Best Practices for Advance Spiking of IV Bags

Best Practices for Advance Spiking of IV Bags To protect the safety of the patient, the Joint Commission and United States Pharmacopeia (USP) advise to always spike IV bags in an ISO Class 5 Cleanroom environment. Following best practices for advance spiking of IV bags helps prevent microbial growth, safeguard the health of the patient, and preserve the beyond-use date (BUD), expiration date, of the IV bag.

What is spiking an IV bag?

advance spiking of IV bags

Healthcare worker adjusts IV bag after spiking for
patient infusion (Source)

Spiking an intravenous (IV) bag occurs when a healthcare professional punctures an IV bag for injecting medication or for that attachment of IV tubes for patient infusion (Ref. 1). To save time, many operating rooms (ORs) will advance spike IV bags for ease of use during procedures. Safe storage and preparation will help ensure the quality of the IV medication.

Advance Spiking of IV Bags Regulations

advance spiking of IV bags

IV Hoods provide easy storage for after advance spiking of IV bags.

The Joint Commission

The Joint Commission is a nonprofit organization that evaluates and certifies healthcare organizations while setting standards to improve the safety and quality of healthcare practices. Recently, the Joint Commission released a standard or best practice that states that an infusion must be used within one hour of spiking unless the IV bag was spiked in an ISO Class 5 Cleanroom (Ref. 2). If an IV bag was spiked in an ISO Class 5 Cleanroom environment, then the healthcare professional can follow the USP 797 guidelines for the beyond-use date.

USP 797

Similarly, USP 797 dictates that if an injection or infusion medication is punctured or spiked in worse than ISO Class 5 air, then the medication must be used within one hour and the remaining contents must be discarded (Ref. 3).

What is an ISO Class 5 Cleanroom?

The International Organization for Standardization (ISO) sets guidelines for the maximum number of particles allowed per cubic meter in order to meet the standardization. The chart below illustrates the differences between ISO 1 – ISO 8 Cleanrooms. Only particle sizes of 0.1 µm, 0.3 µm, and 0.5 µm have been listed below but the standardization also includes particle sizes of 0.2 µm, 1 µm, and 5 µm (Ref. 4).

ISO Class Cleanroom Standards

Advanced Spiking IV Bags Best Practices Solutions

advance spiking of iv bags

Portable IV Hoods provide an ISO Class 5 cleanroom
environment in a compact and easy to install package.

To easily adhere to the Joint Commission and USP 797 regulations, healthcare professionals can compound, spike, and store IV bags in an ISO Class 5 Cleanroom IV Hood. These compact and portable units offer easy installation while still providing vital protection. Converting an entire room to ISO Class 5 Cleanroom environment can be a difficult and costly expenditure. IV Hoods provide the necessary safety precautions in an economical and compact package that can be utilized in any department. Also, IV hoods provide convenient IV bag racks to allow healthcare professionals to prepare up to 7 or 10 bags ahead of time while conforming to the Joint Commission’s standard.


How do IV Hoods work?

Infographic showing how IV Hoods work

1. Ambient room air is pulled into the system with a powerful fan.

2. Air is processed through a MERV 8 pre-filter, where some particles are captured.

3. Air is filtered by passing through a final HEPA or ULPA filter to remove particulate down to 0.3 microns (HEPA) or 0.12 microns (ULPA) of the remaining particulate from the ambient air.

4. The filtered air is discharged into the work area of the hood in a vertical laminar flow pattern, creating a reduced particulate environment.


IV Hood – Portable Clean Room Hood

Best Use: advance spiking and storage of IV bags, non-sterile compounding of IV Bags

• Compact & portable
• Easy to use with simple installation
• Economical price point to allow installation wherever needed
• Provides up to ISO Class 5 Cleanroom
• Convenient IV Bag storage (7 or 10 rack capability)

Filters Available:
HEPA– offers up to 99.97% efficiency on particles down to 0.3 microns
ULPA – offers up to 99.9995% efficiency on particles down to 0.12 microns

Sizes Available: 18”, 24”, 30” and 40”

Air Volume: up to 65 CFM (18” model) to 350 CFM (24”, 30”, and 40”)

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1. “Spiking Your IV Bag.” Infuserve America.

2. The Joint Commission. “Medication Preparation – Spiking Intravenous (IV) Bags in Advance of Administration,” Standards FAQs. 03 March 2021.

3. “Proposed Revisions 797,” USP Compounding Expert Committee. December 2015.

4. “American Cleanroom Systems presents Cleanroom Classifications.” American Cleanroom Systems, 2021.