SOP for Operation of Dissolution Test Apparatus (Make: LAB INDIA)

OBJECTIVE

The purpose of this SOP is to lay down a procedure for the Operation of Dissolution Test Apparatus.

SCOPE

This SOP is applicable for the operation of Dissolution Test Apparatus of Make: LABINDIA, Model No: DS8000 & Model No: DS14000 installed at the Quality Control Laboratory of PharmaInfo Ltd.

RESPONSIBILITY

The analyst / Section Head or his designee shall be responsible for following the SOP.

The Head of the Quality Department or his designee shall be responsible for and implementation of the SOP.

PROCEDURE

Preliminary Checks

• Check and ensure that the equipment is clean, and dust-free from dust. If not, clean the instrument using a lint-free cloth.
• Check that the instrument is connected to a 230-volt stabilized power supply.

Basic Operation

• Connect the mains to the 230 V/AC socket.
• Switch on the power.
• Open the screw of the assembly and put purified water into the vessel to clean the vessel to avoid contamination before the filtration of the mobile phase.
• Ensure that there is no leakage of water.
• The system check starts, after which four parameters will be displayed:

1. Prg      2. Run      3. Prn      4. Func

• Press 1, 2, 3, or 4 whichever is applicable.
• Key ‘1’ – Prg: Program
• On pressing the key ‘1’ for a program, the following details will be displayed on the screen:

1. Add      2. View      3. Copy      4. Delete

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To add a program, ‘1’ and then press ‘Enter’. The system asks for the password. Key in the password and then press ‘Enter.

• Prog. No. (1-15): will be displayed. Key in the program number that is to be added or edited and press ‘Enter’.
• Sample name (max. 20 characters): will be displayed. Key in ‘1’ for a basket and ‘2’ for a paddle and press ‘Enter’.
• USP App: 1. Basket (1) 2. Paddle (II) will be displayed. Key in ‘1’ or ‘2’ for paddle and press ‘Enter’.
• Stirrer Depth: 1.25 mm 2. 40mm’ will be displayed. Key in either ‘1’ or ‘2’, whichever is applicable, and then press ‘Enter’.
• Buffer Volume (500-1000 ml): will be displayed. Key in the volume of the buffer and press 'Enter’.
• Bowl temperature (30-40℃): will be displayed. Key in the relevant temperature and press ‘Enter’.
• Set Bath temperature: will now be displayed. Key in the set temperature as per the specification and press ‘Enter’.
• Set RPM (20-200): will be displayed RPM and press ‘enter’.
• Sampling Mode: Manual: Samplings 1. Fixed 2. Prog. Will be displayed. 

For a fixed number of samplings, key in ‘1’ and press ‘Enter’

1. Total No. Of intervals (1 - 30): will be displayed. Key in the number of intervals after which the sample is to be collected and press ‘Enter’.
2. Intv. (00:01 - 24.00): will be displayed. Key in the time in the minutes for each interval (i.e., 00.30 for 30 minutes and 01:00 for 1 hour, etc.) and press ‘Enter’.
3. Process Time (Hr: Mn): will be displayed. Key in the time and press ‘Enter’.
4. Wavelength: will be displayed. Key in the required wavelength and press ‘Enter’.

For variable sampling, key in ‘2’ and press ‘Enter’

1. Total No. of samplings (1 - 30): will be displayed. Key in the number of samples and press ‘Enter’.
2. Buffer change req.?: 1. Y 2. N. Key in ‘1’ for yes and ‘2’ for no. Press ‘Enter’. If ‘1’ is keyed in, ‘Buffer Change after smpl no.:’ will be displayed. Key in the number of samples after which buffer change is required and press ‘Enter’.
3. Smpl 1 (00:01-720.00): will now be displayed. Key in the time (in hours and minutes) after which the sample is to be taken (i.e., 00:30 for 30 minutes or 00:10 for 10 minutes)

• Press ‘Back’ to go back to the original menu.
• To view an exciting program, press ‘2’ and then press ‘Enter’.
• Prog. No. (1-15) will be displayed. Key in the program number to be viewed (i.e., 1 or 2 or 3…) and press ‘Enter’. All details of that particular program will be displayed.
• To copy a program, press ‘3’. ‘Source program to copy from:’ will be displayed. Key in a number of the program whose details are to be copied and press Enter. 
• Destn. Program to copy to: will be displayed. Key in the program number where details are to be copied and press ‘Enter’.
• To delete a program, press ‘4’. The system asks for the password. Key in the relevant password and press ‘Enter’. ‘Delete 1. Select Prg. 2. All Prg.:’ will be displayed. To delete a selected program, key in ‘1’ and then press ‘Enter’. To delete all programs, key in ‘2’, and then press ‘enter’. To quit, Press ‘Escape’.
• To go back to the original menu, press ‘Back,
• Key ‘2’- Run

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• On pressing the key ‘2’ to run a ‘program no’: will be displayed on the screen. Key in the program number that is to be run and press ‘Enter’.
• Run 2. View:, will appear on the screen.
• To run an existing program, key in ‘1’. The system asks for the identification number, key in the number, and press ‘Enter’. The bowl temperature, set RPM, bath temperature, and depth will appear on the screen after the set temperature has been achieved, press the ‘RUN’ key to start the dissolution process.
• To view an existing program, key in ‘2’ Details of the program will be displayed.
• Key ‘3’- Prn: print
• On pressing the key ‘3’ for print, ‘1. Run Rep. 2. Prg. Para. 3. Validation Rep. Will be displayed.
• Key in ‘1’ to print the report of a program that was run. Key in ‘2’ to print the parameters of a program and key in ‘3’ to print a validation report. After keying in the relevant number, press ‘Enter’.
• Key ‘4’- Fune: Function
• On pressing the key ‘4’ for function, ‘1. Clk 2. Wake up to 3. Configure 4. Validate’ will be displayed.

• On pressing ‘1’ the system asks for the date and time. Key in the relevant information and press ‘Enter’.
• On pressing ‘2’ set wake-up alarm, will be displayed. Key in the date and time to set an alarm and then press ‘Enter’.
• On pressing ‘3’ 1. Password 2. Printer’’ will be displayed. To change an existing password, press ‘1’ and then ‘Enter’. To view details of the printer, press ‘2’.
• On pressing ‘4’ the system asks for the password. Key in the password and press ‘Enter’. 1. Temp. 2. RPM’ will be displayed. Press ‘1’ to set the temperature condition and ‘2’ to set the RPM.
• Press ‘Back’ key to go to the original menu.
• Place the Merlon jars in the flanges provided on the tanks and fit it with the known volume of the dissolution medium as given in the individual standard test procedure.
• Fix all the stirrer paddles very carefully.
• Lower the stirrer paddles by pressing the”▼” key.
• After the set temperature has been attained, add the sample to each jar through the outlet provided at the top and start the operation by pressing the ‘RUN’ key.
• After completion of the set time, the instrument gives out an alarm.
• Withdraw a sample from a zone midway between the surface of the dissolution medium and the top of the routing basket or paddle, not less than 1 cm from the vessel wall.
• Clean the vessels, and paddles/baskets, and switch off the instrument after every use.
• Fill in the instrument usage log whenever the instrument is used.

ANNEXURE

Nil

ABBREVIATIONS

QC: Quality Control

REVISION HISTORY

Nil

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