SOP for Heating Block Validation : Pharmaceutical Guidelines

SOP for Heating Block Validation

Standard operating procedure to validate the heating block which is to be used for LAL test.

1.0  OBJECTIVE

       To validate the Heating block using calibrated thermometer.    

2.0  SCOPE

       This procedure is applicable to validate the heating block which is to be used for LAL test .

3.0  RESPONSIBILITY

3.1  Doing      : Technical Assistant (Microbiologist)/Executive
3.2  Checking : Executive/Manager    

4.0  ACCOUNTABILITY

       Head of the Department     

5.0  PROCEDURE

       Frequency : Every Month
5.1  Take 5 calibrated thermometer and give them No. L1, L2, L3, L4, L5 as mentioned in annexure.
5.1  Keep five thermometer in test tubes at different location inside well of heating block as per location chart enclosed.
5.2  Operate Heating block as per S.O.P.
 5.4  Compare temperature of each thermometer with respect to temperature adjusted one on heating block  at every 15 minutes interval upto 1 hours.
5.5  Record the result as per annexure.

5.6  Acceptance Criteria 

Temperature on display should be within 37°C + 1°C.
5.7  The results obtained at all location of heating block should be within 36 to 38°C.
5.8  Change the location by placing thermometer in other than previously selected location to cover maximum well during validation in a calendar year.

6.0  ABBREVIATIONS

       oC  = Degree centigrade



ANNEXURE    
MICROBIOLOGY LABORATORY
                                            Heating Block Validation                                                                                                                                                                       
Thermometer  ID. NO.
Time
Interval minutes
Location

Temperature on
Calibrated  Thermometer
Temperature on display
Sign
Remarks









L1





L2


L3


L4


L5










L1





L2


L3


L4


L5










L1





L2


L3


L4


L5










L1





L2


L3


L4


L5


Acceptance Criteria : 37°C  + 1°C

Conclusion :


Analyst                                                                                                           Checked by
(Date)                                                                                                             (Date)



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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