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25
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
Readmore...
covid-19. covid-19 test kits, vacuum decay technology, veripac, flexible packaging
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ptiusa

Unsere Technologien entsprechen den ASTM- und anderen gesetzlichen Normen.

Verpackungstechnologien & -Prüfung

PTI bietet Prüfsysteme für die Dichtheitsprüfung von Verpackungen, die Integrität von Siegeln und Behälterverschlüssen (CCIT). Unsere Technologien schließen Subjektivität bei der Verpackungsprüfung aus und wir verwenden Prüfmethoden, die den ASTM-Normen entsprechen. Die Prüftechnologien von PTI sind deterministische Testmethoden, die quantitative Testergebnisse liefern. Wir sind darauf spezialisiert, komplette Lösungen anzubieten, dies umfasst auch die Entwicklung von Prüfmethoden und die Validierung von Geräten.

Kontaktieren Sie uns

 

Verpackungstechnologien & -Prüfung

PTI bietet Prüfsysteme für die Dichtheitsprüfung von Verpackungen, die Integrität von Siegeln und Behälterverschlüssen (CCIT). Unsere Technologien schließen Subjektivität bei der Verpackungsprüfung aus und wir verwenden Prüfmethoden, die den ASTM-Normen entsprechen. Die Prüftechnologien von PTI sind deterministische Testmethoden, die quantitative Testergebnisse liefern. Wir sind darauf spezialisiert, komplette Lösungen anzubieten, dies umfasst auch die Entwicklung von Prüfmethoden und die Validierung von Geräten.

ptiusa

Unsere Technologien entsprechen den ASTM- und anderen gesetzlichen Normen.

Kontaktieren Sie uns

 
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