Blogs

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
146
22
Mar 2022

Flexible Package Integrity Testing Techniques Offered by PTI

Flexible Package Integrity Testing Techniques Offered by PTI

Testing the integrity of newly developed packaging is a critical step in ensuring that it serves its requirements in every situation. Packaging needs to ensure that it sustains physical and mechanical stress and keeps the contents fresh until they reach the end user. In order to understand how packaging behaves under different circumstances, flexible packaging testing is quite important. Procedures for testing flexible packs are quite different from rigid packaging. Compared to rigid packaging, flexible packaging can present unique challenges in how to test both the integrity of the package and the seal quality. Some of the solutions offered for flexible package testing by PTI.

Flexible package integrity testing techniques

1. VeriPac Flex System

PTI's VeriPac FLEX systems are versatile non-destructive CCIT methods, designed specifically for pouches and other flexible packaging with dry-filled products. The technology utilizes an ASTM method for vacuum decay leak testing (F2338) listed in ISO 11607 and recognized by the FDA as a consensus standard for package integrity testing. PTI's VeriPac FLEX Systems are available in several configurators that can accommodate various package specifications and test sensitivity requirements. Such configurators for both the leak test instrument and the test chamber capacity enable evaluation of small format sachets and stick packs, up to large bulk size pouches and bags. A unique feature of this technology is that it requires no changeover of settings or tooling and is proven to provide high levels of sensitivity, reliability and practicality in testing a complete range of flexible packaging formats and sizes.

Technology Overview

The test begins by connecting the VeriPac tester to the appropriate FLEX chamber based on the size range of the package. The two VeriPac systems paired with the FLEX chamber provide different leak detection capabilities depending on the application. While the integrated flexible test chamber (IFC) is intended for sachets or stick packs with low headspace, the Drawer Style test chamber (D-Series) is ideal for package formats and bulk products. The unique difference with VeriPac FLEX systems is how the package is tested. PTI utilizes its flexible membrane that conforms to the package shape and size, eliminating any stress and damage to the film materials. Multiple packages can be tested in a single test cycle.

Benefits of VeriPac Flex System

  • Non-destructive, non-subjective, no sample preparation.
  • Deterministic, quantitative test method.
  • Test multiple packages in a single test cycle.
  • Cost effective with rapid return on investment.
  • Supports sustainable packaging and zero waste initiatives.
  • Simplifies the inspection and validation process.
  • Accurate and repeatable results.
  • ASTM test method and FDA standard.
  • USP < 1207> compliant

2. Airborne Ultrasound Technology

PTI's Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection method. The test is conducted by allowing ultrasound waves to pass through the package seal causing the reflection of sound waves. To identify the defects, variations in the reflected signals’ strength are analyzed. PTI offers two configurations of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor.

Seal-Sensor™ is a deterministic, quantitative method that inspects the final pouch seal non-destructively 100% online. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and many common defects in seals that appear visually acceptable yet possess defects that affect product quality, value and shelf-life.

Seal-Scan® is an Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructively offline for in-depth seal quality evaluation and analysis. Seal-Scan® is a semi-automatic inspection system with x-y drive, used for the detection of seal defects, seal characterization and material analysis.

Advantages of PTI’s Seal Scan and Seal Sensor Method:

  • Deterministic seal quality inspection method that produces quantitative results.
  • This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.
  • Non-destructive and non-subjective test method that requires no sample preparation.
  • Technology can be integrated for 100% online defect detection of the final pouch seal.
  • Repeatable, reproducible and reliable results for seal quality inspection.
  • Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal.
Readmore...
flexible packaging, ccit, seal integrity testing, package integrity testing, veripac flex system, seal scan, seal sensor
131
08
Feb 2022

Snack Food Package Integrity Testing offered by PTI

Snack Food Package Integrity Testing offered by PTI

Ensuring the integrity of product packages is of utmost priority to snack food manufacturers. On-the-go snack products like wafers, chips, jerky,and coffee are vulnerable to deterioration by organic components such as moisture or air. Such foreign contaminants can enter the product through defective packages and accelerate the food decomposition process. In fact, mold, oxidation, flavor degradation, and spoilage are often the direct result of compromised package integrity. These factors can create a negative impact on consumers’ perceptions of a product and brand.

It is vital for manufacturers to ensure that packaged products are properly tested for integrity to insure that products remain fresh until they reach the consumer. Today, the market offers a wide range of leak testing that is both destructive and non-destructive. However, manufacturers should realize that a method applicable for one is not ideal for another. The leak testing method chosen should be based on the specific package specification and defect rate detection. Read on to know in detail about snack food packaging integrity testing method offered by PTI.

Package testing using PTI VeriPac Vacuum Decay Series

PTI's VeriPac inspection systems are ASTM approved vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. Vacuum Decay technology is a container closure integrity test (CCIT) method, referenced in the new USP <1207> Chapter Guidance as a deterministic test method for package integrity testing. This method is also listed in ISO 11607.

VerIPac test systems have a proven capability to non-destructively test a wide range of packaging formats without requiring any changeover when testing different size packages. Additionally, it is also possible to test multiple packages in a single test cycle. VeriPac provides a qualitative result (PASS or FAIL) as well as quantitative data that correlates to leak rate and leak size. Being a non-destructive method, the test allows non-defected packages to be returned to the production line, thereby reducing waste and improving testing capabilities. This makes it a practical alternative to destructive testing methods like water bath and dye ingress.

Technology Overview

The process begins by connecting VeriPac leak testers to a test chamber specifically designed to hold the sample package. Vacuum is applied to the package being tested. Using a single or dual vacuum transducer technology, vacuum levels, as well as changes in vacuum over a predetermined test time, are monitored. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. VeriPac test systems are suitable for laboratory offline testing and can be designed for manual or fully automated operation. The test cycle takes only a few seconds, is non subjective, and non-destructive to both product and package.

VeriPac Inspection system:

  • Non-destructive test method that ensures quantitative test results
  • FDA recognized ASTM test method
  • Referenced in USP 1207 guideline
  • Cost-effective with rapid return on investment
  • Supports zero waste initiatives
Readmore...
flexible packaging, container closure integrity testing, package integrity testing, ccit
180
23
Nov 2021

Ensure Integrity of Flexible Packages with PTI's VeriPac Flex Series

Ensure Integrity of Flexible Packages with PTI's VeriPac Flex Series

Package integrity is of paramount importance in ensuring that sterility is maintained over a product’s entire shelf life. It is also a critical factor in preventing penetration of microorganisms throughout the distribution process. International Organization for Standardization defines package integrity as "the unimpaired physical condition of the final package."

Flexible pouches are extensively being used in the pharmaceutical and food industry as a primary packaging component. Even a minute breach in the sterile condition of the product is often considered a serious risk, resulting in the disposal of valuable products. Therefore, manufacturers give utmost importance for package integrity testing. Today, the market offers a host of techniques that can evaluate packages both destructively and non-destructively. In this blog we will discuss how VeriPac Flex system effectively evaluates integrity of a wide range of flexible packages.

Flexible package inspection using VeriPac Flex Series

Designed specifically for pouches and other flexible packaging with dry-filled products, VeriPac FLEX series are innovative non-destructive container closure integrity testing (CCIT) systems. Applicable across a wide range of flexible packaging formats, this technology provides unparalleled sensitivity, reliability and practicality in testing without requiring change-over of settings or tooling.

Utilizing the ASTM method for Vacuum decay leak testing (F2338), VeriPac inspection systems provide quantitative data and definitive PASS or FAIL results. PTI offers VeriPac FLEX Systems in several configurations to accommodate various package specifications and test sensitivity requirements. Such configurators for both the leak test instrument and the test chamber capacity enable evaluation of small format sachets and stick packs, up to large bulk size pouches and bags.

Because it eliminates subjectivity, reduces the waste and cost associated with traditional test methods, they are perfect alternatives to destructive package inspection techniques. Infact Vacuum decay leak testing technology has proven to provide a short return on investment when compared to destructive methods, such as the water bath or blue dye leak test. Listed in ISO 11607 and recognized by the FDA as a consensus standard for package integrity testing, VeriPac test systems detect critical packaging failures reliably and reveal valuable information on the packaging process.

Understanding the working of VeriPac FLEX systems

Depending on the size of the package, the test operator first connects VeriPac tester to the appropriate FLEX chamber. There are two VeriPac systems namely, integrated flexible test chamber (IFC) and drawer Style test chamber (D-Series) that can be paired with the FLEX chamber to provide different leak detection capability depending on the application. While the integrated flexible test chamber is for sachets or stick packs with low headspace, drawer style test chamber features two standard sizes, the Small (D) or Large (DXL) depending upon the package size and specifications. Customs designs can be manufactured for large package formats and bulk products. The unique difference with VeriPac FLEX systems is how the package is tested. PTI utilizes its flexible membrane that conforms to the package shape and size, eliminating any stress and damage to the film materials.

Benefits of VeriPac FLEX systems

  • Deterministic, quantitative test method
  • Non-destructive, non-subjective, no sample preparation
  • Test multiple packages in a single test cycle
  • Cost effective with rapid return on investment
  • Supports sustainable packaging and zero waste initiatives
  • Simplifies the inspection and validation process
  • ASTM test method and FDA standard
  • Accurate and repeatable results
  • USP < 1207> compliant
Readmore...
veripac flex series, flexible packaging, ccit, container closure integrity testing, vacuum decay technology
215
08
Sep 2020

Airborne Ultrasound Technology-The ultimate choice for Seal Integrity Testing

CCIT - A risk mitigation tool for parenteral products

Seal integrity is the key to ensuring quality of packaging goods. Testing the integrity of package seals helps ensure that packaging provides sufficient product protection. Seal quality test analyses the mechanical strength of the seal thereby securing appropriate material bonding to maintain package quality throughout the product’s shelf life. Any defect in the seal can initiate a leak and will contaminate the product while directly harming its shelf life. With the increasing trend towards flexible packaging, the demand for seal testing has readily grown. Since flexible packaging involves using materials that are sustainable, environment friendly and lower in cost it is essential to ensure that the seals of such package remain intact from the point of manufacture throughout its distribution and use. Seal integrity testing is widely used in different industries including Pharmaceutical, Medical Device, Food & Beverage, Nutrition, Bottles & Containers.

Destructive Vs. Non-Destructive Test Methods

Destructive methods are identified as methods that may damage the product during the assessment and even though the seal passes the test the product becomes useless. Since these tests were incapable of finding non-leaking seal defects, demand for such tests has steadily declined. Traditional test methods like peel strength burst or fish tank bubble come under this category.

Unlike destructive methods, non-destructive test methods are those that do not harm the product and they can be returned to the mark after testing. Reduction in wastage coupled with material cost advantage gives non-destructive methods an edge over destructive methods. According to Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection “There is a huge shift in the industry toward deterministic and quantitative test methods”. Non-destructive test method can be of the following types:

  • 1. Vacuum decay test
  • 2. Ultrasonic seal test

Vacuum Decay Method (VDM) is used by manufacturers of packages for the food, beverage, industrial and pharmaceutical industries in order to detect leaks in rigid or flexible packages.

Ultrasonic seal test is an innovative non-destructive Seal Integrity Test used to examine seal quality for defects. The ultrasonic seal test has wide application and is primarily used to detect any defects in the seal area. PTI uses Airborne Ultrasound technology which is a non-destructive and non-invasive seal quality inspection method. “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are,” says Oliver Stauffer, CEO of PTI. This method is applicable for many materials types such as Tyvek®, paper, foil, film, aluminum, plastic & poly. The test is conducted by allowing ultrasound waves to pass through the package seal causing the reflection of sound waves. To identify the defects, variations in the reflected signals strengths are analyzed

PTI offers two variants of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor. The Airborne Ultrasound testing technology creates a quick analysis of the seal area without tampering with the packaging to identify defects such as incomplete or missing seals, wrinkles, channel defects, and so on. The technology is in high demand due to its applicability across different industries.

Reasons to choose PTI’s Seal Scan and Seal Sensor Method:
  • 1. Provides quantitative results using non-destructive seal quality inspection
  • 2. Accurate and reliable outcome
  • 3. Cost-effective
  • 4. Can be used on materials like Tyvek®, paper, foil, film, aluminum, plastic & poly
Readmore...
seal integrity testing, airborne ultrasound technology, seal quality testing, airborne ultrasound, seal scan, flexible packaging
784

Popular Blogs

Tags

Container Closure Integrity Testing (CCIT) - An Ideal Solution for the Pharmaceutical Industry

Sep 01, 2020   |   1709

Container Closure Integrity Testing is a method of leak detection using a non-destructive packaging inspection system to prevent possible contamination in pharmaceutical products.

CCIT - A risk mitigation tool for parenteral products

Sep 04, 2020   |   1491

Container Closure Integrity Testing is a crucial step in evaluating the integrity of the primary parenteral packaging to avoid any leakage resulting in contamination of the drug.

Automated CCI technologies- Revolutionizing medical device testing

Sep 10, 2020   |   1071

PTI revolutionized medical device package leakage testing with Automated CCI technologies across their different technology platforms

Evaluating Container Closure Integrity of High-Risk Pharmaceuticals

Apr 15, 2021   |   988

High risk pharmaceuticals pose unique package integrity challenges for manufacturers. Even a minute leak in the container closure system can make way for contaminants to enter the products. Non-destructive container closure integrity tests like Vacuum Decay technology and Microcurrent HVLD technology offer highly sensitive leak detection with quantitative results.
COPYRIGHT 2020, PTIUSA, ALL RIGHTS RESERVED PRIVACY AND COOKIES TERMS OF USE
Popup