USP 797 Guidelines for IV Bag Preparation

The official date for USP 797 is steadily approaching. The latest revision of guidelines defines proper sterile compounding procedures for CSP’s (compounded sterile preparations) including injections, infusions, and IV bags. By November 1, 2023 applicable facilities must follow all guidelines in order to preserve medication quality. USP 797 sterile compounding rules applies to hospitals, other healthcare facilities, patient treatment sites, infusion facilities, pharmacies, and physicians/veterinarians practice sites” (USP). Infusion clinics and mobile IV clinics must follow USP 797 guidelines to ensure patient safety.

What is USP 797?

USP 797 defines the best practices for sterile compounding including IV bag infusion or preparing IV bags. The purpose of USP 797 is to “minimize harm, including death, to human and animal patients” (USP). USP 797 defines the proper methods to minimize contamination and maintain sterility including the following subjects (USP):

• Personnel Qualifications
• Personal Hygiene and Garbing
• Facilities and Engineering Controls
• Microbiological Air and Surface Monitoring
• Cleaning and Disinfecting
• Equipment, Supplies, and Components
• Sterilization Methods
• Record Keeping
• Release Testing
• Labeling
• Establishing Beyond-Use Dates
• Quality Control
• Storage, Handling, Packaging, Shipping, and Transport
• Documentation

USP does not enforce these regulations only mandates — local regulatory jurisdictions will ensure compliance for applicable facilities.

What is sterile compounding?

USP defines sterile compounding as “combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication” (USP).

Engineering Controls for USP 797

For sterile compounding of IV infusions or IV bags, USP 797 requires the primary engineering control (PEC) to be certified to meet ISO Class 5 or better, designed to prevent contamination of CSPs, and must maintain a unidirectional airflow. One of the approved PECs is a laminar airflow system or laminar airflow bench. USP 797 requires that PECs must be certified and recertified after 6 months of use.

Sentry Air Systems Solutions for USP 797

Sentry Air Systems’ IV Hoods are designed to meet USP 797 guidelines for sterile compounding of IV infusions or preparing IV bags. Our hoods have been tested stringently by 3rd parties and have passed in strict enforcement states like California, Florida, Iowa, Rhode Island, and Hawaii. Our IV Hoods and Portable Clean Rooms 18” and wider have passed the PAO test required for USP 797 certification.

IV Hoods

Benefits

• • ISO Class 5 Clean Room Certified (copy of test protocol available upon request)
• • Designed to Prevent Contamination
• • Unidirectional Airflow
• • Quick Lead Time – Average of 5 days or less. (Expedite service available for additional fee)
• • Made in the USA
• • IV Bag Rod Storage – 7 hooks for 18”, 10 hooks for 24”, 30”, and 40”
• • Portable carts available

Filters:

• •Pre-filter (MERV 8)
• •Main Filter Choice: HEPA (up to 99.97% efficiency on particles down to 0.3 microns) or ULPA (up to 99.995% efficiency on particles down to 0.12 microns)

Available Sizes

18″, 24″, 30″, and 40″

Approximate Airflow

18″ — up to 111 CFM
24″, 30″, and 40″ — up to 350CFM

_{Credit: Sentry Air System, Inc. — https://www.sentryair.com/blog/industry-news-standards/usp-797-guidelines-for-iv-bag-preparation/?utm_source=email&utm_medium=email&utm_campaign=USP797-blog-email}