Technology
Probe Position Decay™
A patented, deterministic method that reads the whole sealed bag and returns a quantitative result for every unit. Built on Lid Deflection, a principle the pharmaceutical industry already accepts.
How it works
A flat line is good news.
The bag is held in a closed test chamber and its response is measured over the test cycle. A sealed bag gives a steady signal. A leak shows as a measurable change, and the bag is rejected.
No dye, no water bath, no vacuum and no tracer gas. Nothing is added to the bag, and nothing is taken out.
The plain-language description of the method is awaiting sign-off by ASTRACEC engineering.
The test cycle
Three steps, the same for every bag.
The cycle is the same on POLAR in the laboratory and on VEGA at line speed, so laboratory and production results can be compared directly.
- 01
Hold
The bag is placed in a closed test chamber, as it leaves your line: wet, wrapped or dry.
- 02
Measure
The bag’s response is recorded over the test cycle and compared with the limits you have validated.
- 03
Decide
A quantitative result and a pass or reject decision are stored for each bag, ready for your batch record.
What it gives you
A result your quality team can stand behind.
Deterministic
A measured value against a validated limit, not an operator’s judgement. The same bag gives the same answer.
Quantitative
Data for every bag, so trends and drifts are visible before they become deviations.
Non-destructive
Good bags go on to release. No product is sacrificed to sampling.
No vacuum
The method needs no vacuum pump, which lowers energy use and running cost.
Whole-bag coverage
Gas and liquid leaks are detected across the entire bag, including seals and ports.
Real conditions
Unaffected by condensation after autoclaving, so bags can be tested straight off the line.
Lineage
New engineering, a familiar principle.
Probe Position Decay™ is an evolution of Lid Deflection, a deterministic principle already used for container closure integrity in regulated plants. Your validation team starts from a method it recognises, with the same logic of limits and acceptance.
- Patented technology, developed in Bologna, Italy
- Designed around EU GMP Annex 1, USP <1207> and EU GMP Annex 11
- Adjustable to your production rate and detection limit
In numbers
Sensitivity and speed, on two machines.
- detection down to
- 1 µm
- detection down to
- 3 µm
- cycle time from
- 4 s
- bags per hour
- 8 000
VEGA, depending on bag format
POLAR
POLAR
VEGA, 100% in-line
Send us your bags. We will show you the result.
A feasibility study on your own bag formats, with a written report your QA team can use.