quality control
DESCRIPTION
QUALITY CONTROL. of. volumetric devices. M.Jabari 2005. PIPETTES. I Line. To deliver (EX). II Line. Volumetric. To contain (IN) (Wash with solution ). Pipette. Graduated (Measuring ). PRCISION AND ACCURACY. % CV must be less than 0.3 %. % Bias must be less than 0.6%. - PowerPoint PPT PresentationTRANSCRIPT
Pipette
Graduated (Measuring )
To deliver (EX)
To contain (IN) (Wash with solution )
I Line
II Line
Volumetric
First weight a dish . Then with a pipette that you want caliber it
transfer DW into the dish and weight that . Repeat 10 time this action and record weight . Caculate each time pure weight of DW that
transfer with pipette. Caculate SD , %CV and % Biass .
110.100.040.0016
210.150.090.0081
310.250.190.0361
410.120.060.0036
510.0600
610.090.030.0009
79.85-0 .210.0441
810.070.010.0001
99.99-0.070.0049
109.91-0140.0196
(X –mean)2
Mean = 10.06
(x-M)2
n - 1SD=
%CV = X 100Mean
SD
0.1191.0710.06
(x-M)2 = 0.119
= 0.16 = 0.4
= 0.04
Acceptable 0.04 < 0 .3
Mean of Expected weight
Mean of Expected weight
Mean of Observed weight
_
%Bias= X 100
110.100.040.0016
210.150.090.0081
310.250.190.0361
410.120.060.0036
510.0600
610.090.030.0009
79.85-0 .210.0441
810.070.010.0001
99.99-0.070.0049
109.91-0140.0196
(X –mean)2
0.1191.0710.06
10
10
10.06
%Bias= X 100
_
= 0.006
_
Acceptable 0.006 < 0 .6
For 1 ml pipette : In a ballon class A . Prepare 0.1 gr /100 ml (stock ) . Dilute 1 : 11 and measure absorbance . Select 10 tube and add 10 ml DW in each
tube . (for 2 ml add 20 ml DW ) Add 1 ml stock reagent into each tube . Measur absorbance and record it .
Mean of Expected OD
Mean of Expected OD
Mean of Observed OD
_
%Bias= X 100
442
442
435
%Bias= X 100
_
= 1.58
_
1425-10100
2440525
3431-416
4430-525
5428-749
6441636
743500
8440525
9444981
1043611
(X –mean)2
3580435
Absorbance of 1:11 in class A ballone is 442
1.58 > 0.6No acceptable
Mean = 435
(x-M)2
n - 1SD=
%CV = X 100Mean
SD
(x-M)2 = 358
= 39 = 6.2
= 1.4
1425-10100
2440525
3431-416
4430-525
5428-749
6441636
743500
8440525
9444981
1043611
(X –mean)2
3580435 1.4 > 0.3No acceptable
Each sampler shoud assese 3 – 4 time annually .
Acceptable % CV up to 3%
Acceptable % Biass up to 5%
First weight a dish .
Then with a sampler that you want caliber it transfer
DW into the dish and weight that .
Repeat 10 time this action and record weight .
Caculate each time pure weight of DW that transfer
with sampler .
Caculate SD , %CV and % Biass .
1100-0.70.49
21021.31.69
31021.31.69
41032.35.29
599-1.72.89
699-1.72.89
71010.30.09
8100-0.70.49
9101030.09
10100-0.70.49
(X –mean)2
Mean = 100.7
(x-M)2
n - 1SD=
%CV = X 100Mean
SD
16.1100.7
(x-M)2 = 16.1
= 1.78 = 1.33
= 1.3
1.3 < 3Acceptable
Mean of Expected weight
Mean of Expected weight
Mean of Observed weight
%Bias= X 100
100
100
100.7
%Bias= X 100
_
= 0.7
_
1100-0.70.49
21021.31.69
31021.31.69
41032.35.29
599-1.72.89
699-1.72.89
71010.30.09
8100-0.70.49
9101030.09
10100-0.70.49
(X –mean)2
16.1100.7 0.7 < 5Acceptable
ll For 10-100 ml sampler : In a ballon class A . Prepare 0.1 gr /100 ml (stock ) . Dilute 1 : 101 and measure absorbance . Select 10 tube and add 1 ml DW in each tube .
( for 20 l ,50l ,100l add 2 , 5 , 10 ml DW ) Add 10 l stock reagent into each tube . Measur absorbance and record it .
Mean of Expected OD
Mean of Expected weight
Mean of Observed OD
_
%Bias= X 100
455
455
458.4
%Bias= X 100
_
= 0.74
_
14601.62.56
24612.66.76
34590.60.36
4458-0.40.16
5455-3.411.56
6458-0.40.16
74590.60.3684601.62.56
94590.60.36
10455-3.411.56
(X –mean)2
36.40458.4
Absorbance of 1:101 in class A ballone is 455
0.74 < 5Acceptable
Mean = 458.4
(x-M)2
n - 1SD=
%CV = X 100Mean
SD
(x-M)2 = 36.4
= 4.04= 2.01
= 0.43
14601.62.56
24612.66.76
34590.60.36
4458-0.40.16
5455-3.411.56
6458-0.40.16
74590.60.3684601.62.56
94590.60.36
10455-3.411.56
(X –mean)2
36.40458.40.43 < 3Acceptable