The closed system, stage by stage
Intake
Raw material from accredited Australian herds enters the system under controlled conditions. From the moment the line closes, every subsequent stage happens inside it.
Enzymatic digestion
Digestion runs in sealed vessels under monitored parameters. No operator opens the vessel. No hand adjusts the batch. The process is controlled by the system and verified by instrument.
Centrifugal separation
Separation happens in-line. The material never leaves the sealed system between digestion and separation, the two stages where conventional processing is most exposed.
Filtration and fill
Filtration completes the run before fill. The first human contact with the material is a sealed, finished, documented vial.
What the closed system removes
Bioburden variability
No open stages means no stage-by-stage exposure to introduce it.
Batch drift
The system runs the same way every run. The result belongs to the machine, whoever is on shift.
Audit weight
Fewer interventions means fewer procedures to validate and fewer records for your file to carry.
Audit the closed system for yourself
Supplier audits are welcome. The strongest thing we can show a quality team is the line itself.