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GE FineLINE 35 oligo, Operating Instructions Manual

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FineLINE 35 

oligo

 column

 

Operating Instructions

 

28-9649-57

 

AA

5

Introduction 1

1 Introduction

Purpose of the Operating 

Instructions

This Operating Instructions describes the specifications and characteristics of FineLINE 
35 

oligo

 column. It also describes procedures for packing, operation, maintenance and 

troubleshooting in a safe way.

Prerequisites

In order to operate FineLINE 35 

oligo

 column safely and according to the intended 

purpose the following prerequisites must be met:

•

You should be acquainted with the use of general laboratory equipment and with 
handling of biological materials.

•

You must read 

Chapter 2 Safety instructions‚ on page 11

 of these Operating 

Instructions.

•

The system should be installed according to the instructions in 

Chapter 3

 of these 

Operating Instructions. 

In this chapter

This chapter contains important user information and a general description of FineLINE 
35 

oligo

 column and its intended use.

Summary of Contents for FineLINE 35 oligo

Page 1: ...GE Healthcare Operating Instructions Original instructions FineLINE 35 oligo column ...

Page 2: ......

Page 3: ...17 4 Operation 19 4 1 Packing the column 20 4 2 Unpacking the column 22 4 3 Recommended operating conditions 23 4 4 Scaling up 24 5 Maintenance 25 5 1 User maintenance schedule 26 5 2 Cleaning 26 5 3 Storage 26 5 4 Disassembly and assembly 27 5 5 Component maintenance 30 6 Troubleshooting 33 7 Reference information 35 7 1 Specifications 35 7 2 Chemical resistance 36 7 3 Service and training 37 7 4...

Page 4: ...Table of Contents 4 FineLINE 35 oligo column Operating Instructions 28 9649 57 AA ...

Page 5: ...operate FineLINE 35 oligo column safely and according to the intended purpose the following prerequisites must be met You should be acquainted with the use of general laboratory equipment and with handling of biological materials You must read Chapter 2 Safety instructions on page 11 of these Operating Instructions The system should be installed according to the instructions in Chapter 3 of these ...

Page 6: ...ethod development at pilot scale or small scale production of oligonucleotides FineLINE 35 oligo column must not be used for any other purpose Safety notices These Operating Instructions contain WARNINGS CAUTIONS and NOTICES concerning the use of the product with meanings as defined below WARNING WARNING indicates a hazardous situation which if not avoided could result in death or serious injury I...

Page 7: ...y information This section lists the directives and standards that are fulfilled by FineLINE 35 oligo column Manufacturing information CE Conformity International standards Requirement Content Name and address of manufacturer GE Healthcare Bio Sciences AB Björkgatan 30 SE 751 84 Uppsala Sweden Place and date of declaration Uppsala Sweden May 2009 Identity of person authorized to sign DoC See EC De...

Page 8: ...uments or connected to other products recommended or described in the user documentation and used in the same state as it was delivered from GE Healthcare except for alterations described in the user documentation or explicitly authorized by GE Healthcare Regulatory compliance of connected equipment Any equipment connected to FineLINE 35 oligo column should meet the safety requirements of relevant...

Page 9: ...ce between the top end piece and bottom end piece by three support rods The top endpiece houses the hydraulically adjustable adapter The adapter contains a filter unit with a stainless steel 316L filter The adapter is held in place by a mechanical locking unit on the adapter piston The adapter lid is secured to the top end piece with a bayonet fitting O rings seal the lid against the adapter rod a...

Page 10: ...mriz PFR91 and Teflon PTFE In the current FineLINE 35 oligo column the top end piece and adapter lid are made of PEEK Previous versions have these parts made of POM PEEK is necessary only if ACN is to be used in the hydraulic chamber If ACN is to be used in old versions of the column PEEK parts can be ordered and exchanged Section 7 4 Ordering information on page 38 PEEK parts are labelled P to be...

Page 11: ...ctions This chapter describes safety precautions safety labels and recycling of the FineLINE 35 oligo column 2 1 Safety precautions Introduction The safety precautions in this section are grouped into the following categories Explosive environment Flammable liquids Personal protection Installation System operation Maintenance ...

Page 12: ... any potentially explosive fumes WARNING Fire Hazard Before starting the system make sure that there is no leakage if potentially flammable or explosive liquids are used WARNING Hazardous substances When using hazardous chemical and biological agents take all suitable protective measures such as wearing protective glasses and gloves resistant to the substances used Follow local and or national reg...

Page 13: ... spanner or wrench Do not tighten Teflon tubing further as this will damage the end of the tubing CAUTION Do not use in a dusty atmosphere or close to spraying water WARNING Operators should have experience of working with pressure vessels WARNING The design pressure must not be exceeded See Section 7 1 Specifications on page 35 for pressure limit WARNING No other solvents than those specified in ...

Page 14: ...nce CAUTION Use only components and spare parts delivered or authorized by GE Healthcare This equipment is classified with material specifications which must be preserved CAUTION Remove spillage immediately CAUTION Make sure that the column has been cleaned and contains no residual harmful substances before maintenance ...

Page 15: ...t shall be emptied decontaminated cleaned and sterilized All local regulations shall be followed with regard to scrapping of the equipment The different materials must be separated and recycled according to national and local environmental regulations Design pressure must never be exceeded Warning triangle indicates that the Operating Instructions must be read before use CE symbol shows that the p...

Page 16: ...2 Safety instructions 2 3 Recycling procedures 16 FineLINE 35 oligo column Operating Instructions 28 9649 57 AA ...

Page 17: ...th the adapter fitted in the column Packing list Item Article no Qty FineLINE 35 oligo column 28 9461 41 1 User manual 28 9649 57 1 Allen key 4 mm 19 0379 01 1 Allen key 2 5 mm 19 4442 01 1 Union 5 16 female M6 Male 18 1127 76 3 Stop plug M6 56 1163 77 1 Stop plug 5 16 56 1185 81 1 Wrench 18 1110 88 1 Wrench M6 19 7481 01 1 Valve SRV 1 19 2145 01 1 ...

Page 18: ...3 Installation 18 FineLINE 35 oligo column Operating Instructions 28 9649 57 AA ...

Page 19: ...op for that system shall be used in case of an emergency Refer to the Operating Instructions for the used pump or system regarding Emergency Stop before using the column CAUTION Incorrectly fitted tubing may loosen causing a jet of liquid to spray out This is especially dangerous if hazardous chemicals are in use Connect the tubing by first inserting the tubing fully then tightening the connector ...

Page 20: ...igo column is intended for use with ÄKTA oligopilot 100 and the instructions in this section assumes that this is the case Table 4 1 Items required for packing Note Primer Support 200 should be packed as a slurry Item Quantity FineLINE 35 oligo column 1 Operating Instructions 1 Allen key 4 mm 1 Union 5 16 female M6 male 2 Tubing Connectors OD 1 8 tubing 12 Ferrules for OD 1 8 tubing 12 Stop plug 5...

Page 21: ...lurry to the column allow Primer Support to settle for 2 to 3 minutes 5 Mark the column glass with a pen where the adapter should be in the column based on the calculated CV or use the premiered lines on the column 6 Wet the adapter with 50 to 95 ethanol 7 Connect stop plug to the bottom of the column 8 Connect a tube to the adapter and insert the other end securely into a waste vessel 9 Insert th...

Page 22: ... the inlet of the column to allow the Acetonitrile to come out at the bottom of the column 4 Continue the air flow until the support has reduced in volume and is free from the column wall This will take approximately 30 minutes depending on the amount of support in the column and the air flow 5 Turn off the air flow 6 Disconnect the top end piece by turning the bayonet anti clockwise and lift it u...

Page 23: ... flow direction the reagents enter the column through the bottom filter and exit through the top adapter filter Simplifying filter changing Using flow direction from bottom to top also simplifies changing a dirty adapter filter since the inlet filter most likely is dirtier than the outlet filter Time cycle shortening Using a flow from top to bottom will reduce the length of the tubing connecting t...

Page 24: ...everal practical issues to consider such as pressure limitations of related large scale equipment and the special aspects of liquid handling and process control at high volumetric flow rates Linear flow rates and the number of column volumes used during method development should generally be the same as those to be used during the envisaged full scale process ...

Page 25: ...ons before use WARNING Explosion hazard To avoid building up an explosive atmosphere when using flammable liquids make sure that the room ventilation is sufficient to remove any potentially explosive fumes WARNING Fire Hazard Before starting the system make sure that there is no leakage if potentially flammable or explosive liquids are used CAUTION Use only components and spare parts delivered or ...

Page 26: ...E 35 oligo column will not be in use for an extended period in time it is recommended to disassemble the column and then clean the parts according to Section 5 2 Cleaning on page 26 Let the parts dry thoroughly after cleaning The column should then be stored dismantled in a dry and dust free location When taken into service after storage make sure that the O rings are fit for operation refer to Se...

Page 27: ...national regulations for safe operation and maintenance of the system CAUTION After assembly ensure that the column is tight and not leaking NOTICE When working with sealing the nets and surfaces in contact with these components Never use sharp tools Do not scratch any such components or surfaces NOTICE If the support rods between the two end pieces have been removed they must be re tightened with...

Page 28: ...on the top end piece to position 1 as shown in the illustration a If necessary use the supplied wrench b 2 Wet the adapter rod with ethanol and pull the adapter lid to its upper stop position c If the adapter sticks to the column use the wrench as shown in the illustration d 3 Pull out the entire adapter from the column glass tube e 4 Use the wrench supplied to remove the bottom filter unit f from...

Page 29: ... and tighten it with the supplied wrench a 3 Wet the adapter filter unit and the adapter rod with ethanol 4 Move the adapter lid b to its lower stop position 5 Insert the adapter into the column tube so that the slot in the adapter lid is positioned directly above 1 on the column top end piece c 6 To lock the adapter turn the adapter lid clockwise so that the slot is positioned directly above 2 on...

Page 30: ...ters It is recommended to clean the filters and distributors at regular intervals see Section 5 1 User maintenance schedule on page 26 The FineLINE 35 oligo column is designed with a minimum of components which facilitates cleaning and reliable operation In normal routine operation the column requires only a little regular maintenance Excluding the media the main cause of column malfunction is blo...

Page 31: ... filter unit replacement Step Action 1 Use the wrench supplied to remove the old bottom filter unit 2 Wet the new bottom filter unit with ethanol and insert into the column tube 3 Tighten the bottom filter Step Action 1 Unscrew the two screws that hold the adapter filter unit and remove it from the adapter rod 2 Gently pull out the filter unit ...

Page 32: ...e replacement unit 4 Reassemble in reverse order Step Action Step Action 1 Remove the adapter filter unit as described above Unscrew the two screws that secure the adapter knob and the column inlet 2 Pull out the tubing from the adapter rod Unscrew the adapter knob from the tubing using the plastic wrench supplied 3 Insert a new tubing OD 1 8 235 mm 4 Reassemble in reverse order ...

Page 33: ...es should be employed Problem Check possible causes High back pressure Column filters blocked if so clean or replace Refer to Section 5 2 Cleaning on page 26 Equipment before or after the column generates back pressure Connected tubing with too small diameter or bent Pressure indicator faulty Column leakage Solvents used not compatible with O rings and or gaskets Refer to Section 7 2 Chemical resi...

Page 34: ...6 Troubleshooting 34 FineLINE 35 oligo column Operating Instructions 28 9649 57 AA ...

Page 35: ...ht 450 mm Maximum inner length 150 mm Inner diameter 35 mm Inlet and outlet diameter 1 2 mm Footprint 250 x 250 mm Net mesh size 15 µm absolute 20 µm Recommended bedheight 1 to 10 cm Design pressure 20 bar Flow relocity range 0 to 200 ml min WARNING Design pressure MUST NOT BE EXCEEDED Note Using Primer Support 200 according to recommended packing procedures adds no packing pressure ...

Page 36: ...ratures and pressures and that combined effects have not been taken into consideration Concentrations are expressed as volume of saturated solution unless otherwise stated Table 7 1 Chemicals against which wetted parts are fully resistant Chemical CAS no Concentration Acetonitrile 75 05 8 100 Acetone 8006 64 2 10 Ethanol 9003 99 0 100 Hydrochloric acid 9004 54 0 0 1 M Methanol 67 56 1 100 n Propan...

Page 37: ...n Operating Instructions 28 9649 57 AA 37 Reference information 7 Service and training 7 3 7 3 Service and training Please contact your GE Healthcare representative regarding service and training for FineLINE 35 oligo column ...

Page 38: ...iew refer to Table 7 2 for explanations Note The locking device 56 3100 31 is not shown in the illustration It fits between the Adapter Lid 3 and the Adapter tube 6 CAUTION Use only spare parts delivered by GE Healthcare This equipment is pressure classified with material specifications which must be preserved 2 3 4 5 6 7 8 9 10 11 12 21 22 21 23 13 14 7 15 16 4 14 17 4 18 19 10 20 1 ...

Page 39: ... ring 39 2x1 6 EPDM 1 18 1142 95 No Yes 14 Glass tube Borosilicate 1 18 1142 94 Yes Yes 15 O ring 12 3x2 4 PFR91 1 18 1142 95 No Yes 16 Adapter filter unit 35 PEEK 316L 1 18 1137 16 Yes Yes 17 Bottom end piece POM 1 No No 18 Adhesive foot pads 4 No No 19 Bottom filter unit 35 PEEK 316L 1 18 1137 17 Yes Yes 20 Nut M6 316 3 No No 21 O ring 3 6x1 6 EPDM 2 18 1142 95 No Yes 22 Check valve Cheram Al203...

Page 40: ...umn Operating Instructions 28 9649 57 AA 7 5 Material abbreviations Abbreviation Meaning EPDM Ethylene propylene diene monomer ETFE ethylene tetrafluoroethylene PFR Perfluor rubber PEEK Polyetheretherketone POM Acetal plastic THF Tetrahydrofurane FFKM FFPM Perfluoroelastomers ...

Page 41: ... see lower right on this form I also agree to give GE Healthcare Bio Sciences sole control of the system equipment specified above Signed Name in Capital letters Position in Institution or company Date Year month date 20 Specify if the equipment has been in contact with any of the following Radioactivity Must be decontaminated prior to service return yes no Radiation Safety Officer Signature requi...

Page 42: ...Appendix A Health and Safety Declaration Liability Form 42 FineLINE 35 oligo column Operating Instructions 28 9649 57 AA ...

Page 43: ......

Page 44: ...lished Nov 2009 All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them A copy of these terms and conditions is available on request Contact your local GE Healthcare representative for the most current information GE Healthcare UK Ltd Amersham Place Little Chalfont Buckinghamshire HP7 9NA UK GE Healthcare Bio Sciences Corp...

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