Should Compounders Sanitize Their Gloves During a Media-Fill Test?
Should compounders sanitize gloves during a media-fill test? Learn how realistic competency assessments support aseptic technique and USP <797> compliance.
USP <797>: Where Compliance Breaks Down—and How to Close the Gap
USP <797> provides a comprehensive framework for sterile compounding—but it does not function as an operational playbook. Most organizations are not struggling because they are unaware of the requirements. They struggle in the space between what the chapter says and what daily practice actually looks like.
USP <797> Contamination Control: Where Best Practices Make the Difference
USP <797> sets clear expectations for preventing contamination in sterile compounding—but compliance alone doesn’t guarantee control. True contamination control depends on how consistently best practices are applied in daily operations, especially in three high impact areas: garbing and hand hygiene, material transfer, and cleanroom behavior.
USP <797> Table 2 vs. Table 3: What’s the Difference — and Why It Matters for Ongoing Competency
Viable air and surface sampling are often treated as a second thought. Results are reviewed, levels are checked, and the program moves on until there’s exceeded an action level. But USP <797> never intended viable monitoring to be a passive exercise.
Viable Air and Surface Sampling Under USP <797>: What the Data Is Meant to Tell You
Viable air and surface sampling are often treated as a second thought. Results are reviewed, levels are checked, and the program moves on until there’s exceeded an action level. But USP <797> never intended viable monitoring to be a passive exercise.
USP <800> Wipe Sampling: Why It Matters—and How to Implement It Without Fear
For many sterile compounding teams, hazardous drug (HD) wipe sampling is one of the most intimidating aspects of USP <800>. Even organizations with strong sterile compounding programs often delay implementation—not because they don’t care about safety, but because they’re unsure what wipe sampling will uncover, how results will be interpreted, or how regulators will respond.
USP <797> & <800> in Practice: A 5-Step Playbook for Calm, Consistent Compounding
Sterile compounding standards are designed to protect patients and the people who prepare their medications. Yet many pharmacies still experience “compliance whiplash”—surges of activity before audits, followed by drift during normal operations.
Taking USP <797> Best Practices into the New Year: Resolutions for Sterile Compounding Success
Understand how to design effective media-fill tests that accurately simulate real-world sterile compounding workflows and verify personnel competency across both non-HD and HD environments. This article breaks down the key elements, testing schedules, and documentation practices needed to build a reliable, compliant, and sustainable MFT program.
Designing Effective Media-Fill Tests for Sterile Compounders
Understand how to design effective media-fill tests that accurately simulate real-world sterile compounding workflows and verify personnel competency across both non-HD and HD environments. This article breaks down the key elements, testing schedules, and documentation practices needed to build a reliable, compliant, and sustainable MFT program.
A 90-Day USP <797> Tune-Up Plan: Practical Steps, Real Results
Explore a focused 90-day roadmap designed to tune up your sterile compounding program without disrupting daily operations. This guide breaks down the essential actions, checks, and habits that drive real, measurable progress toward USP <797> compliance.