Semi Automatic Disintegration Tester , Purpose:
Semi Automatic Disintegration Tester , The purpose of this SOP (Standard Operating Procedure) is to describe the operation, calibration and cleaning of Disintegration tester.
Semi Automatic Disintegration Tester , Scope:
This procedure is applicable for Semi Automatic Disintegration tester (Electrolab, Model: ED-2 SAPO) at the Product Development area of XX Pharmaceuticals Limited. This procedure is applicable for Core, Uncoated, Coated tablets and capsules.
Definitions / Abbreviation:
Disintegration Test: The disintegration test is a measure of the time required under a given set of conditions for a group of tablets, Capsule and Other solid dosage forms to disintegrate into particles which will pass through a 10 mesh screen.
Responsibilities:
[][]The roles and responsibility is as follows
Executive, Product Development
[][]To follow the procedure as per SOP.
[][]To maintain the Calibration records.
[][]To ensure cleaning of Disintegration tester maintaining safety rules.
Manager, Quality Assurance
[][]To ensure training and implementation of SOP in department.
Procedure:
Precaution:
[][]Do not switch on the mains if water in the tank is not up to mark.
[][]While placing and removing the basket assemblies do not apply excessive force.
[][]Do not bend the heater while cleaning the water bath.
[][]Do not clean the bath with any strong solvent. Use mild detergents for cleaning.
[][]Lift the machine from the base while lifting or installing.
[][]The external probe should be handled carefully.
[][]To prevent algae propagation in the bath replaces water in the bath at least once in a week.
[][]Remove the external probes when baskets are parked out or removed.
[][]Switch OFF the power supply of the instrument before removing water from the bath.
[][]Do not hold the stirrer while in operation.
Operation: Semi Automatic Disintegration Tester
[][]Ensure the cleanliness of area and the instrument.
[][]Fill the bath with purified water up-to the graduated mark.
[][]Connect the power cord of the instrument to the main power supply.
[][]Check the calibration status of the instrument
[][]Insert the test vessel (jar) in the water bath. Fill the test vessels with purified water / desired media up to 800 ml.
[][]Turn on the power switch provided on the rear side of disintegration tester.
[][]After power on, the instrument will initialize by displaying a power flash screen which will flash twice
DISINTEGRATION
TESTER
ED2-SAPO
VER-1.1
[][]After the power flash screen an idle will be displayed showing the last Mode. Protocol selected for basket A and basket B and the temperature of Jar A, Jar B, and Bath temperature.
Mode: Dual Timer
Proto A: # # Proto B: # #
BATH/ Jar A/ Jar B
# #. /ºC # #. /ºC # #. º
[][]Selection of Registration Mode (For Unknown Disintegration time)
[][]There are two modes: Registration Mode & Dual Timer Mode. Select Registration mode with or keys
Mode: Registration
Proto A: # # Proto B: # #
BATH/ Jar A/ Jar B
# #. /ºC # #. /ºC # #. ºC
[][]Press TEMP key from the front panel a screen will be displayed. Using // key set the temperature to 37.7ºC.
[][]Press TEMP key from the front panel a screen will be displayed. Using // key set the temperature to 37.7ºC.
[][]Press F1 to switch ON the heater. Press TEMP key to register the temperature and come out of the TEMP mode. An idle screen will be displayed. Wait to raise the bath and the jar temperature to desired level.
[][]Assemble the basket-rack.
Operation in Registration Mode
[][]Place six test samples in six tubes. Place the disks if stated in the monographs or in the case of floating products / tablets. Place the disk guides properly to prevent floating of samples.
[][]Press RUN/ HALT key of the respective A or B Jar to run the operation. In Registration mode two separate samples can be tested in two separate jars simultaneously.
[][]Observe the test in each of the tube. If the sample in any of the tube is disintegrated completely just press the key of the respective number. For example if the sample in the number 4 tube of Basket A is disintegrated at first press the number 4 key. Same procedure is followed for all the tubes of each basket.
[][]When Disintegration Time of 6 tablets in one Jar is registered the basket will park out of the media automatically. Press ENTER to return to initial screen.
[][]Observe the disintegration time. To see the time press TIME key. Press F1 to scroll to View Timing mode. Press ENTER. The screen will show the disintegration time of all the six samples. Press F1 key to scroll the screen downward.
[][]To come back into idle screen press ENTER key and press F2 key.
Selection of Dual Timer Mode (For Known Disintegration Time)
[][]When we know the disintegration time of any sample the operation can be done in DUAL TIMER MODE. In this mode there are 10 protocols. An individual sample with its known disintegration time is assigned against each protocol. Select Dual Timer Mode using UP or DOWN keys.
[][]Press TEMP key from the front panel a screen will be displayed. Using BACWARD/UP /DOWN key set the temperature to 37.7ºC.
[][]Press F1 to switch ON the heater. Press TEMP key to register the temperature and come out of the TEMP mode. An idle screen will be displayed. Wait to raise the bath and the jar temperature to desired level.
[][]Press TIME key from the front panel to set the time of a protocol.
[][]When (ARROW) indicates SET TIMER press ENTER button. Using BACWARD/UP /DOWN key adjust the required protocol and time. Press ENTER button to register the time and protocol and come out of the screen.
[][]Press F2 and return to the idle screen.
[][]Assemble the basket-rack.
Operation in Dual Timer Mode
[][]By using BACWARD/UP /DOWN key select different protocols for either jar A or jar B.
[][]Place six test samples in six tubes. Place the disks if stated in the monographs or in the case of floating products / tablets. Place the disk guides properly to prevent floating of samples / disks.
[][]Press RUN/ HALT key of the respective A or B Jar to run the operation.
[][]When the set Time for respective Jar is end up, the basket will park out of the media automatically. Press ENTER to return to initial screen.
Halting / Aborting the Test
[][]Press Run / Halt key to the respective test to be halted.
[][]The respective basket will park out of the media and the display will show the elapse cumulative halt time of the test being halted.
[][]To continue or abort test press Run / Halt key again a screen will be displayed for resuming or aborting the test.
[][]To resume test Press F1.
[][]To abort the test press F2. Press ENTER.
Operation Log Book
[][]Record the information’s in the operational log book- “Operation Log Book of Disintegration Tester (MODEL: ED2-SAPO)”
[][]Calibration of Temperature for Jar A and Jar B
[][]Press TEMP key. Use ▲/◄/▼Key to set the temperature at 37ºC.
[][]Press F1 to switch on the heater. The temperature light will blink.
[][]Press TEMP key to register the temperature and come out of the TEMP mode. An idle screen will display. Wait to raise the temperature at 37.7ºC in the both jars.
[][]When the screen displays a fixed temperature for Jar A and Jar B from temperature sensor, measure the temperature of both Jars by a calibrated thermometer.
[][]Keep the records of calibration as per Annexure-I.
[][]Acceptance Range: ± 2ºC of the display temperature.
[][]Calibration of Timer for Basket-A
[][]Select the Dual Timer mode by pressing ▼/▲key.
[][]Use ◄ key to select Proto A.[START OF SECTION ONE]
[][]Press the option menu.
[][]Press F1 (scroll) key to select set protocol. Press Enter key.
[][]Press ▼/▲ key to set a specific protocol no. (e.g. 01, 02, 03 …) under Proto A.
[][]Press F1 (scroll) key to enter the Timer option.
[][]Set the timer (5 minutes) by using ▲/◄/▼key.
[][]Press F2 key twice to return to the idle screen.
[][]Press the Run key in the front panel and start the calibrated stop watch to compare the time.
[][]After completion of the specified time (5 minutes) ‘Test is over’ is appeared on the screen with beeping sound.
[][]Press Enter key to return to the idle screen.
[][]Keep the records of calibration as per Annexure-I.
[][]Acceptance Range: 5 minutes.[END OF SECTION ONE]
Calibration of Timer for Basket-B
[][]Use ◄ key to select Proto B.
[][]Follow previous steps [START OF SECTION ONE] TO [END OF SECTION ONE]
[][]Calibration of Stroke/min. for Basket-A
[][]Check the jar temperature. If temperature is not in the desired level, wait for raising the temperature (37.7°C) in the jar.
[][]Follow previous steps
[][]Press the RUN key and start the stop watch to count the no. of strokes per minute.
[][]Press the Halt key twice and then Test A is displayed.
[][]Press F2 to abort. The screen will display ‘Test is over’.
[][]Press Enter key to return to the idle screen.
[][]Keep the records of calibration as per Annexure-I.
[][]Acceptance Range: 29 to 32 Stroke/min.
[][]Calibration of Stroke/min. for Basket-B
[][]Follow previous steps(In case of Proto B, Use ◄ key to select Proto B).
[][]Calibration of Traveling Distance for Basket-A
[][]Follow previous steps
[][]Press Run key to travel the Basket A in upward and downward stroke.
[][]When the basket is in the downward stroke position, Press the power switch (Rear side of the instrument) to off quickly.
[][]Now Mark the position (Xa) of the basket holder by a pencil.
[][]Press the power switch on.
[][]Press the TEMP key.
[][]Press F1 to on the heater. The temperature light will blink.
[][]Press TEMP key to return to the idle screen position.
[][]Wait for the desired setting temperature (37°C). When it reaches to the desired level, Press the Run key. The basket will travel upward and downward stroke.
[][]When it comes to the upward stroke position, Press the power switch (Rear side of the instrument) to off quickly.
[][]Mark the position (Ya) of the basket holder by a pencil.
[][]Now measure the traveling distance between Xa and Ya by a standard certified scale.
Xa – Ya= ## mm.
[][]Keep the records of calibration as per Annexure-I.
[][]Acceptance Range: 55 ± 2 mm.
[][]Calibration of Traveling Distance for Basket-B
[][]Press the power switch (Rear side of the instrument) to on.
[][]Press the TEMP key. Use ▲/◄/▼key to set the temperature at 37ºC.
[][]Press F1 to switch on the heater. The temperature light will blink.
[][]Press TEMP key to return to the idle screen position.
[][]Wait for the desired setting temperature (37.7°C). When it reaches to the desired level Press the Option Key.
[][]Follow steps (In case of Proto B, Use ◄ key to select Proto B).
[][]Follow steps
Calibration of Basket A to Beaker Bottom Height
[][]Unscrew Basket A from the bottom and remove the basket bottom plate.
[][]Remove one tube (with Blue or Brown indication) and engage the basket to the basket holder.
[][]Insert the measuring scale (6 inch) into the disc from where the tubing has been removed. Care should be taken that the scale touches the bottom of the beaker.
[][]Press the power switch (Rear side of the instrument) to on.
[][]Press the TEMP key.
[][]Press F1 to on the heater. The temperature light will blink
[][]Press TEMP key to return to the idle screen position.
[][]Wait for the desired setting temperature (37°C). When it reaches to the desired level, Follow steps
[][]Press the Run key to travel the Basket A in upward and downward stroke.
[][]When the basket is in the downward stroke position, Press the power switch (Rear side of the instrument) to off quickly.
[][]Measure the Basket A to bottom height during the downward stroke by certified measuring scale.
[][]Keep the records of calibration as per Annexure-I.
[][]Acceptance Range: 25 ± 2 mm.
Calibration of Basket B to Beaker Bottom Height
[][]Follow steps
[][]Set the parts of the instrument and clean the instrument.
[][]Calibration Frequency: 3 months ± 10 days.
Cleaning
[][]After completion of a test clean the basket-rack assembly with potable water and if required with a mild detergent.
[][]Whenever required use a suitable brush to remove any residue of the previous sample from the mesh screen.
[][]Use potable water to clean the jar and bath.
[][]Finally rinse the basket rack assembly, jar & bath with purified water and dry in air.
[][]Cleaning frequency of basket rack assembly & jar : After every test
[][]Cleaning frequency of water bath: Once in a week.
Note: In between when water become dirty change water
[][]After cleaning of the disintegration test apparatus water bath, record it as per Annexure-III
Annexure: Semi Automatic Disintegration Tester
Annexure-I: Operation log book of Disintegration Tester(Model: ED2-SAPO)
Annexure –II: Calibration report of disintegration tester.
Annexure-III: Cleaning record for Disintegration water bath.