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21
May 2021

Pharma Package Testing CCI of High-Risk Pharmaceuticals

Pharma package testing

The pharmaceutical industry is the backbone of our health care system. As the industry is continuously progressing, the requirement for package integrity while being stored and shipped across the world is also increasing. Pharma package testing now has become an integral part of pharmaceutical industry especially when it comes to high-risk pharmaceuticals.

High-risk pharmaceutical products are usually filled and sealed in combination devices. As the design and distribution parameters are critical to both the drug and container, it is highly important for the manufacturers to ensure that the components function well together. Often manufacturing discrepancies in combination packages that contain multiple components primarily contribute to container closure failure causing distribution & shipment issues. It can cause aftereffect not only down the supply chain but also for patient safety. Hence accurate pharma package testing is highly essential for high-risk pharmaceuticals. High-risk pharmaceutical products are usually filled and sealed in combination devices. As the design and distribution parameters are critical to both the drug and container, it is highly important for the manufacturers to ensure that the components function well together. Often manufacturing discrepancies in combination packages that contain multiple components primarily contribute to container closure failure causing distribution & shipment issues. It can cause aftereffect not only down the supply chain but also for patient safety. Hence accurate pharma package testing is highly essential for high-risk pharmaceuticals?

Container Closure Integrity of Pharmaceuticals

The United States Food and Drug Administration recommends container closure integrity testing as part of the stability protocol for sterile biological products, human and animal drugs and medical devices. Traditionally, dye immersion, bubble test and other probabilistic and destructive test methods were used. In 2016, United Stated Pharmacopeia (USP) released a guidance stating that deterministic methods are preferred over the probabilistic methods.

The container closure integrity testing landscape has advances drastically. The USP Chapter <1207> on integrity testing have recommended different deterministic and non-destructive container closure integrity technologies throughout their specific product package life cycle.

The different deterministic pharma package testing technologies include the following:

Vacuum Decay Technology

Vacuum decay is considered as one of the most sensitive, practical and reliable vacuum-based leak detection method. This method gives repeatable and accurate quantitative data result with a pass or fail determination and can be used effectively for different kinds of nonporous, rigid or flexible packages. Vacuum decay technology is referenced in USP 1207 chapter guidance and is also listed in 11607. The vacuum decay method developed by PTI’s VeriPac instruments is capable of detecting microleaks in the range of single digit micron. In this method, the package to be tested is placed inside the test chamber to which vacuum is applied. The changes in absolute and differential vacuum is monitored over period of predetermined test time & is used to detect the presence of leaks within the package.

Benefits of Vacuum Decay Technology:

  • Non-destructive & no sample preparation
  • Deterministic test method
  • Repeatable and quantitative test results
  • Can be deployed in a robotic automated platform
  • Highly sensitive & non- subjective

Microcurrent HVLD

Microcurrent HVLD Technology, the new breakthrough in the field of pharmaceutical package testing & highly effective for all parenteral and biological products. The microcurrent HVLD exposes the product and environment to less voltage and has transformed the conventional HVLD technology. It capable of detecting small pinholes, micro cracks and seal defects in applications that include liquid-based products ranging from extremely low conductivity sterile water for injection (WFI) to large molecule-based proteinaceous products with suspensions.

Benefits of MicroCurrent HVLD technology:

  • Non-destructive & requires no sample preparation
  • Deterministic & non-invasive
  • Higher levels of accuracy, reliability & sensitivity in test results
  • Offline and 100% online inspection at high production speeds
  • Can be deployed in a robotic automated platform
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Pharma package testing, pharmaceutical package testing, CCI of high-risk pharmaceuticals, container closure integrity of pharmaceuticals
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