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Knauer APE20, Инструкция по эксплуатации

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6.  Functionality tests

Note: 

Standard processes regarding IQ and OQ in single devices may 

be handled differently in individual cases.

6.1 

Installation Qualification (IQ)

6.1.1 

Definition of the installation qualification

The qualification document „Installation Qualification (IQ)“ is part of the 
quality management system at the company KNAUER.

6.1.2 

Scope

The customer can request the Installation Qualification. In case of a 
request, the Technical Support of KNAUER or a provider authorized by 
KNAUER performs this functionality test during the installation. The IQ is a 
standardized document and includes the following:

 

ƒ

Confirmation of flawless condition at delivery

 

ƒ

Check if the delivery is complete

 

ƒ

Certification on the functionality of the device

6.1.3 

Instructions

Any deviations to the specifications and problems encountered during 
installation shall be recorded as comments in the document. In addition, 
all courses of action undertaken to resolve the problems and remove 
the deviations shall be recorded as comments in the section „6.1.9 Com-
ments/recommendations“ on page 45. 
If certain items in the report are not applicable, these must be indicated 
by ‘n/a’ (not applicable). Larger sections that are not used must be cros-
sed out (diagonal line through them), marked with ‘n/a’ and date (DD-
MM-YYYY) and signed. 
All required documents have to be completed promptly on-site.
The document will be reviewed by a person authorized by the labo-
ratory director. The inspection must be documented with the date 
(DD-MM-YYYY).
The tests must be carried out in a suitable environment as described in 
the instructions of the device.

6.1.4 

About this document

The information in this document is subject to change without prior noti-
ce. This document may not be used, reproduced or translated without 
written consent of KNAUER Wissenschaftliche Geräte GmbH. 
Depending on the customer’s quality assurance system, the signed docu-
ment must either be filed in the device folder or scanned and stored in an 
electronic archive.

43

AZURA® Pump P 2.1L Instructions V6840

43

Содержание APE20

Страница 1: ...Pump P 2 1L Instructions Document no V6840 HPLC HPLC...

Страница 2: ...auer net KNAUER Wissenschaftliche Ger te GmbH Hegauer Weg 38 14163 Berlin Germany Phone 49 30 809727 0 Fax 49 30 8015010 Internet www knauer net E Mail info knauer net Document number V6840 Version nu...

Страница 3: ...s 3 2 1 2 Foreseeable misuse 3 2 2 User qualification 3 2 3 Operator responsibility 4 2 4 Personal safety equipment 4 2 5 Safety features on the device 4 2 6 Working with solvents 5 2 6 1 General requ...

Страница 4: ...up to LPG 19 4 6 1 Mounting the valve block 20 4 6 2 Connecting the eluent line to the pump head 21 4 7 Priming the pump 22 4 8 Leak management 23 4 9 Control 24 4 9 1 Setting up LAN 24 4 9 2 Configur...

Страница 5: ...ation Qualification IQ 43 6 1 1 Definition of the installation qualification 43 6 1 2 Scope 43 6 1 3 Instructions 43 6 1 4 About this document 43 6 1 5 Device data 44 6 1 6 Customer data 44 6 1 7 Pack...

Страница 6: ...2 Packing the device 59 9 3 Transporting the device 59 9 4 Storing the device 59 9 4 1 Storing the pump head 60 10 Disposal 61 10 1 AVV Marking Germany 61 10 2 WEEE registration number 61 10 3 Eluents...

Страница 7: ...imes You can download these and other instructions from the KNAUER web site www knauer net library 1 2 Signal words Possible dangers related to the device are distinguished in personal and material da...

Страница 8: ...ng company within three workdays 1 4 3 Warranty conditions For information on warranty please refer to our general terms and condi tions on the website www knauer net terms 1 4 4 Warranty seal A blue...

Страница 9: ...y of the device Operation in potentially explosive areas without special and additio nal explosion protection Contact the KNAUER Customer Support for more information 2 2 User qualification The users...

Страница 10: ...to the employees working with the unit see section below 2 4 Personal safety equipment The protective measures required in the laboratory must be observed and the following protective clothing worn du...

Страница 11: ...s could get onto hot surfaces in the interior Degas solvents before use and observe their purity 2 6 2 Contamination by health threatening solvents Contamination with toxic infectious or radioactive s...

Страница 12: ...n wet rooms 2 8 Maintenance care and repair Avoiding electric shock Before performing any maintenance and ser vice work disconnect the device from the power supply Tools Use only tools recommended or...

Страница 13: ...st form and decontamination report Devices which are shipped without the completed document Service request form and decontamination report will not be repaired If you would like to return a device to...

Страница 14: ...ush ing Leak management KNAUER offers the following accessories Stainless steel pump heads Titanium pump heads for biocompatible applications Display software Mobile Control Heating cooling elements f...

Страница 15: ...ig 1 1 2 3 Pump P 2 1L front view Legend 1 Left LED 2 Center LED 3 Right LED 4 Standby switch Fig 2 1 2 3 4 LEDs and switch on the front of the device Legend 1 Serial number 2 Pin header 3 LAN port 4...

Страница 16: ...aration of fine chemicals Separation of active pharmaceutical ingredients API 3 4 Pump heads The pump automatically recognizes the pump head by means of the RFID chips The pump head is equipped with a...

Страница 17: ...d temperature range 2 Not recommended in combination with PEEK small parts and PEEK capillary Less suitable solvents Carbon dioxide liquid 99 999 CO2 Dilute phosphoriac acid Dimethyl sulfoxide DMSO Me...

Страница 18: ...Shortly press the switch to deac tivate the error message Red Serious error Restart the device If the operating condition does not change con tact the Technical Support Green Program or sequen ce is r...

Страница 19: ...s and signs The following symbols and signs can be found on the device Symbol Meaning High voltage hazard Electrostatic discharge hazard damages to sys tem device or components can occur Obey maximum...

Страница 20: ...ched to the device Keep the included packing list for repeat orders Keep the original packaging for safe storage or transportation 4 2 Ambient conditions 4 2 1 Operation site Observe the following req...

Страница 21: ...connected devices must not exceed 50 of the highest connected power capacity since higher currents can flow briefly when the device is switched on Main connection The electrical power supply at the o...

Страница 22: ...lush pump are located on the front of the device The flush pump is inside of the device and not visible from the outside Fig 5 Inlet symbol Fig 6 Outlet symbol The pump has been set up at the site of...

Страница 23: ...nd pressures up to 400 bar for 1 16 and 200 bar for 1 8 4 5 Eluent inlet The eluent lines are connected by the eluent inlet to the pump head Before the eluent lines are connected the eluent inlet must...

Страница 24: ...ml make sure that the tapered side of the cutting ring is pointed towards the fastening screw of the Teflon hose The eluent inlet has been connected Make sure that all connections are tight Make sure...

Страница 25: ...valve block the setup of the system is changed to low pressure gradient LPG The valve block is mounted to the front of the pump There are two types of valve blocks Ternary valve block for flow rates f...

Страница 26: ...s place seals in pairs on both fastening screws Process Figure Procedure 1 Unscrew the inlet 1 from the pump head Fig 14 1 Inlet on the pump head 2 Place the seal rings 3 on the screws and valve block...

Страница 27: ...flon hose 1 through the fastening screw 2 and the cutting ring 3 2 Insert the hose end as far as possible into the eluent inlet fit ting 4 of the pump head Fig 17 Cutting ring with Teflon hose 3 Tight...

Страница 28: ...1 Open the venting screw 1of the pressure sensor 2 With the syringe extract fluid through the priming port 2 3 If the extracted fluid flows con tinuously stop suction and close the venting screw Fig 1...

Страница 29: ...1 Carefully push the funnel 1 into the center opening of the capillary guide 2 Fig 20 1 2 Funnel and capillary guide 2 Push the long ending of the first nozzle 4 into the hose 3 Fig 21 3 4 Hose and n...

Страница 30: ...addresses are needed see section 4 10 Setting IP addresses via software on page 27 The following chapters describe how to set up a chromatography system in a local area network LAN and how a network...

Страница 31: ...utton Properties 4 Select Internet Protocol version 4 TCP IPv4 5 Click on the button Properties 6 Check the settings in the tab General The correct settings for the DHCP client are a Obtain an IP addr...

Страница 32: ...on about address user name and password is noted in the router manual www knauer net router Process 1 To open the router configuration start your Internet browser and enter the IP address does not app...

Страница 33: ...e the same num bers in the device configuration of the chromatography software as in the device otherwise the connection fails Process 1 Find out port number and change it on the device 2 Enter the po...

Страница 34: ...corner 7 Restart the device recommended 1 IP address mode 2 Text box for IP address 3 Text field for subnet mask gateway Fig 26 Network settings for static IP address The device is now accessible via...

Страница 35: ...l is installed and running The connection between Mobile Control and the device has been established Process 1 In Mobile Control click Settings 2 In Network Settings click Reset The windows Reset comm...

Страница 36: ...d on Firmware Wizard is installed and running Process 1 In Firmware Wizard click Reset LAN Settings 2 The window Device connection settings opens Enter serial num ber of the device into the text field...

Страница 37: ...e window Device connection settings opens Enter serial number of the device into the text field Target device serial number 1 3 Select option Obtain an IP address automatically 2 4 Click Reset Conn Se...

Страница 38: ...range can be set to values of max 1 2 5 and 10 V Analog IN Analog input signal for controlling the flow rate e g 1 V for 10 ml min in the case of the 100 ml pump head 1 V for 25 ml min in the case of...

Страница 39: ...the signal inputs Events remote connector For test purposes or in some other cases it can make sense to manually enter these signals Sending control signals Events to external devices Opening and clos...

Страница 40: ...t least 1000 ms 5TTL TTL compatible output Levels passive 0 V active 5 V Pulse 5 V for at least 1000 ms 6OC TTL output Levels passive 0 V active 5 V Pulse 5 V for at least 1000 ms GND Reference point...

Страница 41: ...nge 0 10 V 10 V according to maximum flow rate Start GND Reference point of the voltage at the signal inputs Start OUT TTL output Levels passive 5 V active 0 V Start IN TTL input Low active Secure swi...

Страница 42: ...on device causes a short circuit Turn off the device before connecting cables Pull the power plug Electronic defect Electrostatic discharge can destroy the electronics Wear a protective bracelet agai...

Страница 43: ...12 Analog control Note Contact the customer support to change the default settings and to select the analog control Analog ports serve for exchanging analog control signals Reference point for the sig...

Страница 44: ...the correct solvent as described in the specification table found in the supplement Running In procedure for pump heads V6894 If a pump was not in operation for a long time e g after shipment a runnin...

Страница 45: ...thin shortly The installation has been completed The capillaries and hoses have been connected The pump has been switched on and is in flow mode Syringe with Luer lock Use the purging solvent to be us...

Страница 46: ...a If this value is exceeded during the purging process the pump switches off automatically If you are using very small hoses and capilla ries the pressure can be too high If there are air bubbles in t...

Страница 47: ...simultaneously If the device is connected to the software it cannot be controlled via Mobile Control 5 4 1 Controlling with chromatography software To operate the device with software you have to esta...

Страница 48: ...been purged see 5 2 Purging the pump on p 39 Use isopropanol if you are going to take the device out of operation for a longer period of time or if you want to prepare it for storage The device is no...

Страница 49: ...action undertaken to resolve the problems and remove the deviations shall be recorded as comments in the section 6 1 9 Com ments recommendations on page 45 If certain items in the report are not appl...

Страница 50: ...g 38 14163 Berlin Phone 49 30 809727 111 E Mail support knauer net KNAUER agent 6 1 6 Customer data Customer Customer no Company Contact person Address Postal code City Phone E Mail Location Place of...

Страница 51: ...ice to the power supply The device is connected 5 Connect all loose parts e g capil laries tubings measuring head The device is fully assembled and ready to use 6 Switch on the device The device start...

Страница 52: ...ality test accor ding to KNAUER standard OQ documents The Operation Qualification is a standardized document and free of charge It is not part of the delivery Please contact the Technical Support in c...

Страница 53: ...he router set to DCHP server Is the IP address range sufficient for all the connected devices 3 Check all connections Are the patch cables connected to the LAN ports and not the WAN port Are all cable...

Страница 54: ...the manufacturer Exchange the pump head Pressure and flow rate variations Purge the pump head to remove the air bub bles Let the pump run for 1 h Always tighten the inlet screw fittings and outlet scr...

Страница 55: ...n Auto pump head type RFID hard ware not pre sent or failed Pump head without RFID detection If necessary replace pump head Auto pump head type read failed Switch the device off and on Repeat the auto...

Страница 56: ...se the sys tem message repeats itself Component set tings not compati ble with gradient setup Change the setup settings or change the gradi ent in the program or in setup E Error input acti vated Devi...

Страница 57: ...etup No link available Create a link and edit it No link available Pls edit link first Create a link and edit it No time table to start Edit the data by means of the chromato graphy software Non exist...

Страница 58: ...of program lines A maximum of 100 program lines are possible U Unable to attain min flow set point Confirm pump continues running Unknown pump head type Check the pump head Check whether a pump head w...

Страница 59: ...emselves Replacing the pump head Replacing the check valves of the pumps Proper maintenance of your HPLC device will ensure successful analyses and reproducible results 8 1 Maintenance contract The fo...

Страница 60: ...t Fig 35 2 3 1 4 5 Screw fittings on the pump head 8 3 2 Dismounting the pump head The pump head has been purged The tubes and hoses have been removed Allen wrench Open end wrench sizes 10 17 Chemical...

Страница 61: ...s of the piston backflushing 2 from the flush pump and the pump head 3 Remove the eluent lines 4 from the eluent inlets 4 Unscrew the Allen screws 3 5 Hold the pump head by hand and consecutively pull...

Страница 62: ...r 1 8 Process Figure Procedure 1 Slide the fitting 1 onto the capillary 2 2 Slide the clamping ring 3 onto the capillary so the capillary comes out Fig 37 1 2 3 Screw fitting 3 Using an open end wrenc...

Страница 63: ...1 Removing the check valves The pump head has been purged The capillaries have been removed The pump head has been dismounted Open end wrench sizes 10 17 Process Figure 1 Unscrew the outlet fittings...

Страница 64: ...ll and position of the valves have been harmonized to each other Insert the valves in the direction of flow The pump head has been purged The capillaries have been removed The pump head has been dismo...

Страница 65: ...d onto front cover or leak tray as these parts are loosely attached to the device 9 3 Transporting the device Documents If you want to return your device to KNAUER for repairs enclose the Service requ...

Страница 66: ...pillary at the pump head inlet Leave it for 5 minutes 2 Flush with suitable flushing solution 3 Fill the pump head with isopropanol 4 Seal the inlets and outles with cap fittings The pump head can be...

Страница 67: ...lassifies to category 8 and 9 which among others comprises laboratory equipment All distributors and importers are responsible for the disposal of old devices as defined by the WEEE directive End user...

Страница 68: ...continous working 1000 ml pump head 1 1000 ml min 10 800 ml min recommended 10 400 ml min continous working Maximum pressure 100 ml pump head 400 bar to 100 ml min 250 ml pump head 225 bar to 100 ml m...

Страница 69: ...Pump maximum 320 W Binary or ternary valve block 5 W Protection type IP 20 11 3 General Power Supply Pump 100 240 V 50 60 Hz Binary valve block 24 V Ternary valve block 12 V Dimensions 361 mm x 208 m...

Страница 70: ...wise Please note that higher temperatures can signifi cantly affect the stability of different materials 12 2 Plastics Polyetheretherketone PEEK PEEK is a durable and resistant plastic and next to sta...

Страница 71: ...e POM POM HTF POM is a semi crystalline high molecular thermoplastic material which stands out due to its high stiffness low friction value and thermic stability It can even substitute metal in many c...

Страница 72: ...ized by a high hardness a low coefficient of fric tion and thus low wear In addition it is highly biocompatible DLC is inert against all acids alkalis and solvents commonly used in HPLC Ceramic Cerami...

Страница 73: ...sed or with a mixture of higher compatibility They are inert against almost all solvents Exceptions are biological appli cations which are metal ion sensible and applications with extreme cor rosive c...

Страница 74: ...um APE20KB Pump P 2 1L with 250 ml pump head stainless steel APE20LA Pump P 2 1L with 250 ml pump head titanium APE20LC Pump P 2 1L with 500 ml pump head stainless steel APE20MA Pump P 2 1L with 500 m...

Страница 75: ...ium A4038V2 Pump head 1000 ml stainless steel A4022 1 Pump head 1000 ml titanium A4022V2 Check valves Check valve unit for 100 ml and 250 ml pump heads A1122 Check valve unit for 500 ml and 1000 ml pu...

Страница 76: ...UER instructions online www knauer net library KNAUER Wissenschaftliche Ger te GmbH Hegauer Weg 38 14163 Berlin Phone Fax E Mail Internet 49 30 809727 0 49 30 8015010 info knauer net www knauer net KN...

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