Mar 2022

Evaluating the Integrity of Covid-19 Test Kits

Evaluating the Integrity of Covid-19 Test Kits

The novel coronavirus emerged late December 2019 and spread rapidly globally. It is a notifiable communicable disease of the fifth category and is also known as Severe Pneumonia with Novel Pathogens. The incubation period of coronavirus ranges between 2-14 days and is considered to be highly contagious.

As of now, most of us have either had COVID-19 ourselves or known someone close to us who has had it. Studies show that nearly 80 million U.S. residents have had confirmed COVID-19 infections since March 2019. And many more likely have been infected but without reported tests to confirm. In fact we’re still witnessing variants and mutations of the virus.

One of the smartest and safest measures to know your status and avoid infections is regular testing. With the outbreak of a more contagious Omicron variant of COVID-19, testing remains a critical tool to suppress the spread of the virus. Luckily, COVID-19 tests are getting easier to find. And now, there are different types of home tests that, when used together, paint an accurate picture of your COVID-19 status.

With the rising demand for test kits, ensuring the integrity of testing activities is also critical to fighting the virus. COVID 19 test kits are extremely moisture sensitive as the absorption pad and other critical components are made of filter paper and other absorbent materials. Compromised test cassettes can lead to incorrect results or unusable test kits. False-negative results lead to the further spread of the virus, while false positives can induce fear and unnecessary quarantine.

Common issues in flexible packaging are leaks, poor sealing within the fin seal, cuts in the package, channel leaks, wrinkles, and completely open seals. Low humidity production environments and desiccant packaging materials do not suffice if a leak is present in the package.

PTI has developed a solution for container integrity testing of diagnostic test cassettes in flexible packaging. Utilizing PTI’s VeriPac vacuum decay technology in accordance with ASTM F2338 and USP 1207, leaks in flexible packaging can be detected down to 5 microns. With PTI’s Hand Flex Chamber (HFC), multiple samples can be tested in a single test cycle. The HFC membranes engulf the package to avoid any additional stress to the package seals and remain a non-destructive test method. ?The test cycle is rapid and provides pass/fail results and supporting quantitative result data.

Benefits of Vacuum Decay Technology

  • Non-destructive, non-subjective, no sample preparation.
  • Deterministic, quantitative test method.
  • Repeatable, rapid and reliable testing.
  • Cost effective and economical.
  • Simplifies the inspection and validation process.
  • ASTM test method and FDA standard
covid-19. covid-19 test kits, vacuum decay technology, veripac, flexible packaging
Jan 2022

Package Integrity Testing Using VeriPac Series

Package Integrity Testing Using VeriPac Series

Medical devices and pharmaceuticals products are manufactured with zero tolerance to defects. For this reason, manufacturers give top priority to quality control procedures and regulatory standards. This is to make sure that products maintain the quality standards required for their intended use.

Packaging plays an important role in maintaining product quality and ensuring the product reaches consumers defect-free. While selecting the right packaging material is important, testing integrity of packages also holds high relevance. Traditionally, destructive testing methods like Dye Ingress and Water Bath were popular Container Closure Integrity Testing (CCIT) techniques. However, in recent years, the industry has moved towards deterministic methods to achieve more precise, reliable results.

How PTI's VeriPac Series ensure package integrity?

PTI 's VeriPac series are non-destructive, non-subjective test systems ideal for leak testing high-risk applications that require extreme levels of test reliability and accuracy. This technology uses an ASTM approved vacuum decay leak test method F2338, which is listed in ISO 11607, USP <1207>. It is an FDA recognized consensus standard for package integrity testing. Using cutting-edge innovation, VeriPac inspection systems provide repeatable, sensitive, and more robust detection of defects. VeriPac testers feature the patented PERMA-Vac manifold system and dynamic test modes that provide the ability to test a wide range of package formats including flexible, rigid and semi-rigid packaging. Apart from package integrity testing, VeriPac technology can also be used for stability studies, clinical trials, quality assurance testing and statistical process control (SPC).

Technology Overview

The test method is initiated by connecting VeriPac leak testers to a test chamber that is specially designed to contain the package being tested. The package is placed inside the test chamber to which a vacuum is applied. Using a single or dual vacuum transducer technology, the level of vacuum as well as the change in vacuum over a predetermined test time are monitored. The variations in absolute and differential vacuum indicate the presence of leaks and defects within the package. The sensitivity of a test is a function of the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and production applications for QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.

Benefits of VeriPac series

  • Deterministic, quantitative test method.
  • Defect detection down to 0.034 cc/min.
  • Highest level of repeatability and accuracy.
  • Cost-effective with rapid return on investment.
  • Simplifies the inspection and validation process
  • Results proven superior to dye ingress.
  • ASTM test method and FDA standard
  • USP <1207> Compliant.
container closure integrity testing, package integrity testing, ccit, vacuum decay technology, veripac

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