Pharmaceutical Mass Extraction Vacuum Leak Testing Equipment For Vials And IV Bags
Our USP <1207> and ASTM (F-3287-17) recognized Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV bags, pouches, or glass vials. Larger defect and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for the use in production environment allowing stability control as well as automated 100 % testing (also in inline machines).
FDA laboratories in the US and major pharmaceutical companies have been using the Mass Extraction instruments for over 10 years.
- American Standard for Testing and Materials
- United States Pharmacopeia
- American Society for Testing and Materials
Mass Extraction – The leak test procedure under vacuum without tracer gas
The Mass Extraction method is carried out under vacuum. This results in an improved detection limit and thermal decoupling due to the vacuum’s insulating effect. This type of test is particularly suitable for packaging or sealed objects such as encapsulated electronic assemblies. During the test, the test unit is placed in a vacuum chamber and the chamber is evacuated. The leakage rate of the test unit is determined by the flow from the test unit to the vacuum reservoir. With this method, a detection limit of up to 7 · 10-7 mbar · l/s can be achieved.
In an alternative process of this measuring principle, the interior of the test unit is evacuated and the penetrating ambient air is measured. This method reduces the costs of the test equipment because it does not require a vacuum chamber.
Core competencies
The main benefits of the Micro-Flow and Mass Extraction technology compared to other air testing methods are the higher speed of the test and the lower sensitivity to environmental influences. In addition, they offer lower detection limits, higher accuracy, and better reproducibility. Long calibration intervals of up to one year are another advantage of this non-destructive, quantitative method.
ME2 high-performance Mass Extraction (vacuum) leak testing
The Model ME2 is a popular Mass Extraction test instrument using air for applications replacing helium testing. Designed for medium-sized parts with higher throughput, this instrument is offered for cleanroom or industrial applications. The ME2 is particularly used in high-demanding pharmaceutical applications for CCIT (container closure integrity testing).
Customer Benefits
- Detection of leaks down to 7 · 10-7 sccs (3 µm defect size) with air – highest sensitivity
- With very simple chamber adaption set up can be used for various parts – flexibility
- User-friendly operator interface for stand-alone applications – simple test setup
Applications
- Vials
- IV bags
- Batteries