Pfeiffer Vacuum's Mass Extraction sensors show unmatched sensitivity for air leak testing down to 1µm defect size. Mass Extraction is thereby recognized by USP (Pharma Guideline) and ASTM (ASTM: F3287 - 17 “Nondestructive detection of leaks in packages by Mass Extraction method“).
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The model ME2 is a popular Mass Extraction test instrument using air for high sensitivity demanding applications. Designed for medium sized parts with high throughput, this instrument is offered for cleanroom or industrial applications. The ME2 is particularly useful in high demanding pharmaceutical applications for CCIT (Container Closure Integrity Testing). For sure we also offer FDA 21CFR Part 11 compliant software for the operation of the ME2.
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- Detection of leaks down to 1 µm defect size and below with air – highest sensitivity
- With very simple chamber adaption set up can be used for various part sizes – flexible
- User friendly operator interface for stand-alone applications – simple test setup
Our unique systems can be used for a variety of different packages as for example:
- Parenteral Vials and pre-filled syringes
- Cartridges and auto injection devices
- Flexible bags (IV bags, blood bags), empty and filled
- Single use flexible bag systems for pharmaceutical process-incoming inspection and point of use leak testing
- Pouches and inhalers and many more
Video: Pfeiffer Vacuum's Mass Extraction CCIT for Vials