Questions
Before you book.
The questions clients ask most often, answered plainly. If yours is not here, ask us directly.
Do we have to shut down production?
Not necessarily. Studies are normally run in both at-rest and in-operation states, and the in-operation portion needs the room working the way it really works. Scheduling is agreed during protocol planning — most clients slot the study into a planned shutdown, a changeover, or a quiet shift.
Is the fog safe in a GMP area?
Our system runs on WFI, DI or distilled water only — no glycol and no oil. There is no residue and nothing is deposited on surfaces or product-contact equipment. Cleaning and release requirements remain yours to define, and we work to whatever your site procedure specifies.
How long does a study take on site?
It depends on the number of zones and the intervention scenarios agreed. A single critical zone can be captured in a few hours; a multi-room aseptic suite with transfers and interventions is usually a full day or more. We scope this in the protocol so there are no surprises on the day.
How quickly do we get the footage back?
Edited footage and the dashboard follow the on-site work. Turnaround is agreed up front and is one of the things clients most often tell us they value — see the CSL Behring comment on the smoke study page.
Do you write the report, or do we?
You do. We capture and deliver the visual evidence — edited, zone-referenced footage in a searchable dashboard — and your QA or validation team assesses it against your acceptance criteria and writes it into your own documentation. We agree the standard and the zones up front so the footage covers exactly what your report needs to reference.
Can you support us during an inspection?
Yes. The dashboard is built precisely for that moment — searchable by zone and date so evidence can be produced while the inspector is in the room rather than afterwards.
Do we own the footage?
Yes, entirely. You receive the complete raw capture as well as the edited footage and the dashboard, all yours to keep and store under your own records. Your evidence is never held hostage to a vendor relationship.
Do you travel outside Melbourne?
Yes. The complete system packs into wheeled flight cases and we deploy to sites across Australia. Travel is quoted transparently as part of the proposal.
Reference
The standards we plan against.
- EU GMP Annex 1Manufacture of Sterile Medicinal Products
- The 2022 revision made airflow visualisation an explicit expectation for grade A zones, performed both at rest and in operation, with recordings retained. It is the reason most of our pharmaceutical work exists.
- PIC/S PE 009Guide to Good Manufacturing Practice
- Adopted by the TGA for Australian manufacturers. Annex 1 of the PIC/S guide carries the same requirement for demonstrating unidirectional airflow and protection of the critical zone.
- ISO 14644Cleanrooms and associated controlled environments
- Parts 1 and 3 define classification and the test methods that airflow visualisation supports, including airflow direction and the recovery behaviour of a room after disturbance.
- TGATherapeutic Goods Administration
- Australia's regulator for therapeutic goods. Inspectors routinely ask to see airflow evidence for aseptic areas — footage that is dated, zone-referenced, and traceable to a defined study protocol.
Still have a question?
Send it over. We reply within one business day, and we would rather answer it now than after you have booked.