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

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

1. Objective:

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

 

2. Scope:

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

 

3. Responsibility:

• Quality Control: To prepare and review the SOP. To follow the procedures laid down for operation, cleaning and calibration of Friability Test Apparatus as per this SOP.
• Quality Assurance Department: To review and approve the SOP and Annexures.

 

4. Accountability:

Head Quality Control Department, Head Quality Assurance Department

 

5. Procedure:

5.1	Safety Precautions/Instructions:
5.1.1	Ensure all the electrical connections are properly earthed. Ensure the power plug of the Friability Test Apparatus is fixed in the socket properly.
5.1.2	Wear personal protective equipment’s 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 Friability Test Apparatus.
5.1.4	For safety reasons and to ensure sufficient cooling in the electronic compartment, the side walls of the instrument must be kept at least 30cm away from the walls or other objects.
5.1.5	No containers, chemicals or other appliances should be placed behind the instrument.
5.2	Front Panel-Keyboard:
5.2.1	Introduction to the Keys of Tablet Friability Tester:
5.2.2	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.
5.2.3	Right hand side keys are functional keys as follows:
5.2.4	RESET- To Reset instrument.
5.2.5	BACK- To go backward for previous function display screen.
5.2.6	ESCAPE- To go back to main menu.
5.2.7	ENTER-To acknowledge the entered value.
5.2.8	START- To start the program.
5.2.9	STOP-To stop the run program.
5.3	Operation  of Tablet  Friability 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 Friability tester.
5.3.5	Allow 15 minutes warm up time before operation of Tablet Friability tester.
5.3.6	After instrument is powered “ON”. Press the “RESET” key,it gets initialized and the 2 line LCD display will read as follows.
5.3.7	Press “ENTER” key to select main menu function.
5.3.8	The display shows: 1)Prog    2)Run   3)Print 4)Disp   5)Funct   6)Cfg
5.3.9	1)‘Prog’               : To Add(create)/edit, view, copy, delete Programs. 2)‘Run’                 :To Run the desired Program. 3)‘Print’                :To obtain a hard copy of Method,Result and Validation report. 4)‘Disp’                :To display the result. 5)‘Function’         :Toset Clock & Date.To perform Validation. 6)‘Configuration’:To select Drum,Weight transfer,Data transfer & Password entry.
	1)PROGRAM  ENTRY:
5.3.10	Select   ‘PROG’ from main menu option  by pressing ‘1’. press “ENTER” and the display shows 1)ADD      2)VIEW 3) COPY   4) DELETE
	1) Adding a New Program:
5.3.11	To ADD/Modify a new /existing program, press‘1’. press “ENTER” and it will Display: Login: 1)Admin   2)User
5.3.12	Password is in only numeric form, Entry required is minimum 4 digit And maximum 8 digit.
5.3.13	For User password Press‘2’ and  “ENTER” and thedisplay will show: Enter User Password ————
5.3.14	Enter password  required and press “ENTER” and The display reads  : Enter User Password- xxxx
5.3.15	To create program no.1 press‘1’and press  “ENTER” and  the instrument will display as: Prog No(1-20): 1 ADD/EDIT Mode
5.3.16	Press “ENTER” and the display will read : Sample Name:___________
5.3.17	Use Alphanumeric Keys to Enter Sample Name.
5.3.18	Press “ENTER” and the display will read : Mode: _ 1>Time    2>Count
	To select Time Mode:
5.3.19	Press “1” and “ENTER” and the display will display as : Time (00:01-99:00) 00:00 (hh:mm)
5.3.20	Select time and Press “ENTER”
	2) RUN Process :
	Note:Do not touch / hold the drum during Run process.
5.3.21	To Run the instrument, press ‘2’
5.3.22	Drum gets initialized,  and display  will read: Prog. No. (1-20) :__
5.3.23	Select Prog. No. and Press ‘ENTER’
	·     To Run in Single Drum:
5.3.24	Press‘1’and ‘ENTER’ and the display shows: Identification No. 1: _
5.3.25	Enter ID No. by using alphanumeric Key( Maximum 10 digit).
5.3.26	Press “ENTER” and the display will read as: Initialized to home Load Sample 1 & Enter
5.3.27	Dedust the tablets carefully and weigh accurately the required number of tablets as per standard testing procedure on the balance and note down the weight.
5.3.28	Put the Tablets in drum, Press “ENTER” and the display will read as: Initial Wt.1 (gms) :__
5.3.29	Enter Wt. of Tablets by using alphanumeric Key.
5.3.30	If the Mode is ‘Time Mode’ Press “ENTER” and the display shows, Running Prg : 1 00:00:00
5.3.31	If the Mode is ‘Count Mode’ Press “ENTER” and the display shows, Running Prg : 2 Count: _
5.3.32	Tablet Dropped Final Wt.1 (gms) :__ After end of the run, instrument will rotate the drum in reverse direction and the display will read: Tablet Dropped Final Wt.1 (gms) :
5.3.33	Enter Tablet Final Wt. by using alphanumeric Key.
5.3.34	Press “ENTER” and the display shows: % Loss 1 =
	·     To Run in Dual Drum:
5.3.35	Press‘1’and ‘ENTER’ and the display shows: Identification No. 1:_
5.3.36	Enter ID No. for Drum 1.by using alphanumeric Key( Maximum 10 digit).
5.3.37	Press ‘ENTER’ and the display shows: Identification No. 2:_
5.3.38	Enter ID No. for Drum 2, by using alphanumeric Key( Maximum 10 digit).
5.3.39	Press “ENTER” and the display will read as: Initialized to home Load Sample 1 & Enter
5.3.40	Put the Tablets in drum 1, Press “ENTER” and the display will read as: Initial Wt.1 (gms) :__
5.3.41	Enter initial Tablets Wt. of Drum 1,by using alphanumeric Key.
5.3.42	Press “ENTER” and the display will read as: Initialized to home Load Sample 2 & Enter
5.3.43	Put the Tablets in drum 2, Press “ENTER” and the display will read as: Initial Wt.2 (gms) :__
5.3.44	Enter initial Tablets Wt. of Drum 2, by using alphanumeric Key.
5.3.45	If the Mode is ‘Time Mode’ Press “ENTER” and the display shows, Running Prg : 1 00:00:00
5.3.46	If the Mode is ‘Count Mode’ Press “ENTER” and the display shows, Running Prg : 2 Count: _
5.3.47	Tablet Dropped Final Wt.1 (gms) :__ After end of the run, instrument will rotate the drum in reverse direction and the display will read: Tablet Dropped Final Wt.1 (gms) :
5.3.48	Take the Wt. Of Tablets from tray 1 & Enter the Wt. And  Press “ENTER” and the display will read as: Final Wt.2 (gms) :__
5.3.49	Take the Wt. Of Tablets from tray 2 & Enter the Wt. And  Press “ENTER” and the display will read as: % Loss 1= % Loss 2=
5.3.50	Press “ENTER” and the display will read as: % Loss 1= % Loss 2=
	To perform ‘START’/‘STOP’ Key function:
5.3.51	Press ‘START’ Key,Drum will get initialised to home position and the display will read as: Initialized to home Load Sample  & Enter
5.3.52	Take the Wt. and Load  Tablet,Press “ENTER” and the display will show: Time :00:00:00       Count:XYZ
5.3.53	To STOP the Run, press “STOP” and the display will show: Tablets Dropped   Wait……
5.3.54	Take the Wt. of Tablets from tray & dothe calculation manually.
	Note: In START’/‘STOP’ Key function Print option is not available.
	1) Run data is available during power failure / interruption. Instrument will restart automatically.
	·     For Count Mode:
5.3.55	Continue Run 1)Y 2)N From‘X’ Count Display will show:
5.3.56	1 Count ‘X’ To Continue Run, press ‘1’ and it will display:
5.3.57	Tablet dropped To discontinue Run, press ‘2’ and it will display:
	·     For Time Mode:
5.3.58	Display will show: Continue Run 1)Y 2)N From‘00:XY:XY’
5.3.59	To Continue Run, press ‘1’ and it will display: 1 ‘00:XY:XY’
5.3.60	To discontinue Run, press ‘2’ and it will display: Tablet dropped
5.3.61	After few Seconds display reads, 1)Prg.    2)Run    3)Prn 4)Disp   5)Funct  6)Cfg
	2) If Run data is interrupted by pressing ‘ESC’ Key.
5.3.62	Display will show: 1)Prg.    2)Run    3)Prn 4)Disp   5)Funct  6)Cfg
	·     For Count Mode:
5.3.63	Continue Run 1)Y 2)N From‘X’ Count To Continue Run, press ‘2’ and it will display:
5.3.64	1 Count ‘X’ To Continue Run, press ‘1’ and it will display:
5.3.65	Tablet dropped To discontinue Run, press ‘2’ and it will display:
	·     For Time Mode:
5.3.66	To Continue Run, press ‘2’ and it will display: Continue Run 1)Y 2)N From‘00:XY:XY’
5.3.67	To Continue Run, press ‘1’ and it will display: 1 ‘00:XY:XY’
5.3.68	To discontinue Run, press ‘2’ and it will display: Tablet dropped
5.3.69	After few Seconds display reads, 1)Prg.    2)Run    3)Prn 4)Disp   5)Funct  6)Cfg
	3)  PRINT :
5.3.70	Select Print option from main menu by pressing ‘3’,to obtain a hard copy of Method, Result &Validation Report and the display will read as: 1) Program   2) Result 3) Validation Report
	2)To Print Result :
5.3.71	Press ‘2’and ‘ENTER’ and the display will read as: Printing….
	3)To Print Validation report
5.3.72	Press ‘3’and ‘ENTER’ and the display will read as: Printing…..
	4)  DISPLAY:
5.3.73	% Loss 1 = To Display result for single Drum , press ‘4’ from Main Menu option and the instrument will display:

 

5.3.74		% Loss 1 = % Loss 2 = To Display result for Dual Drum , press ‘4’ from Main Menu option and the instrument will display:
5.3.75		Enter 25 Counts and Press ‘ENTER’, After complition 25 count and display will show:  Counts1:25 RPM:_
5.3.76		Similarly for 50 Counts,75 Counts,100 Counts and 125 Counts, same procedure to be followed for Validation.
5.3.77		Instrument can do validation with 5 different counts OR to discontinue press ‘ESC’ Key
5.4	Calibration Procedure:
	Frequency:Every Quarterly or after carrying out any major maintenance work.
5.4.1	Generate the A.R.No. on the “Instrument/Equipment Calibration Register” as per SOP and give requisition to QA Department for calibration formats of instruments on the due date of calibration.
5.4.2	For issuance of calibration report refer SOP “Control of documents, Preparation, Approval, Issuance and Maintenance.
5.4.3	Check the number of Countscompleted on the display. For operation of stop watch refer SOP “Operation of Stop watch”. Note: Start the stop watch and cycle at once.
5.4.4	Perform the calibration of instrument as per Annexure and procedure mentioned below.
5.4.5	Switch ON the mains of FriabilityTestapparatus.
5.4.6	Select ‘Function’ from Main Menu option by pressing ‘5’ and the display will read as: 1)Clock   2)Validation
5.4.7	Login: 1)Admin  2)User Press ‘2’and the display will read as:
5.4.8	Enter User Password xxxxx To enter User password, press ‘2’and Enter Password (Minimum 4 digit & Maximum 8 digit) the display will read as: Enter User Password- xxxxx
5.4.9	Calibration parameters are as follows: 1) 25 Counts 2) 50 Counts 3) 75 Counts 4) 100 Counts 5) 125 Counts
5.4.10	Enter Counts1:_ (10-999) Press ‘ENTER’,Drums moves to count position and the display will read as:
5.4.11	Set the 25 Counts andPress ‘ENTER’, After completion 25 count and display will show:  Counts 1:25 RPM:_
5.4.12	Note down the Rotation by Tachometer and time by using Calibrated Stop watch.
5.4.13	After completion of Counts, stop the Stop Watch; Check the time taken to complete Entered Counts.
5.4.14	Same procedure to be followed  For 50 Counts,75 Counts,100 Counts and 125 Countsfrom point no. 5.4.10 to 5.4.13
5.4.15	Enter the details in calibration report.Ensure that the results obtained, comply with the acceptance criteria.
5.4.16	Update the “Instrument/Equipment Usage Log Book”,“Annual Calibration Schedule” and “Monthly Calibration Schedule” as per SOP “Calibration of Instruments and Equipments”.
5.4.17	Up to datethe “Calibration Status” on the Instrument as per SOP “Calibration of Instruments and Equipments”.
5.4.18	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	Clean the drums with soft brush or free nylon cloth before and after completion of the test.
5.5.6	If any breakdown occurs, follow procedure as per SOP “Calibration of Instruments and Equipments”.

 

6. Definitions/Abbreviations:

• Definitions:
• Breakdown: Any activity leading to operation of instrument other than the set parameters and/ or unusual sound or vibration observed in the instrument.
• Calibration: Tests performed to ensure that the instrument is functioning as per set parameters. These tests are performed as per predefined frequency and also after any major repair or replacement of parts.
• Friability test: It is designed to evaluate the ability of the tablet to withstand abrasion in packaging, handling and shipping.

 

• Abbreviations:

Abbreviation	Expansion
SOP	Standard Operating Procedure
QC	Quality Control
QA	Quality Assurance
±	Plus or Minus
No.	Number

 

Calibration Report

Sr. No.	Parameters	Acceptance Criteria	Observed counts	Acceptance Criteria	Observed Times(sec)	Complies / Does Not Complies
1.	25 Counts	25 ± 1		60±2 sec
2.	50 Counts	50 ± 2		120 ± 4 sec
3.	75 Counts	75 ± 3		180 ± 6 sec
4.	100 Counts	100 ± 4		240 ± 8 sec
5.	125 Counts	125±5		300±10 sec

 

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.