This
document details the procedure for the operation and calibration of the
disintegration tester apparatus to the intended users or concerned
personnel.
It
is the policy of XYZ Pharmaceuticals Limited that a written procedure shall be
followed for the operation and calibration of the disintegration tester
apparatus.
This
SOP is applicable at the time of the operation and calibration of the
disintegration tester apparatus.
RESPONSIBILITY AND ACCOUNTABILITY
Persons
along with their responsibilities and accountability are given below:
Executive
- Corporate Quality Assurance:- To prepare the SOP. Maintain the record as per
SOP.
Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To
follow the SOP accordingly
Manager - Quality Assurance:- To ensure
implementation of SOP.
PROCEDURE
GENERAL INSTRUCTION
Clean
the instrument with a clean and dry cloth. If required use the wet cloth
followed by a dry cloth.
5.1.2 Check the cleanliness of the instrument, disks, and glass beakers.
5.1.3 Connect the instrument with the main power supply (if not connected) and heater
connector and external probe into their respective sockets provided at the rear
side of the instrument.
Fill
water in the beakers in such a way that the wire mesh at its highest point is
at least 25mm below the surface of the medium, and its lowest point is at least
25mm above the bottom of the beaker.
The
instrument shall be calibrated for temperature, number of oscillations per
minute, timer, and the highest elevation of the shaft holding the basket
assembly.
The
frequency of calibration shall be done on a quarterly basis and after
maintenance (breakdown) of the instrument.
5.2 SYSTEM
SET UP AND PRECAUTIONS
5.2.1 Fill water in the tank up to the marked level (without the beakers) and place
the borosil beaker.
5.2.2 Connect the heater wire and external probe (if not connected) in the socket
provided at the rear right-hand side.
5.2.3 Connect the main cord to a 230 V A.C. socket.
5.2.4 Do not put the mains `ON’ if there is no water in the tank up to the marked
level or if the tank is
empty.
5.2.5 Ensure that the heater connector is not loosely connected.
While
engaging or disengaging the basket assembly, do not apply excessive force.
Disintegration test apparatus uses
Switch
“ON” the mains of the instrument and the power switch “ON” the instrument
(provided at the rear right-hand side) after ensuring that the instrument set
up is OK.
Place
two 1000 ml beakers containing the suitable liquid medium in the space provided
on the beaker stand. Adjust the volume of the liquid in the beaker such
that the wire mesh of the basket is at the highest point is at least 25 mm
below the surface of the liquid.
5.3.3 Place the external probe in the slot provided in anyone of the basket
assemblies.
5.3.4 Follow this procedure to set the temperature of the water bath:
5.3.4.1
Press the “SET”
key: The LED to the
right of the key lights up.
5.3.4.2
Press the “TEMP” key: The temperature display shows the previous set temperature and the digit at the extreme
right flashes.
5.3.4.3
Press the D
key: With every
keypress, the flashing digit can be increased serially.
5.3.4.4
Press Ñ key: With every keypress, the flashing digit can be decreased serially.
5.3.4.5
Press the “DISP SEL”
key: With every
keypress, the required digit of the display can be selected (which is observed
as a flashing digit).
5.3.4.6
Using the D and Ñ keys set the
temperature to about 38°C. (This will ensure a temperature of 37°C within the
beakers).
5.3.4.7
Press the “ENTER” key: Set LED goes off and the set value is accepted.
[Note:
Be sure to press “Enter” to accept the displayed value during the set
procedure]
5.3.5 Now the display shows the temperature which is indicated by the LED i.e. BATH
or EXT. By using the “PROBE” key, select the display to indicate SEL
either the bath temperature or the beaker temperature.
5.3.6 Press the “TEMP” key to start the temperature controller. The LED above the temperature key will glow.
5.3.7 Follow this procedure to set the timer. There are two modes of
operation Timer mode and Manual mode.
5.3.7.1
In the Timer mode, the motor will stop automatically after the elapse of the
set time and gives an alarm for 10 seconds.
5.3.7.2
In the manual mode, the instrument will not give a time indication and the
motor will continue running till it is stopped manually.
5.3.8 Select the required mode by pressing the “TIMER” key.
If
the timer LED is `ON’, you are in timer mode.
If
the timer LED is `OFF’ and the timer display shows ---- then you are in the
manual mode.
5.3.9 In the timer mode, two-timer ranges are possible.
Display
indicates ...... mins. ...... sec.
5.3.10
For changing the range of the timer, press the SET key and then press ENTER
key. The change in range is indicated by the shifting decimal point.
5.3.11
Now program the set time (i.e. the total duration of the TESTER) as follows:
5.3.11.1
Press “SET” key: SET LED lights up
5.3.11.2
Press the “TIMER” key: The timer display shows the previous set value and the
digit at the extreme right flashes.
5.3.11.3 Press D and Ñ key to set the desired
value.
5.3.11.4 Press
the “DISP SEL” key to display the required digit of the timer.
5.3.11.5
Follow steps 3.3.11.3 and 3.3.11.4 until the desired value is set.
5.3.12
Press “ENTER” to accept the set value.
The display shows the present set tone Set LED goes OFF
5.3.13 Check whether the liquid medium in the beakers has attained 37°C. Place
the tablets/capsules in the basket assembly with or without the discs as per
the requirement and engage the assembly by gently pressing and hooking it onto
the arm.
Start
the TESTER using the START / STOP key.
The
display shows time elapsed starting from 00.00 mins. In the timer mode,
the instrument stops after the set time has elapsed. Alternatively, you
can stop the TESTER by pressing START / STOP before completion of the set time.
5.3.14 Pause the TESTER (i.e. time will not be accounted in the timer) by pressing the
TIMER key after starting the TESTER.
Timer
LED flashes the time at which you halted. Press the TIMER key again to resume
the TESTER.
5.3.15
If the power fails for less than 1 min, then when power resumes the instrument
will continue from the last time value.
5.3.16
The instrument will not start the TESTER if the temperature is not reached or
if it is above 0.4°C of the set value. It will display ... rd in this
condition.
5.3.17
The instrument gives an alarm during the TESTER if the temperature of the bath
overshoots above 0.4°C or undershoots below 0.4°C of the set value.
5.3.18
Switch “OFF” the mains of the instrument and main power supply whenever not
required
5.3.19
Daily Record shall be maintained as per XYZ/CQA/SOP-055/FR-01, Logbook for
Disintegration Tester Apparatus (Appendix
I)
5.4 CLEANING PROCEDURE
5.4.1 Disconnect the instrument from the main power supply before the cleaning of the
instrument started.
5.4.2 Clean the instrument, disks, and basket assembly after the completion of the
TESTER firstly with tap water followed by distilled water. If required, use the
Isopropyl alcohol and water in the ratio 50: 50 to clean the basket assembly
Ensure
that the basket assembly should be properly clean.
6.0 Calibration of Disintegration tester Apparatus
TEMPERATURE CALIBRATION
Set
the temperature of 37.5°C of the water tank and allow attaining the set
temperature.
Insert
the calibrated thermometer in the water bath and observed the reading on a
display unit and calibrated thermometer.
Record the observed temperature as per XYZ/CQA/SOP-055/FR-02, Calibration Data Sheet Appendix II
Acceptance Criteria:
The
observed temperature in each beaker should be in the range of 36.5 ˚C to
37.5˚C.
Number
of cycle calibration
Operate
the equipment and check the number of cycles of up and down of the basket
assembly per minute using a calibrated stopwatch.
Repeat
step no. 6.2.1 for another basket.
Repeat
the same procedure twice for each basket.
Record
the observations as per XYZ/CQA/SOP-057/FR-02, Calibration Data Sheet Appendix
II (Page No. 2 of 4).
Acceptance
Criteria:
The
number of cycles per minute should be within the limit of 29 to 32.
Timer
Calibration
Set
the timer for 1 minute (60 Sec) and start the instrument and calibrate the
stopwatch simultaneously.
After
one minute is over in stopwatch stop the instrument and stopwatch at once and
take the reading of stopwatch and display unit.
Repeat
step no. 6.3.1 and 6.3.2 for 3 minutes (180 Sec) and 5 minutes (300 Sec).
Record
the observations as per XYZ/CQA/SOP-055/FR-02, Calibration Data Sheet Appendix
II (Page No. 3 of 4).
Acceptance
Criteria:
Time
should be within 60 ± 02 Sec, 180 ± 05 Sec, 300 ± 05 Sec both the timer and
display unit.
Stroke
Height Calibration
Place
the calibrated scale parallel and vertical to the basket assembly. Operate the
instrument manually and check the highest elevation of the shaft manually and
record the observation as per XYZ/CQA/SOP-055/FR-02, Calibration Data Sheet
Appendix II (Page No. 4 of 4).
Acceptance
Criteria:
The
stroke height should be 53 to 57mm.
6.5 After the calibration of the instrument, affix the calibration status tag on
the instrument and fill in all the required details.
6.6 Summarize all the calibration data as per XYZ/CQA/SOP-055/FR-03, Summary Sheet
(Appendix III)
6.7 Report any discrepancy observed during calibration of instrument to Manager
Technical Quality Control or his authorized representative for corrective and
preventive action.
6.8 Manager Technical Quality Control or his authorized representative will report
the same to Manager-Quality Assurance and notify the defect to Engineering
Department service engineer to rectify the defect. Affix ‘Out of Order’ label
on the instrument as per SOP No. XYZ/CQA/SOP-006, Labelling Policy.
7.0 GENERATION OF INSTRUMENT CALIBRATION NUMBER
Generate
the instrument calibration number on the calibration data sheet as
INSCALXXYYZZZ where INS denotes instrument, CAL denotes calibration, XX denotes
the year, YY denotes month and ZZZ denotes sequence number.
