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Summary of Contents for cytiva FineLINE 35
- Page 1 FineLINE 35 oligo column Operating Instructions Original instructions cytiva.com...
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Page 2: Table Of Contents
Recycling information ..........................44 Regulatory information ..........................45 8.5.1 Contact information ............................ 46 8.5.2 European Union and European Economic Area ................47 Ordering information ........................... 48 Health and Safety Declaration Form ...................... 52 FineLINE 35 oligo Operating Instructions 28964957 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 35 oligo Operating Instructions 28964957 AB... -
Page 4: Important User Information
Intended use of the product FineLINE™ 35 oligo column is intended for process development of oligonucleotide synthesis. FineLINE 35 oligo column shall not be used in any clinical procedures, or for diagnostic purposes. . Prerequisites In order to operate FineLINE 35 oligo column safely and according to the intended purpose the following prerequisites must be met: •... - Page 5 1 Introduction 1.1 Important user information Hardware items are identified in the text by bold text. In electronic format, references in italics are clickable hyperlinks. FineLINE 35 oligo Operating Instructions 28964957 AB...
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Page 6: 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 Instructions manual is valid for and cover the FineLINE 35 oligo column. Typographical conventions Software items are identified in the text by bold italic text. -
Page 7: Abbreviations
PEEK Polyetheretherketone Polyetheretherketone Perfluor rubber Perfluor rubber Acetal plastic Acetal plastic PTFE polytetrafluoroethene polytetrafluoroethene reversed phase chromatography reversed phase chromatography sanitation-in-place sanitation-in-place Tetrahydrofurane Tetrahydrofurane hygienic tubing connection hygienic tubing connection FineLINE 35 oligo Operating Instructions 28964957 AB... -
Page 8: 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 35 oligo Operating Instructions 28964957 AB... -
Page 9: Safety Precautions
The following general precautions must be considered at all times. There are also context related precautions, which are written in their respective chapters. WARNING Only properly trained personnel may operate and maintain the product. FineLINE 35 oligo Operating Instructions 28964957 AB... - Page 10 The process might cause the area to increase or the zone classification to change. Implement the risk reduction measures needed, including use of personal protective equipment. FineLINE 35 oligo Operating Instructions 28964957 AB...
- Page 11 The process might cause the area to increase or the zone classification to change. Implement the risk reduction measures needed, including use of personal protective equipment. FineLINE 35 oligo Operating Instructions 28964957 AB...
- Page 12 CAUTION Make sure that the pressure relief valve is correctly adjusted and that connecting tubing has an unrestricted flow path. CAUTION After assembly, make sure that the column is tight and not leaking. FineLINE 35 oligo Operating Instructions 28964957 AB...
- Page 13 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 35 oligo Operating Instructions 28964957 AB...
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Page 14: Labels And Symbols
The symbols and information on the labels are explained in the following table. Symbol / text Description Code no Ordering number for FineLINE 35 oligo column Design pressure The design pressure, which must never be exceeded Warning! Read the user documentation before using the system. -
Page 15: System Description
3 System description System description About this chapter This chapter gives an overview of FineLINE 35 oligo column, and a brief description of its function. Illustration of the column Part Description Column top connection Adapter shaft Mechanical locking unit Bayonet adapter lid lock... - Page 16 Materials of manufacture of FineLINE 35 oligo column include borosilicate glass, PEEK, polypropylene, stainless steel, FFKM, Tecnoflon PFR91 and 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.
- Page 17 The inlet and outlet of the column are located at the bottom of the column, in the bottom lid, and in the column top. The inlet and outlets have 5/16” fitting and the hydraulic chamber has M6 fitting. FineLINE 35 oligo Operating Instructions 28964957 AB...
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Page 18: Installation
This chapter provides required information to enable users and service personnel to unpack, install, move and transport the FineLINE 35 oligo column system. Introduction The FineLINE 35 oligo column is delivered assembled, with the adapter fitted in the column. Packing list Item Article no. -
Page 19: Operation
5 Operation Operation About this chapter This chapter gives instructions on how to operate FineLINE 35 oligo column in safe way. In this chapter Section See page Safety precautions Packing the column Lekage test Recommended operating conditions Unpacking the column... -
Page 20: Safety Precautions
CAUTION Make sure that any accessories used fulfill the specification requirements (e.g., tubing withstands operating pressure and has adequate chemical resistance). FineLINE 35 oligo Operating Instructions 28964957 AB... - Page 21 NOTICE To avoid precipitation keep all reagents at or above 18°C. NOTICE No other solvents than those specified in the Operating Instruc- tions should be used as they could possibly damage the system. FineLINE 35 oligo Operating Instructions 28964957 AB...
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Page 22: Packing The Column
Read the complete chapter before using the column. FineLINE 35 oligo column is intended for use with ÄKTA™OligoPilot™ 100 and the instructions in this section assumes that this is the case. See the table below for items required for packing. - Page 23 Keep the OD 1/8” tubing as short as possible. Start UNICORN™ method instruction PFlow AB and add value 10 for the bar flow. Continue for 1.5 to 2.0 CV. Stop the flow. Continue with the leakage test below. FineLINE 35 oligo Operating Instructions 28964957 AB...
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Page 24: Lekage Test
Determine the cause of the leakage. See General Problems, on page 39 for more information. c. If needed, exchange a broken part to a new part. d. If needed, repack the column. FineLINE 35 oligo Operating Instructions 28964957 AB... -
Page 25: Recommended Operating Conditions
Flow rate direction The flow direction is not critical for oligonucleotide synthesis applications when using FineLINE 35 oligo column column and Primer Support. However, it is recommended to run the synthesis from bottom to top. Factors to consider before choosing direction include: •... -
Page 26: Unpacking The Column
Disconnect the top end piece by turning the bayonet anti clockwise and lift it Turn the column upside down and collect the support in a suitable vessel. Start the deprotection as described in the ÄKTA oligopilot User Manual. FineLINE 35 oligo Operating Instructions 28964957 AB... -
Page 27: Scaling Up
Linear flow rates and the number of column volumes used during method develop- ment should generally be the same as those to be used during the envisaged full scale process. FineLINE 35 oligo Operating Instructions 28964957 AB... -
Page 28: 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 29: 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 35 oligo Operating Instructions 28964957 AB... -
Page 30: User Maintenance Schedule
Filter care Refer to Section 6.2 User maintenance schedule, on page O-ring check After every 10:th synthesis run or once per year (which- Refer to O-ring check and replacement, on page ever comes first) FineLINE 35 oligo Operating Instructions 28964957 AB... -
Page 31: Cleaning
All column parts can be cleaned with the most commonly used agents, such as deter- gents, ethanol, methanol and weak acids. For chemical resistance to special cleaning agents, see Section 8.2 Chemical resistance, on page FineLINE 35 oligo Operating Instructions 28964957 AB... -
Page 32: Storage
6 Maintenance 6.4 Storage Storage If the FineLINE 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 6.3 Cleaning, on page 31. -
Page 33: Disassembly And Assembly
6 Maintenance 6.5 Disassembly and assembly Disassembly and assembly Disassembly and assembly of the FineLINE 35 oligo column is very straightforward and therefore only basic instructions are necessary. WARNING Pressure may remain in the column and tubing for an extended period after shutdown. - Page 34 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). Pull out the entire adapter from the column glass tube (e). FineLINE 35 oligo Operating Instructions 28964957 AB...
- Page 35 “1” on the column top end-piece (c). To lock the adapter, turn the adapter lid clockwise so that the slot is posi- tioned directly above “2” on the top end-piece (d). FineLINE 35 oligo Operating Instructions 28964957 AB...
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Page 36: Component Maintenance
It is recommended to clean the filters and distributors at regular intervals (see Section 6.2 User maintenance schedule, on page The FineLINE 35 oligo column is designed with a minimum of components, which facili- tates cleaning and reliable operation. In normal routine operation, the column requires only a little regular maintenance. - Page 37 Unscrew the two screws that hold the adapter filter unit and remove it from the adapter rod. Gently pull out the filter unit. Unscrew the adapter tubing and mount it in the replacement unit. FineLINE 35 oligo Operating Instructions 28964957 AB...
- Page 38 .Pull out the tubing from the adapter rod. Unscrew the adapter knob from the tubing using the plastic wrench supplied. Insert a new tubing, OD 1/8’’, 235 mm. Reassemble in reverse order. FineLINE 35 oligo Operating Instructions 28964957 AB...
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Page 39: 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. General Problems If an increased back-pressure is observed, locate the blockage point in the system by systematically isolating the different components in the line of flow. -
Page 40: Reference Information
Reference information About this chapter This chapter lists the technical specifications of FineLINE 35 oligo 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 41: Specifications
15 μm (absolute 20 μm) Recommended bedheight 1 to 10 cm Design pressure 20 bar Flow velocity range 0 to 200 mL/min Note: Using Primer Support according to recommended packing procedures adds no packing pressure. FineLINE 35 oligo Operating Instructions 28964957 AB... -
Page 42: Chemical Resistance
8006-64-2 Ethanol 9003-99-0 100% Hydrochloric acid 9004-54-0 0.1 M Methanol 67-56-1 100% n-Propanol 71-23-8 100% Phosphoric acid 9066-91-5 Sodium hydroxide 95077-05-7 76-05-1 0.4% NOTICE The column material is not compatible with tetrahydrofurane, THF. FineLINE 35 oligo Operating Instructions 28964957 AB... -
Page 43: Service And Training
8 Reference information 8.3 Service and training Service and training Contact your Cytiva representative regarding service and training for FineLINE 35 oligo column. FineLINE 35 oligo Operating Instructions 28964957 AB... -
Page 44: 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 35 oligo Operating Instructions 28964957 AB... -
Page 45: 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 35 oligo Operating Instructions 28964957 AB... -
Page 46: 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 35 oligo Operating Instructions 28964957 AB... -
Page 47: 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 35 oligo Operating Instructions 28964957 AB... -
Page 48: Ordering Information
FineLINE 35 oligo column system. Precautions WARNING Accessories. Use only accessories supplied or recommended by Cytiva. CAUTION Make sure that any accessories used fulfill the specification requirements (e.g., tubing withstands operating pressure and has adequate chemical resistance). FineLINE 35 oligo Operating Instructions 28964957 AB... - Page 49 The table below describes component parts and accessories. The item numbers refer to the illustration above. Items without article number cannot be ordered, they are included as explanation for the illustration above only. FineLINE 35 oligo Operating Instructions 28964957 AB...
- Page 50 O-ring kit PFR 28.25 x 2.62 (item 4) FFPM/FFKM 18110215 Stop Plug M6 18110221 Stop Plug 5/16” 5 18111250 SRV-1 valve 19214501 Union 5/16” female / M6 Male 18112776 T-connector, M6 female 19214401 FineLINE 35 oligo Operating Instructions 28964957 AB...
- Page 51 8 Reference information 8.6 Ordering information Description Material Article no Wetted Wetted (process) (hydraul) Wrench FineLine 351 18111088 Wrench M6 19748101 Operating Instructions 28964957 FineLINE 35 oligo Operating Instructions 28964957 AB...
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Page 52: 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 53 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 54 Standard Software End-User License Agreement is available on request. 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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