SOP for Oven for Depyrogenetion : Pharmaguideline

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SOP for Oven for Depyrogenetion

Standard operating procedure of oven for depyrogenetion.

1.0 OBJECTIVE

To define the operation of the instrument for better and error-free use of the same.

2.0 SCOPE

This procedure is applicable to oven for Depyrogenation installed in Quality Control.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant/ Executive.
3.2 Checking: Executive/ Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Clean the instrument with clean dry cotton cloth and keep the glassware for depyrogenation inside it.
5.2 Switch ‘ON’ the mains.
5.3 Switch ‘ON’ the instrument.
5.4 Set the temperature with the help of control panel keys as follows.
5.4.1 Press set key, so that the ‘PV’ will display which show present temperature and ‘SV’ display will show set temperature.
5.4.2 To set the required temperature, Press ‘△’ key to increase temperature & press ‘▽’ key to decrease the temperature.
5.4.3 Initially the temperature will increase/decrease with 0.1, after 10 step it will increase/decrease by 1.0, Again after 10 step it will increase or decrease by 10.
5.4.4 If the key left unpress the above cycle increase or decrease will start again.
5.4.5 Set the temperature at 200°C. or as per the requirement.
5.4.6 After setting temperature. Press set key so that the SV will indicate ‘hr’ i.e. time. So enter the clock time & again press set key.
5.4.7 The SV indicate ‘nt’ i.e. minutes. Set the clock time minutes & again press set key.
5.4.8 SV indicate ‘th’ i.e. day enter the day & again press set key.
5.5 Now SV indicate ‘Pi’ i.e. print interval.
5.6 Set require time interval and Press set key.
5.7 Now the SV indicate pd, i.e. If we set pd-1 so that the message will be stored & after pressing print the memory will pass for printing.
5.8 If the setting is pd-2 it will give every interval printing during the cycle operation.
5.9 To clear the previous printing date set pd-3 & again press set so that the printing data will be cleared.
5.10 Set pd-1.
5.11 After that press set. It will Blink SC i.e. scanner. Set the required scanner reading interval by △ or ▽ key in seconds & press set key.
5.12 Switch on the heater to ‘ low’ or to ‘high’ , as per required temperature setting.
5.11 Set the programme & run the cycle for 3 hrs. or as per requirement.
5.12 After the completion of 3 hrs. attached the dot metric printer & insert the dot metric code given on right side of the oven.
5.15 Switch ‘ON’ the printer & press the print.
5.16 After completion of printing if the 4 channel scanner print required then press ‘scanner’ & again press ‘print’.

5.17 Switch ‘OFF’ the printer.
5.18 Switch ‘OFF” the Heater.
5.19 Record the results in Annexure-I
5.20 Switch ‘OFF’ the instrument & then switch ‘OFF’ the main.
5.21 Allow to cool and remove the glassware from it.
Note:-
(1) If the ‘Alarm’ is ‘ON’ then press ‘ACK’ key to discontinue it.
(2) During setting a programme to come out from programme press ‘cool’ key.
(3) If the printer is out of order do not attach the print.

6.0 ABBREVIATIONS

°C = Degree centigrade
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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