Packaging has always been an indispensable factor in the pharmaceutical manufacturing process. Since most pharmaceutical products come under high-risk category, appropriate packaging is vital to prevent product deterioration. Faulty or damaged packaging can cause oxygen, moisture, microorganisms or other harmful substances to enter the product- making it unfit for use. Given the sensitive nature of pharmaceutical products, package inspection testing holds high relevance. Let us now understand what CCI techniques are being offered by PTI for pharmaceutical package testing.
Techniques to ensure CCI
1. Vacuum Decay technology
Vacuum Decay is a non-destructive Container Closure Integrity Test (CCIT) method that is highly effective in detecting leaks in nonporous, rigid and flexible packages. It is a simple test method that challenges container integrity based on fundamental physical properties. As the name suggests, this test is conducted by drawing vacuum on a package within a test chamber and monitoring the vacuum level for any decay, which would indicate a leak. 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 has revolutionized Vacuum Decay technology with its s next generation of improvements in the form of PERMA-VAC technology and VeriPac FLEX Series.
PERMA-VAC Technology is a single or dual vacuum transducer technology, which has higher test sensitivity for providing accurate and reliable results. This method can be applied to flexible and semi-flexible packages alike.
The VeriPac FLEX series are innovative packaging inspection systems specifically for flexible packages. These are available in different configurations to accommodate various package specifications, capable of detecting leaks down to the 10 to 20 micron range.
Benefits of Vacuum Decay technology
Non-destructive, non-subjective, no sample preparation
Capable of detecting defects down to 0.05 ccm
Accurate, reliable, repeatable results
Supports sustainable packaging and zero waste initiatives
ASTM test method F2338
2. MicroCurrent HVLD Technology
High Voltage Leak Detection (HDLV) is a Container Closure Integrity test method that utilizes high voltage leak detector system for evaluating integrity of nonporous packages. The latest evolution in the HVLD technology, PTI’s MicroCurrent HVLD is revolutionary technology, a non-destructive, non-invasive CCI technique which can precisely detect any leak in a wide range of liquid filled products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.
This method operates by scanning a sealed container using electrode probes to detect the presence of any leak. By analyzing a change in the current flow, the test operator can detect Defect in the container as well as its approximate location. PTI's MicroCurrent HVLD uses about 50% less voltage and exposes the product and environment to less than 5% of the voltage compared to conventional HVLD technologies. This technology can be easily shifted from offline to 100% inline testing application, thereby simplifying the inspection and validation process.
Benefits of MicroCurrent HVLD technology
- 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
ccit, package integrity testing, vacuum decay technology, microcurrent hvld technology, airborne ultrasound technology