Container closure integrity testing
Integrity testing engineered only for IV bags.
Non-destructive leak testing in the QA laboratory or at full line speed. Designed and built in Bologna, Italy.
Why ASTRACEC
A reference point for every bag that leaves your line.
An IV bag goes straight into a patient’s vein. A leak test is only worth what your quality team can stand behind. We give manufacturers a measurement they can steer by: deterministic, quantitative and taken on the whole bag, in the condition it really leaves the line.
- smallest detectable defect
- 1 µm
- bags per hour
- 8 000
- largest bag volume
- 30 L
- bags destroyed by the test
- 0
VEGA, depending on bag format
VEGA, 100% in-line
VEGA; POLAR up to 10 L
Non-destructive, non-invasive
Machines
One method. Two ways to run it.
Choose by where in your process you need the answer: in the QA laboratory, or on every bag at line speed. Both machines use the same patented method, so results speak the same language.
Laboratory · off-line
POLAR
Compact, low-noise testing for batch release, stability studies and investigations, loaded by an operator.
In-line · production
VEGA
Fully automatic 100% testing on the filling line, with automatic loading, unloading and rejection.
Formats or speeds outside both? Custom systems
Technology
A flat line is good news.
Probe Position Decay™ is an evolution of Lid Deflection, a method the pharmaceutical industry already accepts. It reads the whole sealed bag and returns a quantitative result for every unit, with no dye, no water bath and no vacuum.
- Non-destructive and non-invasive: good bags go on to release
- Deterministic and quantitative, with data for every bag
- Detects gas and liquid leaks across the entire bag
- Unaffected by condensation after autoclaving
- Adjustable to your production rate and detection limit
Applications
Tested as it leaves your line.
Wet after sterilisation, sealed inside an over-wrap, divided into chambers or filled to 30 litres: bags are tested in their real condition, not prepared for the test.
Bag condition
Autoclaved bags
Testing straight after terminal sterilisation, with condensation still on the surface.
Read the application
Bag condition
Over-wrapped bags
The primary bag tested inside its secondary pouch, without opening it.
Read the application
Bag format
Multi-chamber bags
Parenteral nutrition bags with peelable seals between chambers.
Application note in preparation
Bag format
Small and large volumes
From small-volume parenterals to dialysis and irrigation bags of up to 30 L.
Application note in preparation
How we work
Seen working on your bags before you buy.
Every project starts with your own bags in our laboratory and ends with a validated machine on your line, supported for its whole working life.
- 01
Feasibility study
Send us samples of your bags, including known defects. We test them and report the results in writing, so your QA team can judge the method on real data.
- 02
Installation and validation
Factory and site acceptance tests, then documentation and support for IQ, OQ and PQ, so the machine enters production qualified.
- 03
Lifecycle support
Preventive maintenance, spare parts, operator training and remote assistance from the engineers who designed the machine.
Worldwide
Built in Bologna. Working with manufacturers worldwide.
Every machine is engineered and assembled in Italy’s packaging valley and installed wherever IV bags are made. Local partners add support in your language and time zone.
Europe
Served directly from Bologna, Italy.
India
With our partner SVAN, Mumbai.
Middle East and Africa
Served from Bologna. Partner network in development.
Americas
Served from Bologna. Partner network in development.
Asia-Pacific
Served from Bologna. Partner network in development.
Compliance
Designed around the regulations you are inspected against.
Your validation team starts from a method it already recognises. ASTRACEC machines are designed to support your qualification under the main international frameworks for sterile products.
- EU GMP Annex 1 (2022): integrity testing of sterile containers
- USP <1207>: deterministic leak test methods
- EU GMP Annex 11: computerised systems and data integrity
- Validated by leading pharmaceutical manufacturers
Company
An engineering company you can visit.
Small enough that you talk to the engineers who designed your machine. Built on the experience of the Bologna packaging valley.
Manufacturing
Designed, built and tested in Bologna
Every machine is assembled and tested in-house before it ships.
Visit our productionSustainability
A test that keeps every good bag
No product is destroyed and no vacuum is needed: less waste and less energy per batch.
Our approach
Careers
Engineers who like hard problems
Mechanical, software and validation roles in Bologna.
Work with usInsights
From our engineers.
Regulation, methods and real production conditions, explained for QA, validation and engineering teams.
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.