Guideline #25

Labeling and Shelf-life of Sterile Fluids After Opening

1. References:

1.1. Centers for Disease Control and Prevention (CDC) Infection Control Guidelines for Multi-Dose Vial Shelf-life

1.2. United States Pharmacopeia (USP), General Chapter 797

2. Purpose: To provide guidance to investigators for the labeling/dating of opened bags/bottles of sterile fluids (e.g., IV fluid bags, bottles of sterile saline/water, etc.) and how long the sterile fluids may be used after opening (i.e., shelflife/expiration date).

3. Policy:

3.1. Small size/volume sterile fluid bags/bottles (e.g., ≤100 ml) should be used to minimize both the number of times a bag/bottle is opened/accessed and/or shelf-life of the bag/bottle before it is used up.

3.2. Sterile fluid bags/bottles shall be labeled with the date the bag/bottle is first opened/accessed.

3.3. Aseptic technique shall be used when opening/accessing a bag/bottle of sterile fluid in order to maintain sterility and maximize the shelf life of the fluid after the bag/bottle is first opened/accessed.

3.4. The shelf-life/expiration date for sterile fluids that have been opened/accessed are:

• • • Use within 24 hours if there is a break in aseptic technique when opening/accessing the bag/bottle;
    • Do not use and dispose of the fluid if the manufacturer’s expiration date on the bag/bottle has been reached; or
    • Do not use and dispose of the fluid if there is any noticeable/observable discoloration or particulate material in the bag/bottle.

 

LAST REVIEWED AND ADOPTED BY THE IACUC: January 4, 2024