Cell and gene therapy - Gowning and open steps in the biosafety cabinet
ConductVision Aseptic Manufacturing can record each time hands go into the biosafety cabinet and flag missed gowning, glove and cleaning steps for a trained reviewer on your team.
Open steps in the cleanroom
Operators gown, bring materials into the cleanroom and do open steps by hand in a biosafety cabinet.
Your procedures set the gowning sequence, when gloves are disinfected before hands go into the cabinet, how surfaces are wiped and how many people may be in the room.
What goes wrong during open steps
- Hands go into the cabinet without the gloves being disinfected first.
- Surfaces are wiped back and forth, or with more strokes than your procedure allows.
- Someone misses a gowning step, or skin shows after gowning.
- More people are in the room than your procedure allows.
What you get
Every entry into the cabinet, on record
Each time hands go into the cabinet, with the time, the camera and a short clip. It flags each entry made without disinfecting gloves first.
Gowning and cleaning checks
It flags missed gowning steps, skin showing, wiping that does not follow your procedure and more people in the room than allowed.
Decisions kept with the clip
A trained reviewer on your team confirms each event, dismisses it with a reason or escalates it to QA. The audit trail keeps who decided, in what role, when and why.
Records for deviations and investigations
An event record to attach to a deviation or investigation, and a monthly report that one person reviews and a second person approves.
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.
First look
We look at footage you choose to share with us and agree with your team on what to watch for.
Paid pilot
ConductVision connects to your camera system and runs for a set time.
Pilot results report
You get a report of the results on your own footage, checked against the criteria your team set.
Your decision
You decide whether to roll out, change the scope or stop.
One question to start with
Are gloves disinfected each time before hands go into the cabinet?
More pages in this section
- Sterile drugs and biologicsFill-finish lines, RABS and isolators
- Sterile compoundingHospital pharmacies and outsourcing facilities
- Medical devicesAssembly and packaging cleanrooms
- Food and beverageAseptic processing and packaging
- Electronics and semiconductorsFab, assembly and test cleanrooms
- Spacecraft and satellitesFlight hardware cleanrooms
- Cleanroom gowningGowning rooms and gowning procedures
- EU GMP Annex 1Sites making sterile medicines for the EU