certa.fm

Where we sit

Not the building. Not the science.
The room in between

We don't maintain chillers, boilers or your TMVs. We run the controlled environment between them, which is where most inspection findings start.

Three layers, three owners

The room needs an owner too

Your facility manager runs the building. You own the science. The controlled environment in between usually belongs to whoever is nearest, which means nobody. That's the layer we run.

YouThe scienceYour product, your data, your GMP accountability
CertaThe roomCleaning, pest control, monitoring and lab support, kept in control every shift
Your facility managerThe buildingAir handling, BMS, fabric and planned maintenance

Contamination lives in the gaps

Between the cleaning regime and the monitoring locations. Between the pest register and the room classification. Between the stores and the expiry dates. When each is held by a different party, nobody is watching the join.

Accountability stays with you

GMP accountability can't be outsourced, and we'd never pretend otherwise. What we take off your hands is the work, the records and the first look at every result, so guaranteeing the room is in control is easy during audits.

Why one owner matters

Friday, 4 pm. A Grade C room fails its air sample

Monday it's over the action level and a deviation is open. Everybody did exactly what their contract asked. So who manages it?

Cleaning contractor

"Cleaned to schedule, every shift. Here are our sign-off sheets."

Monitoring service

"Method followed. The lab read the plates. Results attached."

Facility manager

"Air handling within defined limits. Pressure cascade held."

Pest contractor

"Bait station activity up in the next corridor. Three weeks ago."

In a quarterly report nobody opened.
2 weeks to root causeFour sets of records, in four formats, from four systems, stitched together by your quality team.

Why now

The rules have caught up with the room

Sept 2025 · PE009-17

Annex 1 made integration a requirement

Since the TGA adopted PE009-17, sterile manufacturers need a contamination control strategy across cleaning, monitoring, outsourced work and trending. That's hard to prove effective when four providers deliver it.

May 2025 · ISO 14644-5

Cleanroom operations got a rewrite

The first new edition of the cleanroom operations standard in over twenty years asks for an operations control programme. A programme, not a list of services.

Every inspection

Inspectors keep finding the gaps

Trending not done. Gowning without a competency check. Logbooks filled in before the event. The data usually exists. Connecting it was nobody's job.

Who runs your room today?

If the honest answer is "a committee" or "QA, by default", let's talk.

Talk to us