SOP for Melting Point Apparatus : Pharmaceutical Guidelines

SOP for Melting Point Apparatus

Standard operating procedure of Melting Point Apparatus used to detect the melting point of powders.

1.0 OBJECTIVE

To describe the procedure for operation and calibration of Melting Point apparatus

2.0 SCOPE

This SOP is applicable for operation and calibration of Melting Point apparatus.

3.0 RESPONSIBILITY

Officer/ Executive - Quality Control

4.0 ACCOUNTABILITY

Manager - Quality Control

5.0 PROCEDURE

5.1 Operation

5.1.1 Ensure that the working area is clean.
5.1.2 Ensure that the instrument is connected to the power supply.
VEEGO INSTRUMENT
CORPORATION  VMP-PM



5.1.3 Display will appear:
14/10/12         13:36:55
TEMP.    : 35.5 ºC
SPEED   : 5




5.2 About start menu

1 TEST
2 VALIDATION
3 UNKNOWN
4 UTILITY





5.2.1 Press “MENU/START” key

5.3 Test

5.3.1 Press “ENTER”  key or press ‘1’ no. key.
Product ID
XYZ
Batch number
1234567890





5.3.2 The display will appear,
5.3.3 The Product ID and Batch number can be changed with the help of alphabet key. By using “UP/DOWN” key and then press ‘ENTER’ key.
5.3.4 If required to delete any words/ number Press “0/STOP” key.
5.3.5 Fill the powder sample in one sealed capillary about 3 to 4 mm and insert in one of the holes provided on the heater stand.
5.3.6 Press “RECORD NEXT” key the display will appear.
TEST
Melting SP       :   00.0
Speed                :   0
Press START   to run





5.3.7 Select the melting speed with the “UP/DOWN” key.
5.3.8 Enter required melting range in a degree centigrade and speed with the help of numerical key and then press  “ENTER” key.
5.3.9 Press “MENU/START” key the display will appear.
T speed  : 5        13:35:55
ID : XYZ       
MELT POINT : 083.0
ACT Temp.      : 035.0





MELT POINT: 082.0 indicate the set Temp.
ACT Temp.: 033.0 indicate the oil bath temp. 
5.3.10 The heater will become “ON” and temperature will start rising. The “GREEN” indicator lamp will start flashing (indicate the heater is ON) and on the display it is.
5.3.11 ACT temperature will start rising, the first buzzer will sound approximately 15.0 ºC before set temp. From this point of temp. the rate of temp. will attain 1.0º C per minute
5.3.12 The second buzzer will sound before 5.0 ºC, i.e. at 77.0 ºC and the temp. will continue to rise at 1.0 ºC per minute. This audio signal intimate the user that the temp. is approaching close to melting point. On observing the melting of the sample.
5.3.13 Press “RECORD NEXT” key and observe the START OF MELTING POINT by pressing “RECORD NEXT” key
T  Speed  : 5        13:35:55
ID : XYZ      
MELT POINT : 082.9
ACT Temp.      : 082.9





5.3.14 The display will appear.
5.3.15 To observe further change in the melting of the sample, then press same “RECORD NEXT” key again. Five times the change can be observed.
5.3.16 This recorded temperature along with the header, rise in temperature/ minute, and melted temperature will get printed. The printer should be connected to the printer port provided on rare side of the instrument and kept on and loaded with paper.
5.3.17 Record the test in usage log book.

5.4 Unknown Sample

5.4.1 If the melting point of the sample is not known.
5.4.2 To select unknown option either press ‘3’ no. key or press ‘DOWN” key.
UNKNOWN
ID :       
RATE   : 1:00





5.4.3 The display will appear.
5.4.4 The curser on message ID is flashing.
5.4.5 Press “ENTER” key the cursor will move the third line. Select product name/ batch number with the help of alphabet key. And press “ENTER” key.
5.4.6 The cursor will move to the fourth line. Select the RATE OF HEATING as per the requirement.
5.4.7 In this case rate of heating is selected as ‘5’. The display will appear.
UNKNOWN
ID :       
XYZ
RATE   : 5:00





5.4.8 Press “RECORD NEXT” key. The display will appear.
UNKNOWN
SPEED :  5
Press start to run




5.4.9 Press MENU/ START key. The display will appear.
UNKNOWN            13:35:55
XYZ
SPEED :  5
Act Temp 





5.4.10 The heater will become ON the temp. start rising at approx 5 ºC/min.
One has to observe to the melting point of a sample manually, and when it is melt for e.g. the sample melt at 187.2 ºC (It indicates the melting point may be between 182.0º C to 192.0 ºC ).
5.4.11 Press STOP key. The heating will stop with the audio signal. The display will appear. 
14/10/12                   13:35:55
ACT TEMP. : 177.8
SPEED :  5




5.5 Utility

5.5.1 To select the “UTILITY” option either press ‘4’ no. key. And then press the ENTER key. The display will appear as.          
UTILITY
Password : 0



5.5.2 The cursor on message password is flashing. Press ENTER key. The cursor will shift. Then press 1111 as the code value. The display will appear password.
1         Print
2         RTC
3         Product IDs
4         Change password





5.5.3 Press ENTER key. The display as.
5.5.4 Print: The print option is for printing the Test store data with date wise.
5.5.4.1 To select the print option with UP/DOWN key. And press ENTER key. The displays will appear as.
From    :  DD/MM/YY
To         :  DD/MM/YY
Found   : 25
Dbl : NO                PRINT : NO





5.5.4.2 Select the date, month and year with the help of numerical key which required to printing.
5.5.4.3 If double-spacing between the two line is required, in the printing. Select YES with the help of  UP/DOWN key.
5.5.4.4 If print required  select YES with the help of  UP/DOWN key.
5.5.4.5 Press enter key it will start print all 25 record.
5.5.5 Clock
5.5.5.1 To enter the current date and time press ‘2’ key. Then press ENTER key the display will appear as.
Set date  :  DD/MM/YY
Set Time :  13:35:55



5.5.5.2 Select the date and time with the help of the numerical key.
5.5.5.3 To go to the main menu, press “ESCAPE PREV” key.
5.5.6 Product IDs
In this option will be store 10 products with its products name and their expected melting point.
01
Product ID  
Set point  : 




5.5.6.1 Press ‘3’ key. The display will appear as.
5.5.6.2 To enter the product name and melting point (set point) with help of numerical /up and down key. And then press the ENTER key.
5.5.6.3 Press RECORD NEXT key. Follow the same steps as explained to store regular 10 products.
5.5.6.4 To go to the main menu, press “ESCAPE PREV” key.
5.5.7 Change passwords
The option ‘Change passwords’ is for the factory setting.

5.6 Calibration

5.6.1 To calibrate the instrument with standard powders.
           A] VANILINE, having melting point 81.0 ºC to 83.0 ºC.
           B] BENZOIC ACID, having melting point 121.0 ºC to 123.0 ºC.
           C] CAFFINE, having melting point 235.0 ºC to 237.5 ºC.   
5.6.2 To select validation option. Press STARTMENU key.
5.6.3 To select validation option. Press ‘2’ no. key or press “DOWN” key. And then press “ENTER” key. The display will appear as.                                                        
Product ID
VANILINE
Batch number
111111111111





5.6.4 Press “RECORD NEXT” key. If the option for validation sample VANILINE is selected then, press “RECORD NEXT” key.
5.6.5 Fill the powder sample in one end sealed capillary about 3 to 4 mm and insert in one of the hole provided on the heater stand.
5.6.6 Press “MENU/START” key.
5.6.7 Follow the procedure as explained in the actual test of the sample (from 5.3.9 to 5.3.15).
5.6.8 If want to validation for second / third sample press ESCAPE PREV key. And follow same above procedure. 
5.6.9 Calibrate the instrument and make the entry in the logbook.
5.6.10 Calibration frequency: Quarterly.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 ID - Identification
6.3 ACT - Actual Temperature





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


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