SOP for Calibration BOD / Bacteriological Incubator : Pharmaceutical Guidelines

SOP for Calibration BOD / Bacteriological Incubator

Standard operating procedure to evaluation of performance of incubators used to incubate the microbial cultures.

1.0 OBJECTIVE

To describe the procedure for the calibration procedure of BOD/bacteriological incubator.

2.0 SCOPE

This SOP is applicable for the calibration procedure of BOD/ bacteriological incubator.

3.0 RESPONSIBILITY

Microbiologist - Quality Control

4.0 ACCOUNTABILITY

Manager - Quality Control

5.0 PROCEDURE

5.1 Ensure that material under test not to be disturbed during the calibration procedure.
5.2 Calibration of the incubator is carried out by Five Pt 100 probes situated on four corners and one in center of the chamber inside the incubator.
5.3 For calibration of incubator scan the all four Pt 100 probes (channels) by pressing the SCANER key on the universal controller of incubator for 24 hrs.
5.4 After scanning take the print out of temperature mapping of 24 hrs duration by pressing the PRINT key on the universal controller of the incubator.
5.5 Record the minimum and maximum temperature attained during 24 hrs temperature mapping and record them in calibration record of the bacteriological incubator as per Annexure I.
5.6 Observe that all temperature values are within ±2.0º C tolerance limit to the set temperature value.
5.7 Frequency: Yearly once

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure

ANNEXURE- I
Calibration record of BOD/Bacteriological Incubator
Asset ID  No.
:

Ref.  SOP No.
:

Make
:

Model No.
:

Date of Calibration :
Next Due Date        :
Frequency               : Yearly
Probe No.
Set Temperature
Observed Temperature 
Tolerance
Observed By
Min. Temp.
Max.Temp.




±2.0º C





±2.0º C





±2.0º C





±2.0º C





±2.0º C

Remark: The calibration procedure of instrument are within tolerance limit /out of tolerance limit and gives satisfactory / not satisfactory results.

Calibrated By:                                                                                       Reviewed By:
Date:                                                                                                     Date:

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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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3 comments: Post Yours! Read Comment Policy ▼

  1. My incubator is set on 44°C but during the calibration at some points the data logger recorded a temperature of 47°C . I Want to know is their any impact on the microorganism icubated in this case please i need an answer

    ReplyDelete
    Replies
    1. Practically it doesn't affect the microbial growth too much but theoretically it would be in specified limits.

      Delete
  2. Ankur sir, can you provide me reference for this temperature limits

    ReplyDelete


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