11/18/2020 Procedure for calibration of calculator.

Quality assurance - Pharmaceutical Guidance

Procedure for calibration of calculator. Quality assurance

 Pharma Editor  January 19, 2017  QA & QC, Quality Assurance, SOP  4,422 Views

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Procedure for calibration of calculator. Quality assurance

OBJECTIVE

To lay down the Procedure for Calibration of calculator.

SCOPE

This SOP provides guidance to calibrate the calculators, which are used for simple and complex
calculations of analysis in quality control department.

1. Scientific calculator

2. Desktop calculator

3. Calculator used in the computer (Windows Version 98, 2000, 2003, XP both standard and scientific)

RESPONSIBILITY

Officer/ Executive – Quality Control

ACCOUNTABILITY

Manager QC/QA

PROCEDURE

Before starting the calibration check the operation of calculator as per manufacturer’s manual.

Calibrate the calculator for Subsraction (-), Addition (+), Multiplication (X), Division (÷), Square root (√),

Logarithmic function (log), Inv (log) or Anti (log), Standard deviation (sd), Memory functions (M+, M–, MRC),
Percentage (%).

Verify the functions calculated using calculator with manual calculations.

Verify
Do Substraction
Not Sell using input
My Personal Information values as given below and report the result in annexure – 1
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11/18/2020 Procedure for calibration of calculator. Quality assurance - Pharmaceutical Guidance

Verify Addition using the set of values given below and report the result in annexure – 1

123456789 + 987654321.

Verify Multiplication using the set of values given below and report the result in annexure – 1
a) 12345679 X 8
b) 12345679 X 9.

Verify Division using the input values of 22 ¸ 7 and report the displayed value in annexure – 1.

Press ‘p’ key and report the displayed value in annexure – 1. (This test is significant in verifying the
standard values that are stored in calculator’s memory).

Verify Square root (Ö) function using logarithmic tables and anti-log tables.

the reference equation used for manual calculation is

ÖX = Y applying log. on both sides,

½ log X = log Y applying anti – log on both sides anti log (½ log X) = antilog (log Y).

The log. Values for reference are enclosed

The complex functions like logarithmic and anti-log functions are counter verified in the square root function
itself.

For calculation consider √100 and report the values in annexure – 1.

Verify standard deviation function using the input values as 1,2,4,4,4.

For manual calculation of standard deviation use the following formula

Std.deviation =

Where x = individual sample, ∑ x2 = sum of squares of x, n = sample size, (∑x) 2 = square of sum of
individual sample.

Upon simplifying the equation the result yields √2 = 1.4142 (this requires logarithmic application).

Verify Sequential group calculations like multiplication, division, subsraction and additions using the known
conversion factor (°F – 32) (5/9) = °C. Verify the values of 0°F, 32°F, 77°F, 104°F, 140°Fand report the
results in annexure –1.

Further verify the group calculation using the conversion factor of (9/5)°C+ 32 = °F verify the values of

-20°C, 0°C, 25°C, 40°C, 60°C and report the results in annexure –1.

(Note: Compare the values with USP 28 pharmacopoeia under reference tables – thermometric equivalents
(Centigrade to Fahrenheit.)
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11/18/2020 Procedure for calibration of calculator. Quality assurance - Pharmaceutical Guidance

Press Memory recall (MRC) to review the final result and enter the details in annexure – 1

Verify Memory functions in M –using the following set of values 1 ⇒ M – ⇒ 2 ⇒ M – ⇒ 3 ⇒ M –

⇒ 4 ⇒ M – ⇒ 5.

Press Memory recall (MRC) to review the result and enter the details in annexure – 1.

Verify the percentage (%) calculations by applying the following values 1/1 x % =. Enter the details in
annexure – 1

Table 1
Acceptance Criteria For Calibration Parameters

S.NO TEST PARAMETER ACCEPTANCE CRITERIA TOLERANCE

1 Subsraction 333 –

2 Addition 1111111110 –

3.1 Multiplication 98765432 –

3
3.2 Multiplication 111111111 –

4 Division 3.1428 –

Up to digits of
5 ‘p’ Value 3.141592653589793238…
Calculator

6 Square root 10 –

7 Standard deviation 1.4142 –

8 Group calculations

0°F -17.78°C

32°F 0.00°C

8.1 77°F 25.00°C

104°F 40.00°C

140°F
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60.00°C
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8.2 -4.0°C 24.8°F 
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11/18/2020 Procedure for calibration of calculator. Quality assurance - Pharmaceutical Guidance

0°C 32.0°F

25°C 77.00°F

40°C 104°F

60°C 140°F

9.1 M+ calculation 15 –
9
9.2 M– calculation -15 –

10 Percentage 100 –

Forms and Records (Annexures)

Calibration format for calculator – Annexure-1

Distribution

Master copy – Quality Assurance

Controlled copies- Quality Assurance, Production, Quality Control.engineering

History

Date Revision Number Reason for Revision

– 00 New SOP

Annexure-1

Calibration format for calculator

Substraction:

by calculator: 654 – 321 =

b) manual calculation: 654 321(-)

Acceptance criteria: display value and calculated value = “333”

Addition:

a) by calculator: 123456789 + 987654321 = .

b) manual calculation:

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123456789
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987654321 (+)
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11/18/2020 Procedure for calibration of calculator. Quality assurance - Pharmaceutical Guidance

WalletWise tips online.

Ts&Cs apply. Auth FSP NCRCP15.

WalletWise tips online.

Ts&Cs apply. Auth FSP NCRCP15.

Acceptance criteria: display value and calculated value = “1111111110”

Multiplication:

a) by calculator: 12345679 x 8 =

b) manual calculation: 12345679 x 8

Acceptance criteria: display value and calculated value = “98765432”

a) by calculator: 12345679 x 9 =

b) manual calculation: 12345679 x 9

Acceptance criteria: display value and calculated value = “111111111”

Division:

WalletWise tips online.

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a) by calculator: 22 ÷ 7 = 
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11/18/2020 Procedure for calibration of calculator. Quality assurance - Pharmaceutical Guidance

b) manual calculation: 7) 22 (

(calculate upto 5th decimal)

“p” value:

by calculator: p =

Reference value: p =

(B.P 2004- volume IV Supplementary Chapter IV G A 525)

Acceptacne criteria: p = 3.141592653589793238… ( match upto decimal indication of calculator)

Square root:

a) by calculator: Ö 100 =

b) manual calculation: Ö 100 = x ( upon applying “log” on both sides)

½ x log (100) = log( x )

log(100) (y) = (by using logarithmic table)

½ x (y) = log( x )

anti- log [½ x (y)] = x (by using anti-logarithmic table) = x

Acceptance criteria: result is “10”

Standard deviation:

a) by calculator: press mode & to shift into standard deviation mode.

Input values = 1 shift M+ , 2 shift M+ , 4 shift M+ , 4 shift M+, 4 shift M+.

1. Shift ‘n’ =

2. Shift Sx2 = ( sum of squares of all sample)

3. Shift (Sx)2 = (square of sum of all sample)

4. n x Shift (Sx)2 = (n= sample size)

standard deviation = ( upon using the equation)

calculated value =

manual calculation: (x)²

input values are 1 1x1 =

2 2x 2 =

4 4x4 =
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(+) 4 x 4 =
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11/18/2020 Procedure for calibration of calculator. Quality assurance - Pharmaceutical Guidance

(Σx) sum of sample Σx² sum of squares

(Σx)² square of sum of sample =

Upon introducing the values in the above formula =

standard deviation (s) = Ö x = log (s) = ½ x log( x ) = (s) = anti log{½ x log( x )} =

(note: use logarithmic and anti- log tables for calculations)

Group Calculations:

A) (°F- 32) ( 5/9) = °C

by calculator:

for input values of ° F 0°F = °C, 32°F = °C, 77°F = °C, 104°F = °C, 140°F = °C.

b) manual calculations: (°F- 32) ( 5/9) = °C ( simplify the equation into i) °F –32 ii) 5/9

( the value of 5/9 is considered for calculations is 0.555556)

For input value 0°F i) °F – 32 = __________ ;

(°F- 32) ( 5/9) = ___________________°C

For input value 32°F i) °F – 32 = __________ ;

(°F- 32) ( 5/9) = ___________________°C

For input value 77°F i) °F – 32 = __________ ;

(°F- 32) ( 5/9) = ___________________°C

For input value 104°F i) °F – 32 = __________ ;

(°F- 32) ( 5/9) = ___________________°C

For input value 140°F i) °F – 32 = __________ ;

(°F- 32) ( 5/9) = ___________________°C

Acceptance criteria: values should match with values in table –1 of SOP BA(II)QA414-00 up to two digits.

(9/5)°C + 32 = °F

by calculator:

for input values of ° C -20.0°C = °F, 0°C = °F, 25°C = °F, 40°C = °F, 60°F =°F.

b) Manual calculations:

(9/5)°C + 32 = °F (simplify the equation into i) 9/5 ii) (9/5) x °C iii) (9/5) x °C + 32

(the value of 9/5is considered for calculations is 1.8)

For input value -20°C i) 1.8 x – 20°C = __________ ;

(1.8 x – 20°C) + 32 = ___________________°F

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For input value 0°C i) 1.8 x 0°C = __________ ;
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For input value 25°C i) 1.8 x 25°C = __________ ; 
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11/18/2020 Procedure for calibration of calculator. Quality assurance - Pharmaceutical Guidance

(1.8 x 25°C) + 32 = ___________________°F

For input value 40°C i) 1.8 x 40°C = __________ ;

(1.8 x 40°C) + 32 = ___________________°F

For input value 60°C i) 1.8 x 60°C = __________ ;

(1.8 x 60°C) + 32 = ___________________°F.

Acceptance criteria: values should match with values in table –1 of SOP BA(II)QA414-00 up to two digits.

Memory functions:1) M+ calculations: a) by calculator:

input values are 1,2,3,4,5 ( at each entry press M+)

Result is (MRC) = _______________________________.

b) manual calculation: 1+2+3+4+5 = _______________________________.

2) M– calculations:

a)by calculator:

input values are 1,2,3,4,5 ( at each entry press M-)

Result is (MRC) = _______________________________.

b) manual calculation: 1+2+3+4+5 = _______________________________.

Percentage Calculations:

a) by calculator:

input values are 1 ÷ 1 (press %) = _______________________________.

b) Manual calculations:

input values are 1 ) 1 (

result = —————- x 100 = —————–.

Remarks: the calculator is calibrated/ not calibrated and approved for usage/ not to be used.

Next calibration due on : ——————————

Approved By

Sign & Date Analysed By Checked By

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