Technical Tip

Disinfectants and Sporicides for 503A Sterile Compounding Facilities: Selection and Use Guide

Product selection and development of an effective disinfection routine is essential for maintaining your sterile compounding facility. Utilizing the table from USP <797> (2019 proposed), this technical tip is a useful aid in selecting products and developing effective routines for best results.
October 15, 2021

Key Takeaways:

  • USP <797> outlines specific cleaning and disinfection frequencies for sterile compounding areas, including daily and monthly tasks for Primary Engineering Controls (PECs), work surfaces, floors and walls.
  • STERIS offers a tiered product portfolio—including Septihol™ Sterile 70% IPA, Vesta-Syde™ SQ 64 RTU disinfectant and Spor-Klenz™ RTU sterilant—to meet daily and monthly microbial control needs.
  • Sporicidal agents like Spor-Klenz™ RTU require a separate cleaning step, while one-step disinfectants like Vesta-Syde™ SQ 64 RTU simplify routine disinfection.
  • Sterile 70% IPA is required for PECs after using disinfectants or sporicides, to remove residues and maintain aseptic conditions.
  • STERIS provides EPA-registered, phosphate-free and low-residue solutions, supporting compliance with USP <797> and enhancing contamination control in sterile compounding environments. 

Disinfectants and sporicides perform critical functions by killing a broad spectrum of common bacteria and fungi, and destroying the toughest environmental contaminants such as spore-formers. Product selection and development of an effective disinfection routine is essential for maintaining your sterile compounding facility. Utilizing the table from USP <797> (2019 proposed), this technical tip is a useful aid in selecting products and developing effective routines for best results.

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