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

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

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

Product catalog summary
Overview
Pfeiffer Vacuum offers the ASM 2000, a high-performance Container Closure Integrity Testing (CCIT) solution for the pharmaceutical industry, utilizing helium mass spectrometry. This technology is designed to ensure the integrity of pharmaceutical packaging, such as vials, syringes, and cartridges, by detecting leaks that could compromise drug stability.

Key Features
  • High Sensitivity: The ASM 2000 provides high sensitivity measurements, crucial for validation and qualification studies of new containers.
  • Turnkey Solution: It includes a helium mass spectrometer leak detector, a helium charging module, and custom fixtures for various container formats.
  • Dependability: The system offers high throughput, accuracy, and reproducibility, with ultra-fast cycle times.
  • Advanced Software: Features intuitive menus, user access levels, and automatic generation of PDF test and calibration reports.

Technical Specifications
  • Measurement Range: Vacuum test range for fine leaks is <10-9 to 10-5 mbar l/s, and for gross leaks is 10-5 to 10-3 mbar l/s.
  • Power and Supply Requirements: Operates on 90-250 V AC, requires helium, nitrogen, and CDA supplies.
  • User Interface: Equipped with a 10” multi-touch Full HD color screen, compliant with 21 CFR part 11.
  • Operating Conditions: Suitable for temperatures between 15 – 25 °C and humidity levels of 30 – 80%.

Leak Detection Methodology
  • Helium Mass Spectrometry: Based on ASTM F 2391-05, suitable for non-porous packaging.
  • Flow Regimes: Considers different flow regimes (choked, laminar, molecular) for accurate leak rate calculations.

Applications and Benefits
  • Integrity Challenges: Addresses contamination risks such as humidity and microbiological ingress that affect drug stability.
  • Proven Solution: Helium leak detection is established as a gold standard for its sensitivity and versatility.
  • Data Storage and Traceability: Ensures high repeatability and traceability of test results.

Conclusion
The ASM 2000 is a comprehensive, reliable, and efficient solution for ensuring the integrity of pharmaceutical packaging, offering advanced features and compliance with industry standards.
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Catalog excerpts

High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry - ASM 2000-1

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

 Open the catalog to page 1
High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry - ASM 2000-2

ASM 2000 High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry High sensitive measurements for project and validation studies of new containers Your added value Turnkey solution Our know-how 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...

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High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry - ASM 2000-3

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” Key features 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...

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High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry - ASM 2000-4

ASM 2000 High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry The laptop is not provided by Pfeiffer Vacuum

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High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry - ASM 2000-5

l5 High performance helium leak testing for validation and qualification of new packagings. Specific tooling’s according container design Automatic test sequence including He charging Massive leak detection prior to He charging Test duration < 20 sec. Pressure (mbar) Test of open containers Sniffer probe for leak localization Helium spray gun for charging vials Test of He pre-filled containers Vacuum test chamber according container design Test chamber volume: 3 liters max. Typical test duration < 8 sec. (depend on free volume)

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High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry - ASM 2000-6

ASM 2000 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...

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High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry - ASM 2000-7

l7 Dimensions 7 screen positions 125° Software Operating system Network connection Interfaces (printer, bar code reader, data export) Operating conditions Temperature (min./max.) Humidity (min./max.) Dimensions (l x w x h) (Including trolley) Weight, (Including trolley) Noise level Vacuum and sniffing leak detection 460 Test methods Measurement range (vacuum test) Quantitative range – Fine leak Helium Qualitative range – Gross leak Helium Qualitative range – Massive leak Air Minimum detectable He leakage (sniffing test) Power supply Typical power consumption CDA supply Quality Pressure (min./max.)...

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High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry - ASM 2000-8

Errors excepted. All data subject to change without prior notice. PL 0025 PEN (March 2022/PoD) Are you looking for an optimal vacuum solution? Please contact us: Pfeiffer Vacuum GmbH Germany Phone +49 6441 802-0

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