SOP for Steam Penitration Study by Bowie-Dick Test : Pharmaguideline

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SOP for Steam Penitration Study by Bowie-Dick Test

Standard operating procedure to study the even steam penetration of steam in double door autoclave/sterilizer.

1.0 Objective 

To study of steam penetration evenly in double door Autoclave with use of Bowie-dick type test kit.

2.0 Scope

This procedure is applicable to study even and rapid steam penetration in Double door Autoclave.

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 Keep the Bowie-Dick type test pack in the lower shelf of autoclave near drain on SS stand.
Set the Bowie-Dick cycle for 18 min.
5.2 Run the cycle as per SOP for 18 min.
5.3 After Completion on cycle remove the test pack from chamber, remove the cover and paper sheets Around Test paper.
5.4 Observe the Bowie-Dick test paper for even colour change of the indictor which is distributed on test paper.
5.5 Record the results and attach this test paper with annexure.
5.6 The test should be considered satisfactory if there is a uniform colour change through out the indicator.
5.7 It there is a failure check the pervious load and previous results.
5.8 Inform to engineering department for the rectification and corrective action.

6.0 ABBREVIATION

NIL

ANNEXURE-I
                                                                                                                                                                           SOP No : ___________
MICRO SECTION QUALITY CINTROL

RESULTS OF BOWIE-DICK TYPE TEST KIT
(Study of steam penetration study in Double door Autoclave)
Date of Sterilization
:
Ster-Hold Time
: 8 minutes
Sterilization Cycle No.
:
Autoclave ID No.
:
BOWIE-DICK TYPE TEST KIT
Manufacturer
:
Mfg date
:
Lot Number
:
Exp. date
:

Observation :
Conclusion: Steam penetration is SATISFACTORY / NOT SATISFACTORY
Acceptance Criteria: The colour of Bowie-dick test paper should be changed from yellow to blue evenly


























Analyst                                                          Date of report                                        Checked By

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