Mar 2021

How is Vacuum Decay Technology an Ideal Nutrition Package Inspection Solution

How is Vacuum Decay Technology an Ideal Nutrition Package Inspection Solution

Nutritional products are expected to be manufactured with zero tolerance to defects and should reach the consumers in the best and safest possible state. This is a criterion that cannot be ignored due to health and safety regulations. This is because most nutritional products are subject to innate chemical reactions. Defects in the nutritional packaging can cause the products to deteriorate with exposure to oxygen, moisture and bacteria. Fats and other infant nutrients can go rancid and inert.

Among other nutritional products, the standard of quality within dehydrated dairy industry is most critical. Even a minute defect in the package can deteriorate product quality, making it unfit for consumption. This is especially true for protein-based powders which are manufactured under controlled conditions to prevent spoilage and retain its nutritional purpose throughout its shelf life.

The protein content in most dairy products allows bacteria to consume majority of oxygen content before an increase in oxygen is detected by gas testing equipment. Leaks as small as 10-20 microns will only increase the oxygen content to levels below 3%, which cannot be detected using conventional testing methods. However, such leaks can dramatically decrease the typical 12 to 24 months shelf life of protein-based products. Oxygen and moisture ingress into the package will rapidly degrade the product prior to use, changing flavor, texture, and ultimately turning any valuable product into a liability.

Since conventional testing methods like water bath or dye ingress fall short of detecting such defects, it is important to apply techniques that offer high sensitivity leak testing and quality assurance.

Ensuring package integrity with Vacuum Decay technology

Vacuum Decay technology is a Container Closure Integrity test method with proven capability of non-destructively testing packaging at the production line with unmatched reliability and sensitivity. Non-destructive testing not only allows a greater understanding of package quality, but also reduces waste as compared to destructive test methods. Waste reduction in turn results in higher return on investment and brings operations closer to green initiatives.

Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. Single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. PTI’s VeriPac Series a practical alternative and significant improvement to destructive test methods and can precisely detect leaks as small as 5 microns, identifying process issues before they become critical, avoiding catastrophic quality deviations.

Benefits of Vacuum Decay technology:

  • Non-destructive technology
  • ASTM Test Method F2338, FDA Consensus Standard and referenced in USP 1207 Guidelines
  • Accurate, repeatable results
  • Pass/fail results backed by quantitative test data
  • Completely tool-less with no changeover to test different packaging formats
  • Identifies which cavity is defective
  • Eliminates destructive, subjective testing methods
nutrition package inspection, vacuum decay technology, cci, container closure integrity test, nutritional packaging inspection
Mar 2021

Why is MicroCurrent HVLD Technology a Preferred CCI Technique for Ensuring Integrity of Biologic Products

Why is MicroCurrent HVLD Technology a Preferred CCI Technique for Ensuring Integrity of Biologic Products

Often described as the driving force of pharmaceutical industry, biologic drugs have the ability to address chronic diseases, unmet medical needs and comprise of more than half of the drugs in development. These are generally large complex molecules, derived from human, animal, or microorganisms through biotechnology. Examples include blood components, cells, vaccines, tissues, and recombinant proteins. The ability of biological drugs to treat life threatening diseases coupled with aging population has lead to tremendous growth in the global biological drugs market. However, the rapid growth of biological products has also increased packaging challenges to deliver safe and effective products.

Drug contamination is a serious concern in any medical industry; however, for biologics, it amplifies several folds because they are used to treat serious illnesses and chronic conditions. Contamination has a direct impact on product stability resulting in reduced shelf life and efficacy. Along with maintaining an acceptable shelf-life, there are other challenges too. Another important factor that can affect the quality of a drug is environmental conditions. For example, if a product is exposed to extreme temperature during transit, the product quality may be compromised. A biologic can also lose its stability if it’s unable to withstand variations in light and chemicals that it might encounter. Therefore, in order to cover packaging challenges associated with biological products, ensuring its container closure integrity is crucial.

Ensuring package integrity with PTI’s MicroCurrent HVLD technology

PTI’s MicroCurrent HVLD technology is a non-destructive, non-invasive container closure integrity test method that is found to be highly effective across applications such as pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. This technique 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. Under this method, the sealed container is scanned using electrode probes to detect the presence of any leak. Defects in the container as well as its approximate location can be identified by analyzing a change in the current flow. MicroCurrent HVLD technology utilizes about 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. It is one of the most effective CCI technologies for all parenteral and biologic products.

Benefits of PTI’s MicroCurrent HVLD technology

  • Non-destructive, non-invasive, no sample preparation
  • Highly effective across all parenteral products, including extremely low conductivity liquids (WFI)
  • Ensure higher levels of accuracy and reliability in results
  • Offline and 100% online inspection at high production speeds
  • Simplifies the inspection and validation process
  • Referenced in USP 1207 Guideline
Microcurrent HVLD, CCI, container closure integrity, container closure integrity testing, Integrity of biologic products

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