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21
Dec 2021

Why Manufacturers Rely on High Voltage Leak Detection Technology to Ensure Pharmaceutical Package Integrity

Why Manufacturers Rely on High Voltage Leak Detection Technology to Ensure Pharmaceutical Package Integrity

Packaging is an essential part of the pharmaceutical industry, given the sensitive nature of the contents. High-risk medications and lifesaving drugs need utmost care and protection until they reach the patient. As such, stringent industry standards apply to pharmaceutical packaging. Manufacturers give high priority to safety and quality while selecting packaging materials for a drug or healthcare product. The packaging should be able to act as a barrier against external contamination and chemical reactions. Exposure to reactive gases can alter the physical, chemical and biological attributes of the products. This makes Container Closure Integrity Testing of pharmaceutical packaging a regulatory requirement.

Role of MicroCurrent HVLD in ensuring pharmaceutical package integrity

Often referred to as the conductivity and capacitance test, High Voltage Leak Detection (HVLD) is a test method found to be highly effective in detecting the presence and location of leaks in a wide range of pharmaceutical and parenteral applications. It can be used for leak testing in nonporous, rigid or flexible packages, as well as packages containing liquid or semi-liquid products. High Voltage Leak Detection test is conducted using electrical conductivity and resistance principle. This method operates by passing high voltage micro current signals through sample packages. Under the presence of a leak, the electrical resistance of the sample declines, causing an increase in current. Compared to other leak detection methods that rely on flow of gas or liquid, HVLD technology relies on “flow” of current. This reduces challenges with defect clogging compared to flow-based analysis.

The latest evolution of HVLD, PTI’s patent pending MicroCurrent technology, aims to achieve a high level of CCI assurance across the entire range of pharmaceutical products. The MicroCurrent HVLD reduces voltage exposure to the product to less than 5% of the voltage exposure experienced when testing with comparable HVLD solutions. Reducing exposure voltage not only reduces any risk that the voltage poses to the product, but also greatly reduces the production of Ozone during operation when compared with traditional HVLD solutions. Ozone in the headspace of a container can be detrimental to the product, and in the operating environment can affect respiratory health.

Benefits:

  • Non-destructive Container Closure Integrity Test (CCIT)
  • Requires no sample preparation
  • Capability to test multiple packages in a single test cycle
  • Identifies which package is defective
  • Simplifies the inspection and validation process
  • Supports sustainable packaging initiatives
  • ASTM test method and FDA standard
  • Cost effective with rapid return on investment
  • Readmore...
    hvld, package integrity testing, ccit, container closure integrity, microcurrent hvld
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    16
    Dec 2021

    How Automated CCI Testing Ensures Integrity and Quality of Pharmaceutical Packages and Containers?

    How Automated CCI Testing Ensures Integrity and Quality of Pharmaceutical Packages and Containers

    Maintaining quality requirements and ensuring package integrity are important criteria for pharmaceutical product manufacturers. As such, the shift to more automated processes and digital measurement systems have systematically become a greater part of pharmaceutical manufacturing. In this blog, we will discuss automated package inspection techniques offered by PTI.

    1. Vacuum Decay technology

    Vacuum Decay technology is a non-destructive Container Closure Integrity Test (CCIT) used for leak detection in nonporous, rigid, or flexible packages. It is an ASTM-approved, FDA-recognized test method with proven capabilities to provide reliable, reproducible, repeatable and accurate quantitative results. This method involves drawing vacuum on the sample package kept in the test chamber and analyzing the vacuum level for any defect, indicating a leak.

    Vacuum Decay technology is applicable across a wide range of pharmaceutical and medical devices with the capability of detecting leaks in single digit micron range while accommodating multiple packaging types. PTI has made further advancements in Vacuum Decay technology with its PERMA-VAC technology and VeriPac FLEX Series.

    PERMA-VAC technology that addresses vacuum decay detection at the very core of physical test measurement, controlling the test system volume and maximizing the SNR between good and defective samples. It is a a single or dual vacuum transducer technology, which has higher test sensitivity for providing accurate and reliable results.

    The VeriPac FLEX series, designed specifically for dry filled pouches and flexible packaging are available in several configurations with the ability to accommodate various package specifications. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics. The VeriPac FLEX series offer defect detection to the 10 to 20 micron range.

    2. MicroCurrent HVLD Technology

    PTI's MicroCurrent HVLD technology is a unique High Voltage Leak Detection Technology for container closure integrity testing. It is found to be highly effective across a wide range of high-risk pharmaceutical products and medical devices. When compared to traditional HVLD solutions, this method uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. Being a non-invasive technique it requires no sample preparation and has a high degree of reproducibility and accuracy throughout.

    The Microcurrent HVLD test method can detect the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects. It assures product CCI by scanning a non-conductive sealed container with electrode probes. Any defect in the packaging results in resistance differential and change in current flow in the container as well as the approximate defect location.

    Such automated platforms would provide the same 100% testing capability with an accurate inspection that includes quantitative test data and a pass/fail result. Proper sensory measurement requires time to capture a result. However, these new automated technologies can still reliably inspect containers at a much higher rate than was possible before, with a more sensitive leak detection capability.

    Readmore...
    CCIT, container closure integrity testing, package integrity testing, vacuum decay technology, HVLD technology
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    14
    Dec 2021

    Testing Integrity of Low Headspace Packages with VeriPac 410 Series

    Testing Integrity of Low Headspace Packages with VeriPac 410 Series

    According to USP1207, the headspace inside a sterile pharmaceutical or medical device packaging is an important part of a product. Therefore, it should comply with corresponding quality-relevant attributes. The attributes may vary depending on the product. For instance, the residual oxygen concentration is one of the attributes for oxygen-sensitive formulations. Testing low headspace packages like sachets and blister packages can be quite challenging for manufacturers. Read on to know how PTI's VeriPac 410 ensures package integrity of low headspace packages.

    Leak testing using VeriPac 410 series.

    Over the years, manufacturers of multi-cavity blister packs and low headspace packaging have been using destructive test methods to evaluate the integrity of such packages. However, such traditional test methods lacked accuracy and produced subjective, and unreliable results. In order to overcome the limitations of destructive test methods, PTI has developed VeriPac 410 inspection system - a non-destructive seal and leak detection technology for blister packs, sachets, and pouches with low headspace.

    The VeriPac 410 employs a mix of vacuum decay technology and differential force measurement to identify defects in packages. Multiple packages can be tested in a single test cycle, depending on package specifications. The non-deterministic nature of the test produces accurate and reliable results, removes subjectivity and the operators can get a definite pass/fail outcome. Additionally, being a non-destructive test method, the VeriPac 410 allows tested packages to be returned to the production line and eliminates the cost and waste associated with destructive leak test methods. This test method has a wide range of applications including low volume flexible and semi-flexible package leak testing.

    Technology Overview

    The VeriPac 410 tester is connected to a specially designed drawer-style test chamber. A custom package insert that conforms to the package shape increases test sensitivity. Certain types of packages can be tested in multiple during a single test cycle. The location of the defective package or cavity is identified. Vacuum levels are monitored during the test cycle to evaluate the package using the ASTM F2338 vacuum decay leak test method. Decay of the vacuum level indicates that air is leaking from the package into the test chamber.

    Once the vacuum testing phase is complete, a pressure plate maps the surface pressure of the flexible package lidding. The pressure plate system recognizes the pressure pattern exerted by the package when it is not defective, and the lack of pressure exerted on the pressure plate by a defect, allowing for both defect detection and location of the defective package or cavity.

    Benefits of VeriPac 410 system

  • Non-destructive, non-invasive, no sample preparation
  • Non-subjective, accurate and repeatable results
  • Capability to test multiple packages in a single test cycle
  • Identifies which package is defective
  • Simplifies the inspection and validation process
  • Supports sustainable packaging initiatives
  • ASTM test method and FDA standard
  • Cost effective with rapid return on investment
  • Readmore...
    CCIT, container closure integrity testing, package integrity testing, veripac 410
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