Standard Operating Procedure for Aseptic Processing Area Management

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the management and operation of the Aseptic Processing Area used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the Aseptic Processing Area utilized in the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, cleaning, and maintenance of the Aseptic Processing Area. The personnel working in the area are responsible for following the procedure, and the maintenance team is responsible for regular maintenance and validation.

4) Procedure

4.1 Preparation

1. Ensure the Aseptic Processing Area and surrounding zones are clean and sanitized.
2. Verify that all necessary equipment and materials are available and within expiry dates.
3. Check that all equipment in the area is connected to the appropriate power supply and is functioning properly.

4.2 Gowning Procedure

1. Enter the gowning area and remove all jewelry and personal items.
2. Wash hands and arms thoroughly with a suitable disinfectant.
3. Don sterile gowning attire including gloves, mask, hairnet, and gown as per the gowning procedure.
4. Ensure that gowning attire is worn properly to avoid contamination.

4.3 Entry into Aseptic Area

1. Enter the Aseptic Processing Area through the airlock system.
2. Ensure that the airlock doors are not opened simultaneously to maintain air pressure.
3. Sanitize hands using a suitable disinfectant before entering the processing area.

4.4 Operation

1. Perform all aseptic operations within the designated sterile area.
2. Minimize movement and talking within the area to prevent contamination.
3. Use sterile tools and materials for all processing activities.
4. Regularly monitor environmental conditions (temperature, humidity, and pressure) to ensure compliance with standards.
5. Record all operations and observations in the aseptic area logbook.

4.5 Post-Operation

1. Clean and disinfect all surfaces and equipment used during the process.
2. Properly dispose of all waste materials as per the waste disposal procedure.
3. Exit the Aseptic Processing Area through the airlock system, following proper gown removal and hand sanitization procedures.

4.6 Maintenance

1. Regularly inspect the Aseptic Processing Area for any signs of wear or damage.
2. Perform environmental monitoring and validation checks as per the schedule.
3. Replace any worn-out parts or equipment promptly.

5) Abbreviations, if any

None

6) Documents, if any

1. Aseptic area logbook
2. Maintenance record
3. Validation record

7) Reference, if any

GMP Guidelines for pharmaceutical production and aseptic processing.

8) SOP Version

Version 1.0