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 (https://www.pfeiffer-vacuum.com/en/products/leak-detection/leak-testing-ccit-solutions-for-pharma/) 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

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

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

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