Standard Operating Procedure for Using Sterility Test Isolator
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the sterility test isolator in the pharmaceutical manufacturing of otic dosage forms to ensure aseptic conditions during sterility testing.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of sterility test isolators in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the sterility test isolator as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying aseptic conditions during testing.
Maintenance Personnel: Responsible for maintaining the sterility test isolator in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the sterility test isolator for cleanliness and integrity before use.
4.1.1.2 Ensure that all seals, gloves, and connections are intact and functional.
4.1.1.3 Verify that the isolator’s HEPA filters and airflow system are operational.
4.1.2 Preparation
4.1.2.1 Ensure that all necessary materials and equipment are ready for sterility testing.
4.1.2.2 Set up the isolator according to the specific requirements of the sterility test.
4.1.2.3 Perform a leak test and decontamination cycle as per manufacturer’s instructions.
4.2 Operation
4.2.1 Testing Process
4.2.1.1 Power on the sterility test isolator and initiate the airflow system.
4.2.1.2 Introduce the test samples and necessary materials into the isolator through the pass-through chamber.
4.2.1.3 Perform the sterility test according to the approved testing protocol, ensuring aseptic technique is maintained.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate PPE when operating the sterility test isolator.
4.2.2.2 Handle all materials and equipment inside the isolator with care to prevent contamination.
4.2.2.3 Follow all safety protocols for working with potentially hazardous materials.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Remove all test samples and materials from the isolator after completing the test.
4.3.1.2 Clean the interior surfaces of the isolator with appropriate disinfectants.
4.3.1.3 Power off the isolator and secure it for the next use.
4.3.2 Maintenance
4.3.2.1 Regularly inspect the sterility test isolator for wear and tear, and perform necessary repairs.
4.3.2.2 Replace HEPA filters and other consumable components as per the manufacturer’s recommendations.
4.3.2.3 Keep maintenance records and document any issues or repairs performed.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
HEPA: High-Efficiency Particulate Air
6) Documents, if any
Sterility test records
Maintenance records for the sterility test isolator
7) Reference, if any
Manufacturer’s manual for the sterility test isolator
Pharmacopeial guidelines for sterility testing in pharmaceutical manufacturing
8) SOP Version
Version 1.0
