GE ÄKTAprocess Site Preparation Manual

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ÄKTAprocess
Site Preparation Guide
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Table of Contents
31 Introduction ..........................................................................................................
52 Site preparation overview ..................................................................................
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Table of Contents
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1 Introduction
Purpose of this document
The purpose of this document is to provide the information you need to fully prepare your site for the installation and testing of the system.
A site preparation checklist is included in this document.
You must return this checklist to GE before GE Service personnel can install and test the system.
WARNING
The product must be installed and prepared by GE personnel or a third party authorized by GE.
Scope of this document
This Site Preparation Guide covers the ÄKTAprocess system.
Feedback to GE
Make sure to read the entire Site Preparation Guide and complete the Site preparation checklist in Chapter 3.
Return the completed Site preparation checklist to the GE service office in your region. You will findE-mail address and faxnumbers to the GE service officein your region under:
www.gelifesciences.com/contact .
If your region is not listed, select the nearest region.
Assign personnel for site preparation tasks
The site preparation tasks listed in the following table can be assigned to more than one person at the customer site.
It is recommended that the same people assist the GE service personnel during the subsequent installation process.
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Site preparation tasksPersonnel
Site preparation/ installation coordinator
Review the site preparation guide for safety information and system re­quirements.
Choose the site.
Coordinate personnel and tasks.
Coordinate the installationtiming of thesystem with any domesticsafety procedures and testings.
Order the required materials.
Schedule the installation and inform the relevantpersonnel of the instal­lation date.
Laboratory personnel/ Primary users
Review the safety information.
Make sure that all customer-provided materials for the installation are present at the site.
Facilities personnel
Make sure that the installation requirements are met for:
-
Space at the installation site
-
Environmental conditions
-
Biosafety
-
Ventilation and waste collection
-
Electrical supply
-
Safety and installation materials
The personnel at the customer facility are also responsible for making sure that the instal­lation requirements are met for:
Note:
Compressed air supply
Network communication (if applicable)
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2 Site preparation overview
Introduction
Before the product is delivered, you must prepare the site according to the instructions in this chapter.
Select the site
Select a site that complies with national and international requirements for biosafety.
WARNING
Spread of biological agents. The operatormust take all necessary
actions toavoid spreading hazardous biological agents.The facility must comply with the national code of practice for biosafety.
General site requirements
The following requirements must be fulfilled at the location where the ÄKTAprocess system will be installed:
ÄKTAprocess is intended for indoor use only
The system units must not be installed in a dusty environment
The system units must not be exposed to sources of heat, such as direct sunlight
The system units must not be exposed to strong magnetic or electrical fields
The system units must not be exposed to vibrations
The system units must not be exposed to corrosive gas
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Space requirements
The followingspace requirementsmust be fulfilled atthe location where the ÄKTAprocess system will be installed:
SpecificationParameter
2050 x 2250 mmMinimum floor area for operating the ÄKTAprocess 6 mm, 10 mm 3/8 and 1/2 system (Cabinet 10)
(including 1 m of free space around the
system to allow service and mainte-
nance)
2050 x 3200 mmMinimum floor area for operating the ÄKTAprocess 1 SS and PP system (Cabinet 30)
(including 1 m of free space around the
system to allow service and mainte-
nance)
Horizontal +/- 1°Floor inclination
WARNING
Access to power cord. Do not block access to the power cord. The
power cord must always be easy to disconnect.
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Dimensions and weight
The following illustration shows the dimensions of the ÄKTAprocess 6 mm, 10 mm 3/8 and 1/2 (Cabinet 10) system.
1650 mm
1250 mm
1050 mm
ÄKTAprocess 6 mm, 10 mm 3/8 and 1/2 (Cabinet 10): 1050 x 1650 X 1250 mm (W x H x D) (illustration)
ÄKTAprocess 1 SS and PP (Cabinet 30): 1050 x 1890 X 2200 mm (W x H x D) (not shown)
The weight of the ÄKTAprocess system is:
ÄKTAprocess 6 mm, 10 mm 3/8 and 1/2 (Cabinet 10): Approximately 400 kg (exact weight is configuration dependent)
ÄKTAprocess 1 SS and PP (Cabinet 30): Approximately 800 kg (exact weight is con­figuration dependent)
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WARNING
Heavy object. Because of the significant weight of the product,
great care must be taken not to cause squeezing or crushing in­juries during movement. Atleast two, but preferably three or more, people are recommended when moving the unit.
NOTICE
Operator console
Do not use the operator console to push or drag the system
Do not lean on the console
The console arm is only designed to support the weight of the operator console.
The ÄKTAprocess system is shipped in a crate with the following dimensions.
Dimensions (mm)Contents
2070 x 1730 x 1110 mm (W x H x D)ÄKTAprocess 6 mm, 10 mm 3/8 and 1/2 system (Cabinet 10)
2680 x 1930 x 1310 mm (W x H x D)ÄKTAprocess 1 SS and PP system (Cabinet 30)
If the floor quality does not allow rolling ÄKTAprocess on its own wheels, it can be moved with a pallet jack or forklift under the bottom of the system skid.
Note:
Environmental requirements
The installation site must comply with the following specifications:
SpecificationParameter
2°C to 30°CAmbient temperature, operation
20% to 95%, non-condensingRelative humidity
Up to 2000 mAltitude
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Electrical requirements
SpecificationParameter
6 mm, 10 mm 3/8 and 1/2 (Cabinet
10): 100, 120, 200 to 208, 230 or 240 V AC
6 mm, 10 mm 3/8 and 1/2 (Cabinet
30): 200 to 208, 230 or 240 V AC
Supply voltage
50/60 HzFrequency
6 mm, 10 mm 3/8 and 1/2 (Cabinet
10):
-
15/16 A (100, 120 V AC)
-
10 A(200 to 208, 230or 240 V AC)
6 mm, 10 mm 3/8 and 1/2 (Cabinet
30): 15/16 A
Minimum power supply fuse rating
1Number of wall outlets
WARNING
Protective ground. The product must always be connected to a
grounded power outlet.
The system power cord is connected in one of the following ways:
A fixed power supply by means of a permanent connection with a safety switch (UL or CE classified systems)
A connector compliant with IEC 60309-2 (CE classified systems only)
GE does not offer a UPS (Uninterrupted Power Supply) as an accessory. How­ever, the system is prepared for UPS operation.
Note:
The mains power supply cable is shielded ÖLFLEX™ of type:
CE-classified: 150CY Quattro (3 x 2.5 mm2)
UL-classified: CRF (3 x 14AWG)
If the cable needs to be replaced due to damage, the same type of cable or equivalent must be used.
All live and neutral wiring must have a cross section area equal to or greater than the specification in the following table:
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Mains and neutral conductor minimum area
Mains current up to
16 AWG or 1.5 mm
2
10 A
14 AWG or 2.5 mm
2
16 A
12 AWG or 4 mm
2
25 A
Computer requirements
An external computer is not required. ÄKTAprocess is provided with a built-in industrial computer.
User-supplied accessories and consumables
The following equipment must be supplied by the user:
SpecificationTool
Used for unpacking the system13 mm wrench (or ratchet
wrench with 13 mm socket)
Used for unpacking the systemElectrical TX25screwdriver or power driver witha hexalobu­lar TX25 bit
Used for unpacking the systemSafety knife
Used duringinstallation, operation and maintenancePersonal Protective Equip­ment (PPE) as required, (e.g., gloves, lab coats, etc.)
Suitably sized vessels to allow collection of liquid for
10 minutes at maximum flow rate, and a suitably
dimensioned waste system.
Buffer and waste vessels
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SpecificationTool
Certified and calibratedBalance
The balance must be able to weigh enough solution for the maximum flow rate for each system.
6 mm and 3/8”: The balance must be able to weigh 10 kg/2 minutes collect (maximum flow rate: 180 l/h)
10 mm and 1/2”: The balance must be able to weigh 30 kg/2 minutes collect (maximum flow rate: 600 l/h)
1” SS and PP: The balance mustbe able to weigh 80 kg/2 minutes collect (maximum flow rate: 2000 l/h)
Three (3) hoses (2 meters each) of the correct in­ternal diameter
TC connections
Flexible hoses
System documentation is delivered with the system and is required during installation.
Reference Manuals System Binder I, II and III
The following chemicals and supplies must be supplied by the user:
SpecificationItem
For example, WFI/MQ purifiedWater of suitable standard for use in the
system
1.0% vol/vol
0.5% vol/vol
0.1% vol/vol
in sealed containers
Acetone solutions
20%Ethanol
pH 4.00 (200 ml)
pH 7.00 (200 ml)
Calibration solutions for pH
Approximately 2, 12 and 110 mS/cmConductivity solutions
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SpecificationItem
Approximately 1 M sodium chlorideSaline solution (gradient systems only)
All reagents should be filtered and degassed, and all reagents should have relevant certificates.
Note:
Gas supply
The following table lists the air supply requirements.
SpecificationGas
5.5 to 7 barCompressed air,
pressure
Airflow minimum 50 Nl/min during normal operationCompressed air,
supply
Other product specifications
SpecificationParameter
≤ 80 dB(A)Noise
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3 Site preparation checklist
Introduction
Read theprevious chapters in thisSite Preparation Guide before completingthe checklist.
Complete the checklistin this chapter to makesure thatall necessary preparations have been made for the installation of ÄKTAprocess.
You must send the completed checklist to a GE office before GE service personnel can install ÄKTAprocess. See details in Chapter 1.
Checklist
Comment/specifyN/ANOYESRequirement
General
When was the ÄKTAprocess system received (month/year)?
Will the GE service personnel be required to take site EHS(Environment, Health and Safety)or secu­rity training before doing the installation?
Assigned personnel
Personnel are assigned as specified.
Does the personnel experience level with the ÄKTAprocess system correspond to:
new user?
intermediate user?
advanced user?
Will the personnel require training on how to use the ÄKTAprocess system?
Site selection
Site complies with requirements for biosafety
General site requirements are fulfilled
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Comment/specifyN/ANOYESRequirement
Space requirements
Space is available as specified.
Environmental requirements
The proper environmental conditions are fulfilled as specified.
Ambient temperature
Relative humidity
Altitude
Electrical requirements
Electrical requirements are fulfilled as specified.
User supplied equipment
Personal Protective Equipment (PPE) as required, (e.g., gloves, lab coats, etc.)
13 mm wrench (or ratchet wrench with 13 mm socket)
Electrical TX25screwdriver orpower driver with a hexalobular TX25 bit
Safety knife
Buffer and waste vessels
Balance
Flexible hoses and TC connections
Reference Manuals System Binder I, II and III
User supplied consumables
Purified water (e.g., WFI/MQ)
Acetone solutions (1.0%, 0.5% and 0.1%)
pH solutions (pH 4.00 and 7.00)
Conductivity solutions
Sodium chloride (for gradients only)
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Comment/specifyN/ANOYESRequirement
All reagents have relevant certificates
Gas supply
Requirements for compressed air are fulfilled as specified (pressure and supply)
Additional information
Customer contact information
Date (dd-mmm-yyyy)
Company/Customer name
Company/Customer representative
Name
Address
Email
Phone number
AdvancedIntermediateBeginnerCustomer experience level
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GE and GE monogram are trademarks of General Electric Company.
ÄKTA, ÄKTAprocess and UNICORNare trademarks of General Electric Company or one of its subsidiaries.
ÖLFLEX is a trademark of the Lapp Group.
All other third party trademarks are the property of their respective owner.
© 2015 General Electric Company – All rights reserved. First published Jan. 2015
All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare whichsupplies 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 Europe GmbH Munzinger Strasse 5, D-79111 Freiburg, Germany
GE Healthcare UK Limited Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK
GE Healthcare Bio-Sciences Corp. 800 Centennial Avenue, P.O. Box 1327, Piscataway, NJ 08855-1327, USA
GE Healthcare Japan Corporation Sanken Bldg. 3-25-1, Hyakunincho Shinjuku-ku, Tokyo 169-0073, Japan
For local office contact information, visit www.gelifesciences.com/contact
GE Healthcare Bio-Sciences AB Björkgatan 30 751 84 Uppsala Sweden
www.gelifesciences.com/contact
29-1396-55 AA 01/2015 a19
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