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

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

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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