1.0 OBJECTIVE

The objective of this Standard Operating Procedure (SOP) is to establish a consistent and controlled process for the procurement, storage, handling, and disposal of biological indicators used for the qualification and monitoring of sterilization processes.

2.0 SCOPE

This procedure applies to the following types of biological indicators (BIs) used within the facility:

2.1 Bacillus subtilis

2.2 Bacillus stearothermophilus

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 Approved suppliers and qualified sources for procuring biological indicators.

4.2 Access to a certified biosafety cabinet or equivalent controlled environment for handling BIs.

4.3 Trained personnel on the proper use, handling, and disposal of biological indicators.

5.0 PROCEDURE

5.1 Procurement

5.1.1 Determine the quantity and types of biological indicators required based on the scheduled sterilization validation activities and routine monitoring needs.

5.1.2 Raise a purchase order (PO) to an approved supplier, specifying the required details such as product code, quantity, and delivery date.

5.2 Receiving and Storage

5.2.1 Upon receipt of the biological indicators, inspect the packaging for any signs of damage, tampering, or compromised integrity.

5.2.2 Verify the labeling information, including the organism name, lot number, expiration date, and all relevant certificates or documentation provided by the supplier.

5.2.3 Store the biological indicators in a cool, dry location, away from potential sources of contamination.

5.2.4 Maintain a stock inventory record, tracking the receipt, issuance, and remaining quantities of each biological indicator type and lot number.

5.3 Handling and Use

5.3.1 Prior to use, retrieve the required quantity of biological indicators from the storage area, ensuring proper aseptic techniques are followed.

5.3.2 Gown according to the established aseptic gowning procedure for working in controlled environments.

5.3.3 Enter the designated inoculation or microbiological room, maintaining aseptic conditions.

5.3.4 Open the biological indicator container inside the biosafety cabinet or controlled environment, using sterile forceps to handle the individual BI strips or units.

5.3.5 For steam sterilization validation:

5.3.5.1 Carefully place each Bacillus stearothermophilus BI strip at specified loacations, ensuring proper identification and traceability.

5.3.5.2 Proceed with the sterilization validation process according to the relevant SOP.

5.3.6 For dry heat sterilization validation:

5.3.6.1 Place each BI strip into an appropriately sized aluminum foil pouch or envelope.

5.3.6.2 Seal the foil pouch, ensuring proper identification and traceability.

5.3.6.3 Proceed with the dry heat sterilization validation process according to the relevant SOP.

5.3.7 Ensure that the treated biological indicators are promptly processed within 2 hours of exposure to the sterilization process, following the specified incubation and analysis procedures.

5.4 Expiration and Disposal

5.4.1 Routinely check the expiration dates of the biological indicator stock, and plan for the timely replacement of any soon-to-expire units.

5.4.2 If any expired biological indicators remain in stock, dispose of them by subjecting them to a validated sterilization cycle (e.g., steam sterilization at 121°C for 30 minutes).

5.4.3 Record the details of the disposed biological indicators, including the type, lot number, quantity, and sterilization cycle parameters used for disposal.

6.0 DOCUMENTATION

6.1 Maintain accurate and up-to-date records of the biological indicator stock, including the receipt, issuance, and remaining quantities, along with relevant lot numbers and expiration dates.

6.2 Document the use of biological indicators in sterilization validation studies, including the BI type, lot number, quantity used, and the corresponding sterilization cycle parameters.

6.3 Record any deviations, corrective actions, or incidents related to the handling or use of biological indicators, following established deviation management procedures.

6.4 Ensure all records and documentation related to biological indicators are reviewed, approved, and retained according to the facility’s quality management system and regulatory requirements.

7.0 SAFETY PRECAUTIONS

7.1 Follow all biosafety and aseptic techniques when handling biological indicators to prevent potential exposure or contamination.

7.2 Wear appropriate personal protective equipment (PPE), such as lab coats, gloves, and safety goggles, when working with biological indicators.

7.3 Ensure proper disposal of used or expired biological indicators by subjecting them to a validated sterilization cycle before discarding them as biohazardous waste.

7.4 Adhere to all relevant safety protocols and emergency procedures in case of any incidents or accidents involving biological indicators.

8.0 TRAINING

8.1 All personnel involved in the procurement, storage, handling, and use of biological indicators must receive comprehensive training on this SOP and related procedures.

8.2 Training should cover topics such as aseptic techniques, biosafety practices, proper handling and disposal methods, documentation requirements, and contingency plans for potential incidents or deviations.

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

9.0 ABBREVIATIONS

BI: Biological Indicator

PO: Purchase Order

PPE: Personal Protective Equipment

SOP: Standard Operating Procedure

• Author:  Bhavana Tatineni
• Qualification: MSc Microbiology