Standard Operating Procedure for Using Aseptic Filling Isolator

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the aseptic filling isolator in the pharmaceutical manufacturing of otic dosage forms to ensure aseptic conditions during the filling process.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of aseptic filling isolators in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the aseptic filling isolator as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying aseptic conditions during filling.
Maintenance Personnel: Responsible for maintaining the aseptic filling isolator in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the aseptic filling 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 aseptic filling.
4.1.2.2 Set up the isolator according to the specific requirements of the filling process.
4.1.2.3 Perform a leak test and decontamination cycle as per manufacturer’s instructions.

4.2 Operation
4.2.1 Filling Process
4.2.1.1 Power on the aseptic filling isolator and initiate the airflow system.
4.2.1.2 Introduce the product containers, closures, and filling materials into the isolator through the pass-through chamber.
4.2.1.3 Perform the aseptic filling according to the approved filling protocol, ensuring aseptic technique is maintained.

4.2.2 Safety Precautions
4.2.2.1 Wear appropriate PPE when operating the aseptic filling 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 filled product containers and materials from the isolator after completing the filling process.
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 aseptic filling 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

Filling records
Maintenance records for the aseptic filling isolator

7) Reference, if any

Manufacturer’s manual for the aseptic filling isolator
Pharmacopeial guidelines for aseptic processing in pharmaceutical manufacturing

8) SOP Version

Version 1.0