Intelligence for sterile vision

Aseptic technique is the last unmonitored control.

Apex Zero watches the workzone the way a trained observer would — every shift, every connection, every batch — and turns what it sees into coaching, trend data, and evidence you can put in front of an inspector.

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ISO 5 · Suite 2 · APEX-02 · CAM 1 of 4 Observing

EVT-4417 · flagged 00:14:22 Hand over open vial in first air

Illustrative view. Detection runs on the device; the flagged clip and its metadata are what leave it.

The gap

In a process with no terminal sterilization, technique is the barrier.

Cell and gene therapy products cannot be sterilized in their final container. Everything that protects the patient happens at the bench, in the hands of an operator, inside a few square feet of first air — and almost none of it is captured while it happens.

Coverage

Observation doesn't scale

Media fills get watched closely. A routine Tuesday does not. Quality observes a small fraction of processing hours, and the hours nobody watched are the hours that show up in a sterility investigation.

Evidence

Recall is not a record

When a positive lands, the investigation runs on memory, a room log written after the fact, and an interview three weeks later. There is rarely a contemporaneous record of what actually happened at the bench.

Feedback

Coaching arrives too late

Technique drifts quietly between qualifications. By the time a gap surfaces in an audit or an annual requalification, it has been in routine practice for months.

The hardware · Unit 01

Prototype

12 in × 6 in Ø · 316L

Apex Zero

A sealed stainless cylinder that stands on the bench or hangs from the ceiling and sees the entire room at once. Four wide-angle cameras, no blind side, no pan-tilt mechanism to qualify or maintain.

Everything happens inside the can. The compute module runs detection on the unit, the SSD holds the flagged events, and the speaker closes the loop in the room — a quiet cue to the operator at the moment it matters, not a report three weeks later.

360° coverage

Four 120° wide-angle cameras with deliberate overlap — every critical zone is in at least one field, most are in two.

Edge AI

Detection runs on the on-board compute module. No outbound connection is required for the system to work.

Audio feedback

An integrated speaker delivers a discreet, configurable cue in real time. Off by default until your site enables it.

Cleanroom build

316L stainless, smooth surfaces, no fabric or vents, sealed removable base plate so service never opens the shell in a classified room.

One unit, one field, no blind side

A single pan-tilt camera watches wherever it was last pointed. Apex Zero holds all four fields at once, so an operator stepping out of one camera's frame is still in another's — and the overlap gives an investigation two angles on the same connection.

Prototype specification

Cameras4 × 120° wide-angle, fixed — 360° horizontal coverage

Construction316L stainless steel, sealed smooth-surface enclosure

Height12 in (30.5 cm)

Diameter6 in (15.2 cm)

Weight8–10 lb (3.6–4.5 kg), estimated

ComputeOn-board edge AI module with internal SSD storage

PowerMains with internal battery pack and power management; rear power button

AudioIntegrated speaker for real-time operator feedback

IndicatorsFront status LED

Mounting360° mount for pole or ceiling; free-standing on the bench

ServiceSealed removable base plate for access

Figures are for the current prototype build and are subject to change through design freeze.

What it does not do

No facial recognition. Operators are identified by badge and shift assignment, not by their face.
No continuous upload. Raw footage stays on the unit and purges on your schedule; flagged events are what move.
No moving parts in the room. Fixed optics — nothing to pan, tilt, lubricate, or requalify after service.
No process interface. Apex Zero observes. It does not control equipment, gate a step, or write to your batch record.

Engineering views of Apex Zero: front, side, back, top, internal and bottom, with camera, speaker, status LED, power button, compute module, SSD, battery pack and removable base plate labelled.

Apex Zero · prototype engineering viewsFront · Side · Back · Top · Internal · Bottom

The loop

Capture, detect, coach, and keep the evidence.

One closed loop, run per suite. Each stage produces something a quality organization already knows what to do with.

Capture

The whole campaign, not a sample

Continuous coverage of the critical zone from the first aseptic connection to close-out, with the unit's field fixed and documented in the room qualification.

Detect

Defined behaviours, not verdicts

The model flags a specific list of technique events — first-air interruption, reach-over, glove contact with a critical surface, wipe reuse, item accumulation in the work zone.

Coach

In the room, then on the record

Where your site enables it, the unit gives a quiet audio cue at the moment of the event. Either way the flagged clip routes to the operator and their supervisor, and trends roll up per operator, suite, shift, and unit operation.

Evidence

A record with a timestamp on it

Every event carries lot, room, operator, unit operation, and time — attributable to an investigation, an APS review, or an inspector's question about a specific batch.

Where it earns its place

Six jobs it does on day one.

Aseptic process simulation

Full-duration coverage of every media fill, with observer notes anchored to a timestamp instead of a clipboard.

Operator qualification

Objective, comparable technique data for initial qualification and periodic requalification — the same criteria applied to everyone.

Contamination investigations

Go back to the actual processing window instead of reconstructing it. Confirm or rule out technique as a root cause with something on the record.

Training and onboarding

A library of real footage from your own suites — good practice and near-misses — instead of a generic vendor video.

Inspection readiness

Demonstrable, continuous oversight of aseptic behaviour to support the contamination control strategy an inspector will ask you to evidence.

Tech transfer and engineering runs

Watch a new process settle. Catch the technique problems that a new layout creates before the first GMP lot.

Non-negotiables

Built for a regulated room and the people standing in it.

A camera in a cleanroom fails on two fronts if you get it wrong: the record isn't defensible, or the operators don't trust it. Both were designed for first.

The record

Attributable and contemporaneous. Every event carries user, time, room, lot, and unit operation at the moment of capture.
Audit trail on review actions. Who watched, who classified, who dispositioned — with no destructive edit path.
Time synchronisation to the site time source, so events line up with your EM data, EBR, and room logs.
Validation support. IQ/OQ/PQ templates, a traceability matrix, and change control documentation written for a GMP QA reviewer.
Data residency. On-premise deployment available; the unit does not require an outbound connection to detect.

The people

Coaching by default. The system is configured for feedback, not discipline. Punitive use destroys the reporting culture it depends on.
Visible when observing. A clear indicator in the room. No covert operation, ever.
Defined retention. Raw footage purges on your schedule; only flagged events persist.
Audio cues are opt-in. The in-room speaker is disabled until your site turns it on, and the cue is a prompt to the operator, not an announcement to the room.
Role-based access. Operators see their own record first, before anyone else acts on it.
Consultation support. Deployment materials for works councils, unions, and employee notice requirements, including EU and UK sites.

Pilot programme

One suite. Eight weeks. A number you didn't have before.

We install in a single suite, run through one campaign or media fill sequence, and hand back a technique baseline for that room — event rates by type, by shift, by operation. If the baseline doesn't tell you something you didn't already know, we take the unit back.

Start the conversation

What we install

One Apex Zero unit over your critical zone, plus the on-site review workspace. No changes to your process or room classification.

What we need

A suite, a PoE drop, a named quality contact, and an operator briefing before the first shift is observed.

What you get

A written technique baseline, the flagged event library from your own room, and the validation package if you continue.