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