Customized Leak Detection Solutions
For our customers with special leak testing requirements, we offer customized leak detection solutions, such as for the pharmaceutical & CCIT industry, as well as manual or integrated leak test modules that can be used in a wide range of markets.
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Leak Test Modules
The ultimate solution for high-quality acceptance tests
Our Leak Test Modules consist of the regular range of the Pfeiffer components and can be utilized either as manual test stations or for the integration into larger production and assembly lines. For pre-series production, a manual test bench is often suitable, whereas high-volume series production requires an in-line test bench. Our experience enables us to support you in regard to mechanical and software integration.
Thanks to our long-standing expertise in leak detection and vacuum technology we understand that the entire leak detection process can be complex and challenging. The consideration of how these fits into the overall, even more complex process is key for success. That is why we have expanded our portfolio of Leak Test Modules to increase the value proposition for you and provide a higher value chain solution.
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Brochure: Leak Test Modules
Seamless integration into your production lines
We pride ourselves on providing project-based and customized solutions for our customers. Our Leak Test Modules are easy to integrate into your production lines, with mechanical connections, electrical and PLC interfaces. This makes the installation process straightforward, ensuring that you can start testing right away.
Multiple test methods are available
For the realization of your (leak test) project you can chose from a wide range of test methods, such as all relevant tracer gas test methods (Helium, Hydrogen), OES (Optical Emission Spectroscopy), RGA (Residual Gas Analysis) or the conduction of a leak test with air (Micro-Flow/Mass-Extraction). This allows a pressurization of the test object in variable pressure levels.
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Webinar: Leak Test Module: From Your Request to a Customized Solution
Customer benefits
Project-based and customized solutions
Full range of test methods and parameters
Pressurization of test object in variable pressure levels
Automated process incl. tracer gas filling
Easy integration into your production lines
Modular approach for adaption to requirements
Secure supply chain and decades of experience with leak detection
Applications
Hydrogen economy
Automotive
HVAC-R
Medical Devices
and more
Pharma & CCIT Solutions
Innovative leak detectors for the pharmaceutical industry
We offer a unique portfolio of equipment dedicated to the pharmaceutical industry and medical markets. Using three different technologies, leak testing and CCIT (Container Closure Integrity Testing) applications can address a wide range of products.
Integrity challenges
Contamination such as humidity, oxygen or microbiological ingress can impact drug stability throughout the product life cycle. To prevent the risks of stability failure of highly moisture-sensitive drugs (e.g. dry powder for inhalation), or the risk of biological ingress of parenteral drugs, integrity tests with a high sensitivity are required. Most test methods are very challenging in regards to time effort, complexity or the limitation of sensitivity and detection range.
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Experience our virtual CCIT-Showroom for the Pharma Industry
Helium mass spectrometry
Helium mass spectrometry based upon ASTM3 F 2391-05 is applicable to non-porous packaging such as vials, syringes and cartridges. Currently, the helium leak test, a deterministic method, is being established as the gold standard for its sensitivity and versatility. Furthermore, helium leak detection offers the capability also to locate the position of a leak.
The perfect solution for MALL testing
Pfeiffer helium leak detection solutions are perfect for MALL (Maximum Allowable Leakage Limit) testing in the pharmaceutical industry. In order to ensure a correct measurement, it is very important to manage the tracer gas concentration during the measurement. This is especially tricky when handling vials or other sealed packages. Therefore, Pfeiffer offers complete solutions including tracer gas handling and charging, as well as adaptations for your packaging and test chambers.
ASM 2000
Turnkey solution for high sensitivity
Our ASM 2000 integrity tester for helium mass spectrometry is a comprehensive solution that is fully tailored to the needs of pharmaceutical customers. Based on a helium mass spectrometer leak detector, it also includes the helium handling as well as the charging module, and can be equipped with custom fixtures for the particular containers to be tested. The instrument is calibrated against NIST2-traceable standard leaks.
Dependable, fast and sensitive
Further advantages of the ASM 2000 are its high helium pumping, its integrated automatic helium charging module as well as the optimized free internal volumes. Those features guarantee high performance measurements on helium filled sealed containers and open sub-assemblies. The ASM 2000 sustains very high throughput, ensures the accuracy and the reproducibility of the measurement results, and allows ultra fast cycle time.
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Brochure: ASM 2000
Advanced software
The software proposes intuitive menus easy to navigate. User log in is required to operate the equipment, and four access levels are available (operator, advanced user, maintenance, administrator). Test recipes can be managed for each part format. At the end of the test sequence, the result is clearly displayed and PDF test and calibration reports are automatically generated at the batch closure.
ASM 2000 – A High Sensitivity Solution for Pharma CCIT
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”
Applications
Pharmaceutical industry: Syringes, Blister, Vials
Optical emission spectroscopy
Our patented method does not require any specific tracer gas. Instead, the gas mixture present in the container headspace of the primary packaging is used to perform high sensitivity tests over a large detection range. Therefore, our method is non-destructive, easy to use and to set up and has higher sensitivity than other conventional methods. AMI equipment has been qualified by leading pharmaceutical companies as in-process control (IPC) leak testing for blister packs. Our software is 21 CFR part 115 compliant.
AMI 1000
Dedicated to the pharmaceutical industry
With the AMI 1000, the products can be sampled directly from the production line and loaded in the test chamber without any specific conditioning. At the end of the test sequence, the result is clearly displayed and a PDF report is automatically generated at the batch closure. Full automation of the test cycle including loading/unloading of the samples can be easily implemented for in-line tests.
AMI 1000 equipment has been qualified by leading pharmaceutical companies as in-process control (IPC) leak testing for blister packs. Our software is CFR21 part 115 compliant.
Deterministic test method
As no operator intervention is required, the measurement results are totally objective. High accuracy measurements can be achieved thanks to a calibration-validation sequence of the equipment based on certified calibrated leaks.
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Brochure: AMI 1000
Large detection range
Different detection methods can be combined in order to cover the complete detection range. Massive leak and fine leak tests are performed within a single test sequence, any additional gross leak test (e.g. blue dye ingress) can be omitted.
High sensitivity, high throughput
High sensitivity tests combined with high throughput enables trend analysis to early indicate production issues. In high sensitivity mode, O.E.S is able to detect 0.2 μm defect size on glass containers which corresponds to the sterility barrier defined as the MALL (Maximum Allowable Leakage Limit) in the USP4 <1207> guidelines.
Customer benefits
Improves sensitivity, capacity and reliability of your integrity test.
Large detection range – can replace gross leak and helium test
Improves manufacturing productivity with equipment that is easy to use and to set up.
Lower cost of non-quality thanks to advanced process monitoring and feedback control
Fast return on investment
Applications
Pharmaceutical industry: Blisters, Syringes & Vials, IV bags, Plastic bottles
AMI 1000 – An Innovative CCIT Solution for the Pharmaceutical Industry
Dry Chiller Module
Mastering integrity under cold storage conditions
The Dry Chiller Module is a versatile addition to both new and existing leak detection systems. Serving as an external cooling component, it is compatible with the ASM 2000 for helium pre-filled containers and the AMI 1000 without any sample preparation, utilizing naturally present gas. This module sets new benchmarks in delivering reliable data for testing container closure integrity at low temperatures. Benefit from real-time results of temperature and leak rate, optimizing your process without wasting cycle time.
The Dry Chiller Module is designed to prove that the container closure system maintains integrity at deep cold storage temperatures, either at -80°C (-112°F) or even lower. It ensures the quality of substances requiring cold storage conditions, particularly in medical and pharmaceutical environments. Its flexibility ensures that the Dry Chiller Module can be integrated seamlessly into existing equipment.
Advantages
Fast cool down and heat up
Control over entire temperature profile
Continuous leak rate measurement
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Dry Chiller Module
Need any help?
We are available for your questions
Our team of product experts is always available to answer your questions about our products and your applications.
Mass Extraction
The leak test procedure under vacuum without tracer gas
The Mass Extraction method is carried out under vacuum. This results in an improved detection limit and thermal decoupling due to the vacuum’s insulating effect. This type of test is particularly suitable for packaging or sealed objects such as encapsulated electronic assemblies. During the test, the test unit is placed in a vacuum chamber and the chamber is evacuated. The leakage rate of the test unit is determined by the flow from the test unit to the vacuum reservoir. With this method, a detection limit of up to 7 · 10-7 mbar · l/s can be achieved.
Our USP4 <1207> and ASTM3 (F-3287-17) recognized Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV-bags, pouches or glass vials. Larger defect and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for the use in production environment allowing stability control as well as automated 100 % testing (also in inline machines).
FDA laboratories in the US and major pharmaceutical companies have been using the Mass Extraction instruments for over 10 years.
SpeedAir 3050: Enhance Pharmaceutical Product Safety
Versatile CCIT for a wide range of applications
The SpeedAir 3050 is your all-in-one solution for nonporous pharmaceutical applications. Whether your products are flexible or rigid, liquid or solid, the SpeedAir 3050 can swiftly and accurately test them all. With testing times as short as 30-45 seconds, it delivers results you can rely on, ensuring the integrity of your pharmaceutical containers.
Unmatched sensitivity for liquid products
When it comes to liquid products, the SpeedAir 3050 stands out as the most sensitive air-based technology available. You can count on its results for their repeatability and reliability, significantly reducing the risk of false negatives and positives.
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Brochure: SpeedAir 3050
Global NDT on the container
Unlike alternative methods that focus on specific areas or access points, the SpeedAir 3050 provides a comprehensive global Non-Destructive Testing (NDT) approach for your containers. It adheres to ASTM3 Standard F3287-17, demonstrating the ability to detect even the tiniest defects using an air-based technology.
Regulatory compliance assured
The SpeedAir 3050 is fully compliant with industry standards. It utilizes the USP4 <1207> recognized and deterministic Mass Extraction technology and operates with FDA5 21 CFR Part 115 compliant software, ensuring your testing processes meet the highest regulatory standards.
Customer benefits
High sensitivity for reliable results
Covers a wide range of containers
USP4 <1207> recognized test method
Non-destructive testing (NDT)
Fast cycle times compared to competing air technologies
Applications
The SpeedAir 3050 is suitable for a wide range of pharmaceutical products, including but not limited to:
Ampoules
Autoinjectors
Bottles
Cartridges
Flexible bags (IV Bags, pouches, etc.)
Syringes
Vials
Would you like to find out more about the individual components?
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1) Container Closure Integrity Testing
2) US National Institute of Standards and Technology
3) American Standard for Testing and Materials
4) United States Pharmacopeia
5) Code of Federal Regulations by the United States Food and Drug Administration (FDA)
