Container Closure Integrity testing (CCIT) has become an essential component in ensuring product safety and quality in industries such as pharmaceuticals, medical device and food/nutrition. The need for precise, non-destructive, and efficient testing methods has driven innovation in this field. PTI’s VeriPac Delta is redefining the standards for CCI testing with its advanced features and capabilities, providing a reliable solution for detecting leaks in various package types.
Modern advancements in CCI testing employ deterministic technologies that offer quantifiable and repeatable results. These methods are non-subjective and capable of identifying both gross and micro leaks in a variety of packaging formats. Among these, vacuum decay and pressure decay technologies have gained prominence for their accuracy, speed, and non-destructive nature.
Package Integrity Testing Using VeriPac Delta
The VeriPac Delta is a next-generation package integrity testing system designed to address the challenges of modern CCI testing. It incorporates two core technologies: vacuum decay and pressure decay. Vacuum decay technology, based on ASTM F2338 and recognized by the FDA as a consensus standard, detects leaks as small as 5 microns, using either vacuum or pressure. The vacuum decay test measures the level and change in vacuum over a defined time interval, ensuring high sensitivity and repeatability. Pressure decay technology complements this by detecting leaks also down to 5 microns and delivering results within 10 seconds, making it one of the fastest testing methods available. The VeriPac Delta’s modular and portable design allows it to accommodate a wide range of packaging types, including lyophilized and liquid-filled vials, prefilled syringes, ampoules, non-porous pouches, BFS containers, and ophthalmic bottles. During the testing process, the package is placed inside a test chamber connected to the VeriPac Delta. A vacuum or pressure is applied, and a high-resolution absolute transducer monitors changes in pressure or vacuum levels. This system is capable of identifying both gross and micro leaks, ensuring precise results in laboratory and QA/QC settings.
Benefits of VeriPac Delta
The VeriPac Delta sets a new benchmark in CCI testing with its advanced features and benefits:
- Non-Destructive Testing: Unlike traditional methods, the VeriPac Delta preserves the integrity of both the product and packaging.
- High Sensitivity: Capable of detecting leaks as small as 0.2 ccm or 5 microns, it ensures comprehensive testing.
- Deterministic and Quantitative: Provides accurate and repeatable results, reducing operator error and subjectivity.
- Fast Test Cycle: Results are delivered within seconds, enhancing throughput and efficiency.
- Versatile Application: Suitable for a variety of packaging formats and test configurations, it meets the needs of diverse industries.
- Data Integration: Test results can be stored and integrated into manufacturing execution systems (MES), enabling better traceability and process control.
The VeriPac Delta represents a significant advancement in package integrity testing, offering unparalleled accuracy, speed, and reliability. Its adoption can enhance product safety, reduce waste, and ensure regulatory compliance, making it an invaluable asset for industries that prioritize quality and efficiency.
By setting new standards in CCI testing, the VeriPac Delta paves the way for a future where package integrity is guaranteed with precision and confidence.
ccit, package integrity testing, container closure integrity testing
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