A cleanroom is not a room with HEPA filters. It is a controlled space with defined particle performance, airflow intent, pressure relationships, and a qualification/certification program that proves the controls work — then verifies they keep working. In compounding, this includes your primary engineering control (PEC) and the surrounding secondary engineering controls (SEC).

• Air cleanliness classification: room classification is based on particle concentration performance (ISO 14644-1 principles apply).
• Airflow intent: how air moves in the PEC and room matters. People placement, reach, staging, and “where you park supplies” can defeat good engineering.
• Pressure and flow discipline: pressure relationships and one-way flows reduce cross-contamination (personnel flow, material flow, waste flow).
• Recovery and operational impact: a space can pass at-rest tests and still struggle operationally if work practices create turbulence and repeated intrusions.
• Certification evidence: your certification reports and corrective actions are part of the compliance narrative.

Environmental monitoring (EM) becomes meaningful when it is trended, reviewed, and tied to action. Pharmacies often “collect samples” but do not close the loop: What did we see? What changed? What did we do? How do we prevent recurrence?

1. Define sampling locations by risk: ISO-critical touchpoints, high-touch surfaces, pass-through interiors, and gowning interfaces.
2. Define cadence by zone and behavior: higher-risk zones more frequent; adjust when workflows change.
3. Trend by organism and location: “repeat offender” sites signal resident contamination or technique breakdown.
4. Link excursions to response: cleaning reset, sporicidal event, retraining, facility repairs, or workflow changes — documented with dates and sign-off.
5. Keep EM records audit-ready: easy retrieval, clear ownership, and documented review intervals.

Cleaning and disinfection is a method, not a product. Your best chemistry will fail if soil remains, if contact time is not achieved, or if technique spreads contamination from dirty to clean. The core operational goal is to keep high-risk surfaces in a known state of control and to generate documentation that is defensible when an excursion occurs.

• Step 1 — Clean: remove soil/residue so the disinfectant can contact the surface uniformly.
• Step 2 — Disinfect: apply approved disinfectant with correct coverage and wet contact time.
• Step 3 — Alcohol step (where applicable): use sterile alcohol as your routine final step in ISO-critical workflows if your procedure defines it.
• Step 4 — Sporicidal cadence: periodic and event-driven sporicidal “reset” to control spore burden and resident flora risks.

• Low-linting materials: select wipers and swabs for shedding control and compatibility. Nothing is truly lint-free; aim for low-linting and controlled extractables.
• Fold discipline: manage wipe faces intentionally. Change faces frequently; do not “stretch” a loaded face across multiple surfaces.
• Pattern: clean-to-dirty, top-to-bottom, and defined directional passes to avoid redistributing contamination.
• Contact time: train for “wet for full dwell time.” If it dries early, the claim may not be achieved in practice—build re-wet rules into the method.
• No-spray rule in ISO-critical spaces: in PECs, controlled wipe application reduces aerosols/overspray and is easier to standardize and document.

USP <797> is the sterile compounding backbone. Even when local enforcement is uneven, the “language of control” used by regulators, accreditors, and health systems often maps to USP expectations: cleaning/disinfection method discipline, competency, and evidence that the space stays in control over time (not just at certification).

• ISO-critical surface control: PEC interior surfaces are cleaned and disinfected with a repeatable method, correct materials, and documented completion.
• Personnel competency evidence: staff demonstrate consistent technique (hand hygiene, garbing discipline, and aseptic behaviors that preserve airflow intent).
• Material introduction discipline: what enters the room is controlled, wiped down, and staged to avoid contaminating critical zones.
• Monitoring and response: you can show EM review, trending, and documented response to excursions.
• Controlled substitutions: you have an approved list of wipers/swabs/chemistries and a documented substitution process.

If you handle hazardous drugs, your surface program must control both contamination and exposure. USP <800> became official December 1, 2019. The hazardous drug universe is not static; it is updated over time (NIOSH publishes lists used widely by healthcare).

• Identify HDs: maintain a current hazardous drug inventory (many organizations anchor to the NIOSH list).
• Define where HDs are received, stored, compounded, and disposed: these steps define where DDC and PPE controls apply.
• Train to behaviors, not posters: the most common failures are inconsistent glove changes, incomplete deactivation/decontamination steps, and unclear spill responses.

• Spills, glove tears, or visible residues.
• Workflow changes (new HDs, new volumes, new staff, new equipment, new shift patterns).
• Monitoring signals or recurring incidents that suggest “residue persistence.”

People are often the dominant contamination source in compounding cleanrooms. Gloves and garments are not an afterthought; they are contamination controls and, for HD work, worker-protection controls. The fastest way to reduce variation is to standardize a short list by zone and task, then train and document execution.

• Sterile vs. non-sterile: ISO-critical compounding commonly drives sterile glove programs to reduce avoidable risk and strengthen traceability.
• Material selection: nitrile vs. latex vs. polychloroprene (neoprene) should match dexterity, comfort, allergen profile, and chemistry exposure.
• HD work: confirm chemotherapy drug handling suitability for your use case, and standardize double-gloving where required by your program.
• Packaging discipline: wallet/pouch systems that support controlled opening help reduce handling variability at the hood.

• Low-linting and cleanroom compatibility: garments reduce particle shedding and fiber transfer during movement.
• Fit and closure controls: hoods, protective flaps, thumb loops, and sealed closures reduce exposure gaps and repeated “adjustment touches.”
• HD context: align gowns/coveralls to your hazardous drug risk and procedure (PPE is a core control in USP <800> programs).

Wipers and swabs are performance tools. In compounding, they must remove soil, deliver chemistry consistently, avoid shedding, and avoid leaving residues that complicate disinfection and investigations. The more critical the zone, the more sealed edges, controlled manufacturing, sterility (where required), and traceability matter.

• Polyester (knit/synthetic): strong low-linting baseline and chemical resistance for critical surfaces.
• Microfiber/microdenier: helps on scratch-sensitive surfaces and residue removal where haze/film affects outcomes.
• Cellulose/polyester blends: “workhorse” sorption for lower-risk areas and spills while maintaining controlled shedding.
• Polypropylene (often pre-wetted): consistent solvent delivery formats and controlled wetness to reduce variation.
• Format drives behavior: pre-wetted reduces bottle variability; sterile formats reduce ISO-critical handling risk and improve documentation discipline.

• Ports, hinges, seams, and corners: swabs make the method complete. If you never clean the seam, it becomes the reservoir.
• Head material by task: polyester knit (low background), foam (precision solvent work), and specialty geometries for tight access points.
• Traceability cues: favor cleanroom-intended, lot-controlled swabs where documentation and repeatability matter.

Risk statement: In ISO-classified and sterile compounding environments, alcohol is not “just alcohol.” Uncontrolled solvent quality and uncontrolled delivery (consumer bottles, triggers, and pump tops) can introduce particles, residues, variability, and documentation gaps that undermine state of control.

• Fast-acting against many vegetative organisms when applied correctly.
• Often leaves minimal residue when properly specified and applied.
• Important limitation: alcohol is not reliably sporicidal.

• Sterility and packaging: general-purpose alcohol is typically not sterile and not packaged for ISO-critical handling.
• Particle risk from delivery components: consumer nozzles and pump tops can shed particles and become contamination reservoirs at the interface.
• Impurity and residue risk: denaturants and uncontrolled water quality can leave films and increase variability.
• Traceability gaps: missing lot/expiry documentation complicates investigations and change control.

• PEC rule: do not spray in the hood. Apply alcohol using sterile, low-linting wipes/applicators to control aerosols and overspray.
• Sequence: clean first, then disinfect. Alcohol is not a substitute for cleaning when soils are present.
• Drying: allow surfaces to dry before resuming compounding to reduce recontamination and pooling risk.

Risk statement: If a contamination-control program relies only on non-sporicidal disinfectants, bacterial spores and other resistant forms can persist on surfaces, seed recurring contamination, and drive long-cycle resident flora problems that routine chemistries may not reliably eliminate.

1. Clean: remove soils/residues so chemistry contacts the surface.
2. Routine disinfect: daily/shift control for vegetative organisms.
3. Sterile alcohol (as applicable): routine ISO-surface step; not sporicidal.
4. Periodic + event-driven sporicide: reduces spore burden and provides a deliberate reset mechanism.

• Routine cadence: define a minimum schedule for classified areas (often monthly or risk-based by zone).
• After viable excursions: adverse trends, repeated mold recoveries, recurring Bacillus, resident flora signals.
• After disruptive events: maintenance intrusions, construction, HVAC upset, water leaks, drain backups, ceiling disturbance, power outages.
• After procedure breakdowns: gowning breaches, uncontrolled traffic, improper material introduction, spill events beyond the initial footprint.

• Pre-clean first: sporicides do not reliably “cut through” heavy films.
• Wet contact time: “wet for full dwell time” must be explicit; include re-wet rules.
• Prefer wipe application in critical zones: controlled wiping reduces aerosolization and improves repeatability.
• Residue management: many sporicides leave films; define when to follow with sterile water and/or sterile alcohol (based on your compatibility and validation approach).
• Compatibility and safety: specify do-not-use surfaces, PPE, ventilation notes, and spill response for selected chemistry.

Documentation is not paperwork for its own sake. In an excursion, documentation is the mechanism that narrows scope, protects patients, protects staff, and speeds recovery. Strong programs document the method at the point of performance and tie it to certification identifiers and monitoring locations.

• Approved product list: disinfectants, sporicides, alcohol, wipers, swabs, gloves, garments — by zone and task.
• Lot/expiry controls: how you receive, store, stage, and retire expired materials; what is allowed in the cleanroom.
• Cleaning logs: completion by zone with method cues (sequence, chemistry, contact time acknowledgment where required).
• EM records: results + review + trending + documented response.
• Training/competency: initial and ongoing competency evidence, direct observations, and retraining triggers.
• Deviation/CAPA: event description, scope, containment, root-cause rationale, corrective action, and effectiveness check.

Use the following as a checklist for your own procedures. These items are written as “what a good SOP covers,” not as a prescriptive SOP. Align details (frequency, sites, thresholds) to your facility design, certifier guidance, risk assessment, and local enforcement expectations.

• Zones and surfaces with unique identifiers that match certification reports.
• Sequence: clean → disinfect → alcohol step (where applicable) → sporicidal cadence/reset.
• Approved chemistries and compatible substrates (wipers/swabs) for each zone.
• No-spray rules for PECs and controlled wipe application requirements.
• Contact time rules (wet for full dwell) and re-wet instructions.
• Residue-management step after sporicide when required.
• Documentation: what is recorded, where, and by whom; what requires second-person verification.

• HD inventory management and how you update the list.
• DDC workflow: deactivation → decontamination → cleaning (plus disinfection for sterile areas as applicable).
• PPE by task: gloves, gowns/coveralls, eye/respiratory protection where applicable.
• Spill response, waste flow, and “what gets removed from the room” rules.
• Change-out triggers: glove tears, task changes, leaving the room, visible residue events.

• Direct observation checklists (hand hygiene, garbing, wipe technique, staging discipline).
• Requalification triggers (new staff, extended absence, excursion trends, process changes).
• “Stop the line” authority: when staff must pause compounding and escalate.