Standard Operating Procedure for Using Cryogenic Storage Equipment

1) Purpose

The purpose of this SOP is to provide guidelines for the proper use and maintenance of cryogenic storage equipment to ensure the safe and effective storage of temperature-sensitive ocular dosage forms.

2) Scope

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

3) Responsibilities

The responsibilities include operating the cryogenic storage equipment, monitoring storage conditions, performing regular maintenance, and ensuring safety protocols are followed. Production staff and warehouse 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 safe use of cryogenic storage equipment.
2. Verify that the storage equipment is clean, sanitized, and free from any contaminants.
3. Check that the cryogenic storage equipment is functioning properly and at the required temperature.

4.2 Operation

1. Loading:
   1. Wear appropriate personal protective equipment (PPE) including cryogenic gloves, face shield, and lab coat.
   2. Open the cryogenic storage unit and carefully place the ocular dosage forms inside, ensuring they are securely positioned.
   3. Close the storage unit securely to maintain the desired temperature.
2. Monitoring:
   1. Regularly monitor the temperature of the cryogenic storage unit using the built-in temperature monitoring system.
   2. Record the temperature readings at regular intervals in the temperature logbook.
   3. Ensure that the temperature remains within the specified range for the stored products.

4.3 Maintenance

1. Perform regular cleaning of the cryogenic storage unit to remove any frost or ice build-up.
2. Inspect the seals and gaskets for any signs of wear or damage and replace them if necessary.
3. Check the liquid nitrogen levels (if applicable) and refill as needed to maintain the required temperature.
4. Document all maintenance activities in the maintenance logbook.

4.4 Safety Protocols

1. Ensure all personnel handling cryogenic storage equipment are trained in emergency procedures.
2. Maintain proper ventilation in the area where cryogenic storage equipment is used.
3. Immediately report any equipment malfunction or temperature deviation to the supervisor and take corrective actions.

5) Abbreviations, if any

PPE – Personal Protective Equipment

6) Documents, if any

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

7) Reference, if any

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

8) SOP Version

Version 1.0