Extrusion International 1-2018

ATC’s patented Micro-Flow technology and Mass Extraction technology ensure product sterility and comply with regu- latory expectations and USP standard for container closure integrity testing. The non-destructive, deterministic leak testing uses Mass Extraction technol- ogy to detect defect sizes as small as 1-2 micron (microbial challenge). With short cycle times, high sensitivity and repeatability these systems are very cost-effective. Pfeiffer Vacuum was presented its he- lium tracer gas leak detection solutions as well as the AMI non-destructive integrity test system which conducts qualitative and quantitative leak mea- surements in real time without using any specific tracer gas. This self-calibrating method offers the widest test range in the market and has higher sensitivity than conventional methods. For all leak testing solutions, Pfeiffer Vacuum offers FDA 21CFR Part 11 compliant software as well as IQ/OQ qualification support. Leak testing with Mass Extraction technology (air) At Pack Expo Pfeiffer Vacuum was dis- play products from its new subsidiary Advanced Test Concepts (ATC) from In- dianapolis, Indiana, USA. The leak tes- ters that will be exhibited work on the basis of leading leak testing technology using air, and therefore do not require any special tracer gases. The devices operate according to pat- ented Micro-Flow and Mass Extraction technology. The USP 1207 recognized Mass Extraction thereby works on the Leak testing with patented Mass Extraction technology: ME2 from ATC Pfeiffer Vacuum ASM 340 multipurpose leak detector principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This type of testing is particularly suitable for pack- aging or enclosed objects, such as phar- maceutical packaging as for example IV-bags or glass vials. Defect sizes small- er than 2 μm respectively leak rates of down to 5•10 -6 mbar l/s can be detected with this method. The method is there- by suitable for laboratory applications as well as for the use in production en- vironment allowing stability control as well as automated 100% testing. Leak detection with tracer gas The ASM 340 leak detector delivers very good performance for tracer gas leak detection using helium (or hydro- gen) as a tracer gas. The device com- bines high performance, reliability and repeatability with fastest time to test. This leak detector is easy to use thanks to its user-friendly and intuitive color touch control panel. The ASM 340 is the leak detector for MALL (Maximum Allowable Leakage Limit) testing within the packaging de- velopment process, e.g. for syringes. Pfeiffer Vacuum also supplies corre- sponding adaptions for specific test parts as well as process support. Optical emission spectroscopy The Pfeiffer Vacuum AMI integrity test systems measures leak tightness using a patented process that does not require a tracer gas. Instead, this method uses the existing gas mixture in the cavities Pfeiffer Vacuum AMI 121 Integrity Test System inside the packaging to perform high- sensitivity testing over an extended measuring range. The procedure offers great flexibility: a variety of different packaging types such as blister packs, pouches, vials, plastic bottles, and sealed parts such as battery casings, can be tested in this way. A big advantage of the AMI is its wide measuring range that also offers high- er sensitivity than conventional tests, down to 1 μm respectively leak rates of down to 1•10 -7 mbar l/s. As a result, the AMI device provides gross and fine leak test in just one device. The procedure delivers deterministic test results with high repeatability, irrespective of the user, and with reliability and accuracy that comply with USP 1207.1. It can be used in laboratory testing as well as IPC (In Process Control) during production testing. Depending on the packaging the simultaneous testing of multiple parts at the same time is also possible. Pfeiffer Vacuum GmbH www.pfeiffer-vacuum.com 33 Extrusion International 1/2018