Entries by Pepper Group

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 <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.

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.