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SOP for Heat Distribution Study in Chamber of Dry Heat Sterilizer Using Different Probe with Data Logger

Standard operating procedure to ensure proper heat distribution in the chamber of dry heat sterilizer with load using data logger.

1.0  Objective 

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

2.0  SCOPE

       To ensure proper heat distribution in the chamber of dry heat sterilizer with load using data logger.    

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 DHS with the glassware and accessories to be sterilized.
5.2  Put six calibrated flexible probes in the DHS 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 DHS 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 DHS cycle, note down the hottest location and coldest location in temperature record for DHS in annexure II .
5.7  Record the reading of each probe temperature kept inside DHS and temperature on digital temperature indicator at every 10 minute interval in annexure –II till completion of sterilization cycle.
5.8  Attach the data logger print out with Annexure II data.
       Acceptance criteria   :  Temperature at each point must reach 180 °C   +10 °C. 

6.0  Abbreviations

6.1  oC = Degree centigrade
6.2   DHS= Dry heat  sterilization

Heat  distribution study in DHS  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

Heat  distribution study in  DHS with load Temperature records( Temperature to be recorded every 10 min.)
Date :

Sr no.

Digital temperature
           Temperature  of probes at Location

Conclusion and results    :

Location no.  ________    is the   hottest location  in the DHS.

Location no ._________  is the coldest location  in the  DHS .
Date   :

Microbiologist                   Q.A.Dept.                        Engineering dept.                    Q.C. Manager

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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