cytiva FineLINE Pilot 35 column Operating Instructions Manual
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cytiva FineLINE Pilot 35 column Operating Instructions Manual

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FineLINE Pilot 35 column
Operating Instructions
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  • Page 1 FineLINE Pilot 35 column Operating Instructions Original instructions cytiva.com...

  • Page 2: Table Of Contents

    Recycling information ..........................57 Regulatory information ..........................58 8.5.1 Contact information ............................ 59 8.5.2 European Union and European Economic Area ................60 Ordering information ........................... 61 Health and Safety Declaration Form ...................... 66 FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 3: Introduction

    This chapter contains information about this manual and associated user documenta- tion, important user information and intended use of the product. In this chapter Section See page Important user information About this manual Abbreviations FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 4: Important User Information

    FineLINE™ Pilot 35 column is intended for separation of biomolecules such as proteins, peptides and oligonucleotides, at pilot scale, primarily with SOURCE™ resin. FineLINE Pilot 35 column must be used in accordance with the instructions given in these Operating Instructions.

  • Page 5: About This Manual

    The Operating Instructions manual provides information needed to install, operate and maintain the product in a safe way. Scope of this manual This Operating Instruction manual is valid for and covers the FineLINE Pilot 35 column. Typographical conventions Software items are identified in the text by bold italic text.

  • Page 6: Abbreviations

    PEEK Polyetheretherketone Polyetheretherketone Perfluor rubber Perfluor rubber Acetal plastic Acetal plastic polypropylene polypropylene PTFE polytetrafluoroethene polytetrafluoroethene reversed phase chromatography reversed phase chromatography sanitation-in-place sanitation-in-place hygienic tubing connection hygienic tubing connection FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 7: Safety Instructions

    Safety precautions Labels and symbols Important WARNING Before installing, operating or maintaining the product, all users must read and understand the entire contents of this chapter to become aware of the hazards involved. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 8: Safety Precautions

    General precautions The following general precautions must be considered at all times. There are also context related precautions, which are written in their respective chapters. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 9 Make sure that any accessories used fulfill the specification requirements (e.g., tubing withstands operating pressure and has adequate chemical resistance). WARNING There should NEVER be air or gas under pressure in the column. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 10 • Protective glasses • Working gloves to protect against sharp edges • Protective footwear, preferably with steel toe-cap • Disposable gloves Always use clean disposable gloves when manually handling parts. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 11 Remove any spillage on the floor immediately to mini- mize the risk for slipping accidents. CAUTION Make sure that the pressure relief valve is correctly adjusted and that connecting tubing has an unrestricted flow path. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 12 Make sure that any accessories used fulfill the specification requirements (e.g., tubing withstands operating pressure and has adequate chemical resistance). CAUTION After assembly, make sure that the column is tight and not leaking. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 13: Labels And Symbols

    Do not open any covers or replace parts unless specifically stated in the user documentation. The system complies with applicable European direc- tives. Catalog number or System serial number Product no Mfg Year Manufacturing year FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 14: System Description

    3 System description System description About this chapter This chapter gives an overview of FineLINE Pilot 35 column, and a brief description of its function. Illustration of the column FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 15 FineLINE Pilot 35 column has a simple design. They comprise a number of complete units which are easily assembled together. The column tube is held in place between the top end-piece and bottom end-piece by three support rods.
  • Page 16 “dry” parts, which do not. A special O-ring kit is recommended when eluents for RPC resin are used (see Accesso- ries, on page 64 for details). FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 17: Installation

    Also check the equipment for signs of damage that may have occurred during transportation. Report any damage immediately to your local Cytiva representative and to the trans- port company concerned. We recommend you keep the packaging material.
  • Page 18 4 Installation Items on packing list The table below describes the packing list for the FineLINE Pilot 35 column. Item Article no. FineLINE Pilot 35 column 18110202 Tubing, D-flanged L 420 mm 18110220 i.d. 1.2 mm L 750 mm 18454601...

  • Page 19: Operation

    5 Operation Operation About this chapter This chapter gives instructions on how to operate FineLINE Pilot 35 column in safe way. In this chapter Section See page Safety precautions Systems and pumps Packing the column Evaluating the packing Recommended operating conditions...

  • Page 20: Safety Precautions

    Remove any spillage on the floor immediately to mini- mize the risk for slipping accidents. CAUTION Make sure that the pressure relief valve is correctly adjusted and that connecting tubing has an unrestricted flow path. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 21 5 Operation 5.1 Safety precautions CAUTION Do not remove the support rods between the two end-pieces. They must be tightened with a torque key to 1.4 Nm for safe operation. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 22: Systems And Pumps

    Systems or pumps that have the required flow rate and pressure capacities can be used (100 mL/min for SOURCE 15 and 200 mL/min for SOURCE 30; pressure rating of at least 10 bar g). FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 23: Packing The Column

    Pack the column at the temperature at which it will be used to prevent the hydraulic liquid expanding/contracting with tempera- ture variations. For optimum performance from FineLINE Pilot 35 column and SOURCE media, the following packing procedures outlined below are recommended. Read the complete chapter before using the column.
  • Page 24 Attach the packing pump to the hydraulic inlet with the check valve (7), pressure relief valve (8) pre-adjusted to 10 bar g, and a pressure gauge (9) in line. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 25 Move the adapter lid to its lower stop position while positioning the slot in the adapter lid directly above “1” on the column top end-piece. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 26 Check for any leakage. The pressure should soon reach 10 bar g. The pressure relief valve will help keep the pressure constant throughout the packing procedure. If leakage is discovered, see possible solutions in Section 7.1 General problems, on page FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 27 One example is moving the adapter at a constant velocity of 1 cm/min to the desired compression (calculated as the settled bed height divided by the packed bed height). FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 28: Evaluating The Packing

    In the table below test set-up recommendations for SOURCE resin is shown. Other resins may have other optimal test velocities. Running the HETP test at a higher velocity or using a larger sample volume will affect both HETP and A values. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 29 The peak should be symmetrical and the asymmetry factor as close to 1 as possible. A change in the shape of the peak is usually the first indication of bed deterioration due to use. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 30 As a guideline, value of 0.8 to 1.8 is good. Note: Note: If the results of the evaluation procedures described here prove unsat- isfactory, refer to Section 7.2 Column packing related problems, on page for resolution guidance. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 31: Recommended Operating Conditions

    SOURCE resin is in the range of 100 to 1000 cm/h. See the figure below for maximum flow at 10 bar g at different bed heights for SOURCE 30 and SOURCE 15 packed in FineLINE Pilot 35 column (pressure measured over the column). Viscosity 1.0 cP.

  • Page 32: Unpacking The Column

    Turn the column upside down over a beaker and pour the resin out of the column. If needed continue pumping trough the bottom inlet. Do not attempt to stir the packed bed. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 33: Scaling Up

    FineLINE columns for scaling up, on page You may also contact your Cytiva representative or refer to our website as found on the back page on this instruction for more information regarding these columns. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 34: Maintenance

    To make sure that the system works according to specifications, planned maintenance should be performed annually by a Cytiva service engineer, or service personnel authorized by Cytiva. A list of planned maintenance actions is presented in this chapter. In this chapter...

  • Page 35: Safety Precautions

    Make sure that any accessories used fulfill the specification requirements (e.g., tubing withstands operating pressure and has adequate chemical resistance). CAUTION After assembly, make sure that the column is tight and not leaking. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 36: General Information

    6.2 General information General information FineLINE Pilot 35 column contain a minimum of components to facilitate cleaning and promote reliable operation. The columns require little regular maintenance. Excluding the separation resin, the main causes of column malfunction are blockage of the column net and worn O-rings.

  • Page 37: User Maintenance Schedule

    When repacking column Nets Refer to Care of filters, on page 43 When O-rings loose flexibility Replace O-rings Refer to O-ring replacement, on page As required Sanitization Refer to Sanitization, on page FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 38: Cleaning

    Note: Note: Avoid sodium chloride solutions below pH 4.0. Rinse the column thor- oughly immediately after it has been in contact with salt solutions. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 39 Reverse the flow direction through the column during CIP. Suggested methods to remove strongly bound hydrophobic proteins, lipoproteins and lipids from SOURCE resin packed in FineLINE Pilot 35 column are: • Wash the column with 4-10 bed volumes of up to 70% (v/v) EtOH or 30% isopro- panol followed by 3-4 bed volumes of water.

  • Page 40: Assembly And Disassembly

    General The columns are delivered assembled, with the adaptor fitted in the column. Assembly and disassembly of FineLINE Pilot 35 column is very straightforward and therefore only basic instructions are necessary. Pre-flanged inlet and outlet tubing of 1.2 mm i.d. is supplied with the column delivery.
  • Page 41 Lock the adaptor by turning the adaptor lid clockwise so that the slot is posi- tioned directly above “2” on the top end-piece (d). Disassembly Follow the steps below to disassemble the column. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 42 (c). If the adaptor sticks to the column, use the wrench as shown in the illustration (d). Pull out the entire adaptor from the column glass tube (e). Use the wrench supplied to remove the bottom filter unit (f) from the column. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 43: Component Maintenance

    EPDM O-rings supplied with the columns are not compatible with the solvent to be used. Adaptor filter unit replacement Step Action Unscrew the two screws that hold the adaptor filter unit and remove it from the adaptor rod. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 44 Bottom filter unit replacement Use the wrench supplied to remove the old bottom filter unit. Wet the new bottom filter unit with distilled water and insert into the column tube. Tighten the bottom filter. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 45 Replace the tubing and assemble the filter unit in the reversed order. Note: When reinserting the adaptor knob with the new tubing in place, it should be turned 180°. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 46: Storage

    Make sure that the nets and o-rings are stored in a way that prevents mechanical damage. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 47: Troubleshooting

    If the suggested actions in this guide do not solve the problem, or if the problem is not covered by this guide, contact your Cytiva representative for advice. In this chapter...

  • Page 48: General Problems

    Air leaking into the column from the suction side of the pump. Column not connected correctly. Column pressure too high. Chromatograms / Liquid velocity not as intended. results not as Back-mixing has occurred. expected FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 49 After reverse pumping, test the column again prior to use (refer to Section 5.4 Evaluating the packing, on page 28). FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 50: Column Packing Related Problems

    – Increased • If the asymmetry factor and inlet. tailing changes from less than – Column not one to one, reequilibrate – Decreased properly equili- the column and test leading brated. again. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 51 Decreasing Bed packed too • Check if it is leading or number of loosely or too tailing. See comments plates. hard. above. • Repack the column. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 52: Reference Information

    Reference information About this chapter This chapter lists the technical specifications of FineLINE Pilot 35 column. The chapter also includes a chemical resistance guide, recycling information, regulatory informa- tion and ordering information, and Health and Safety Declaration form for service.

  • Page 53: Specifications

    The design pressure must not be exceeded. A rough estimate with a security margin is to add the packing pressure to the operating pressure in the process chamber. Note: All used materials conform to US Pharmacopoeia requirements. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 54: Chemical Resistance

    57-13-6 Tween™/TNBP 1%/0.3% OK - Excellent resistance for all materials. Use PFR - EPDM seals not recommended, use PFR seals. Use PFR/PP - EPDM seals not recommended, use PFR or Polypropylene seals FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 55 8 Reference information 8.2 Chemical resistance NOTICE Do not use the following chemicals in FineLINE Pilot 35 column: • Extreme oxidizers (such as peroxides). • Fluorine and halogenated compounds. • Chlorinated solvents (such as methylene chloride). • Esters (such as acetates).

  • Page 56: Service And Training

    8 Reference information 8.3 Service and training Service and training Contact your Cytiva representative regarding service and training for FineLINE Pilot 35 column. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 57: Recycling Information

    Disposal When taking the product out of service, the column should be emptied, cleaned and sterilized. The different materials must be separated and recycled according to national and local environmental regulations. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 58: Regulatory Information

    8.5 Regulatory information Regulatory information Introduction This section lists the regulations and standards that apply to the product. In this section Section See page 8.5.1 Contact information 8.5.2 European Union and European Economic Area FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 59: Contact Information

    The table below summarizes the required manufacturing information. Requirement Information Name and address of manufacturer Cytiva Sweden AB Björkgatan 30 SE 751 84 Uppsala Sweden Telephone number of manufacturer + 46 771 400 600 FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 60: European Union And European Economic Area

    • used according to the Operating Instructions or user manuals, and • used in the same state as it was delivered, except for alterations described in the Operating Instructions or user manuals. FineLINE Pilot 35 column Operating Instructions 28964850 AB...

  • Page 61: Ordering Information

    Isolating the column after packing For FineLINE Pilot 35 column, an SRV-1 valve to close off the bottom of the column is required. The stop plug to the upper column inlet is supplied with the column. Connecting the column to your system For connecting FineLINE Pilot 35 column to ÄKTA systems, a separate tubing kit is...
  • Page 62 8 Reference information 8.6 Ordering information Components and spare parts FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 63 Check valve assembly Includes items 20, 21 and 22. In contact with process liquids. In contact with hydraulic liquid. Note: It is recommended to keep a set of O-rings as spare parts on site. FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 64 SOURCE 15 and 30 resins Media Article no. SOURCE 15Q and SOURCE 15S 18112365 SOURCE 30Q and SOURCE 30S 18110712 SOURCE 15ETH, SOURCE 15ISO and SOURCE 15PHE 18112886 SOURCE 15RPC 18112350 SOURCE 30RPC 18112973 FineLINE Pilot 35 column Operating Instructions 28964850 AB...
  • Page 65 8 Reference information 8.6 Ordering information Refer to the Cytiva web site as found on the back page to acquire these data files. FineLINE columns for scaling up Column Article no. FineLINE 70/70L/100/100L/200/200L 18113000 Operating Instructions FineLINE 70-350 columns 28960378 Contact your Cytiva representative for further advice regarding the FineLINE column range for scaling up.

  • Page 66: Health And Safety Declaration Form

    Service Ticket #: To make the mutual protection and safety of Cytiva service personnel and our customers, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts a repair. To avoid delays in the servicing of your equipment, complete this checklist and present it to the Service Engineer upon arrival.
  • Page 67 To make sure the mutual protection and safety of Cytiva personnel, our customers, transportation personnel and our environment, all equipment must be clean and free of any hazardous contaminants before shipping to Cytiva. To avoid delays in the processing of your equipment, complete this checklist and include it with your return.
  • Page 68 © 2020–2021 Cytiva All goods and services are sold subject to the terms and conditions of sale of the supplying company operating within the Cytiva business. A copy of those terms and conditions is available on request. Contact your local Cytiva representative for the most current information.

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