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CCI Technologies

Vacuum Decay

Vacuum decay has been verified that it is the most practical and sensitive vacuum-based leak test method. The test measurement creates a reliable and accurate quantitative result and a pass or fail determination. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207). PTI’s VeriPac technology is the ideal non-destructive solution for container closure integrity determination for many package formats. The VeriPac Series will evaluate a wide variety of high-risk package applications and verify that the product meets regulatory and consumer integrity expectations.


MicroCurrent HVLD

PTI innovators have taken conventional HVLD technology and revolutionized the leak detection method to create HVLDMC – MicroCurrent HVLD, a non-destructive highly sensitive alternative that makes no physical contact with the package. This new class of HVLD utilizes proprietary technology to determine container closure integrity on a wide variety of liquid-based products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions. Referenced in USP <1207>, PTI’s HVLDMC has proven to be a highly sensitive leak detection method for various types of liquid-filled. The unique mode of HVLDMC utilizes about 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to conventional HVLD solutions


Helium Leak Detection

Helium leak testing is a method for finding leaks in enclosed or sealed systems using helium as a tracer gas. The concentration of helium is measured as it escapes due to leakage. This method is highly sensitive and can detect even very small leaks.


Airborne Ultrasound

PTI’s proprietary Airborne Ultrasound technology is a non-destructive seal quality inspection solution. Airborne ultrasound can be used for many material types such as Tyvek, paper, foil, film, aluminum, plastic & poly. PTI’s Seal-Scan (Offline) and Seal-Sensor (Online) both utilize the non-contact airborne ultrasonic testing technology. As a package seal passes through the sensor head, ultrasonic waves propagate through the material causing reflection of the sound waves. When defects are encountered, they result in a reduction/elimination of the signal strength – identifying the defect. The greater the acoustic difference between mediums (most evident at gas to solid transition) the more sound is reflected, and the less sound transmitted through the seal.


Automated Inline Solutions

CCIT provides automated inspection solutions across all PTI technology platforms – Vacuum Decay, Airborne Ultrasound and MicroCurrent HVLD. In addition to offline laboratory systems for leak detection and package quality testing, we offer configurations that provide the capability of fully automated inspection. Automated Systems have been designed using PTI’s VeriPac, MicroCurrent HVLD and Airborne Ultrasound technologies for applications that include automated statistical process control (SPC) testing up to fully automated robotic pick and place package handling. PTI’s robotic automated inspection platform provides best in class CCI testing with no compromise within the parenteral process. PTI’s technologies provide the reliability and accuracy in test measurement, while the automation platform provides the flexibility needed to not compromise on quality.


Volumetric Imaging Technology

The OptiPac Leak Detection System is a deterministic non-destructive technology engineered and designed with One-Touch operation to achieve a rapid test cycle requiring no changeover or sample preparation. OptiPac utilizes volumetric imaging technology: a deep algorithm with multi-imaging under vacuum, to detect the presence and location of leaks. Under this method, operators place the blister package on the test plate and press the START button. Vacuum is pulled to a defined vacuum level. The blisters expand under vacuum, driving air out of the blister through any leaks present. During the dynamic vacuum test sequence, a volumetric image and measurement reading is taken that determines which blister cavities are defective. A definitive pass/fail result is displayed as well as the quantitative measurement for each package tested. OptiPac technology can provide rapid detection of sub-5-micron defects depending on blister cavity volume and requires no change over for different blister formats.

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