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Navigating the New USP <797> Media Fill Testing Requirements for Sterile Compounding

Navigating the New USP <797> Media Fill Testing Requirements for Sterile Compounding

New USP <797> Media Fill Testing Requirements for Sterile Compounding

 

By Roberto Juarez Jr. BS, M(ASCP)CM

USP <797> Revamps Media Fill Testing Requirements

The United States Pharmacopeia has been setting the standards for compounding pharmacies for a long time. On 11/1/23, several new updates were made to USP<797> which significantly changed the compounded sterile products (CSPs) test requirements for sterile compounding pharmacies. USP<797> is important because it establishes the minimum requirements for preparing sterile medications to ensure patient safety and reduce the chance of harm. This means there is an increase in the cost of supplies, more opportunities for testing failures, and the need for adjusting current workflows to remain compliant per USP<797> guidelines. In this blog post, we review the changes that went into effect as it relates to media fill testing.

What Media Fill Testing is and Why it Matters

Sterile compounding involves manipulating medications in a controlled environment to address individual patient needs. However, even the most stringent protocols carry a risk of microbial contamination.

To reduce contamination risk, sterile compounding personnel must complete media fill competency testing of their aseptic manipulation regularly. Essentially, it acts as a simulated test for real-world compounding, ensuring proper aseptic technique and environmental controls.

Compounders should simulate the most difficult and challenging aseptic compounding manipulations when performing media fill testing. Compounding personnel use sterile culture media such as Trypticase Soy Broth (Soybean Casein Digest) instead of the actual drug components to assess the aseptic technique and practices of personnel. The result of simulating the most difficult aseptic compounding manipulations during media fill testing ensures their aseptic technique is effective and their processes can produce compounded sterile preparations (CSPs).

New CSP Categories 1, 2, and 3

Before we talk about the new changes to media fill testing, it’s worth briefly mentioning the updated CSP categories 1, 2, & 3. In a nutshell, the categories refer to the different conditions associated with the compounding of sterile preparations.

  • Category 1: Compounded under the least controlled environmental conditions and has the shortest beyond-use-dates (BUD).

 

  • Category 2: Require more environmental controls and testing compared to category 1 CSPs and may have longer BUDs.

 

  • Category 3: Requires sterility testing, endotoxin testing if applicable, and has more personnel qualifications than category 2. CSPs in category 3 may be assigned longer BUDs than CSPs in category 2.

 

  • Frequency of aseptic technique and gloved fingertip testing
    • Every 12 months for those who have direct oversight of compounders:
    • Every 6 months for those who compound Category 1 and 2 CSPs
    • Every 3 months for those who compound Category 3 CSPs

 

What’s New in USP 797 Media Fill Testing

  • Increased Frequency: For high-risk Category 3 CSPs, testing frequency has doubled to every 3 months
  • Standardized Procedure: The distinction between batch and single-dose testing is gone. All media fill tests now follow the same rigorous procedures, ensuring consistency and comparability.
  • Expanded Incubation Temperatures: Media fill test samples must be incubated at both 30-35°C and 20-25°C for 7 days each to detect a broad spectrum of microorganisms. The order of incubation temperatures will be described in the facility’s SOPs. Failure is indicated by visible turbidity in the media in one or more containers on or before 14 days.
  • Glove Fingertip and Thumb Sampling: This new requirement provides a more direct assessment of personnel aseptic technique, adding another layer of safety verification. In addition, the new standard requires that there should be glove fingertip and surface sampling performed after media fill to further assess the aseptic technique of the personnel and the overall sterility of the compounding process. A failure in the media fill, glove fingertip and thumb sampling, or surface sample constitutes an overall failure of the aseptic manipulation competency and requires repeat testing of all three tests.

Implementation Tips for Success

  • Thorough Training: Ensure all personnel involved in sterile compounding are adequately trained in the updated media fill testing procedures.
  • Precise Documentation: Maintain detailed records of each test, including dates, personnel involved, media used, and incubation temperatures. If the facility purchased sterile commercial microbial media, a Certificate of Analysis (COA) must be obtained from the manufacturer stating that a lot of media can support microbial growth. The media should be stored according to manufacturer’s instructions and used by the expiration date.
  • Investigate and Learn: If a media fill test shows microbial growth, conduct a thorough investigation to identify the root cause and implement corrective actions to prevent future occurrences.
  • Continuous Improvement: Embrace media fill testing as an ongoing quality control measure, promoting a culture of continuous improvement in your compounding practices.

Conclusion

By adapting to the new USP <797> media fill testing requirements, clinical microbiologists can play a pivotal role in safeguarding patient safety and ensuring the highest standards of sterility testing in compounded sterile preparations.

Have questions about the new USP <797> media fill testing requirements? Call us today at (713) 663-6888 to schedule a consultation or visit our website for any other testing services your facility may require such as clinical, environmental, or infection prevention services.  Microbiology Specialists Inc. is a full-service microbiology laboratory based in Houston, Texas. Every dose you prepare deserves the highest standards of sterility. Trust Microbiology Specialists Inc. to safeguard your patients with accurate and compliant USP <797> and USP <71> media fill testing. We’re your dedicated partner in building a culture of compounding confidence.

Sources:

  1. Hardy Diagnostics – Upcoming Revisions to USP <797>
  2. USP <797>  Pharmaceutical Compounding – Sterile End Preparation – official as of 11/1/23