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| Examples of CCIT application |
Leak testing is vital in many an industry; when it comes to pharmaceutical sector, it simply cannot be underestimated. Pfeiffer Vacuum, a top world player in vacuum and detection equipment technologies, has acquired the U.S. company Advanced Test Concepts (ATC) as a full subsidiary as to extend its range of leak testing/detection solutions. At the recent Pack Expo trade fair in Las Vegas, the group experts have highlighted numerous technologies for container closure integrity testing aimed at pharma specialists.
ATC boasts several original technologies that keep the products sterile for the compliance with various regulations i.e. the U.S. Pharmacopeia norm for CCIT. The nondestructive Micro-Flow and Mass Extraction processes allow for detecting defects as tiny as 1 to 2 μm during microbial challenge testing. The systems from ACT are highly sensitive and boast short testing cycles and impeccably reproducible results.
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| The patented Mass Extraction technology: ATC ME2 device |
Pfeiffer Vacuum has also highlighted its ASM helium-tracer leak-detection systems. Finally, the nondestructive AMI integrity test system for qualitative/quantitative real-time leak measuring with no need for a tracer gas whatsoever has been presented. Every leak-testing solution from Pfeiffer Vacuum comes with FDA 21CFR part 11-compliant software and supports installation/operational (IQ/OQ) qualification.
The Mass Extraction leak testers that have been displayed at Pack Expo work with air; no dedicated tracer gas is needed. The vacuum technology employs rarefied gas flow for higher sensitivity and is the best fit for pharma packaging, e.g. vials or intravenous (IV) bags. It can detect defects as small as 2 microns with leak rates as low as 5∙10–6 mbar∙l/s. The technology is good both for lab applications and for production testing thanks to high degree of automation.
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| Pfeiffer Vacuum ASM 340 tracer-gas leak detector |
On the other hand, the performant ASM 340 leak detector can use H or He for tracing. The device is highly reliable, rapid and consistently precise. It boasts increased user friendliness thanks to the full-color touch screen with operator-friendly interface. This tracer-gas leak detector is generally used for MALL (maximum allowable leakage limit) testing of e.g. syringes in the packaging development phase. The device is customizable, and Pfeiffer Vacuum offers the related process support.
Finally, the AMI integrity test systems use optical emission spectroscopy (no tracer gas). Instead, existing atmosphere in package cavities allows for highly precise testing. The method is extremely versatile and can be applied equally to blister packs, pouches, vials, polymer bottles, and sealed items (e.g. battery casings).
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| AMI 121 integrity test system |
AMI device boasts an extended measurement range with an impressive sensitivity of down to 1-micron defect size and 1∙10–7 mbar∙l/s leak rates. Thus, it provides both gross and fine leak-test capabilities. High results repeatability excludes human factor, while the precision attained complies with USP 1207.1. Just as Mass Extraction testers, AMI is a good fit for both lab applications and on-site in-process control. Testing of several items in parallel is also conceivable.
Overall, the Pfeiffer Vacuum group today is rightfully proud of its comprehensive portfolio of leak detection solutions, adaptable equally to product types tested and to tester gas availability. This extensive range of equipment is of a great help to medical/pharma packaging producers.
