Aseptic manufacturing - Video review of gowning and cleanroom behavior

ConductVision Aseptic Manufacturing can review video from your cleanroom cameras against your written procedures. It sends each event it flags to a trained reviewer on your team as a short clip and saves their decision with it.

Patent pending

A person in a hair cover, mask and gown opens a cleanroom door, with gowned staff working inside

Industries and cleanroom gowning

Two operators in blue cleanroom suits beside a vial filling line behind glass, with round glove ports along its front

Sterile drugs and biologics

Fill-finish lines, RABS and isolators

Interventions in the Grade A zone, glove disinfection and gowning sequence.

See sterile drugs and biologics 

A person in a cleanroom hood, mask and gloves seen through a door window, next to shelving with disinfectant bottles

Cell and gene therapy

Open steps in biosafety cabinets

Hands into the biosafety cabinet, glove disinfection and wipe technique.

See cell and gene therapy 

A person in a cleanroom hood, mask and gloves reaches for a disinfectant bottle at a stainless steel work surface

Sterile compounding

Hospital pharmacies and outsourcing facilities

Garbing sequence, hand hygiene before gloving and glove disinfection before re-entering the hood.

See sterile compounding 

Hands pulling a sterile glove over the cuff of a disposable gown, with sterile supply tubs on the counter behind

Medical devices

Assembly and packaging cleanrooms

Gowning, occupancy limits, airlock doors and components off the floor.

See medical devices 

A beverage filling hall with bottles on conveyors, a covered filler and stainless steel process piping

Food and beverage

Aseptic processing and packaging

Sterile zone entries, jam clearing and PPE before the filler room.

See food and beverage 

A person in a full cleanroom suit pushes a cart down a semiconductor fab bay lined with enclosed tools

Electronics and semiconductors

Fab, assembly and test cleanrooms

Gowning, rushing in the bay, touching safety glasses and airlock doors.

See electronics and semiconductors 

Two people in full cleanroom suits work beside large hexagonal mirror segments on a stand

Spacecraft and satellites

Flight hardware cleanrooms

Gowning, glove changes and hands near flight hardware.

See spacecraft and satellites 

A person in a blue gown reaches behind their neck to tie it

Cleanroom gowning

Gowning rooms and gowning procedures

The steps of your gowning procedure, checked in sequence, with a clip of any missed step.

See cleanroom gowning 

A row of glass vials with metal caps on a white machine table

EU GMP Annex 1

Sites making sterile medicines for the EU

What Annex 1 says about people, gowning and interventions, and the video checks that fit beside it.

See eu gmp annex 1 

What you get

  • Gowning checks. The steps of your gowning procedure, checked in sequence. A missed or out-of-sequence step is flagged with a short clip.
  • A record of each intervention. Each time a hand or arm enters the critical zone, with the time, the camera and a short clip, for your reviewer to check against your list of approved interventions.
  • Events flagged for a trained reviewer. A trained reviewer on your team confirms each flagged event, dismisses it with a reason or escalates it to your quality team.
  • Decisions kept with the clip. The audit trail keeps every decision with its clip: who decided, in what role, when and why.
  • Reports for quality investigations. A record of each event, to attach to a deviation or investigation, and a monthly report by area and shift that one person reviews and a second person approves.
  • People shown by number. Reports show each person as a number, not a name. When a camera view is blocked, the report says so instead of counting that time as clear.

Practices it can check

Each check is set up from your written procedure. Your site sets every limit.

Gowning

  • Steps missed or out of sequence
  • Skin showing after gowning
  • Goggles touched after gowning
  • Hands not disinfected before gloving
  • More people in the gowning room than allowed

Hands and gloves

  • Hands or arms passing over open containers
  • Hands entering the critical zone
  • Gloves not disinfected before handling sterile supplies or before an intervention
  • No glove change after touching the floor
  • Doors pushed open with gloved hands

Movement and doors

  • Fast movement near open product
  • Leaning on equipment
  • More people in a room than allowed
  • More than one person through a door at a time
  • Both airlock doors open at once

Cleaning and materials

  • More strokes on a surface than your procedure allows, or wiping back and forth
  • Alcohol sprayed straight onto a garment
  • Components loaded in the wrong orientation
  • Component bags touching the hopper
  • Components stored on the floor
  • Jams cleared outside your procedure

How a pilot works

Full recordings stay on your network. For each event it flags, ConductVision saves a record and a short clip at your site.

  1. First look

    We look at footage you choose to share with us and agree with your team on what to watch for.

  2. Paid pilot

    ConductVision connects to your camera system and runs for a set time.

  3. Pilot results report

    You get a report of the results on your own footage, checked against the criteria your team set.

  4. Your decision

    You decide whether to roll out, change the scope or stop.