Purpose & when to use

High-Speed Imaging and Velocimetry (HSI / Vel) captures microsecond aerosol and spray events with synchronized lighting — transient plume formation, leaks, breakup, nozzle dynamics, and multi-step mechanism timing — for medical, industrial, consumer aerosol, and fire-suppression devices. Particle Image Velocimetry (PIV) and Particle / Droplet Velocimetry (PDV) add quantitative flow-field and particle-speed data. The work supports root-cause investigations under ICH Q9 and design validation under 21 CFR Part 820. HSI / Vel is foundational for:

  1. Transient leak investigation in medical, consumer, and industrial dispensing systems — leak paths, splatter, and unintended aerosolization captured at microsecond resolution under ICH Q9 quality-risk framing.
  2. Velocity benchmarking for nozzle, valve, and trigger redesigns — particle-speed and flow-field data supporting predicate comparisons and change control under ICH Q5E and 21 CFR Part 820.
  3. Design-validation packages and engineering review decks for medical device, consumer aerosol, and industrial sprayer programs — annotated high-speed footage and timing data aligned to 21 CFR Part 820 design controls.
  4. Pairing with spray pattern, plume geometry, and PSD studies — connects transient actuation behavior to steady-state outcomes for nasal sprays and consumer aerosols under FDA nasal / oral spray framing.
  5. Multi-step mechanism timing validation for valves, triggers, and pump assemblies — trigger-to-frame alignment logs and event-duration metrics under 21 CFR Part 820 design-validation and ICH Q9 risk framing.

Use HSI / Vel when an event occurs too quickly for a standard camera to capture, when leak paths or transient dynamics affect a design or compliance question, or when the design team needs quantitative flow-field data to support a change.

Built for medical, consumer, industrial, and fire-suppression devices

HSI / Vel work spans the device classes where transient events drive the design or safety question — medical, consumer-aerosol, industrial-spray, and fire-suppression product programs under one analytical roof.

  • Medical deviceDrug delivery and emission
  • Consumer aerosolSprays · fogs · misters
  • Pump sprayMechanical pump bottles
  • Industrial sprayerCommercial dispensing rigs
  • Fire suppressionDischarge and aerosol jets

Instrumentation & measurement ranges

We set the frame rate, exposure, field of view, and seeding conditions to match the event duration and spatial scale of the device under test. Every parameter is documented in the study plan.

1 – 100 kfpsframe-rate

High-speed cameras (microsecond capture)

Microsecond-scale capture of transient plume formation, breakup, leaks, and mechanism timing — frame rate and exposure tuned to the event duration and trigger window.

0.5 – 10 µspulse-width

Synchronized lighting

Pulsed and continuous lighting locked to the camera trigger — freezes motion at the exposure level and improves plume-boundary contrast for downstream tracking.

0.1 – 100 m/svector-field

Particle Image Velocimetry (PIV) optics

Seeded flow imaging with planar laser sheet and DaVis vector-field analysis — quantitative airflow and seeded-flow maps across the field of view.

0.5 – 100 m/ssingle-particle

Particle / Droplet Velocimetry (PDV)

Single-particle and feature-tracking velocimetry for cases where global seeding isn't practical — particle-speed estimates with documented contrast and feature-trackability checks.

Test method options

MethodStrengthsTradeoffAligned with
High-speed visualization (qualitative + measured timing)
  • Fast to deploy with minimal setup — the default first-pass method for design / debug investigations.
  • Annotated footage with frame-by-frame timing supports engineering reviews and inspection-readiness narratives under ICH Q9.
Limited quantitative flow detail without velocimetry overlays — bridge to PIV / PDV when speeds need to be measured, not inferred.
ICH Q9
Particle tracking velocimetry (fit for purpose)
  • Direct particle-speed estimates in regions of interest without global seeding — works when natural contrast is available.
  • Lower setup overhead than full PIV — the right method when single-particle speed is the decision driver.
Requires sufficient particle contrast and trackable features — fails on diffuse plumes or low-contrast backgrounds.
PIV flow-field mapping
  • Quantifies velocity vectors and shear regions across the imaging plane — supports mechanism insights and CFD validation.
  • Datasets feed design-validation packages and predicate comparisons under 21 CFR Part 820 when product variations are assessed.
Requires careful seeding, illumination control, and alignment — higher setup overhead than visualization-only work.
21 CFR Part 820
Leak visualization study (enclosure, joints, interfaces)
  • Pinpoints leak origin and directionality — annotated footage drives CAPA packages and design controls under 21 CFR Part 820.
  • Pairs naturally with high-speed visualization on adjacent components — supports system-level investigations end to end.
Often needs iterative fixture tuning to expose the leak path — schedule unpredictability is higher than fixed-protocol studies.
21 CFR Part 820
Combined high-speed + plume geometry workflow
  • Links transient actuation behavior to steady-state plume angle and pattern outcomes — explains the dynamic behind the static result.
  • Strong framing for comparability studies under ICH Q9 risk framing where the regulator wants the dynamic explanation behind a spray-pattern submission.
More instrumentation, synchronization, and analyst time per condition — reserve for cases where the combined view materially changes the decision.
ICH Q9

Setup configurations

Each HSI / Vel study uses a configuration matched to the event, the device, and the decision the data must support. The fit-for-purpose setup balances time resolution and field of view with optical alignment and controlled triggering. During study planning, we define the dimensions below:

Device interfaces

In-house fixtures sized to the device under test — repeatable orientation, distance-to-target, and actuation access for medical, consumer, industrial, and fire-suppression devices.

Flow & actuation profiles

Controlled actuation stroke, force, and timing — manual, pneumatic, or mechanical fixtures sized to mimic use conditions when actuation drives the event.

Calibration & verification

Spatial pixel-to-mm scaling, trigger-to-frame alignment, and timing-channel calibration against traceable standards before each capture block.

Environmental controls

Lighting alignment, ambient illumination minimization, and optional flow seeding for PIV — environment recorded alongside each capture in the chain of custody.

Sample numbers

Replicate captures per condition with declared shot-to-shot variability — power sized to the precision target and the decision risk.

Method development inside a documented quality system

HSI / Vel is methodological work without a single formal pharmaceutical standard. Each study operates within a documented quality system built around the three anchors below, with the data contract carried through to the Section 7 outputs.

  • ISO 17025AccreditedTesting-laboratory competence — documented methods, calibration traceability, and uncertainty contributors.
  • ICH Q9AlignedQuality-risk management — investigation framing for transient defects and root-cause work.
  • 21 CFR Part 820AlignedFDA design controls — validation framing for medical-device design and change-control packages.

Key data outputs & reporting

Each HSI / Vel study provides annotated high-speed footage, time-resolved metrics, and the underlying datasets. Standard outputs include event duration, onset timing, repeatability statistics, and, when selected, velocity vectors or particle-speed tables. Results are formatted for engineering reviews, change-control packages, or design-validation documentation. The deliverables below cover the standard report, while comparability programs and design-validation packages include the extended artifacts listed beneath the table.

Primary outputs

  • Annotated high-speed videos and still-frame sequences highlighting key events with frame-by-frame time stamps.
  • Time-resolved metrics (event duration, onset timing, repeatability) with replicate statistics across conditions.
  • Optional velocity-vector summaries (PIV) and particle-speed distributions for tracked features (PDV).

Deliverables

#FormatContents
01PDF reportSetup, parameters, findings, and analysis notes.
02Video files and still framesAnnotated captures and exported frames.
03CSV / XLSX datasetsTiming and velocity metrics with replicate statistics.
Extended deliverables · multi-arm comparability · stability · predicate studies
  • Comparability appendixSide-by-side high-speed overlays plus velocity-vector deltas across lots, designs, or actuation conditions.
  • Design-validation packEvent-timing logs and trigger-to-frame alignment records aligned to 21 CFR Part 820 design-controls documentation.
  • Method-development notesFixture-selection rationale, illumination and seeding decisions, and acceptance criteria — for design reviews and inspection readiness.

QA / QC & data integrity

Each HSI / Vel study includes a documented QA / QC framework matched to the method plan. Calibration, timing verification, and analysis controls are audited under our ISO 17025 quality system and remain traceable from sample receipt through the final result. For investigations rather than fixed-protocol studies, ICH Q9 quality-risk principles guide the scope of these controls.

Spatial calibration checks for pixel-to-mm scale and field-of-view geometry before each capture block.

Timing verification (trigger-to-frame alignment, clock-channel sync) recorded with the captured frames.

Repeat runs to confirm event reproducibility and quantify shot-to-shot variability across conditions.

Documented camera, lighting, and seeding settings with analysis-software version control alongside exports.

Chain of custody from sample receipt through capture, analysis, and final reporting.

Why ARE Labs

ARE Labs connects technical topics to practical study design, method selection, controlled aerosol work, and reportable evidence without turning technical pages into sales pages.

Reviewed byJamie Balarashti (25 yrs - cascade & inhalation methods) - Weston Schaper (7 yrs - real-time sizing & nanoparticle work)
17025Accredited testing
900+Studies Performed
17+Years in operation
300+Clients supported

Common questions

These answers address common questions from medical-device, consumer-aerosol, and industrial-spray teams planning a high-speed imaging or velocimetry study, including method selection, velocimetry options, capture parameters, and deliverables. They are starting points, not protocols. Most HSI / Vel studies require at least one custom fixture or triggering decision, so contact us if your device, event duration, or investigation scope falls outside these examples.

Q.What problems is high-speed imaging best at solving?
A.HSI is well suited to short, transient events such as leak puffs, pulsing plumes, spray breakup, and timing problems in multi-step mechanisms. When the event occurs faster than a standard camera can resolve, high-speed imaging is usually the right place to start.
Q.Do I need PIV?
A.Only when the decision requires quantitative flow-field data. Many investigations begin with visualization, then add PIV when the design team needs measured velocities to support a change or model the flow.
Q.Can you measure droplet speeds?
A.Often, yes. We may use particle-tracking methods or PDV-style approaches, depending on particle visibility, image contrast, and whether seeding is practical for the device and tested use condition.
Q.What affects the setup most?
A.The main factors are event duration, required field of view, illumination constraints, and whether flow seeding is permitted. We define these during study planning so the rig is properly sized before the device arrives at the lab.
Q.What do I receive?
A.Deliverables include annotated videos and still frames, a PDF report describing the setup and findings, and CSV / XLSX tables containing timing and velocity metrics. Quantitative velocity tables are included when the study uses PIV or PDV.

Standards & guidance

HSI / Vel is used for methodological work and engineering investigations, and no single formal pharmaceutical standard covers the test category. Each study operates within a documented quality system. Methods within our third-party-accredited scope are identified as ISO 17025 accredited; methods used for investigation or design-validation work are aligned with the applicable standard. The cards below identify the standards most often relevant to HSI / Vel packages.