Nuclear Pharmacy

The Technical Vault

By SOSCleanroom

Nuclear Pharmacy Cleanrooms: A Practical, Audit-Ready Guide to Contamination Control, Consumables, and Daily Readiness

Written as an educational resource for licensed nuclear pharmacy and radiopharmaceutical operations. Always follow your Radiation Safety Officer (RSO), Pharmacist-in-Charge, facility procedures, and applicable regulators.

Why this matters

Nuclear pharmacy is a time-sensitive discipline: dose accuracy, sterility/cleanliness expectations, and radiation safety requirements intersect under tight turnaround windows. When something drifts—surface bioburden, residues, particles, glove failures, or inconsistent documentation—the downstream impact shows up as delayed studies, repeat work, deviations, and avoidable staff exposure.

Core cleanroom controls that drive outcomes in nuclear pharmacy

Cleanroom performance is ultimately a risk-management problem: you are controlling viable and nonviable contamination, chemical residues, and workflow variability—while also managing radioactive material handling under a defined compliance scope. The most resilient programs treat contamination control as a system: engineered airflow, disciplined techniques, validated chemistries, and consumables that reduce variability shift-to-shift.

Risk factors that determine the control strategy

Product risk: Define sterile vs. non-sterile scope; assess sensitivity to endotoxin/pyrogens, particles, residues, and handling errors.
Process risk: Identify where contamination is introduced—open manipulations, transfers, changeovers, maintenance intrusions, and high-touch steps.
People risk: Gowning, traffic, and technique consistency are often the dominant contamination source; training and standardized work matter as much as the facility.
Compliance scope: Confirm whether USP <825> (radiopharmaceutical prep/compounding/dispensing/repackaging) applies and where USP <797> (sterile compounding) and USP <800> (hazardous drugs) apply to your operation.

Controls that must work together

Airflow and filtration: HEPA is not the finish line—qualification plus ongoing verification and operator behaviors determine real-world performance.
Flow discipline: One-way personnel/material movement reduces crossovers, rework loops, and repeated exposure opportunities.
Surface control: Cleaning and disinfection is a method, not a label. Outcomes depend on chemistry selection, application, coverage, and technique.
Evidence of control: Certification, monitoring, trending, and documented response to excursions are the backbone of defensible operations.

Regulatory and standards context (how customers typically frame requirements)

USP <825>: Establishes minimum practice expectations for radiopharmaceutical preparation/compounding/dispensing/repackaging and emphasizes controlled, repeatable processes.
USP <797>: Governs sterile compounding risk controls (facility, environmental monitoring, personnel qualification, cleaning/disinfection program). Many radiopharmacy workflows align controls here when sterile preparation is in scope.
USP <800>: Applies when hazardous drugs are handled—engineering controls, PPE, deactivation/decontamination/cleaning, and documentation expectations change materially.
NRC medical-use requirements: NRC (or Agreement State) expectations focus on authorized personnel, safe handling, training, and radiation protection programs—including the Authorized Nuclear Pharmacist qualification path.

Practical takeaway

Even when two facilities “meet the same chapter,” their day-to-day outcomes can differ dramatically based on consumable standardization, technique training, and how quickly they can recover from disruption (maintenance, traffic spikes, spill events, or supply interruptions).

What we see and have learned from our customers

“Same products, different results.” The difference is almost always technique: wipe-face control, coverage patterns, and dwell-time discipline.
Spraying in critical zones creates avoidable variability. Aerosols, overspray, and nozzle contamination are recurring root causes—especially around PECs and high-control work areas.
Residues quietly accumulate. Even effective chemistries can leave films if the program doesn’t define residue management (follow-up wipes when appropriate).
Stockouts become quality events. When a team substitutes “almost equivalent” wipes, gloves, or alcohol formats mid-week, drift shows up in particles, residues, and training gaps.

How SOSCleanroom fits

We do not write your SOPs. We help customers reduce risk by standardizing best-in-class consumables, packaging formats, and replenishment discipline—so your team can work the same way every day without worrying about supply. Fast shipping, excellent customer service, fair pricing, continuity of supply, and 40+ years supporting controlled environments—backed by a multi-award-winning track record—are how we help keep your operation ready.

Wiping and cleaning technique (high-impact details)

Technique rules that prevent rework

Low-linting materials: Select wipers based on shedding, extractables, and surface compatibility to reduce particles and residues.
Fold discipline: Control wipe faces intentionally; change faces frequently to prevent redeposit.
Pattern: Use clean-to-dirty and top-to-bottom patterns; avoid circular scrubbing unless your procedure explicitly validates it for that soil.
Contact time: “Wet for full dwell time” must be achieved in practice. If the surface dries early, the disinfection claim may not be met.

Wiper and swab types (what to choose and why)

Selection is driven by substrate, edge treatment, cleanliness/traceability, and format (dry vs. pre-wetted; sterile vs. non-sterile). In nuclear pharmacy, “operator variability” is a quality risk—so packaging and consistency matter as much as the substrate.

Polyester wipers: Durable, low-linting options for critical surfaces; sealed-edge variants are typically favored in higher-control zones.
Microfiber / microdenier: Useful on scratch-sensitive surfaces and when residue removal is a major concern (match to compatibility).
Nonwoven blends: Good “workhorse” options in lower-risk zones where sorption and strength are important and allowed by procedure.
Polypropylene (often pre-wetted): Frequently used for controlled solvent delivery; always confirm compatibility and residue behavior.
Cleanroom swabs: Choose by head material, geometry, and traceability needs—especially for corners, seams, vial/port interfaces, and sampling tasks.

Cleanroom-grade alcohol: why sterile, controlled alcohol is the standard

Risk statement

In ISO-classified and sterile workflows, alcohol is not “just alcohol.” Uncontrolled solvents and delivery methods can introduce particles, residues, variability, and documentation gaps that undermine investigations and day-to-day control.

Why normal/general-purpose alcohol does not belong in controlled environments

Not sterile / not packaged for ISO handling: General-purpose bottles and closures can become contamination reservoirs.
Particles and packaging risks: Consumer triggers, pumps, and nozzles can shed, leak, and accumulate residues at the interface.
Residue and impurity risk: Denatured or low-grade alcohols may contain denaturants/impurities that leave non-volatile residues or compatibility issues.
Water-quality variability: “70%” performance is only as consistent as the water used. Uncontrolled water introduces ions/residues/microbial risk.
Documentation gaps: Missing lot traceability, expiry, and quality documentation complicates deviation investigations and change control.

Best-practice alcohol use (operator-ready)

PEC rule: Do not spray in the hood. Apply using sterile, low-linting wipes/applicators to control aerosols and overspray.
Sequence: Clean first (soil removal), then disinfect. Alcohol is often a routine/final step—never a substitute for cleaning when soils exist.
Drying: Allow surfaces to fully dry before resuming operations to support intended effectiveness and reduce wet-contact recontamination risks.

Sporicidal disinfectants: where they fit, and when they are needed

Risk statement

If a program relies only on non-sporicidal disinfectants, spores and resistant environmental forms can persist, seed recurring contamination, and drive long-cycle “resident flora” problems.

How sporicides fit into a layered program

Clean: Remove soils/residues so chemistry contacts the surface.
Routine disinfect: Daily/shift control for vegetative organisms.
Sterile alcohol (as applicable): Fast routine step for ISO/PEC workflows; not sporicidal.
Periodic + event-driven sporicide: A deliberate “reset” to reduce spore burden and prevent long-cycle contamination.

When sporicide is needed (routine and event-driven triggers)

Routine cadence: Define a minimum schedule by zone risk (higher-risk zones more frequent).
After viable excursions: Repeated mold recoveries, recurring Bacillus, adverse trends, or “resident flora” signals.
After disruptive events: Maintenance intrusions, construction, HVAC upset, leaks, drain backups, ceiling disturbance, power outages.
After procedural breakdowns: Gowning breaches, uncontrolled traffic, spill events that spread beyond the initial footprint.

Technique that makes sporicides work (and prevents damage)

Pre-clean first: Sporicides do not reliably cut through heavy films.
Control wet contact time: “Wet for full dwell time” must be explicit, including re-wet rules.
Prefer wipe application in critical zones: Controlled wiping is more repeatable and reduces aerosolization.
Residue management: Many sporicides leave films—define follow-up steps where required to avoid buildup and compatibility issues.
Compatibility and safety: Define do-not-use surfaces, PPE, ventilation notes, and spill response aligned to your selected chemistry.

Gloves in nuclear pharmacy: consistency, dexterity, and protection

Gloves are both a contamination-control tool and a safety control. Customers typically standardize glove choices by zone and task: high-control sterile work, routine handling, and any hazardous drug interfaces (when in scope).

Selection drivers (what matters in practice)

Zone fit: ISO compatibility and sterile packaging where required by procedure.
Grip + tactile control: Reduced slip supports safer, more repeatable manipulations under time pressure.
Chemical splash / compatibility: Consider disinfectants, solvents, and any deactivation agents used in your facility.
Double-don strategy: Often used to reduce breach risk and improve doffing control in higher-risk tasks (align to your SOP).

Manufacturer examples customers frequently evaluate

Ansell TouchNTuff 93-700 (sterile nitrile): Positioned for ISO 5 / “Class 100” cleanroom compatibility and sterile packaging formats.
Kimtech G3 Sterile White Nitrile (Kimtech): Positioned for sterile cleanroom use; published features include AQL targets, anti-static testing, and double-don suitability.

Note: Final selection should be based on your facility risk assessment, compatibility needs, and validation/qualification expectations.

Radiation safety and decontamination: keep it procedural

This page is not a substitute for your RSO program. However, one recurring best practice is to ensure your contamination-control consumables support controlled, repeatable decontamination steps when surface contamination events occur—especially around seams, corners, and high-touch interfaces. Maintain clear segregation of tools by area/task, and ensure your spill response materials and monitoring expectations are trained and documented.

Consumable-related readiness checks customers use

Spill kit completeness (per RSO program), including appropriate wipes, absorbents, bags, and labeling.
Dedicated “event” tools stored separately from routine tools to avoid cross-use.
Lot traceability and expiry visibility for sterile chemistries and sterile packs.
Training refreshers on wiping patterns, dwell-time, and doffing discipline (especially after staffing changes).

SOSCleanroom training materials you can use in your program

Our Training Materials and How-To Guides include operator-focused tools that customers commonly use to standardize technique: Isolator Cleaning Guide; Mopping Guide; Wiping Guide; Swab Sampling Guide; Wiper Chemical Compatibility; Wiper Cleanliness Chart; Swab Solvent Compatibility. If you want help aligning these to your facility’s procedure set, our team can help you map “which tool for which zone and task.”

Featured Texwipe product recommendations (commonly used configurations)

These examples reflect common controlled-environment configurations. Align final selection to your SOPs, zoning, and validation requirements.

Use case	Example items	Why customers choose this
Sterile low-linting wipers (Vertex)	TX3049 (9" x 9") dry TX3042 (12" x 12") dry TX3049P (9" x 9") pre-wetted 70% IPA TX3042P (12" x 12") pre-wetted 70% IPA	Supports repeatable wiping technique (fold discipline, one-direction strokes) with sterile handling formats.
Adhesive mats (CleanStep)	18" x 36", 18" x 46", 24" x 36", 25" x 45", 36" x 46"	Helps reduce particulate transfer at key entry points and supports flow discipline.
Mop systems	TX7108 Alpha flat mop TX7106 Beta string mop TX7101 Isolator/hood mini flat mop	Zone-appropriate floor and small-surface control without introducing avoidable residues or shed.
Sterile denatured ethanol	TX3267 (70% ethanol), 16 oz bottles TX3265 (70% ethanol), 32 oz bottles	Controlled, SOP-friendly sterile chemistry formats to reduce variability and improve documentation defensibility.
Individually packaged sterile swabs	STX705P poly handle cotton swab STX705W wood handle cotton swab STX708A circular foam swab STX712A rectangular foam swab STX763 polyester swab STX764 small polyester swab	Precision cleaning and sampling where geometry and controlled handling are major success factors.

Tip: Customers often reduce deviations by standardizing a “core kit” per zone (same SKUs, same packaging, same replenishment cadence) and keeping it stable through change control.

Suggested SOP modules (templates to adapt, not one-size-fits-all)

SOSCleanroom does not write your SOPs. The modules below reflect the structure many customers use to make programs trainable and auditable. Your final procedure set should be authored/approved internally and aligned to your regulators and RSO program.

Zoning and tool segregation: Define “what lives where,” including dedicated tools for PEC/critical zones vs. general areas.
Daily wipe-down (routine): Specify sequence, wiping pattern, fold discipline, and dwell-time verification (wet for full contact time).
Periodic sporicide step: Define cadence, event triggers, compatibility notes, and residue management (when follow-up is required).
Glove program: Zone-based glove types, don/doff steps, double-don logic where applicable, and replacement triggers.
Disruption recovery: Maintenance intrusion reset, traffic excursions, leak response, and return-to-service checks.
Documentation essentials: Lot/expiry capture for sterile chemistries and sterile packs; deviation notes; corrective actions; training sign-offs.

Source basis

SOSCleanroom — “Nuclear Pharmacy: Why it matters” and recommended Texwipe configurations (Vertex wipers TX3049/TX3042/TX3049P/TX3042P; TX7108/TX7106/TX7101; TX3267/TX3265; STX705P/STX705W/STX708A/STX712A/STX763/STX764).
SOSCleanroom — Training Materials and How-To Guides (Isolator Cleaning Guide; Mopping Guide; Wiping Guide; Swab Sampling Guide; compatibility/cleanliness charts).
USP–NF — General Chapter <825> revision bulletin posting (official date shown as Jan. 1, 2024) and related compendial materials.
USP — General Chapter <797> overview materials (sterile compounding requirements context).
NRC — 10 CFR 35.55 (training requirements for an Authorized Nuclear Pharmacist).
SNMMI / Journal of Nuclear Medicine Technology — articles discussing practical impact of USP <825> in nuclear medicine settings.
Institutional radiation safety decontamination guidance (example university EHS training manuals) for general awareness of procedural spill response concepts; follow your facility RSO program.
Manufacturer literature: Ansell TouchNTuff 93-700 sterile nitrile product information; Kimtech G3 sterile nitrile product information.
IAEA / international guidance on current good radiopharmacy practice (cGRPP) for small-scale preparation (international best-practice framing).

Editorial note: This page is designed for customer education and program planning. It does not replace licensed professional judgment, facility validation, or regulator/RSO requirements.