SOP Title: Operation, Cleaning and Calibration of Disintegration Tester

SOP Title: Operation, Cleaning and Calibration of Disintegration Tester

1. Objective:

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

 

2. Scope:

This SOP is applicable for Operation, Cleaning and Calibration of Disintegration 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 Disintegration 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 Disintegration Test Apparatus 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 Disintegration Test Apparatus.
5.2	Front Panel-Keyboard:
5.2.1            Introduction to the Keys of Disintegration 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 or initialize the Disintegration Tester.
5.2.5	BACK- To go backward for previous functional 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 program.
5.2.9	STOP-To stop the run program.
5.2.10	BASKET A-To store disintegration time for basket A.
5.2.11	BASKET B-   To store disintegration time for basket B.
5.3	Operation of Disintegration 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 Disintegration tester.
5.3.5	Allow 15 minutes warm up time before operation of Disintegration tester.
5.3.6	After instrument is powered “ON”. Press the “RESET” key and the 2 line LCD display will read as follows.
5.3.7	Press “ENTER” key to select main menu function.
5.3.8	1)Prog    2)Run   3)Print 4)Disp   5)Other    25.0 The display shows:
	Main Menu Function  as Follows:
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 Program, Result and  Validation  report. 4) ‘Disp’                  :To display the result. 5) ‘Other’                : a) ‘Function’          :To set Clock & Date. To perform Validation. b) ‘Configuration’:To select Data transfer & to set password.
5.3.51	2)  RUN  Process :
5.3.52	To perform Disintegration Test, press ‘2’ from Main Menu  and display  will read: Prog. No. (1-20) : RUN Mode
5.3.53	Select Prog. No. and Press ‘1’and ‘ENTER’ and the display reads: Beaker Selection :           1)A    2)B   3)Both
5.3.54	To Select Beaker A, press     1 ABC
5.3.55	To Select Beaker B, press     2 DEF
5.3.56	To Select Both Beaker , press     3 GHI
5.3.57	Press “ENTER” and the display will read as: Identification No. A: _
5.3.58	Enter ID No. of sample in Beaker ‘A’ by using alphanumeric Key.
5.3.59	Press “ENTER” and the display will read as: Identification No. B:_
5.3.60	Enter ID No. of sample in Beaker ‘B’ by using alphanumeric Key.
5.3.61	Press “ENTER” and the display will read as: Wait! Reading Temp.
5.3.62	The Basket Arms will start moving Up & Down. Once the media temperature in the beakers reaches expected temperature of media (±0.5°C), the buzzer starts giving beep sound indicating the system is ready and display reads: T(A)=36.9   T(B)=37.0 Bt=37.0       Enter/Esc
5.3.63	Note: T(A): Temperature Sensor 1 for Beaker A. T(B): Temperature Sensor 2 for Beaker B.
5.3.64	To start the Run Press “ENTER” and the display will read as: Initialized to home Load Sample & Enter
5.3.65	Insert the Sample Tablets in the Basket Tubes and load the Floating Discs, if noted in the monograph. After Pressing “ENTER”, The Basket Arms  will starts  moving Up & Down and the display will read as: 00.00.00     Bt = 38.0       01   T(A) =37.0       T(B) =37.0
	To perform ‘START’/‘STOP’ Key function:
5.3.66	Press ‘START’ and the display will read as: Media temp.(20-45):_______
5.3.67	Select 37°C by using Alphanumeric Keys ,Press ‘Enter’ and the display will read as: Bath temp. : ______ (37.0-50.0)
5.3.68	Select 38°C by using Alphanumeric Keys, Press ‘Enter’ and the display will read as: T(A)=36.9   T(B)=37.0 Bt=37.0       Enter/Esc   Wait! Reading Temp.
5.3.69	To Start the Run, Press ‘Enter’ and the display will read as: Initialised to Home Load Sample & Enter
5.3.70	Insert the Sample Tablets in the Basket Tubes and load the Floating Discs, if noted in the monograph and Press ‘Enter’ and the display will read as: 00.00.00   Bt =38.0 T(A)=37.0  T(B)=37.0
5.3.71	To Start the Run, Press ‘ENTER’ option.
	Note: In START’/‘STOP’ Key function Print option is not available.
	3)  PRINT :
5.3.72	Select Print option from main menu by pressing ‘3’, to Print Program, Result &Validation Report and the display will read as: 1) Program   2) Result 3) Validation Report
5.3.73	Press ‘2’and ‘ENTER’ and the display will read as: Printing…..
	2)To Print Result :
5.3.74	Press ‘2’and ‘ENTER’ and the display will read as: Printing….
5.3.75		Note: While Printing if printer is not ready, the display reads: Printer not Ready! 1) Continue   2)Quit
5.3.76		To continue the printing, Press ‘1’and to discontinue the Run, Press ‘2’
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		Perform the calibration of instrument as per Annexure and procedure mentioned below.
5.4.4		Calibration parameters are as follows: 1) Distance travelled by the basket per minute 2) Temperature 3) Number of cycles  of basket A and  basket B per minute 4) Integrity of mesh. 5) Timer check
		1) Distance travelled by the basket per minute
5.4.5		Verify that both the baskets (Basket A and Basket B) are in their top position.
5.4.6		Mark the TOP position of both baskets on the body of Disintegration Test apparatus with temporary marking pen.
5.4.7		When the basket reaches to its lowest position, stop the cycle by pressing STOP key.
5.4.8		Mark the lowest position of both the basket near to the basket on body of Disintegration Test apparatus with temporary marking pen.
5.4.9		Determine the distance travelled by the basket between the lowest and the highest point of oscillations with the help of calibrated measuring scale.
5.4.10		Enter the details in calibration report. Ensure that the results obtained, comply with the acceptance criteria.
		2) Temperature of the fluid in the beaker
5.4.11		Switch on the Disintegration Test apparatus and the heater, and set the temperature for heating the fluid to 37°.
5.4.12		Check the temperature of the fluid in the beaker after 30 minutes.
5.4.13		Enter the details in calibration report. Ensure that the results obtained, comply with the acceptance criteria.
		3) No of cycles  of basket A and  basket B per minute
5.4.14		Set the time for 01:00 minute as per defined procedure.
5.4.15		Start the cycle of basket A by pressing START/STOP key. Count the cycle of the baskets for 01 minute.
5.4.16		Similarly for 02:00 minutes and 05:00 minutes, same procedure to be followed for basket B.
5.4.17		Enter the details in calibration report. Ensure that the results obtained, comply with the acceptance criteria.
		4) Integrity of mesh
5.4.18		By visual observation check the sieve integrity of both baskets.
5.4.19		Enter the details in calibration report. Ensure that the results obtained, comply with the acceptance criteria.
		5) Timer check
5.4.20		Set the timer to 10 minutes and check the set time using calibrated stop watch.
5.4.21		Similarly set the timer to 20 minutes and 30 minutes and check the set time using calibrated stop watch.
5.4.22		Enter the details in calibration report. Ensure that the results obtained, comply with the acceptance criteria.

 

5.4.23	Update the “Instrument/Equipment Usage Log Book” as per SOP “Calibration of Instruments and Equipments”.
5.4.24	Up to date “Calibration Status” on the Instrument as per SOP “Calibration of Instruments and Equipments”.
5.4.25	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 spills as soon as they occur.
5.5.3	The exterior surface can be cleaned with tepid water and soft cloth.
5.5.4	Clean the water bath once in a week, by removing water through tap attaching to instrument and fill purified water up to the marked water level.
5.5.5	To clean inside of the water bath, gently wipe with soft cloth.
5.5.6	Clean the basket in a beaker containing methanol water to remove it`s the deposition of items on mesh or on acrylic surfaces, glass tube &on top disc.
5.5.7	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.
• Disintegration Test: It is a measure of the time required under a given set of conditions for a group of tablets to disintegrate into particles which will pass through a 10 mesh screen.

 

• Abbreviations:

Abbreviation	Expansion
SOP	Standard Operating Procedure
QC	Quality Control
QA	Quality Assurance
±	Plus or Minus
No.	Number
v/v	Volume by volume
mm	millimetre
0.1M	0.1 Molar
°C	Degree
ml	Millilitre

 

                                          Calibration Report

Sr. No.	Parameters	Set value	Acceptance Criteria	Observed Values	Complies / Does Not Complies
1.	Distance travelled by the basket per minute	Basket  A (left side)	55 ± 2 mm
		Basket  B (right side)
2.	Temperature of the fluid in the beakers	Basket  A (left side)	37ºC ± 2ºC
		Basket  B (right side)
3.	No. of Cycles per min (Basket  A)	0th to 01st min	29 to 32 Cycles
		0th to 02nd min	58 to 64 Cycles
		0th to 05th min	145 to 160 Cycles
	No. of Cycles per min (Basket  B)	0th to 01st min	29 to 32 Cycles
		0th to 02nd min	58 to 64 Cycles
		0th to 05th min	145 to 160 Cycles
4.	Integrity of mesh	By visual observation check for damage	Mesh should not be damaged
5.	Timer Check	10 Minutes	9 Min. 30 Sec.  to  10 Min. 30 sec.
		20 Minutes	19 Min. 30 Sec. to  20 Min. 30 sec.
		30 Minutes	29 Min. 30 Sec. to  30 Min. 30 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.