Product category: Laboratory equipment - pharmacy and cosmetics
Vacuum Decay Technology
Vacuum decay technology is referenced in the new USP <1207> Chapter Guidance as a deterministic test method for package integrity testing.
Packages can be non-destructively evaluated using the VeriPac inspection method which is based on vacuum decay technology. Package types include filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials.
VeriPac's non-destructive technology is capable of detecting package leaks and invisible defects using an absolute or differential pressure transducer leak test system. Package leaks may appear as imperfections in the package components themselves or at the seal juncture between mated components.
Principles of VeriPac Technology VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The sensitivity of a test is a function of the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and production applications for QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.
VeriPac inspection systems utilize an ASTM approved vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. Vacuum decay technology is also referenced in the new USP <1207> Chapter Guidance as a deterministic test method for package integrity testing.
The criteria for selecting the appropriate VeriPac model is based on the type of package and leak test sensitivity desired. Configurations can be optimized with either single or dual high resolution transducers as well as type of vacuum supply, i.e. internal, external, high vacuum, etc.
Product category: Inspection machines for pharmaceutical and cosmetic products
Seal Quality Inspection with Airborne Ultrasound Technology
Airborne ultrasound is a referenced technology in the new USP <1207> Chapter Guidance as a deterministic test method for seal quality testing.
A pouch seal is a structural element that joins flat film material, and a component designed to close a pouch airtight. Traditional test methods e.g. peel strength or burst, can measure the joint strength of the seal, using destructive methods. However, this type of testing is often unreliable. A strong seal is not necessarily an airtight one, and the flow of gas or liquid through the seal (leak) is just one type of seal defect. As such, there is a fundamental challenge to any leak testing method, whether it is a fish tank-bubble, vacuum deferential, or helium test: none of these methods detect non-leaking seal defects.
PTI's Seal-Scan® and Seal-Sensor are non-contact airborne ultrasonic testing technology. In order to use ultrasonic inspection effectively, it must be possible to place the seal in a direct line between a pair of transducers and move it (or move the transducers) along the seal. The ultrasound is transmitted and reflected at the transition from one media to the next. The greater the acoustic difference between mediums (most evident at a gas to solid transition) the more sound is reflected and the less sound transmitted through. The variation of the material thickness has only a minor effect.
Any material fold, foreign media inclusion and even a microscopic air gap between layers of pouch material causes the significant reflection, so transmitted signal is lower. A small cut, abrasion or missing layer in a material causes the less reflection, so transmitted signal is higher. Therefore, the level of a signal received after passing through the seal is a function of the seal quality. Various types of defects, visible and invisible, leaking and non-leaking, process-related and random, are detectable.
Seal-Scan® technology has been proven in the field with several online and offline units installed. PTI's ability to adapt this technology into various production constraints and environments make it an excellent solution for flexible packaging systems. It has been established as one of the most effective methods for non-destructive testing of flexible packages. In 2013, ultrasound technology was awarded the ASTM Test Method F3004-13.
MicroCurrent HVLD technology is the CCIT solution for all parenteral and biologic products.
Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing. The E-Scan testing process uses a set of electrode probes to scan a non-conductive container that is sealed. The container material can be glass, plastic, or poly laminate. The container or package must contain liquid (minimum fill 30%). If a pinhole, crack, or other defect is present, there is a resistance differential and change in current flow indicating a breach in the container. The approximate defect location can be identified.
MicroCurrent HVLD can be used on a wide range of liquid based products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.
PTIs patent pending technology uses a unique mode of MicroCurrent HVLD, applying no more than 50% of the voltage used on conventional high voltage technologies. The MicroCurrent applied to the product during the test greatly reduces the voltage exposure to the product and environment. In fact, using MicroCurrent HVLD reduces voltage explosure to the product to less than 5% of the voltage exposure experienced when testing with comparable HVLD solutions.
Non-destructive, non-invasive, no sample preparation
High level of repeatability and accuracy
Effective across all parenteral products, including extremely low conductivity liquids (WFI)
Low voltage exposure to the product and environment
Listed in USP Chapter <1207> as recommended method for parenteral liquid package inspection
Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats
Simplifies the inspection and validation process
Offline and 100% online inspection at high production speeds
PTI – Packaging Technologies & Inspection is headquartered in Tuckahoe, New York, a Westchester county community close to New York City. We are a team of engineers, scientists and professionals serving the packaging industry as a leading equipment manufacturer of package inspection equipment and an American agent for high performance packaging machinery for the food and pharmaceutical industries.
PTIs history began circa 1980 as a distributor for high performance can coating equipment. In 1984 PTI began sales and service of package inspection and leak detection equipment. Several years later, PTI began manufacturing high performance leak testing systems in our Tuckahoe, New York factory. Our R & D team focus has been on developing inspection technologies for the packaging industry that perform with a high degree of precision and reliability, and simplify testing and validation processes in the pharmaceutical, medical device, food and container industries.
PTIs inspection technologies are non-destructive, non-invasive and provide companies with solutions to improve their quality and process control, while reducing product waste and cost. PTI President and Owner, Tony Stauffer, as well as several PTI principals have been awarded multiple U.S. patents for leak detection, seal integrity inspection technologies and system designs.
PTIs inspection technologies are deterministic test methods that produce quantitative test result data. Our technologies conform to ASTM and other regulatory standards. We specialize in offering our customers the entire solution including test method development and equipment validation. PTI installations have been successful in globally transferrable and validated test methods. Contact us to learn more.