, disconnection the pipework to the top of the column. Turn on the pump and prime the pipework valve. When a steady flow of buffer or solvent is achieved fit a blank cap to the pipework. and the pump should be switched off. 3. Switch the valve to ensure the bubble trap is online and open the shut off valve at the top of the bubble trap, 4.

Turn on the pump and the bubble trap will start to fill.

5. When the bubble trap is approximately 2/3 full, turn off the pump and close the shut off valve. 6. Remove the blank cap from the top process port and connect to the column. The bubble trap is now ready to use.

Sample loading To prevent over dilution or mixing effects while the sample is being applied to the column, the bubble trap should be temporarily isolated from the system. 1. Turn the valve handle to direct the flow directly to the column 2. Once the sample application is complete return the Valve handle to its original position to redirect flow through the bubble trap

Maintenance Cleaning and Storage Cleaning NOTE: Do not use abrasive cleaning materials or pads, as these may score plastic components The extensive solvent and chemical resistance of the bubble trap components allows the use of a wide range of Clean in Place (CIP) solutions, including: Sodium hydroxide (0.5M - 1.0M) Sodium hydroxide (0.1M) + ethanol (20%) Peracetic acid (300 ppm) For thorough cleaning after use the column should be dismantled into its component parts and thoroughly washed with detergent and rinsed thoroughly with deionized water. The column should then be dried prior to storage. Storage Empty Bubble Traps should be kept in a cool, dry, dust-free location and protected from light. In particular, do not expose acrylic column tubes to direct sunlight for prolonged periods or sterilize with ultra-violet lights as this may reduce the mechanical strength of the tube.