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USP 797 Cleaning Solutions


USP <797> Cleaning & Disinfection Solutions
A practical guide to building a repeatable cleaning, disinfecting, and sporicidal program for sterile compounding — plus the consumables that help teams stay consistent and audit-ready.
Last updated: February 2026
By: SOSCleanroom
For pharmacies, hospitals, clinics, and sterile compounding teams
Quick links to common
<797> cleaning chemistries
and rotation programs.
Sterile 70% IPA EPA disinfectants Sporicidal program Low-lint tools Category 1–3 awareness Audit-ready logs

USP <797> sets minimum standards intended to reduce preventable patient harm from microbial contamination, excessive endotoxins, and other contamination risks that can arise during sterile compounding. The revised chapter structure also ties beyond-use dating (BUD discipline) to how controlled your environment and processes are.

Important note on sources: USP standards are copyrighted. This SOSCleanroom page is an educational, operational interpretation written in plain language. It does not reproduce USP–NF text verbatim and is not a substitute for the official USP–NF chapter. Always consult the official USP–NF text and your jurisdiction’s adoption/enforcement requirements for definitive requirements.
Why this page exists: Most compliance failures are not “lack of knowledge” — they’re variation. Standard chemistries + standard tools + standard technique + documented contact times = fewer excursions and easier audits.
Hazardous drugs note: If you compound sterile hazardous drugs, you must also comply with USP <800> in addition to <797>.
What changed (and why it matters for cleaning)
Modern framing: The revised USP <797> model is category-based (Category 1, 2, and 3) and ties beyond-use dating (BUD) discipline to environmental/process controls. Cleaning and disinfection must be standardized, documented, and repeatable — not “who cleaned today.”
Category 1 (least controlled)
  • Often prepared in an unclassified segregated compounding area (SCA) with an ISO Class 5 PEC.
  • Short BUD limits drive why consistency and wipe discipline still matter.
Category 2 (cleanroom suite)
  • More facility controls and monitoring support longer BUDs (within chapter limits).
  • Cleaning becomes a system across the PEC and surrounding classified areas.
Category 3 (additional QA)
  • Adds more requirements (e.g., more frequent monitoring and stronger QA expectations; sterility testing may apply depending on how BUDs are assigned).
  • Programs typically increase sporicidal and documentation rigor.
Cleaning program fundamentals
Cleaning ≠ disinfecting ≠ sporicidal
  • Cleaning removes soils/residues (the “stuff” disinfectants may have to fight through).
  • Disinfecting reduces microorganisms using a chemical agent and correct contact time.
  • Sporicidal addresses spores and is typically used on a defined cadence as part of a rotation program.
Two rules that prevent most findings
  • Contact time discipline: follow the manufacturer’s minimum wet contact time — “spray and wipe immediately” is a common failure mode.
  • Dry time discipline for sterile 70% IPA: allow it to dry (don’t rush back to compounding).
Implementation tip: If your SOP does not define “what chemical + what tool + what pattern + what contact time + what log entry,” you do not have a repeatable system — you have individual habits.
PEC clarity (critical): When a chemical agent is used inside the ISO Class 5 PEC, USP <797> expects the cleaning, disinfecting, and sporicidal agents (and any water used for dilution) to be sterile. EPA registration alone does not address sterility. Always follow label directions and your SOP-defined contact times.
Chemistry & toolkit map (what teams typically standardize)
Non-endorsement clarity: USP does not endorse brands or products. The examples below help you map “requirement → execution tools” inside your SOPs and validation expectations.
Program need Typical tools & chemistries Shop on SOSCleanroom
PEC wipe-downs + residue-sensitive final step Sterile cleaning/disinfecting agents as defined by SOP (sterile when used inside the PEC) + sterile low-lint wipers + sterile 70% IPA for final residue removal, used with documented contact times and dry time discipline Shop sterile 70% IPA
Shop sterile wipers
Routine disinfection (classified areas / support zones) EPA-registered disinfectants used per SOP, with documented contact times (and sterile formulations when used inside the PEC); mop systems for floors/walls as applicable Shop disinfectants
Shop cleanroom mops
Spore control / rotation program Sporicidal disinfectant used on a defined cadence; ensure compatibility with surfaces and SOP-defined neutralization/residue control if needed (sterile agents when used inside the PEC) Shop sporicides
Material transfer wipe-downs Low-lint wipes + facility-approved sporicidal/disinfectant/sterile 70% IPA method (without damaging packaging/labels) Shop low-lint wipers
Shop sterile IPA
Precision cleaning of small surfaces/components Cleanroom swabs for controlled application and targeted wipe-down Shop cleanroom swabs
Practical rule: Standardize the tool format. Pre-wetted sterile wipes and unit-controlled packaging reduce “improvisation” (variable wetting, variable wipe patterns, missed contact times).
Material transfer wipe-downs
Goal: prevent outer packaging and uncontrolled surfaces from contaminating cleaner zones and the ISO Class 5 PEC.
Before items enter cleaner zones (SCA / anteroom clean side / pass-through)
  • Wipe items with an approved method (sporicidal, disinfectant, or sterile 70% IPA) using low-lint wipers — without damaging packaging integrity or labels.
  • If using a disinfectant/sporicidal, honor the minimum wet contact time; if using sterile 70% IPA, allow it to dry.
  • Use gloves and define the wipe pattern in SOPs (direction, overlap, face control, change-out rules).
Just before items enter the PEC (ISO Class 5)
  • Wipe items with sterile 70% IPA using sterile, low-lint wipers and allow to dry before use.
  • Where applicable, define exceptions for sterile items received in sealed containers designed to keep them sterile until opening (handled per facility SOP).
Technique matters: Mechanical action + wipe face control + contact time + drying = the repeatable result.
Shop the common USP <797> execution tools
Sterile 70% IPA
Solutions and wipes for daily disinfection and residue-sensitive final steps.
Shop IPA
EPA disinfectants
Routine disinfection options with manufacturer contact times and documentation. (Sterile agents are used inside the PEC.)
Shop disinfectants
Sporicides
Rotation programs and spore control (cadence per SOP). (Sterile agents are used inside the PEC.)
Shop sporicides
Sterile wipers & pre-wetted wipes
Low-lint, controlled formats that reduce variation.
Shop wipers
Mops & large-surface tools
Floor/wall/ceiling programs with zone segregation discipline.

Shop mops
Swabs (precision)
Controlled application for small parts and hard-to-reach areas.

Shop swabs
FAQ (common cleaning & disinfection questions)
Do I have to use EPA-registered disinfectants?
In the U.S., disinfectants are registered with the EPA. Your SOPs should specify the exact agent(s), use areas, and the contact times you will follow. Important: if a disinfectant/sporicidal agent is used inside the ISO Class 5 PEC, USP <797> expects it to be sterile (EPA registration does not address sterility).
Can cleaning and disinfecting be combined?
Many programs use one-step disinfectant cleaners that are formulated to clean and disinfect together when used with the proper contact time (as stated on the label). If used inside the PEC, the agent must meet the facility’s sterile-agent expectations per USP <797>.
How often do I need a sporicidal disinfectant?
Set this in SOPs based on your category and risk posture. As a baseline, many programs apply a sporicidal disinfectant at least monthly for Category 1–2 areas. Category 3 programs often increase rigor (commonly weekly for key ISO Class 5/ISO Class 7 internal surfaces, plus defined broader-area cadence), based on the facility’s assigned BUD strategy, monitoring results, and risk assessment. Always follow label directions, compatibility requirements, and your SOP-defined contact times.
Can I reuse opened containers of sterile wipes or sterile alcohol?
Many facilities allow reuse within the same controlled area after opening, but only within an SOP-defined time period after opening and consistent with manufacturer instructions. Discard immediately if the container is contaminated, compromised, or incorrectly stored.
Official USP references

Use official USP resources as your source of truth for chapter text, official dates, and current pathways.

  • USP compounding portal (General Chapter <797>): https://www.usp.org/compounding/general-chapter-797
  • USP FAQ hub: https://www.usp.org/frequently-asked-questions
  • USP–NF DOI record (chapter reference/preview pathway): https://doi.usp.org/USPNF/USPNF_M99925_07_01.html
  • USP FAQ — Identifying “official text” in USP–NF: https://www.usp.org/frequently-asked-questions/identifying-official-text
Need help standardizing your cleaning program (chemistry + tools + logs)?

SOSCleanroom supports critical environments with cleanroom-grade consumables and practical guidance that helps teams stay consistent, audit-ready, and in control.

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SOSCleanroom is the source for this educational entry.
Briefed and approved by SOSCleanroom staff.
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Last reviewed: February 18, 2026 Customer-first, audit-ready guidance Cleanroom consumables + education
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