SOP for Heat Distribution Study in Depyrogemation Oven using Different Probes with Data Logger : Pharmaceutical Guidelines

SOP for Heat Distribution Study in Depyrogemation Oven using Different Probes with Data Logger

Standard operating procedure for study heat distribution in the chamber of depyrogenation oven using probes with data logger.

1.0 Objective

To study heat distribution in the chamber of Depyrogenation oven using probes with the data logger.

2.0 Scope

This procedure is applicable for physical verification for proper heat distribution in the chamber of Depyrogenation oven.

3.0 Responsibility

3.1 Doing: Engineering department
3.2 Checking: Executive /Manager

4.0 Accountability

Head of the Department

5.0 Procedure

Frequency : Once in a Year
5.1 Load the Depyrogenation oven with the glassware and accessories for Depyrogenation.
5.2 Put six calibrated flexible probes in the Depyrogenation oven as per location chart attached.
5.3 Connect the flexible probes to the recorder of data logger & set the record interval 10 minute.
5.4 Operate the Depyrogenation oven as per SOP .
5.5 Note down the validation parameters and sterilization cycle details like time, temperature etc. in annexure – I.
5.6 After completion of Depyrogenation cycle, note down the hottest location and coldest location in temperature record for Depyrogenation oven in annexure II .
5.7 Record the reading of each probe temperature kept inside Depyrogenation oven and temperature on digital temperature indicator at every 10 minute interval in annexure –II till completion of depyrogenation cycle.
5.8 Attach the data logger print out with Annexure II data.
Acceptance criteria : Temperature at each point must reach 200 °C +10 °C.

6.0 Abbreviations

6.1 °C = Degree centigrade

ANNEXURE-I 
Q.C.DEPT.
MICROBIOLOGY LAB. 
 S.O.P.NO.:____________________
Heat distribution study in Depyrogenation oven with load
Date :_________

(A)    Validation parameters
        (1) Sterilization time                            : 
        (2) Set temperature                            :
(B)   Cycle details 
        (1)  Cycle start time                           :
        (2)  Temperature achieved                 :
(3)  Time of temperature  Achieved    :
(4)  Sterhold started at                      :
(5)  Sterhold completed at                :
(6)  Cycle completed at                    :
(C)   Load details                                     :

Remark          :

Microbiologist                          QA Dept                        Eng. Dept                                Q.C.  Manager


ANNEXURE-II
Q.C.DEPT.
MICROBIOLOGY LAB 
 S.O.P.NO.:_______________
Heat distribution study in Depyrogenation oven with load
Temperature records (Temperature to be recorded every 10 min.) 
Date :
Sr.
No

Time
Digital temperature
Indicator
1
2
3
4
5
6














































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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.
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