Sterile drugs and biologics - Gowning and interventions on the filling line
ConductVision Aseptic Manufacturing can record each intervention in the Grade A zone and flag missed gowning and glove steps for a trained reviewer on your team.
Work on an aseptic filling line
To fix a problem on the line, such as a fallen vial, operators reach in through the glove ports.
Your procedures set how fast people move near open product, where hands may go, when gloves are disinfected and which interventions are allowed.
What goes wrong during a fill
- A gloved hand passes over open containers.
- Gloves are not disinfected before an intervention.
- Someone misses a gowning step or does it out of sequence.
- An operator performs an intervention that is not on your approved list.
- A jam is cleared in a way your procedure does not allow.
What you get
Each intervention on record
Each time a hand or arm enters the Grade A zone, with the time, the camera and a short clip. Your reviewer checks it against your list of approved interventions.
Gowning and glove checks
It flags missed or out-of-sequence gowning steps, gloves not disinfected before an intervention and hands over open containers.
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 your quality unit
An event record to attach to a deviation, a monthly report that one person reviews and a second person approves, and one package of the records an inspector asks for.
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 before each intervention?
More pages in this section
- Cell and gene therapyOpen steps in biosafety cabinets
- 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