Standard Operating Procedure for Performing the Bowie-Dick Test on Steam Sterilizers

1.0 OBJECTIVE

The objective of this Standard Operating Procedure (SOP) is to describe the method for evaluating the even and rapid steam penetration in a double-door autoclave/sterilizer using the Bowie-Dick test.

2.0 SCOPE

This procedure is applicable for performing the Bowie-Dick test to assess the steam penetration capability of double-door autoclaves or sterilizers used for sterilization processes.

3.0 RESPONSIBILITIES

3.1 Operator: Technical Assistant or Executive responsible for executing the procedure as described.

3.2 Reviewer: Executive, Manager, or designated personnel responsible for reviewing documented activities against the SOP to ensure compliance.

3.3 Approver: Head of Department or relevant authority responsible for approving the SOP and any future revisions.

4.0 PREREQUISITES

4.1 Availability of a Bowie-Dick test pack or kit suitable for the specific autoclave or sterilizer.

4.2 Access to the autoclave or sterilizer, along with the corresponding operating procedures and cycle settings.

4.3 Appropriate personal protective equipment (PPE) as required for working with autoclaves or sterilizers.

4.4 Trained personnel on the proper use and handling of the Bowie-Dick test kit and interpretation of results.

5.0 PROCEDURE

5.1 Preparation

5.1.1 Takeout the required Bowie-Dick test pack or kit from the designated storage area, ensuring that it is within the specified expiration date.

5.1.2 Verify the test pack or kit for any signs of damage, tampering, or compromised integrity.

5.1.3 Prepare the autoclave or sterilizer for operation according to the established procedures and recommended loading patterns.

5.2 Test Setup

5.2.1 Place the Bowie-Dick test pack on a stainless-steel stand or tray near the drain or lower shelf of the autoclave chamber.

5.2.2 Ensure that the test pack is positioned in a manner that allows for optimal steam penetration and exposure.

5.2.3 Set the autoclave or sterilizer to run the Bowie-Dick cycle, typically a shorter cycle of approximately 18 minutes or as per the manufacturer recommendation.

5.3 Test Execution

5.3.1 Initiate the Bowie-Dick cycle according to the specified parameters and instructions provided by the autoclave or sterilizer manufacturer.

5.3.2 Monitor the cycle progression and ensure that all cycle phases are completed successfully.

5.4 Test Evaluation

5.4.1 Upon completion of the cycle, carefully remove the Bowie-Dick test pack from the autoclave chamber, taking appropriate precautions to avoid potential burns or injuries.

5.4.2 Remove the cover and any protective paper sheets from the test pack, exposing the indicator sheet or test paper.

5.4.3 Visually inspect the indicator sheet or test paper for a uniform color change across its entire surface.

5.4.4 Record the observations and results, including any notable patterns or deviations, in the designated log or report.

5.4.5 Attach the used indicator sheet or test paper to the corresponding report or annexure for future reference and traceability.

5.5 Result Interpretation

5.5.1 The Bowie-Dick test is considered satisfactory if there is a uniform color change throughout the indicator sheet or test paper, indicating even and rapid steam penetration.

5.5.2 If the color change is non-uniform or shows distinct patterns or areas without color change, it may indicate inadequate steam penetration or other issues with the autoclave or sterilizer.

5.6 Corrective Actions

5.6.1 In case of a failed or unsatisfactory Bowie-Dick test, review the previous load and test results to identify potential patterns or root causes.

5.6.2 Inform the engineering department or relevant personnel responsible for the maintenance and troubleshooting of the autoclave or sterilizer.

5.6.3 Initiate appropriate corrective actions, such as equipment adjustments, repairs, or further investigations, as recommended by qualified personnel or the manufacturer’s guidelines.

5.6.4 Repeat the Bowie-Dick test after corrective actions have been implemented to verify the effectiveness of the corrective measures.

 

 

6.0 DOCUMENTATION

6.1 Maintain accurate records of the Bowie-Dick test results, including the date, autoclave or sterilizer identification, cycle parameters, test pack details (manufacturer, lot number, expiration date), observations, and any relevant comments or remarks.

6.2 Ensure that all test reports and associated documentation are reviewed, approved, and retained according to the facility’s quality management system and regulatory requirements.

7.0 SAFETY PRECAUTIONS

7.1 Exercise caution when working with autoclaves or sterilizers, as they operate at high temperatures and pressures.

7.2 Wear appropriate personal protective equipment (PPE), such as heat-resistant gloves, lab coats, and safety goggles, when handling hot or pressurized equipment.

7.3 Follow all safety protocols and emergency procedures in case of any incidents or accidents involving autoclaves or sterilizers.

8.0 TRAINING

8.1 All personnel involved in conducting the Bowie-Dick test or operating autoclaves or sterilizers must receive comprehensive training on this SOP and related procedures.

8.2 Training should cover topics such as test setup, execution, evaluation, result interpretation, corrective actions, documentation requirements, and relevant safety practices.

8.3 Maintain records of personnel training, including the training content, dates, and attendance.

9.0 ABBREVIATIONS

SOP: Standard Operating Procedure

PPE: Personal Protective Equipment

 

Author:  Bhavana Tatineni

Qualification: MSc Microbiology