SOP Title: Operation, Cleaning and Calibration of Tablet Hardness Tester

SOP Title: Operation, Cleaning and Calibration of Tablet Hardness Tester

Objective:

To lay down the procedure for Operation, Cleaning and Calibration of Hardness Test Apparatus.

Scope:

This SOP is applicable for Operation, Cleaning and Calibration of Hardness Test Apparatus located in Quality Control Laboratory.

Responsibility:

Quality Control: To prepare and review the SOP. To follow the procedures laid down for Operation, Cleaning and Calibration of Hardness Test Apparatus as per this SOP.
Quality Assurance Department: To review and approve the SOP and Annexures.

Accountability:

Head Quality Control Department, Head Quality Assurance Department

Procedure:

Sr. No.

Procedure

5.1

Safety Precautions/Instructions:

5.1.1

Ensure all the electrical connections are properly earthed. Ensure the power plug of the Tablet Hardness Tester is fixed in the socket properly.

5.1.2

Wear personal protective equipments such as safety glasses, hand gloves during operation of instrument.

5.1.3

Ensure that the ON/OFF switch is working properly by switching “ON” the Tablet Hardness Tester.

5.1.4

During the test do not put Fingers between movable test jaw and Fixed jaw, it can be squeezed.

5.1.5

During breaking the test samples fragments of the samples can spring off. Use only protective glasses.

5.2

Front Panel-Keyboard

Introduction to the Keys of Disintegration Tester :

5.2.1

Left hand side keys on the front panel of the instrument are alphanumeric keys having dual functions are (A-Z, 1-9), Zero (0) with Dash (-), Dot (.), Slash (/), Decimal point (.) and Clear Entry (CE) Key.

5.2.2

Right hand side keys are functional keys as follows:

5.2.3

RESET- To Reset instrument.

5.2.4

BACK-To go backward for previous function display screen.

5.2.5

ESCAPE

To go back to main menu.

5.2.6

ENTER-To acknowledge the entered value.

5.2.7

START- To start the direct measurement.

5.2.8

STOP-To stop the direct measurement.

5.3

OPERATION OF TABLET HARDNESS TESTER:

5.3.1

Check the validity of calibration before starting any operations.

5.3.2

Ensure that the instrument should be cleaned before operation.

5.3.3

Connect the power cord to 230 VAC/50 Hz stabilized power supply.

5.3.4

Switch ON the mains of Tablet Hardness Tester.

5.3.5

Allow 15 minutes warm up time before operation of Tablet Hardness Tester.

5.3.6

After instrument is powered “ON”. Press the “RESET” key, it gets initialized and the 2 line LCD display will read.

5.3.7

V3.03 indicates the firmware version of the system.

5.3.8

If instrument is not calibrated display shows:

Perform calibration for Hardness, Length/Diameter/Width/Thickness

5.3.9

Press “ENTER” key to select main menu function.

5.3.10

The display shows:

1)Prog 2)Run 3)Print 4)Disp

5)Function 6)Configuration J=40mm

5.3.11

1)‘Program’ :To Add(create)/, edit, view, copy, delete Programs.

2)‘Run’ :To Run the desired Program.

3)‘Print’ :To obtain a hard copy of Program, Result, Calibration Report, Validation report, Template.

4)‘Disp’ :To display the result.

5)‘Function’ :To set Clock & Date. To perform Calibration, Clear the calibration, Edit Run No., Cal. Reminder

6)‘Configuration’:To select Weight transfer, Data transfer to pc/ printer ,to set Password , to set System setting , to set Report Setup.

1)PROGRAM ENTRY:

5.3.12

Select ‘PROG’ from main menu option by pressing ‘1’. press “ENTER” and the display shows :

1)ADD 2)VIEW

3) COPY 4) DELETE

5.3.13

To create program no. 1 press ‘1’ and press “ENTER” and the instrument will display as:

Prog No(1-20): 1

ADD/EDIT Mode

5.3.14

Press “ENTER” and the display will read :

Product Name:___

5.3.15

Use Alphanumeric Keys to Enter Sample Name.

5.3.16

Press “ENTER” and the display will read :

No. of Table (1-99):_

5.3.17

Enter value and press “ENTER”, the display will read:

% Length/Diameter Limit (0.01-100):-_

5.3.18

Select % Length/Diameter Limit and press “ENTER”, the display will read:

Length Sensitivity: (10-30)———-

5.3.19

Select Length Sensitivity and press “ENTER”, the display will read:

Breaking Sensitivity (30-250) :————–

5.3.20

Select Breaking Sensitivity and press “ENTER”, the display will read:

Speed:1)0.2 2)0.4 3)0.6 4)0.8

5)1.0 6)1.2 7)1.4 8)1.6:

5.3.21

Enter speed and press “ENTER”, the display will read:

Program No. 1 Stored———–

b) To select tolerance limit in Value:

5.3.22

Select Hardness limit and press “ENTER”, the display will read:

Nominal Length/Diameter (0.1-40 mm):

2) RUN Process :

5.3.23

Note: 1) During the test, part of the body like fingers etc. can be squeezed between the movable test jaw and fixed jaw.

2) Please place the sample tablets with tweezers or a similar tool.

3) To remove the remaining test pieces use the supplied brush.

4) During breaking the test samples fragments of the samples can spring off. Use only protective glasses.

5.3.24

To Run the instruments, 1^st Check & Clean the Sample tablet Carousel base for fragments of earlier test sample, Clean the fragments by the brush.

5.3.25

To Run the instrument, press ‘2’ and the display shows :

1)Admin 2)User

5.3.26

To run through User,press‘2’ and Press ‘ENTER’ and the display shows :

User (1- 25) :

5.3.27

Enter User No. press “ENTER” and it will Display:

Enter User Password —-

5.3.28

Password is in numeric for ( minimum 4 digit And maximum 8 digit).

5.3.29

Enter password and Press “ENTER” and the display will show:

Enter User Password————–

5.3.30

To Run program press ‘2’ refer point no.5.3.11 and and the instrument will display as:

Program No(1-99):

RUN Mode

5.3.31

Enter Program No. and Press “ENTER” and the display will read :

Product Name:______

5.3.32

Use Alphanumeric Keys to Enter All the data.

5.3.33

Press “ENTER” and the display will read :

Batch No:—————

5.3.34

Enter batch No. and Press “ENTER” and the display will read :

Stage:

5.3.35

Enter Stage and Press “ENTER” and the display will read :

Press Details:

5.3.36

Enter Press Detail and Press “ENTER” and the display will read :

Comment:

5.3.37

Enter Comment and Press “ENTER” and the display will read :

Weight 1 (0.01-99999.9 mg):

5.3.38

For manual weight entry set in the ‘Configuration’ option then, Enter the Weight manually by keyboard for 1^st Tablet in mg.

5.3.39

Continue entering weights of remaining tablets, one by one, as per No. of tablets entered in program.

5.3.40

Press Print Key of

Balance to Xfer Wt.

Note: When Weight Transfer is in AUTO mode from Balance, Balance should be ‘ON’ & connect to the instrument to transfer the weight press “PRINT” key of balance after stable display, and Display will show:

5.3.41

If the tablet Wt. entry selection is No., then display will show:

Initialized to home

Load Sample & press ‘Enter’

5.3.42

Place tablet in proper position to measure Width & press ‘Enter’

Keep the weighed tablets on the Tablet Base positioning towards the fixed Jaw and display will show:

5.3.43

Press “ENTER” and the display will read :

Wait….

Measuring Width

5.3.44

Movable jaw will start moving towards fixed jaw with high speed until it reaches to pre-calculated distance (width + limit + 1.0 mm), Display show:

Place tablet in proper position to measure Width & press ‘Enter’

Width = x.xxmm

5.3.45

Keep the tablet on the Tablet Base positioning towards the fixed Jaw.

5.3.46

Press “ENTER” and the display will read :

Thickness = x.xxmm

Wait….

Measuring Thickness

5.3.47

Keep the tablet on the Tablet Base positioning towards the fixed Jaw, and the display will read :

Place tablet in proper position to measure Width & press ‘Enter’

5.3.48

Press “ENTER” and the display will read :

Length diameter =xx.xmm

Hardness = x.xxN

Wait….

Measuring Length/Hardness

5.3.49

Repeat this operation until all the tablet measurement are over, Press ‘ENTER’ to continue.

Note: if Tablet is not detected, display shows ‘No Tablet’.

5.3.50

After completion of RUN, Display will show :

Run Over

To perform ‘START’/‘STOP’ Key function:

5.3.51

Press ‘START’ Key and the display Show as:

1)Hardness 2)Length / Diameter 3)Width

4) Thickness 5)All

5.3.52

To measure only Hardness Select ‘1’

To measure only Length / Diameter Select ‘2’

To measure only Width Select ‘3’

To measure only Thickness Select ‘4’

To measure all three parameters sequentially Select ‘5’

1) To Measure Hardness:

5.3.53

Press ‘1’ and “ENTER” and the display will read :

1) Measure 2)Print

5.3.54

To measure Hardness, press ‘1’ and “ENTER” and the display will read :

Product Name:

5.3.55

Enter product Name by using alphanumeric Key and Press “ENTER” and the display will read

Batch No. :

5.3.56

Enter Batch No. by using alphanumeric Key and Press “ENTER” and the instrument will read :

Nominal length /Dia. (0.1-40.0):

5.3.57

Enter value and press ‘ENTER’, the display read as:

Length/Dia/Thick/Width Sensitivity

(10 -30):

% Limit(L/D):

5.3.58

Select Sensitivity and press “ENTER”, the display will read:

Breaking Sensitivity:

(30-250)

5.3.59

Select Sensitivity and press “ENTER”, the display will read:

Speed: 1)0.2 2)0.4 3)0.6 4)0.8

5)1.0 6)1.2 7)1.4 8)1.6:

5.3.60

Enter Speed and press ‘ENTER’, the display read as:

Initialized to Home

Load Sample & press “ENTER”,

5.3.61

Keep the tablet at the Hardness measurement area and display will show:

Place tablet in proper position to measure Hardness & press ‘Enter’

5.3.62

Moveable jaw will start moving towards fixed jaw with High Speed until it reaches to pre-calculated distance (i.e. nominal length + 1mm) & continuous to move further with displacement speed as per selection, until the tablet breaks & giving hardness of tablet.

5.3.63

Note: 1) If Tablet is not detected, display shows ‘No Tablet’.

2) Eye protection is required when operating the Hardness Tester. Wear approved safety glasses.

3) There is pinch hazard between the sensing jaw and the power jaw.

5.3.64

Hardness = xx.xxN

Wait….

Measuring Hardness

Press “ENTER” and the display will read :

Press “ENTER” or “STOP”

5.3.65

Wait….

Measuring Length &Hardness

Hardness = xx.xxN

If no. of tablet are 2 or more,To continue hardness measurement, Press “ENTER” and the display will read :

5.3.66

Repeat the above operation until all the tablet measurements are over.

2) To Measure Length / Diameter :

5.3.67

Press ‘2’ refer point no. 5.3.51 and “ENTER” and the display will read :

1) Measure 2)Print

5.3.68

To measure Length /Diameter, press ‘1’ and “ENTER” and the display will read :

Product Name:————

5.3.69

Enter product Name by using alphanumeric Key and Press “ENTER” and the display will read

Batch No. :————-

5.3.70

Enter Batch No. by using alphanumeric Key and Press “ENTER” and the instrument will read :

Nominal length /Dia. (0.1-40):

5.3.71

Enter value and press ‘ENTER’, the display read as:

Length/Dia/Thick/Width Sensitivity

(10 -30):

% Limit(L/D):

Note: The jaw advance speed is set to default value 0.8mm/sec.

5.3.72

Press ‘ENTER’, the display read as:

Initialized to Home

Load Sample & press “ENTER”,

5.3.73

Keep the tablet at the Hardness measurement area and display will show:

Place tablet in proper position to measure Length & press ‘Enter’

5.3.74

Moveable jaw will start moving towards fixed jaw with High Speed until it senses the tablet for Length /Diameter.

5.3.75

Press “ENTER” and the display will read :

Press ‘Enter’ or ‘STOP’

Wait

Length / Diameter =x.xx mm

Wait……

Measuring Length

5.3.76

To continue Length /Diameter measurement, Press “ENTER”

5.3.77

Repeat the above operation until all the tablet measurements are over.

3) To Measure Width :

5.3.78

Press ‘3’ and “ENTER” and the display will read :

1) Measure 2)Print

5.3.79

To measure Width, press ‘1’ and “ENTER” and the display will read :

Product Name:———-

5.3.80

Enter product Name by using alphanumeric Key and Press “ENTER” and the display will read

Batch No. :

5.3.81

Enter Batch No. by using alphanumeric Key and Press “ENTER” and the instrument will read :

Nominal Width (1-15mm):

5.3.82

Enter value and press ‘ENTER’, the display read as:

Length/Dia/Thick/Width Sensitivity:

(10 -30)

% Limit(L/D):

Note: The jaw advance speed is set to default value 0.8mm/sec.

5.3.83

Press ‘ENTER’, the display read as:

Initialized to Home

Load Sample & press “ENTER”,

5.3.84

Keep the tablet at the Hardness measurement area and display will show:

Place tablet in proper position to measure Width & press ‘Enter’

5.3.85

Moveable jaw will start moving towards fixed jaw with High Speed until it senses the tablet for Width.

5.3.86

Press “ENTER” and the display will read :

Wait

Width =x.xx mm

Press ‘Enter’ or ‘STOP’

Wait……

Measuring Width

5.3.87

To continue width, Press “ENTER”

5.3.88

Repeat the above operation until all the tablet measurements are over.

4) To Measure Thickness :

5.3.89

Press ‘4’ refer point no.5.3.124 and “ENTER” and the display will read :

1) Measure 2)Print

5.3.90

To measure Thickness, press ‘1’ and “ENTER” and the display will read :

Product Name:

5.3.91

Enter product Name by using alphanumeric Key and Press “ENTER” and the display will read

Batch No. :

5.3.92

Enter Batch No. by using alphanumeric Key and Press “ENTER” and the instrument will read :

Nominal Thickness (1-15mm):

5.3.93

Enter value and press ‘ENTER’, the display read as:

Length/Dia/Thick/Width Sensitivity:

(10 -30)

% Limit(L/D):

Note: The jaw advance speed is set to default value 0.8mm/sec.

5.3.94

Press ‘ENTER’, the display read as:

Initialized to Home

Load Sample & press “ENTER”,

5.3.95

Keep the tablet at the Hardness measurement area and display will show:

Place tablet in proper position to measure Thickness & press ‘Enter’

5.3.96

Moveable jaw will start moving towards fixed jaw with High Speed until it senses the tablet for Thickness.

5.3.97

Press “ENTER” and the display will read :

Press ‘ENTER’ or ‘STOP’

Wait…….

Measuring Thickness

Wait…..

Thickness = x.xxmm

5.3.98

To continue Thickness measurement, Press “ENTER”

5.3.99

Repeat the above operation until all the tablet measurements are over.

5) To Measure Width/Thickness/Length/Hardness parameters sequentially :

5.3.100

Please note: Measurement parameter sequence is Width / Thickness / Length/Diameter/ Hardness

5.3.101

Press ‘5’ refer point no.5.3.124 and “ENTER” and the display will read :

1) Measure 2)Print

5.3.102

To measure all parameters, press ‘1’ and “ENTER” and the display will read :

Product Name:———–

5.3.103

Enter product Name by using alphanumeric Key and Press “ENTER” and the display will read

Batch No. :–

5.3.104

Enter Batch No. by using alphanumeric Key and Press “ENTER” and the instrument will read :

Nominal Length /Dia.(0.1-40.0):

5.3.105

Enter Nominal Length /Dia by using alphanumeric Key and Press “ENTER” and the instrument will read :

Nominal Thickness (0.1-15mm):

5.3.106

Enter Thickness by using alphanumeric Key and Press “ENTER” and the instrument will read :

Nominal Width (1-15mm):

5.3.107

Enter value and press ‘ENTER’, the display read as:

Length/Dia/Thick/Width Sensitivity

(10 -30):

% Limit(L/D):

5.3.108

Select Sensitivity and press “ENTER”, the display will read:

Breaking Sensitivity:

(30-250)

5.3.109

Select Breaking Sensitivity and press “ENTER”, the display will read:

Speed: 1)0.2 2)0.4 3)0.6 4)0.8

5)1.0 6)1.2 7)1.4 8)1.6:

Note: The jaw advance speed is set to default value 0.8mm/sec.

5.3.110

Enter Speed and press ‘ENTER’, the display read as:

Initialized to Home

Load Sample & press “ENTER”,

5.3.111

Keep the tablet at the Hardness measurement area and display will show:

Place tablet in proper position to measure Width & press ‘Enter’

5.3.112

Keep the tablet on the base of positioning towards fixed jaw.

5.3.113

Press “ENTER” and the display will read :

Place tablet in proper position to measure Thickness & press ‘Enter’

Wait…..

Width = x.xxmm

Wait…….

Measuring Width

5.3.114

Press Enter and the display will read:

Place Tablet in proper position To

measure Thickness and ‘ENTER’

Wait…..

Thickness =x.xxmm

Wait…..

Measuring Thickness

5.3.115

Length =x.xxmm

Hardness=x.x N

Press Enter and the display will read:

Wait……

Measuring Length &Hardness

5.3.116

To continue measurement, Press “ENTER”

5.3.117

Repeat the above operation until all the tablet measurements are over.

To STOP the RUN:

5.3.118

Press ‘STOP’ Button and the display will read :

Press ENTER or STOP

5.3.119

Press ‘STOP’ Button and the display will read :

1) Measure 2)Print

5.3.120

Press ‘2’ and the display will read :

Printing…….

Printing Over

3)To Print program parameters / Result / Calibration Report / Template / Verification Report :

5.3.121

· Ensure the Printer is properly connected, powered On and is online with A4 size paper is loaded in it.

5.3.122

Select Print option from main menu by pressing ‘3’, and the display will read as:

1) Program Parameters 2) Result 3)Template

4) Calibration Report 5)System parameter Report

1) To Print Program Parameter :

2) To Print Result :

5.3.123

Press ‘2’ refer point no. 5.3.195 and ‘ENTER’ and the display will read as:

1)All:

2)Skip out of Limit

5.3.124

To print all tablet results select ‘1’ & to print only tablets result which are in limits select ‘2’ and press ‘ENTER’ the instrument will display:

Printing….

5.3.125

To continue the printing, Press ‘1’and to discontinue the Run, Press ‘2’

5.3.126

No Data

B) If calibration data is not available display reads,

1) Clock :To enter Date & Time (this setting is available for Admin only)

5.3.127

Enter Admin Password

–

Press ‘1’and the display will read as:

5.3.128

Enter Admin Password and Press ‘ENTER’ and the display will read as:

Press ‘Enter’ to Edit

05/08/08 10.10

5.3.129

To edit Date & Time, press ‘ENTER’

2) To Calibrate the instrument :

5.3.130

To ensure the precision of the Instrument it must be calibrated at regular time intervals and when the measuring results are in doubt.

5.3.131

On completion of a calibration and verification cycle, calibration report can be printed.

5.3.132

Press ‘2’and the display will read as:

1)Admin 2)User

5.3.133

Enter Admin Password

Press ‘1’and the display will read as:

5.3.134

Enter Admin Password and Press ‘ENTER’ and the display will read as:

1)Hardness 2)Length/Dia/Width/Thickness

a) To Perform Hardness Calibration

Note: TH1050 M provides 3 point hardness calibration by using standard calibrated weights. We suggest weight from 5 – 30kg.

5.3.135

Press ‘2’and the display will read as:

1)Admin 2)User

5.3.136

Press ‘ENTER’ and the display will read as:

Remove L-jaw, Connect Pan, Remove all

Weight, Press ‘ENTER’

5.3.137

The moving jaw arm will be moved forward & stops midway. Remove the L jaw from the moving jaw arm by removing screws by using PH Screw Driver & fix the hardness calibration bracket assembly (Pan) on the moving jaw by using the same screws by using PH Screw Driver.

5.3.138

Once the bracket is fixed on the moving jaw, place the instrument carefully on its right side so that the calibration pan is pointing vertically upward.(Do not hold the carousel top assembly & the Pan assembly.

5.3.139

Press ‘ENTER’ and the display will read as:

Press ‘ENTER’ if stable reading

Pan weight (Kg)=x.xx

5.3.140

Press ‘ENTER’ and the display will read as:

Enter Weight W1( 1-50Kg) :

5.3.141

Keep 5 Kg Weight and press ‘ENTER’ and the display will read as:

Measured Weight (Kg) = xx.xx

Press ‘ENTER’

5.3.142

After stable reading ,press ‘ENTER’ and the display will read as:

Enter Weight W2( >5-50Kg) :

–

5.3.143

Keep 10 Kg Weight and press ‘ENTER’ and the display will read as:

Measured Weight (Kg) = xx.xx

Press ‘ENTER’

5.3.144

After stable reading ,press ‘ENTER’ and the display will read as:

Enter Weight W3( >10-50Kg) :

5.3.145

Keep 20 Kg Weight and press ‘ENTER’ and the display will read as:

Measured Weight (Kg) = xx.xx

Press ‘ENTER’

5.3.146

After stable reading ,press ‘ENTER’ and the display will read as:

Remove Pan & all weight,Fix L-Jaw

press ‘ENTER’

5.3.147

Now place the instrument carefully on its base. Remove the hardness calibration bracket assembly (Pan) fixing screws & refit the L jaw. (Do not hold the carousel top assembly & pan assembly).

5.3.148

While fixing ensure that there is no gap (Flush mounted) left between the L jaw & moving arm.

Note: After every calibration of hardness, a calibration of Length / Diameter is necessary.

5.3.149

Now the moving arm will advances further to touch the fixed jaw and the display will read as:

Tighten the L-Jaw srew and press ‘ENTER’

5.3.150

Now slightly loosen the L Jaw screws and re-tighten them to ensure they are parallel, press ‘ENTER’, and the display will read :

Perform Length /Diameter Calibration

For Correct measurement

Verification Over

Note: If calibration reminder function is enabled.

5.3.151

Enter Due Date :

dd / mm / yy

After few seconds ,and display will read as :

5.3.152

1) Hardness 2)Length/Dia/Width/Thickness

Enter new calibration Due date, and display will read as :

b) To Perform Length Calibration:

5.3.153

1) Hardness 2)Length/Dia/Width/Thickness

Press‘2’, and display will read as :

5.3.154

To enter Length sensitivity and Press‘ENTER’, and display will read as :

Place Gauge & Press ‘ENTER’

5.3.155

Clean the movable jaw and fixed jaw using the brush.Now position the

gauge close to fixed jaw orienting it in the centered axis between the fixed & moveable jaw. and display will read as :

Enter Length/Diameter (1-40 mm) =

5.3.156

Length Gauge for 25.1-65mm Jaw

Length Gauge for 0.1-40mm Jaw

5.3.157

Wait…..

Place 5 mm gauge, by pressing key “1” & “5” from the keyboard. Press ‘ENTER’ and display will read :

5.3.158

Moveable flat jaw will start moving towards fixed jaw until it senses the gauge for length & displays the Raw values of length with offset and returns to home position.

5.3.159

Same procedure to be followed for measured raw value length of 10mm and 20mm from point no. 5.3.239 to 5.3.241

5.3.160

Display will show:

Measured Length/Diameter = xx.xx mm

Place standard for verification

Press‘ENTER’

Calibration Over

c) To Verify Length Calibration

5.3.161

Enter Length/Dia/Thickness/Width( 1-40 mm )=

Clean the movable jaw and fixed test jaw using the brush. Press‘ENTER’and display will read as:

5.3.162

Place 5 mm Length gauge, Enter Value 5mm and Press ‘ENTER’

5.3.163

Enter Length/Dia /Thickness/Width( 1-40 mm )=

To verify with 2^nd standard and Press ‘ENTER’ display will read as:

5.3.164

Place 10 mm Length gauge, Enter Value 10 mm and Press ‘ENTER’

5.3.165

Enter Length/Dia /Thickness/Width( 1-40 mm )=

To verify with 3^rd standard and Press ‘ENTER’ display will read as:

5.3.166

Place 20 mm Length gauge, Enter Value 20 mm and Press ‘ENTER’

5.3.167

After few seconds ,and display will read as :

Enter Due Date :

dd / mm / yy

5.3.168

Enter new calibration Due date, and display will read as :

1) Hardness 2)Length/Dia/Width/Thickness

5.4

Calibration Procedure:

Frequency: Every Quarterly or after carrying out any major maintenance work.

5.4.1

Refer Annexure for calibration test to be performed and acceptance criteria.

5.4.2

Generate the A. R. No. on the “Instrument/Equipment Calibration Register” as per SOP number and give requisition to QA department for calibration formats of equipment/instruments on the due date of calibration.

5.4.3

For issuance of calibration report refer SOP “Control of documents, Preparation, Approval, Issuance and Maintenance.

5.4.4

Same procedure to be followed For Calibration of Tablet Hardness Tester from point no. 5.3.130 to 5.3.168.

5.4.5

Calibration parameters are as follows:

1) Hardness

2) Length

5.4.6

Enter the details in calibration report. Ensure that the results obtained, comply with the acceptance criteria.

5.4.7

Update the “Instrument/Equipment Usage Log Book” and “Monthly Calibration Schedule” as per SOP “Calibration of Instruments and Equipments”. Update the “Annual Calibration Schedule” as per SOP i.e. Equipment’s/Instruments Calibration.

5.4.8

Up to date “Calibration Status” on the Instrument as per SOP “Calibration of Instruments and Equipments”.

5.4.9

If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.

5.5

Cleaning Procedure:

5.5.1

Before cleaning the instrument unplug the power cord from the power source.

5.5.2

It is good laboratory practice to wipe away any spillage.

5.5.3

The exterior surface can be cleaned with soft cloth.

5.5.4

Do not use solvents like Chloroform, toluene.

5.5.5

Before and After use, clean the apparatus by removing tablet particles and powder from the platform using a brush and finally clean with lint free dry cloth.

5.5.6

If any breakdown occurs, follow procedure as per SOP “Calibration of Instruments and Equipments”.

Definitions / Abbreviations:

Definitions:
Breakdown: Any activity leading to operation of instrument/equipment other than the set parameters or unusual sound or vibration observed in the equipment.
Calibration: Tests performed to ensure that the instrument/equipment is functioning as per set parameters. These tests are performed as per predefined frequency and also after any major repair or replacement of parts.
Hardness Test: This test is performed to measure of the mechanical integrity of tablets is their breaking force, which is the force required to cause them to fail (i.e.,break) in a specific plane.
Abbreviations:

Abbreviation	Expansion
SOP	Standard Operating Procedure
QC	Quality Control
QA	Quality Assurance
A. R. No.	Analytical Reference Number
kgf	Kilo gram force
NLT	Not less than
NMT	Not more than
±	Plus or Minus

Calibration of Hardness Test Apparatus

1) Hardness Calibration:

Sr. No.	Parameters	Set Value (Kg)	Acceptance Criteria	Measured Value (Kg)	Complies / Does Not Complies
1	Hardness	5	±0.1Kg
		10	±0.1Kg
		20	±0.1Kg

2) Length Calibration:

Sr. No.	Parameters	Set Value (mm)	Acceptance Criteria	Measured Value (mm)	Complies / Does Not Complies
1	Length	5	± 0.06mm
		10	± 0.06mm
		20	± 0.06mm

Remark: The result Complies/Does not complies as per acceptance criteria.

Performed By: ________________ Date:________________ Checked By: ______________ Date: ______________

*Note – Ready to use SOP available in “DOWNLOAD” Section.

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