Standard Operating Procedure for Using a Desiccator

1) Purpose

The purpose of this SOP is to provide guidelines for the proper use and maintenance of a desiccator to ensure the effective storage of moisture-sensitive ocular dosage forms.

2) Scope

This SOP applies to all desiccators used for storing ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include operating the desiccator, monitoring storage conditions, performing regular maintenance, and ensuring safety protocols are followed. Production staff and quality control personnel are responsible for following this procedure, and the maintenance team is responsible for regular checks and servicing of the equipment.

4) Procedure

4.1 Preparation

1. Ensure all personnel are trained in the proper use of desiccators.
2. Verify that the desiccator is clean and free from any contaminants.
3. Check that the desiccant inside the desiccator is fresh and effective.

4.2 Operation

1. Loading:
   1. Wear appropriate personal protective equipment (PPE) including gloves and lab coat.
   2. Open the desiccator carefully to avoid any contamination.
   3. Place the moisture-sensitive ocular dosage forms inside the desiccator on the designated shelves or racks.
   4. Ensure the desiccator is properly sealed to maintain a moisture-free environment.
2. Monitoring:
   1. Regularly monitor the humidity level inside the desiccator using a hygrometer.
   2. Record the humidity readings at regular intervals in the humidity logbook.
   3. Ensure that the humidity level remains within the specified range for the stored products.

4.3 Maintenance

1. Perform regular cleaning of the desiccator to remove any dust or contaminants.
2. Inspect the seals and gaskets for any signs of wear or damage and replace them if necessary.
3. Check the desiccant regularly and replace it when it becomes saturated or ineffective.
4. Document all maintenance activities in the maintenance logbook.

4.4 Safety Protocols

1. Ensure all personnel handling the desiccator are trained in emergency procedures.
2. Maintain proper handling and storage of desiccant materials to avoid exposure.
3. Immediately report any equipment malfunction or humidity deviation to the supervisor and take corrective actions.

5) Abbreviations, if any

PPE – Personal Protective Equipment

6) Documents, if any

1. Humidity logbook
2. Maintenance records
3. Training records

7) Reference, if any

GMP Guidelines for the storage of moisture-sensitive pharmaceutical products.

8) SOP Version

Version 1.0