PFEIFFER VACUUM
Increasing demands for Container Closure Integrity Testing (CCIT) in the pharmaceutical industry are driven by recent FDA and international guidelines for sterile barrier. Whether you are testing sterile barrier, moisture barrier or general protection packaging we offer nondestructive and deterministic container closure integrity test equipment for:
- Off-line CCIT
- Automatic, high speed Robotic sampling
- In-line 100% inspection.
As part of the Pfeiffer Vacuum cooperation we are offering a variety of different CCIT solutions with different test technologies. These include helium leak detection (e.g. ASM2000) as well as our unique USP 1207 recognized Mass Extraction (e.g. ME2) and optical emission spectroscopy (e.g. AMI1000) technologies. With this broad solution portfolio we are able to support you with the various challenges that come along with CCIT for all different kinds of packaging's like vials, IV bags, syringes, pouches, blisters and more including method validation, process validation and IQ/OQ of our equipment at your facility.
We thereby have 2 major CCIT laboratories offering feasibility studies and application support in Annecy, France and Indianapolis, USA plus a network of more than 20 sales and service locations all over the globe.
Furthermore we also offer leading Micro-Flow leak and flow test equipment for Medical Devices such as catheters, drug delivery systems and similar devices.
For more information, please check our additional information on products and applications below.
LEAK & FLOW TESTING EQUIPMENT
Container closure integrity (CCI) testing for pharmaceutical syringes is essential to confirm that syringes maintain their sterility and ensure the safety and effectiveness of their contents. Accurate CCI testing prevents contamination and guarantees that the injectable product remains free from leaks or defects in the seal.
Container closure integrity testing (CCIT) is crucial in the pharmaceutical industry to ensure that vials maintain their sterility and product quality throughout their shelf life. These systems are designed to detect any leaks or defects in the vial's seal that could compromise the product.
Versatile CCIT1 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.
Pharmaceutical leak testing is a crucial process for ensuring the safety and sterility of medical and drug packaging, particularly in applications such as CCIT Test Method Validations, pilot production runs, and small-scale production runs. While pharmaceutical manufacturers may not have the resources to invest in leak testing equipment or trained personnel, inadequate testing can have serious consequences. In this article, we will discuss the leak testing services offered by Pfeiffer Vacuum and how they can help manufacturers meet regulatory requirements and ensure the safety of their products.
Our USP <1207> and ASTM (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).
Our patented O.E.S. (Optical Emission Spectroscopy) 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 with high throughput. A multi-gas sensor is used to independently track the different gases (i.e. argon, nitrogen, CO2, humidity,…) escaping from a leaky container exposed to vacuum. Our method is non-destructive, deterministic, easy to use and to set up, faster and has higher sensitivity than other conventional methods. O.E.S. is able to detect down to 0.2µm defect size on glass containers which corresponds to the sterility barrier defined as the MALL (Maximum Allowable Leak Limit) in the USP<1207> guidelines.
While in the early development stage of packaging, the supplier is obliged to ensure that the packaging is by design capable of ensuring sterility. Therefore, the packaging must to be tested for defects in the range of 0.2 µm, respectively 6 * 10-6 mbar*l/s („maximum allowable leak level“; MALL). Based on a study from Kirsh, this is the defect size where the microbial ingress failure rate is 0 %. Integrity tests are mainly performed in the range of 2 to 20 µm defect size. The main reason for this is the feasibility of the available methods to detect smaller defects in a reasonable test time. When dealing with 100 % inspection of the production line that operates at speeds for 120 to 600 parts per minute, the allowed defect size is sometimes even increased to a significantly higher level. To compensate on the risk-based approach, additional off-line sample testing is performed to a tighter specification in the range of 1 to 10 µm. This also applies to stability testing which is performed in laboratory tests. Here again the sensitivity is more important than the test time.
There is an increasing demand for CCIT (Container Closure Integrity Testing), in the pharmaceutical industry that are driven by strict FDA guidelines requiring a sterile barrier. Whether you are testing sterile barrier, a moisture barrier or general protection packaging we can offer nondestructive container closure integrity test equipment.
There is an increasing demand for CCIT (Container Closure Integrity Testing), in the pharmaceutical industry that are driven by strict FDA guidelines requiring a sterile barrier. Whether you are testing sterile barrier, a moisture barrier or general protection packaging we can offer nondestructive container closure integrity test equipment.
Pfeiffer Vacuum applications are Ideal for medical device and medical package leak testing. Unlike pressure decay, we offer a faster, more accurate test as well as direct measurement capabilities that are not volume sensitive.
Container Closure Integrity Testing of Pouches is common across many industries.
There is an increasing demand for CCIT (Container Closure Integrity Testing), in the pharmaceutical industry that are driven by strict FDA guidelines requiring a sterile barrier.
Pfeiffer Vacuum offers a wide range of different leak testing methods to address the multitude of challenges within the pharmaceutical industry as there is no one solution that fits all different challenges connected to a specific product.
Pfeiffer Vacuum's Mass Extraction Technology takes advantage of the Micro-Flow phenomena and gas expansion, which occurs while the test is conducted in a vacuum.
Optical emission spectroscopy, an innovative CCIT solution for the pharmaceutical industry.
Turnkey solution for high sensitivity CCIT
Integrity test equipment for helium mass spectrometry
The quality, safety and effectiveness of drugs significantly depends on their proper packaging.
IV bags are vulnerable to leaks around the seams and especially around the ports where tubes or drugs could be inserted. With our unique USP 1207 recognized Mass Extraction Test Method we offer a deterministic and non destructive test method for this application, which offers various benefits for example in comparison to the “Probabilistic” dye ingress test. “Deterministic” methods are validatable relying on physical measurement technologies where test results are variable and can be compared to pass/fail criteria. Whereas, “Probabilistic” methods, such as dye ingress testing are highly subjective, rely on human interpretation and are prone to error.
Our Medical Device Leak And Flow Testing capabilities surpass other existing methods. We offer nondestructive (NDT) leak testing instruments for your flexible and rigid products.
With the AMI and its optical emission spectroscopy Pfeiffer Vacuum has introduced a method with lower detection limits compared to any other method that uses gas trapped in the cavity.
CONTACT INFORMATION
Pfeiffer Vacuum Inc.
4037 Guion Lane
Indianapolis, IN 46268
UNITED STATES
Phone: (317) 328-8492
WEBINARS
FEATURED CONTENT
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![Dry Chiller Module for Container Closure Integrity Testing]( "Pfeiffer Vacuum Introduces Dry Chiller Module For Container Closure Integrity Testing (CCIT) At Low Temperatures")
Pfeiffer Vacuum introduces an innovative addition to both new and existing leak detection systems: the Dry Chiller Module. Serving as an extended cooling component for ASM 2000 and AMI 1000 leak detectors, this module sets new benchmarks in producing dependable data for testing container closure integrity at low temperatures. It ensures the quality of substances that require cold storage conditions, particularly in medical and pharmaceutical environments.
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![Pfeiffer Vacuum at ACHEMA]( "Pfeiffer Vacuum To Present \"Advanced Container Closure Integrity Testing At Low Temperatures\" At ACHEMA 2024 Conference In Frankfurt")
When developing new cell and gene therapy drugs and mRNA-based vaccines, it is necessary to store the substances at extremely low temperatures. This raises the question of how the tightness of the containers can be guaranteed at these temperatures.
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![1]( "\"What You Should Know About CCI Testing At Low Temperatures” Webinar Announced")
Learn more about how known but also new container closure integrity test method can help you break the ice and step up your testing strategy at low temperatures.
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![SpeedAir 3050]( "SpeedAir 3050 From Pfeiffer Vacuum")
Pfeiffer Vacuum, a leading provider of vacuum technology, introduces the new leak tester SpeedAir 3050, an all-in-one solution for nonporous pharmaceutical containers.
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![Vials GettyImages-116406654]( "CCIT Comparative Study Between Dye Ingress And Deterministic Methods")
Explore the results of a unique comparative study of CCIT, and find a suitable deterministic test method to replace the blue dye test that follows the latest guidelines.
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![ASM 2000 Bucket]( "A High Sensitivity Solution For Pharma CCIT")
Experience a comprehensive CCIT solution completely adapted to the needs of pharma customers. The software features intuitive menus, simple navigation, 21 CFR part 11 compliance, traceability, and data storage.
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![roots-pumps-oktaline-atex]( "Pfeiffer Vacuum To Exhibit OktaLine® ATEX Series Of Explosion-Proof Roots Pumps At ACHEMA Show 2022")
Roots pumps from Pfeiffer Vacuum’s OktaLine are ideal for use in processes in potentially explosive environments or for evacuating explosive gases. Designed in accordance with the ATEX Directive (2014/34/EU1 and/or 1999/92/EC) with pressure surge resistance of PN 16, they meet the very highest explosion protection requirements. Zone entrainment of explosive gases is ruled out as a result. Potential applications range from the chemical, biotechnology and pharmaceutical industries to industrial applications such as vacuum furnaces or heat treatment.
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![PIlls Blister Packaging GettyImages-174777552]( "Innovative Leak Testing Of Pharmaceutical Blister Packages")
Learn how to obtain highly sensitive, quantitative measurements in real-time without specific tracer gases.
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![Blister packaging capsules iStock-948395410]( "How To Select The Ideal Leak Testing Method For Your Application")
Here, we present the pros and cons of electronic leak testing methods, their suitability for different leak detection applications, and professional advice on selection criteria.
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![Pfieffer]( "AMI 1000 – An Innovative CCIT Solution For The Pharmaceutical Industry")
This innovative CCIT solution based on Optical Emission Spectroscopy (O.E.S.) is an deterministic test method according to USP 1207 that can be used for in-process control during production or for laboratory purposes.
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![Pfeiffer]( "ATC By Pfeiffer Vacuum Receives FDA Approval For Pharmaceutical Package Leak Testing")
Pfeiffer Vacuum, one of the world's leading providers of vacuum technology, has announced that the ATC by Pfeiffer Vacuum Mass Extraction leak testing process meets FDA standard F3287 for leak testing.
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Italian-based Stevanato Group, a leading producer of glass primary packaging and provider of integrated capabilities for combination products and the US-based Pfeiffer Vacuum specialized in leak testing & CCIT technologies announces recently an agreement thanks to which the US Technology Excellence Center, opening in Boston in the second half of 2020, will be providing characterization testing of the container-closure system for the Biopharma industry.
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![CCIT Solutions]( "CCIT Solutions For The Pharmaceutical Industry")
The quality and effectiveness of drugs significantly depend on their packaging. Explore a wide range of leak testing methods that address package integrity challenges in the life science industry.
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![ATC]( "Mass Extraction CCIT For Vials")
This video shows ATC's patented Mass Extraction technology in a container closure integrtiy testing example of system verification and system testing.
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The poster shall explain a Mass Extraction technology, especially suitable for Pharmaceutical Container Closure Integrity Testing (CCIT) applications and is acknowledged by an own ASTM standard.
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![Syringe Vials]( "Container Closure Integrity Testing: Risks And Methods")
We share an overview of integrity tests where high sensitivity is required to prevent the risks of stability failure of highly moisture-sensitive drugs or biological ingress of sterile parenteral drugs.
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![ATC]( "Replace Dye Ingress With Mass Extraction To Mitigate Risks")
A major pharma company had a problem. Its manufacturing process engineers could not reliably verify that pouch packages were sealed properly. Product could potentially ship with questionable packaging.
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![Pfeiffer_Logo_RGB_ClaimBelow-(002)]( "USP <1207> Updates Leak Testing Recommendations For Pharma Companies")
Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.
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![Container Closure Integrity Testing Utilizing Mass Extraction Technology]( "Container Closure Integrity Testing Utilizing Mass Extraction Technology")
Mass extraction tests are nondestructive and offer higher measurement sensitivity. In addition, the instruments are efficient, offer short test times, and are more accurate than many of the other methods.
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![Flexible Pouch Integrity Test System]( "Flexible Pouch Integrity Test System")
CCIT system for flexible pouches using mass extraction technology.
