Medical Devices

What we see and have learned from our customers

• Catheters, tubing sets, connectors, valves, infusion components
• Diagnostic cartridges and microfluidic assemblies (channels, ports, seals)
• Electronics-bearing devices and sensors where particles, films, and ESD can impact performance

• Form/fill/seal and pouch sealing processes that must be validated and repeatable
• “Aseptic presentation” workflows: clean handling to keep sterile barrier systems intact and clean at opening
• Sealer surfaces and guides where dust, films, and adhesive/ink transfer become repeat defect drivers

• Bioburden control before terminal sterilization where required by risk model
• Residue and particle control for tight-tolerance devices (valves, filters, microchannels, optical or sensing elements)
• “Hidden surfaces” and pockets where soils persist if swabbing methods are not defined

A practical way to categorize “device sensitivity”

Use these tiers to decide where you need sealed-edge materials, sterile consumables, and higher monitoring intensity.

A decision shortcut we use with customers

If you are fighting particles, tighten material introduction + low-linting tools. If you are fighting films, tighten solvent grade + wipe technique + residue management. If you are fighting viables, tighten disinfectant layering + sporicide triggers + EM trending. Most programs fail because they treat all three as the same problem.

• Classification is a baseline. Continued compliance requires testing/verification and behavior that matches the room’s design.
• Recovery after disruptions matters: doors, gowning breaches, maintenance intrusions, and changeovers create spikes that need defined recovery steps.

• One-way flows reduce cross-contamination and stop “rework loops” that repeatedly expose product.
• Define controlled staging surfaces; remove corrugate/paper sources from the critical zone.

• Cleaning is soil removal. Disinfection is microbial reduction. The method must define both.
• Wiper and swab selection is part of validation: shedding, extractables, and compatibility affect residues and particulate load.

• What you measure, how you trend, and how you respond are what make a program defensible during investigations.
• Consumable traceability and substitution rules reduce “unknown variable” problems after excursions.

How SOSCleanroom helps device manufacturers keep control stable

• Particles/fibers: corrugate, paper, shop wipes, and garment shedding land at the seal interface.
• Films: glove residues, silicone transfer, cleaning-fluid residues, and adhesive/ink transfer change sealing behavior.
• Method drift: unstandardized wipe wetness, inconsistent station cleaning, and uncontrolled staging surfaces.

• No-cardboard boundary: corrugate stays outside the critical zone; define where outer packaging is removed.
• Approved staging surfaces: trays and bench liners that are low-linting and replaced on a schedule.
• Sealer surface cleaning method: defined wiper + chemistry + pattern + frequency; include guides and touch points.
• Glove triggers: any door/cart/packaging contact triggers re-glove before touching sterile barrier materials.

A simple packaging-line rule that reduces defects

Treat sterile barrier materials like exposed product. If an operator touches anything “outside the station footprint,” they re-glove before touching materials again. This one rule eliminates a large percentage of film transfer and particle drag-in at seal interfaces.

• Define a gowning sequence by zone (support vs. critical) and train it the same way every time.
• Garment system selection should match your ISO class and shedding tolerance (IEST guidance is commonly used for garment system considerations).
• Build in “pause points” (mirror check, glove check, sleeve interface check) before entering the critical zone.

• Define re-glove triggers: doors, carts, corrugate, phones, keyboards, trash, tools outside the station footprint.
• Prefer powder-free, silicone-free options when films/residue transfer is a known risk.
• For electronics-bearing devices, pair glove choice with ESD controls where required (grounding, mats, handling rules).

Wipers (bench, fixture, packaging station, tools)

Think in “families” and map them to zones rather than letting every department buy their own wipe.

Operator cue: wipe faces are inventory. If you use one face on a dirty surface, you do not “upgrade it” by folding; you discard or move to the next controlled face.

Swabs (ports, pockets, corners, seal interfaces, small features)

Common failure mode: re-dipping a used swab into the main solvent container. This is one of the fastest ways to contaminate chemistry and spread soils across lots. Define a transfer method (dispense into a small, controlled secondary container) and discard the secondary at a defined frequency.

Gloves and garments (human-generated contamination control)

Wiping and cleaning technique (high-impact details)

Risk statement: In ISO-classified and sterile-handling environments, alcohol is not “just alcohol.” Uncontrolled solvent and packaging can introduce particles, residues, variability, and documentation gaps that undermine control and investigation defensibility.

• Why alcohol is used: fast acting vs. many vegetative organisms and can leave minimal residue when properly specified and applied.
• Why general-purpose alcohol does not belong: not sterile; packaging sheds; impurities/denaturants can leave films; water variability changes consistency; traceability gaps complicate investigations.
• Operator-ready rule: in critical zones, avoid uncontrolled spraying; apply with low-linting wipers/applicators to control aerosols and ensure coverage.
• Sequence: clean first (soil removal), then disinfect. Alcohol is not a substitute for cleaning when soils are present.

Risk statement: Programs that rely only on non-sporicidal disinfectants can allow spores and resistant environmental forms to persist, seed recurring contamination, and create resident-flora trends.

• Where they fit: clean → routine disinfect → (as applicable) alcohol step → periodic + event-driven sporicide reset.
• Routine cadence: define schedule by zone risk; higher-risk zones are more frequent.
• Event triggers: viable excursions, repeated mold/Bacillus signals, maintenance intrusions, HVAC upsets, water leaks, construction, ceiling disturbance, drain events, traffic breakdowns.
• Technique: pre-clean, control wet contact time, prefer wipe application in critical zones, and manage residues with defined follow-up wipes where required.

Dwell time reality check (a training cue)

If the surface dries early, the chemistry may not achieve its intended claim in practice. The SOP must define “wet for full dwell time,” including how to re-wet, how much fluid to apply, and how to avoid recontamination when re-wetting.

• Cleaning: proves soil/residue removal to an acceptable level for your process (method, tools, chemistry, technique).
• Disinfection: reduces microbial load; effectiveness depends on contact time, coverage, and surface condition.
• Many failures come from skipping the “clean first” step and expecting disinfectants to cut through films.

• Wipers and swabs can add particles or residues; selection should be justified by zone and task.
• Define change control and substitution rules so a shortage does not become an unqualified method change.

• If sealing processes must be validated, define station cleaning and materials handling so the validated state is maintained day to day.
• Station buildup (films/particles) is a repeat defect driver; treat it like a controlled parameter, not a housekeeping item.

• Use ISO classification expectations in the classified zone and trend by location and by event type.
• Trend “near product” points separately from “room background” points to avoid masking risk-zone issues.

• Define sampling points at high-touch and high-risk interfaces (gowning exits, packaging stations, pass-throughs).
• Trend repeat organisms/locations; link to sporicide cadence, residue management, and traffic patterns.

AAMI TIR52 provides guidance for establishing environmental monitoring programs for terminally sterilized healthcare products, including viable/nonviable monitoring of air, surfaces, water, and compressed gases. It is useful for keeping EM actionable and aligned to risk.

Four-step response

A quick “root cause” filter we use

If the event is localized to one station, suspect method drift/materials intro. If it is facility-wide, suspect airflow/pressure/HVAC. If it recurs in the same place, suspect resident flora or a persistent film/soil source that needs a reset method.

• Remove non-approved items (paper, corrugate, personal items) from the station.
• Wipe down benches, fixtures, and tools using approved wiper + chemistry + pattern; define frequency.
• Stage only approved swabs/wipers/gloves; verify lot/expiry if required.
• Re-glove before handling exposed product or sterile barrier components.

• Outer packaging stays out: remove corrugate outside the classified zone.
• Wipe down inner packaging using a clean-to-dirty pattern; discard wipes when loaded.
• Define quarantine rules for damaged packaging, wet cartons, unknown suppliers, and “rush” exceptions.
• Document exceptions—exceptions are where investigations start.

• Define fold pattern (quarters) and face-change rules; do not “polish” with a spent face.
• One direction, overlapping strokes; top-to-bottom; clean-to-dirty.
• Define re-wet rules and dwell time expectations where disinfection claims apply.

• Select swab geometry by feature; avoid unknown adhesives and uncontrolled cotton tips in critical zones.
• Wet to damp, not dripping; rotate to a clean surface; discard after visible loading.
• Do not re-dip used swabs into the master chemistry container.

• Define “no cardboard” and “no paper” zones around sealers and sterile barrier materials.
• Clean sealer surfaces, guides, and staging areas with approved low-linting wipers on a defined schedule.
• Define glove change triggers and “outside touch” rules for packaging handlers.

• Define periodic reset (including sporicide where required) by zone risk.
• Trigger event-driven recovery after ceiling disturbance, maintenance intrusion, traffic spikes, pressure alarms, water leaks, or drain events.
• Document the event, recovery actions, and verification step before resuming exposure work.

• Define “no silicone” rules if adhesion and sealing surfaces are sensitive to films.
• Define solvent grade and wipe selection to avoid leaving residues that change surface energy.
• Include a visual acceptance check (lighting/angle) for haze/film before bonding or sealing.

• Before exposure: re-glove; station wipe-down complete; approved consumables staged; “no cardboard” boundary confirmed.
• During work: wipe-face control; swab discard rules; no re-dip; keep chemistry delivery consistent.
• Before closeout: defined final clean; inspection cues; packaging station clean; document lot/ID if required.
• If disturbed: trigger defined recovery step (wipe-down + verification) before proceeding.

Example SOP template excerpt (operator-ready): cleaning a fixture before assembly

Use as a template suggestion. Tailor chemistry and surfaces to your compatibility limits and validation strategy.

Stop condition: If haze/streaking remains after two passes, stop and investigate chemistry grade, wetness control, and wiper selection—do not dry-wipe “to fix it.”

A practical engagement model

Why customers choose this approach: it reduces rework, reduces surprises in packaging and inspection, and keeps the method stable when staffing or supply conditions change.

Editorial note: This resource supports customer education and method standardization. Any SOP templates or checklists are suggestions only; customers should adapt, approve, and validate them within their own quality systems.