Mass Extraction
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.
1) American Standard for Testing and Materials
2) United States Pharmacopeia
3) 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.
Enhance Pharmaceutical Product Safety with SpeedAir 3050
Versatile CCIT1) for a wide range of applications
The SpeedAir 3050 is your all-in-one solution for nonporous pharmaceutical applications. Whether your products are flexible or rigid, liquid or solid, the SpeedAir 3050 can swiftly and accurately test them all. With testing times as short as 30-45 seconds, it delivers results you can rely on, ensuring the integrity of your pharmaceutical containers.
Global NDT on the container
Unlike alternative methods that focus on specific areas or access points, the SpeedAir 3050 provides a comprehensive global Non-Destructive Testing (NDT) approach for your containers. It adheres to ASTM2) Standard F3287-17, demonstrating the ability to detect even the tiniest defects using an air-based technology.
Unmatched sensitivity for liquid products
When it comes to liquid products, the SpeedAir 3050 stands out as the most sensitive air-based technology available. You can count on its results for their repeatability and reliability, significantly reducing the risk of false negatives and positives.
Regulatory compliance assured
The SpeedAir 3050 is fully compliant with industry standards. It utilizes the USP3) <1207> recognized and deterministic Mass Extraction technology and operates with FDA4) 21 CFR Part 11 compliant software, ensuring your testing processes meet the highest regulatory standards.
Applications for SpeedAir 3050
The SpeedAir 3050 is suitable for a wide variety of pharmaceutical products, including but not limited to:
– Ampoules
– Autoinjectors
– Bottles
– Cartridges
– Flexible bags (IV Bags, pouches, etc.)
– Syringes
– Vials
Experience the precision, versatility, and compliance offered by the SpeedAir 3050 – your ultimate solution for Pharmaceutical Container Closure Integrity Testing (CCIT).
1) Container Closure Integrity Testing
2) American Society for Testing and Materials
3) United States Pharmacopeia
4) Food and Drug Administration (USA)