ASM 2000 High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry

High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry Pfeiffer Vacuum is one of the world´s leading providers of vacuum and testing solutions. The product portfolio comprises vacuum pumps, measurement and analysis devices, components, as well as vacuum chambers and high performance detection systems. Furthermore, we offer a unique portfolio of equipments based on three technologies that are dedicated to the pharmaceutical and medical markets. Leak testing and CCIT can be performed on a large variety of drug/container combinations. Integrity challenges...

11 The laptop is not provided by Pfeiffer Vacuum Customer benefits ■ High sensitivity measurements required for design and validation studies of new containers ■ Turnkey solution including high performances helium leak detector, helium charging module and customized tooling ■ User-friendly interface ■ Fast and fully automatic test sequence to guarantee high repeatability tests ■ Data storage and traceability ■ Identifying the source of leaks using the "sniffer mode"

High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry ASM 2000 is a comprehensive solution completely adapted to the needs of pharma industry. ASM 2000 is the perfect solution for the validation and qualification of new containers. Based on a high performance helium mass spectrometer leak detector, it also includes a helium charging module, and can be equipped with custom fixtures for the particular container formats. The instrument is calibrated against NIST3)-traceable standard leaks. Dependable, fast and sensitive Further advantages of the ASM 2000...

■ Specific tooling's according container design ■ Automatic test sequence including He charging ■ Massive leak detection prior to He charging ■ Test duration < 20 sec. Sniffer probe for leak localization ■ Vacuum test chamber according container design ■ Test chamber volume: 3 liters max. ■ Typical test duration < 8 sec. (depend on free volume)

Equivalence between defect size & air leak rate Leak rate versus defect size Historically, dye ingress testing has been the container closure integrity test of choice. The detection limit of this method is around 20 μm. Since the test is strictly visual, the detection limit has experimentally been determined by using orifices of known diameter. As a consequence, tightness criteria in pharmaceutical industry are usually expressed as an equivalent hole diameter in μm. However, an equivalent hole diameter is not enough to define the tightness criterion of a packaging. Depending on the diameter of...

Technical data Features Operating system Network connection Interfaces (printer, bar code reader, data export) 21 CFR part 11 compliance PDF GMP test and calibration reports authentication local or domain (LDAP) Windows 10 1 x LAN (RJ45) 2 x USB 3.0 (ext.) 1 x HDMI Operating conditions Temperature (min./max.) Humidity (min./max.) Dimensions (l x w x h) (Including trolley) Weight, (Including trolley) Noise level Order information Please contact your local Pfeiffer Vacuum sales adminstration PFEIFFER^VMCUUM

VACUUM SOLUTIONS FROM A SINGLE SOURCE Pfeiffer Vacuum stands for innovative and custom vacuum solutions worldwide, technological perfection, competent advice and reliable service. COMPLETE RANGE OF PRODUCTS From a single component to complex systems: We are the only supplier of vacuum technology that provides a complete product portfolio. COMPETENCE IN THEORY AND PRACTICE Benefit from our know-how and our portfolio of training opportunities! We support you with your plant layout and provide first-class on-site service worldwide. Are you looking for a Pfeiffer Vacuum GmbH perfect vacuum solution?...