News | October 14, 2014

See Solutions For Container Closure Integrity Testing At Pharma Expo

Source: PTI - Packaging Technologies & Inspection
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Tuckahoe, NY - PTI Inspection Systems will showcase the E-Scan 625 HVLD Micro Leak Detection System at  Pharma Expo, November 2-5, 2014 in McCormick Place, Chicago IL in Booth W-439.

The HVLD (high voltage leak detection) non-destructive test method ensures container closure seal integrity by identifying small pinholes, micro cracks, and seal imperfections.  Applications include pre-filled syringes, liquid filled vials, ampoules and BFS containers.  HVLD is the only technology that does not rely on mass to transfer through a defect.  A proteinaceous product or products with a certain viscosity are at high risk of plugging or obstructing defects.  HVLD detects these difficult to find leaks.  Another benefit is the HVLD method can be easily migrated from the laboratory offline for 100% online testing at high production speeds.  It is very effective for online CCIT with minimal infrastructure modification.   This is a huge advantage and overall simplifies the inspection and validation process. 

PTI’s E-Scan 625 is an offline lab instrument that utilizes HVLD leak detection technology to inspect individual samples for container closure integrity, Heinz Wolf, general manager of PTI Inspection Systems, commented.  “HVLD has proven to be a highly sensitive leak test method for various types of pharmaceutical and biological products.  Prefilled syringes, in particular can be an especially challenging application due to the lack of headspace, and HVLD has proven to be the go-to solution for syringe CCIT.  Research studies have also demonstrated HVLD’s improved detection capabilities compared to conventional dye and microbial ingress methods."

Wolf adds, “HVLD technology is also referenced in the new Chapter of USP 1207 for integrity testing methods.   When this document is finally approved and released, it will have a significant impact on how companies weigh their choices in measuring the integrity of a package.”

Benefits:

  • Non-destructive, non-invasive, no sample preparation
  • Pharmaceutical, nutritional and food products
  • Detects pinholes, cracks, leaks, crystallized leaks, and channel defects
  • Capable of testing a variety of liquid filled packaging and containers including flexible and rigid packaging made of glass, plastic and poly laminates.
  • No secondary contamination to the product
  • Laboratory offline testing and 100% inline inspection at high production speeds
  • High level of repeatability and accuracy

About PTI Inspection Systems
PTI Inspection Systems is the leading manufacturer of non-destructive package inspection technologies for the pharmaceutical industry. We offer inspection systems for package integrity testing, seal integrity, leak testing and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI Inspection systems provide repeatable, reliable results and can be used at any point in the manufacturing process as they are non-destructive, non-invasive and require no sample preparation.  Visit www.ptiusa.com.

For more information, please contact Heinz Wolf:   h.wolf@ptiusa.com  or Jesse Sklar j.sklar@ptiusa.com  or Oliver Stauffer o.stauffer@ptiusa.com, Tel:  914.337.2005.

SOURCE: PTI - Packaging Technologies & Inspection

PTI - Packaging Technologies & Inspection