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Spectroquant Pharo 300 - 5 Analytical Quality Assurance (AQA)

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18
Spectroquant
®
photometers
Release 06/2014
5 Analytical Quality Assurance (AQA)
The certificate for the test kit, available for each lot produced, docu-
ments the quality of the reagents contained in the test kit.
Calibration function:
The calculated function must agree, within specified tolerances, with the
function electronically stored in the photometer.
Confidence interval:
Maximum deviation from the desired value over the entire mea suring
range; every measurement value can be affected by this deviation; this
parameter is a measure for the accuracy.
Standard deviation for the procedure:
Measurement for the dispersion of the measurement values over the
entire measuring range, ex pressed in ±mg/l.
Coefficient of variation for the procedure:
Measurement for the dispersion of the measurement values over the
entire measuring range, ex pressed in %. The smaller the standard devia-
tion/ coefficient of variation for the procedure, the more pronounced the
linearity of the calibration curve.
5.2 Quality Control for the User
= Test for the
overall system
Checking the
working equip-
ment
Pipette Test kit Photometer Thermoreactor
Checking the
handling
operations
Test for recovery
Carefully pipette 3.0 ml
of the sample into a
reaction cell, close tight-
ly with the sc re w c ap ,
an d mi x vigorously.
Caution, the cell
becomes very hot!
Suspend the bottom
sediment in the cell by
swirling.
Heat the reaction cell in
the thermoreactor at
148 °C for 2 hours.
Remove the reaction
cell from the thermo-
reactor and place in a
test-tube rack to cool.
Swirl the cell after
10 minutes.
Influence of the sample
Mischen
Küvette wird heiß,
am Verschluss
anfassen
2 ml Prob
elösung
in ein Reaktions-
vette geben
im Thermoreaktor
erhitzen
148 C, 120 min
mind. 10 min
abhlen
Abhlen auf
Raumtem
peratur
(mind. 30 min)
Mischen
Messen
C2/25 CSB
1500 Chemischer
Sauerst
offbedarf
Me§bereich
100 1500 mg/l CSB
1
4
.
7
2
5
8
0
3
6
9
C
14 mm
A complete check comprises the entire system, i. e. the working equipment
and the mode of operation. The photometer offers an optimum degree of
support in this re gard, in the form of the different quality mode. The instru-
ment, or the whole system (includ ing reagents and all accessories) will be
checked, depending on which quality mode selected. All of checking oper-
ations can thus be supported by the pho tometer and the check values
accordingly docu mented as per GLP (Good Laboratory Practice) recom-
mendations (see Function description, “Analytical Quality Assurance”).
The following diagram provides an overview regarding internal quality-
assurance aspects:
Art.Nr. / Cat. No. / Art. Nro. 1.14560.0001
Messbereich
Measuring Range / Int ervalo de medida
4,0 - 40,0 mg/ l CSB/COD/DQO
Sollwert
Target value
Valor nominal
(Standard / Patrón)
mg/l
CSB/COD/DQO
Messergebnis
Result / Resultado
(Standard / Patrón)
mg/l
CSB/COD/DQO
Charge-Nr. / Lot no. / Lote nro. HC119527 4,0 4,7
8,0 8,7
12,0 11,8
Standard / Standard / Patrón Potassium hydrogen phthalate 1.02400 16,0 16,4
Photometer / Photomet er / Fotómetro Referenz / Reference / Referencia 20,0 19,9
Wellenlänge / Wavelength / Longitud de onda 340 nm 24,0 24,1
Küvette / Cell / Cubeta 16 mm rund / round / redonda 28,0 28,4
Prüfer / Tester / Verificador Fr. Brandner 32,0 32,4
Datum / Date / Fecha
20.09.2011 36,0 36,3
Datei / File / Fichero 1145600001_HC119527_EN 40,0 40,2
Sollwert
Target value
Valor nominal
Chargenwert
Lot value
Valor del lote
1,00 ± 0,03 0,99
99
0,4
1,410 ± 0,020 A 1,403 A
99
± 1,0 mg/l ± 0,8 mg/l
99
± 0,3 mg/l
99
± 2,5 % ± 1,4%
99
Merck KGaA
Qualitätskontrolle Laborleiter / Head of Lab.
Quality control / Control de calidad Jefe de laboratorio
n = 10
Verfahrensvariationskoeffizient
Variation Coefficient of the Method / Coeficiente de variación del procedimiento
31.10.2012
Reag.blindwert / Reagent blank / Valor en blanco del react +/- Tolerance / Tolerancia
Verfahrensstandar dabweichung
Standard Deviation of t he Method / Desviación e stándar del procedimi ento
Vertrauensberei ch (95% Wahrscheinl ichkeit)
Confidential interval (P=95%) / Intervalo de confianza (95 % de probabilidad)
Spectroquant
®
CSB-Küvettentest
Spectroquant
®
COD Cell Test / Spectroquant
®
Test en cubetas DQO
Chargenzertifikat
Lot Certificate / Certificado del lote
Ordinatenabschnitt / Ordinate segment / I ntersecto en ordenadas
Kalibrierfunkt ion / Calibration Functi on / Función de calibrac ión
DIN 38402 A51 / ISO 8466-1
Steigung / Slope / Pendiente +/- Tolerance / Tolerancia
Verwendbarkeit
Expiry date / Fecha de ca ducidad
0,0
5,0
10,0
15,0
20,0
25,0
30,0
35,0
40,0
0,0 5,0 10,0 15,0 20,0 25,0 30,0 35,0 40,0
Messergebnis / Result / Resultado (mg/l)
Sollwert / Target value / Valor nominal (mg/l)

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