USP <797> & <800>
Revision Enforcements Are Coming
Is your facility compliant?
Are you ready for the revised USP <797>?
Common Concerns
Cost
New equipment, changes to facility design, seperation of hazardous/non-hazardous compounding, more frequent monitoring
Time
More frequent environmental sampling, personnel assessment, and record-keeping
Training & Education
Training on new procedures in a short time span
The clock is ticking!
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Contec Healthcare can help you get prepared for
Step 2
Our experts will break down everything you need to know about cleaning, disinfecting and gowning regarding the June 2019 USP <797>/<800> regulation changes. Join our mailing list to hear how the changes are going to affect your facility and employees.
Follow Contec Healthcare to be informed of the new changes and how they will affect your facilities.
Step 1
Contec Healthcare can help prepare your employees with training and education regarding cleaning and disinfecting.
Contact a representative to learn how you can access our exclusive training portal with best practices, how-to series, webinars, and more.
Step 3
USP <797> Compliance Laws
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On June 1, 2019 the new revision of USP <797> was published and will be enforcable December 1, 2019.
Support for USP <797> Regulation Changes
The revised chapter will require monthly application of a sporicidal disinfectant on every surface in the cleanroom (PEC and SEC).
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Key Changes in Cleaning, Disinfecting and Garbing Related Activities
USP <797> was revised June 1, 2019. We're here to help you navigate the changes to ensure your facility is compliant by the enforceable date of December 1, 2019.
Download our PDF change document which highlights the topics that matter for you as a Contec customer.
USP <797> Revision
Download Change Document
New Requirements for
cleaning & disinfecting the sink
Peek Inside
Download Change Document
Critical Site
Requirements
New Requirements for
Cleaning and Disinfecting the PEC
Click to see the old chapter vs. the revised changes to USP Chapter <797>
More of these changes as they relate to cleaning, disinfecting and garbing can be found inside.
The original USP <797> Did not address cleaning and disinfecting the sink.
original chapter
The revised chapter states: “Surfaces of sink(s) must be cleaned and disinfected at least daily and a sporicidal agent must be applied at least monthly.”
revised usp <797> chapter
The original USP <797> Chapter did not address critical site wiping with its own section.
original chapter
"Critical sites (e.g., vial stoppers, ampule necks, and intravenous bag septums) must be wiped with sterile 70% IPA in the PEC to provide both chemical and mechanical actions to remove contaminants. The sterile 70% IPA must be allowed to dry before entering or puncturing stoppers/septums or breaking the necks of ampules”.
revised usp <797> chapter
Required the cleaning and disinfecting the PEC at the “beginning of each shift”
original chapter
The revised chapter (see Table 8 in section 7) requires to clean all interior surfaces of the PEC daily (once per day) and when surface contamination is known or suspected.
revised usp <797> chapter
