DQdocument For VP - Eng
DQdocument For VP - Eng
DQdocument For VP - Eng
Shimadzu Corporation
Analytical & Measuring Instruments Division
Page 1/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Contents
1. Summary....................................................................................................................................... 3
7. Reference Documents................................................................................................................. 18
(1) Pump....................................................................................................................... 18
(2) Auto-Sampler........................................................................................................... 19
Page 2/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
1. Summary
This document, “Shimadzu HPLC System Customer Requirements and Proposals from Shimadzu”, was created to support customers with the DQ (Design
Qualification) process.
DQ is the first step a customer takes before purchasing a system. The DQ process is a necessary step for verifying the suitability of the equipment selection, by
listing all the requirements and criteria with respect to the total system, based on the objectives for acquiring the system. If inappropriate requirements or criteria
are designated during DQ it could have a major effect on the effectiveness or economics of the equipment after installation. Therefore, it is necessary to thoroughly
verify the requirements. Shimadzu will help customers prepare the DQ documentation by providing documents such as this one and IQ/OQ information for each
analytical device.
Page 3/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Stipulate Requirements
Select vendor
Confirmation of evaluation contents
Sign Contract
Page 4/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Page 5/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Page 6/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Requirements regarding the vendor and the support they will provide
Requirements Select User Comments
1 Must have ISO 9001 or equivalent quality standards
certification □
2 Product development records must be accessible □
3 Products must include a validation declaration or equivalent
documentation □
4 Must have a revision management system that notifies users
when products are upgraded □
5 Must provide support via telephone □
6 Must provide support via email □
7 Must provide support via the Internet □
8 Must sponsor seminars, etc. □
9 Operator training support must be available □
10 IQ/OQ support must be available □
11 □
12 □
Page 7/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Page 8/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Must check firmware version □
Must test initialization □
Must test the time program □
Must test lamp energy □
Must test wave length accuracy □
Must test light source illumination time □
Must check indicated light absorption and voltage output □
Must test leak sensor □
4 Oven Must perform ROM and RAM self-diagnostics □
Must check firmware version □
Must test display and LEDs □
Must test the time program □
Must test accuracy of temperature settings (room temp.-5 ºC) □
Must test accuracy of temperature settings (40/50 ºC) □
Must check precision of temperature adjustments (room temp.-5 ºC) □
Must check precision of temperature adjustments (40/50 ºC) □
Must check functionality of leak sensor □
6 System Controller Must perform ROM and RAM self-diagnostics □
Must check firmware version □
Must adjust display screen contrast □
Must check each display screen □
Must check system control □
Must check the backup memory system □
7 Auto-Sampler Must perform ROM and RAM self-diagnostics □
Must check firmware version □
Must test display and LEDs □
Must check basic functionality □
Must test accuracy of injection volume □
(Sample Cooler) Must test accuracy of temperature □
Page 9/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
8 Workstation Must check the computer memory □
Must check date and time □
Must check the security system □
Must test the hard disk drive □
Must check the printer driver □
Must check the software version □
Must perform program alteration check □
Must check user access control system □
Functionality must be checked □
9 System Must test the concentration gradient □
Must test noise and drift levels □
Must test UV-VIS reproducibility □
Page 10/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
The proposal from the vendor is evaluated to determine whether it satisfies the customer requirements. For each item, place a check mark in the checkbox if
the requirement has been satisfied.
Page 11/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Page 12/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Page 13/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Page 14/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Page 15/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Must check precision of temperature Able to satisfy the requirement
adjustments (room temp. - 5 ºC) □
Must check precision of temperature Able to satisfy the requirement
adjustments (40/50 ºC) □
Must check functionality of leak sensor Able to satisfy the requirement □
4 Auto-Sampler Must perform ROM and RAM self-diagnostics Able to satisfy the requirement □
Must check firmware version Able to satisfy the requirement □
Must test display and LEDs Able to satisfy the requirement □
Must check basic functionality Able to satisfy the requirement □
Must test accuracy of injection volume Able to satisfy the requirement □
(Sample Cooler) Must test accuracy of temperature Able to satisfy the requirement □
5 System Controller Must perform ROM and RAM self-diagnostics Able to satisfy the requirement □
Must check firmware version Able to satisfy the requirement □
Must adjust display screen contrast Able to satisfy the requirement □
Must check each display screen Able to satisfy the requirement □
Must check system control Able to satisfy the requirement □
Must check the backup memory system Able to satisfy the requirement □
6 Workstation Must check the computer memory Able to satisfy the requirement □
Must check date and time Able to satisfy the requirement □
Must check the security system Able to satisfy the requirement □
Must test the hard disk drive Able to satisfy the requirement □
Must check the printer driver Able to satisfy the requirement □
Must check the software version Able to satisfy the requirement □
Must perform program alteration check Able to satisfy the requirement □
Must check user access control system Able to satisfy the requirement □
Functionality must be checked Able to satisfy the requirement □
7 HPLC System Must test the concentration gradient Able to satisfy the requirement □
Must test noise and drift levels Able to satisfy the requirement □
Must test UV-VIS reproducibility Able to satisfy the requirement □
Shimadzu Corporation will provide OQ documentation for the proposed equipment.
Page 16/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
The manufacturer will be selected based especially on the following evaluation criteria.
・ The manufacturer can satisfy all analytical system requirements
・ The manufacturer has a thorough quality management system with respect to product development.
・ The manufacturer is able to fully support the system after installation.
Shimadzu Corporation’s “Shimadzu HPLC System” fully satisfies all these requirements, so Shimadzu has been selected. The table below lists the criteria for
selecting the vendor.
Page 17/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
7. Reference Documents
7.1 Standard LC Specifications
Standard specifications for an HPLC system manufactured by Shimadzu Corporation
(1) Pump
Product Name LC-10ADvp / LC-10ATvp
Pump Method Micro-volume double plunger (LC-10ADvp) and serial double plunger (LC-10ATvp)
Flow Rate Setting Range (in 0.001 - 5.000 mL/min [1.0 - 39.2 MPa]
constant flow rate mode) 5.001 - 9.999 mL/min [1.0 - 19.6 MPa]
Flow Rate Accuracy Within ±2% or ±2 µL/min, whichever is greater.
(in constant flow rate mode) [Given 0.01 - 5 mL/min (for LC-10ADvp) or 0.1 - 5 mL/min (for LC-10ATvp), and 1.0 - 39.2 MPa, using water and with a constant room
temp of 20 ºC. Except during low pressure gradient liquid delivery mode.]
Flow Rate Precision Within ±0.3% (RSD < 0.1 %)
(in constant flow rate mode) (Given 0.1 - 5 mL/min, 1.0 - 39.2 MPa, water, constant room temp of 20 °C.)
Pressure Limiters High pressure and low pressure
Time Program Flow rate, pressure, events, LOOP (program iteration), 10 files. A total of 320 steps.
Accuracy of Indicated Pressure Within ±2% or ±0.5 MPa, whichever is greater.
Size and Weight W260 x H140 x D420 mm, 11 kg
Operating Temperature Range 4 - 35 °C
Power Supply Requirements AC 100 V, 100 VA, 50/60 Hz
(1-1) High Pressure Gradient Specifications
When controlled by a liquid delivery unit When controlled by a SCL-10Avp unit
Number of liquids in solvent mixtures Two liquids Two or three liquids
Gradient Profiles Step and linear, multi-step Step, linear and exponential, multi-step
Time Program Steps 10 Programs, 320 steps total 20 Programs, 400 steps total
Program Time Settings 0.01 - 999.99 min, 0.01 min steps 0.01 - 9999.9 min, 0.01 min steps
Mixing Ratio Setting Range 0 - 100% (0.1 % steps)
Accuracy of Concentration Settings ±1%
(Given a water/acetone mixture at 0 - 100%, 0.1 - 3 mL/min and 1.0 - 39.2 MPa)
(1-2) Low Pressure Gradient Specifications
When controlled by a liquid delivery unit When controlled by a SCL-10Avp unit
Number of liquids in solvent mixtures Four liquids max. Four liquids max.
Gradient Profiles Step and linear, multi-step Step, linear and exponential, multi-step
Time Program Steps 10 Programs, 320 steps total 20 Programs, 400 steps total
Program Time Settings 0.01 - 999.99 min, 0.01 min steps 0.01 - 9999.9 min, 0.01 min steps
Mixing Ratio Setting Range 0 - 100% (0.1 % steps)
Accuracy of Concentration Settings ±1% (Given a two-liquid gradient of water/acetone, 1 mL/min flow and 10.0 MPa pressure or less.)
Page 18/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
(2) Auto-Sampler
(2-1) Model SIL-10ADvp
Product Name SIL-10ADvp
Method Total sample volume injection and variable sample volume injection (zero sample loss during injection)
Injection Volume Setting Range 0.1 - 50 µL (standard)
1 - 500 µL (with optional 500 µL sample loop [228-33355-01])
Number of Samples Processed 150 (using 1 mL vials), 768 (using micro plates)
Injection Volume Reproducibility RSD < 0.3% (when injecting 10 µL, depending on conditions)
Number of Injection Iterations 1 - 30 per sample
Analysis Time Settings 0.01 - 9999.9 min. (0.01 min. steps)
No. of Steps for Injection Conditions 102 steps maximum
Sample Suction Rate 0.1 - 15 µL/sec (0.1 µL/sec steps for 1 µL/sec or less, 1 µL/sec steps for over 1 µL/sec)
Operating Pressure 34.3 MPa (350 kgf/cm2) maximum
Operating pH range pH 1 - 13
(If using a liquid of pH 10 or higher, the gasket for the 6-port valve rotor and stator, and the needle seal must be replaced by the Delrin
gasket kit [228-21708-92] and PEEK needle seal [228-33355-01] respectively. In this case, the 6-port valve max pressure will be 19.6
MPa)
Liquid Contact Surfaces Stainless steel (SUS 316), ceramics, Vespel, Teflon, etc.
Number of Pretreatment Files 20
Reagent Vials Three 10 mL capacity vials can be installed. (using racks 6, 7, or 16)
Reagent Mixing Possible
Reaction Time Settings Possible (0.1 - 120.0 min (0.1 min steps)
Size and Weight W260 x H280 x D420 mm, 19 kg
Ambient Operating Temp Range 4 - 35 °C
Power Supply Requirements AC 100 V, 300 VA, 50/60 Hz
(Sample Cooler)
System Method Aluminum block is cooled via Peltier elements
Temperature Setting Range 4 - (room temp - 5) °C
(Can be controlled to 4 °C, given a 30 °C or less room temp and 60% or less humidity)
Temperature Setting Accuracy ±3 ºC
Size and Weight Controller Section: W260 x H70 x D420 mm, 6.5 kg
Cooling Rack Section: W135 x H150 x D220 mm, 3.6 kg
Ambient Operating Temp Range 4 - 35°C
Power Supply Requirements AC 100 V, 200 VA, 50/60 Hz
Page 19/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Page 20/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
Page 21/23
Shimadzu HPLC Systems Created on: June 07, 2002 – Ver. A
・ CLASS-Agent Manager
・ LC10/VP File Converter
・ Adobe Acrobat 5.0 (installed separately)
Main Features ・ The CLASS-VP workstation PC comes with a two-year warranty (free repair) and a maintenance contract from Fujitsu Support and
Service. If any trouble should occur with the PC, dedicated support personnel will work to restore the system promptly and reliably.
・ Analytical instrument control and data processing
・ User management features
・ Can generate analytical reports in PDF file format
・ Can generate files in Andi format (AIA files)
・ Audit trail features
・ Automatic record keeping of analytical data
Page 23/23