Standard Operating Procedure for Using Glove Box

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the glove box in the pharmaceutical manufacturing of otic dosage forms to ensure containment and protection of sensitive materials from external contaminants.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of glove boxes in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the glove box as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying containment within the glove box.
Maintenance Personnel: Responsible for maintaining the glove box in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the glove box for cleanliness and integrity before use.
4.1.1.2 Check that gloves are intact and in good condition.
4.1.1.3 Verify that all necessary supplies (e.g., desiccants, cleaning materials) are available.

4.1.2 Preparation
4.1.2.1 Ensure that the materials to be handled inside the glove box are compatible with containment requirements.
4.1.2.2 Perform any necessary setup of equipment or tools inside the glove box.
4.1.2.3 Set up and check the gas purification system (if applicable).

4.2 Operation
4.2.1 Entry and Exit
4.2.1.1 Put on appropriate PPE, including gloves, before entering the glove box.
4.2.1.2 Open the glove box door slowly and enter while maintaining containment.
4.2.1.3 Close the door carefully to maintain the integrity of the glove box environment.

4.2.2 Handling Procedures
4.2.2.1 Handle materials and equipment inside the glove box gently to avoid spills or contamination.
4.2.2.2 Use designated tools and equipment suitable for use inside the glove box.
4.2.2.3 Follow all procedures to prevent moisture ingress or exposure to outside contaminants.

4.3 Post-operation
4.3.1 Exit and Cleanup
4.3.1.1 Remove gloves and dispose of them properly as per facility protocols.
4.3.1.2 Perform any required cleaning of the glove box interior and replace desiccants as needed.
4.3.1.3 Leave the glove box in a clean and ready condition for the next use.

4.3.2 Maintenance
4.3.2.1 Regularly inspect gloves for wear and replace them as necessary.
4.3.2.2 Clean the glove box exterior and monitor seals and connections for leaks.
4.3.2.3 Perform scheduled maintenance and certification of gas purification systems (if applicable).

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment

6) Documents, if any

Glove box log
Maintenance records for the glove box

7) Reference, if any

Manufacturer’s manual for the glove box
Pharmacopeial guidelines for containment systems in pharmaceutical manufacturing

8) SOP Version

Version 1.0