Alpstein Biotech · The closed system
ALPSTEIN

The closed system

The line closes at intake. It opens at the vial.

Collagen processing has always needed people: opening vessels, transferring material, checking stages by hand. Every intervention is a contamination vector and a variable. Alpstein engineered the interventions out. From intake to fill, the material moves through one sealed, continuous system.

Intake · Digestion · Separation · Vial
01

The closed system, stage by stage

Intake
Stage 01 · The system closes
Stage 01

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
Stage 02 · Sealed vessels
Stage 02

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.

Pending: vessel specifications and monitoring method
Centrifugal separation
Stage 03 · Still sealed
Stage 03

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
Stage 04 · First human contact
Stage 04

Filtration and fill

Filtration completes the run before fill. The first human contact with the material is a sealed, finished, documented vial.

Pending: filtration steps and fill detail
02

What the closed system removes

01

Bioburden variability

No open stages means no stage-by-stage exposure to introduce it.

02

Batch drift

The system runs the same way every run. The result belongs to the machine, whoever is on shift.

03

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.

Pending: keep only if the founder will honour the invitation

Request the process documentation for every stage

Request the process documentationWhere the material starts