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
20
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.
Readmore...
container closure integrity testing, package integrity testing, ccit, vacuum decay technology, veripac
202
18
Jan 2022

Evaluating Quality Control Solutions for Parenteral Products

Evaluating Quality Control Solutions for Parenteral Products

Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants. They are sterile products intended to be administrated directly into human bodies. Parenteral drug products are expected to be free from microorganisms, pyrogenic substances as well as other visible particles. Contaminated parenteral drug products can cause serious health concerns to the patient. Hence, sterility assurance and package integrity testing are of paramount importance in parenteral drug manufacturing. Read on to know more about parenteral products package testing methods offered by PTI.

Parenteral products package testing methods:

1. Vacuum Decay technology

Vacuum Decay technology is a non-destructive Container Closure Integrity test method primarily used to detect leaks in package seals. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is capable of identifying leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection. Vacuum Decay technology has established itself as a non-destructive alternative to traditional test methods like Water Bath and Dye Ingress, making it a practical solution for leak detection in the Pharmaceutical and Medical Device industry.

How does Vacuum Decay technology work?

The principle behind Vacuum Decay technology is simple and it challenges container integrity based on fundamental physical properties. The test begins by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. Based on the test sample and level of sensitivity required, a pre-determined vacuum level is chosen for the test. The next step involves evaluating the test chamber and test system dead space for a pre-determined period. Differential pressure transducers are used to monitor changes in vacuum levels for a specified period. A pressure increase beyond the predetermined pass/fail limit indicates container leakage.

Benefits of Vacuum Decay technology

  • Non-destructive package inspection system
  • Accurate and reliable results
  • Definite pass/fail result based on quantitative test data 
  • Accommodates multiple packaging formats
  • Eliminates destructive, subjective testing methods
  • Effective in detecting even minute leaks
  • ASTM Test Method F2338, FDA Consensus Standard and USP 1207 compliant
  •  

2. MicroCurrent HVLD Technology

PTI’s Microcurrent is patent-pending unique CCI technology that has revolutionized the conventional high voltage leak detection method. It is a non-invasive and deterministic container closure integrity testing method that is effective across all parenteral and biologic products including low conductivity liquids such as sterile water for injection. The Microcurrent HVLD test method is highly effective in detecting the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects across applications like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. A unique mode of Microcurrent HVLD uses about 50% less voltage and reduces the exposure of product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. The E-scan HVLD series is a leading solution of sturdy container closure integrity test equipment.

Benefits of MicroCurrent HVLD technology

  • Non-destructive & requires no sample preparation
  • Deterministic & non-invasive
  • Highly effective across all parenteral products
  • High levels of sensitivity, accuracy and reliability in results
  • Offline and 100% online inspection at high production speeds
  • Simplifies the inspection and validation process
  • Referenced in Chapter USP 1207 Guidance for CCIT
Readmore...
parenteral product leak testing, container closure integrity testing methods, ccit, hvld, vacuum decay technology, package integrity testing
198
16
Dec 2021

How Automated CCI Testing Ensures Integrity and Quality of Pharmaceutical Packages and Containers?

How Automated CCI Testing Ensures Integrity and Quality of Pharmaceutical Packages and Containers

Maintaining quality requirements and ensuring package integrity are important criteria for pharmaceutical product manufacturers. As such, the shift to more automated processes and digital measurement systems have systematically become a greater part of pharmaceutical manufacturing. In this blog, we will discuss automated package inspection techniques offered by PTI.

1. Vacuum Decay technology

Vacuum Decay technology is a non-destructive Container Closure Integrity Test (CCIT) used for leak detection in nonporous, rigid, or flexible packages. It is an ASTM-approved, FDA-recognized test method with proven capabilities to provide reliable, reproducible, repeatable and accurate quantitative results. This method involves drawing vacuum on the sample package kept in the test chamber and analyzing the vacuum level for any defect, indicating a leak.

Vacuum Decay technology is applicable across a wide range of pharmaceutical and medical devices with the capability of detecting leaks in single digit micron range while accommodating multiple packaging types. PTI has made further advancements in Vacuum Decay technology with its PERMA-VAC technology and VeriPac FLEX Series.

PERMA-VAC technology that addresses vacuum decay detection at the very core of physical test measurement, controlling the test system volume and maximizing the SNR between good and defective samples. It is a a single or dual vacuum transducer technology, which has higher test sensitivity for providing accurate and reliable results.

The VeriPac FLEX series, designed specifically for dry filled pouches and flexible packaging are available in several configurations with the ability to accommodate various package specifications. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics. The VeriPac FLEX series offer defect detection to the 10 to 20 micron range.

2. MicroCurrent HVLD Technology

PTI's MicroCurrent HVLD technology is a unique High Voltage Leak Detection Technology for container closure integrity testing. It is found to be highly effective across a wide range of high-risk pharmaceutical products and medical devices. When compared to traditional HVLD solutions, this method uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. Being a non-invasive technique it requires no sample preparation and has a high degree of reproducibility and accuracy throughout.

The Microcurrent HVLD test method can detect the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects. It assures product CCI by scanning a non-conductive sealed container with electrode probes. Any defect in the packaging results in resistance differential and change in current flow in the container as well as the approximate defect location.

Such automated platforms would provide the same 100% testing capability with an accurate inspection that includes quantitative test data and a pass/fail result. Proper sensory measurement requires time to capture a result. However, these new automated technologies can still reliably inspect containers at a much higher rate than was possible before, with a more sensitive leak detection capability.

Readmore...
CCIT, container closure integrity testing, package integrity testing, vacuum decay technology, HVLD technology
197
25
Nov 2021

Container Closure Integrity Techniques for Pharmaceutical Package Integrity

Container Closure Integrity Techniques for Pharmaceutical Package Integrity

Packaging has always been an indispensable factor in the pharmaceutical manufacturing process. Since most pharmaceutical products come under high-risk category, appropriate packaging is vital to prevent product deterioration. Faulty or damaged packaging can cause oxygen, moisture, microorganisms or other harmful substances to enter the product- making it unfit for use. Given the sensitive nature of pharmaceutical products, package inspection testing holds high relevance. Let us now understand what CCI techniques are being offered by PTI for pharmaceutical package testing.

Techniques to ensure CCI

1. Vacuum Decay technology

Vacuum Decay is a non-destructive Container Closure Integrity Test (CCIT) method that is highly effective in detecting leaks in nonporous, rigid and flexible packages. It is a simple test method that challenges container integrity based on fundamental physical properties. As the name suggests, this test is conducted by drawing vacuum on a package within a test chamber and monitoring the vacuum level for any decay, which would indicate a leak. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207). PTI has revolutionized Vacuum Decay technology with its s next generation of improvements in the form of PERMA-VAC technology and VeriPac FLEX Series.

PERMA-VAC Technology is a single or dual vacuum transducer technology, which has higher test sensitivity for providing accurate and reliable results. This method can be applied to flexible and semi-flexible packages alike.

The VeriPac FLEX series are innovative packaging inspection systems specifically for flexible packages. These are available in different configurations to accommodate various package specifications, capable of detecting leaks down to the 10 to 20 micron range.

Benefits of Vacuum Decay technology

  • Non-destructive, non-subjective, no sample preparation
  • Capable of detecting defects down to 0.05 ccm
  • Accurate, reliable, repeatable results
  • Supports sustainable packaging and zero waste initiatives
  • ASTM test method F2338
  • 2. MicroCurrent HVLD Technology

    High Voltage Leak Detection (HDLV) is a Container Closure Integrity test method that utilizes high voltage leak detector system for evaluating integrity of nonporous packages. The latest evolution in the HVLD technology, PTI’s MicroCurrent HVLD is revolutionary technology, a non-destructive, non-invasive CCI technique which 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.

    This method operates by scanning a sealed container using electrode probes to detect the presence of any leak. By analyzing a change in the current flow, the test operator can detect Defect in the container as well as its approximate location. PTI's MicroCurrent HVLD uses about 50% less voltage and exposes the product and environment to less than 5% of the voltage compared to conventional HVLD technologies. This technology can be easily shifted from offline to 100% inline testing application, thereby simplifying the inspection and validation process.

    Benefits of MicroCurrent HVLD technology

    • Non-destructive, non-invasive, no sample preparation
    • High level of repeatability and accuracy
    • Effective across all parenteral products, including extremely low conductivity liquids (WFI)
    • Low voltage exposure to the product and environment
    • Listed in USP Chapter <1207> as recommended method for parenteral liquid package inspection
    • Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats
    • Simplifies the inspection and validation process
    • Offline and 100% online inspection at high production speeds
    Readmore...
    ccit, package integrity testing, vacuum decay technology, microcurrent hvld technology, airborne ultrasound technology
    210
    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
    18
    Nov 2021

    VeriPac 465 Technology for Highly Sensitive Micro Leak Testing

    VeriPac 465 Technology for Highly Sensitive Micro Leak Test

    Container closure integrity testing (CCIT) or leak testing is an important process in the manufacturing phase of a pharmaceutical drug product in particular parenteral products. CCIT is performed to evaluate and maintain sterility over the shelf life of a product as well as to prevent contamination of the product from moisture, reactive gases, or micro-organisms. In earlier times, dye ingress, microbiological ingress and other probabilistic test methods were being used in the industry. However, the results produced by such methods lacked accuracy, reliability and were highly subjective. Therefore, manufacturers are now replacing probabilistic test methods with deterministic methods, which reduce the needs for sample preparation and validation and provide more accurate detection of leaks and defects.

    Why is VeriPac 465 effective in highly sensitive micro leak testing?

    PTI's VeriPac 465 is a deterministic, quantitative inspection technology that is non-destructive and non-invasive to the package being tested. This technology requires no sample preparation and performs leak detection based on the basic principles of physics. The VeriPac 465 is an ASTM approved, FDA recognized package integrity testing method which is based on vacuum decay leak test method (F2338). This test method was developed using VeriPac leak test instruments. Unique test cycles, pneumatic controls and processing algorithms are certain features of VeriPac 465 system that make it the foremost vacuum-based leak test for parenteral products.

    This inspection method is suitable for laboratory offline testing and QA/QC statistical process control. The test cycle takes only a few seconds, results are non-subjective and testing is non-destructive to both product and package.

     

    Technology overview

    The test begins by connecting VeriPac 465 leak tester to a chamber that is specially designed to contain the package to be tested. Vacuum is then applied to the test chamber in which the package is placed. Using dual transducer technology, the test chamber is monitored for both- level of vacuum and 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. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. VeriPac 465 technology reduces the baseline measurement for good samples and amplifies the test result for defective samples. This technology is geared towards detecting leaks in the MALL range for parenteral packaging and can also be applied to flexible and semi flexible package formats

    Inspection Criteria

    • Measures seal integrity of entire container or package
    • Measures and verifies container closure system integrity
    • Tests for gas leaks for dry products (lyophilized vials, powder filled)
    • Tests for liquid leaks (liquid filled vials, pre-filled syringes)

    Benefits of VeriPac 465

    • Non-destructive, non-subjective, no sample preparation
    • Defect detection down to 0.002 cc/min
    • Highest level of sensitivity, repeatability and accuracy
    • Results proven superior to dye ingress
    • Deterministic, quantitative test method
    • Supports sustainable packaging and zero waste initiatives
    • ASTM test method and FDA standard
    Readmore...
    container closure integrity testing, ccit, leak test, vacuum decay technology, veripac 465, package integrity testing
    330
    08
    Sep 2021

    A Quick Rundown on Medical Device Package Inspection Techniques Offered by PTI

    A Quick Rundown on Medical Device Package Inspection Techniques Offered by PTI

    Package validations for medical devices play a significant role in ensuring safe and effective use of products when they reach the patient. Packaging for these safety-critical products must withstand the rigors of the manufacturing process, storage, and the distribution cycle. Package integrity is crucial to maintaining sterility for medical devices, especially those that are to be used during medical procedures or implanted into patients. This is because even a minute defect in the package can affect sterility of the device and cause health risk to the patient. Given below is a list of non-destructive package inspection techniques that help maintain highest quality standards.

    CCI techniques offered by PTI

    Vacuum Decay technology

    Vacuum Decay is a non-destructive package inspection technique that offers the ability to inspect both the entire body of the package and seals for micro leaks and defects. The technology proven to provide reliable, reproducible, repeatable, and accurate quantitative results, is recognized by the FDA as a consensus standard for container closure integrity testing (CCIT). Vacuum Decay leak test method is an ASTM Test method (ASTM F2338) that was developed using PTI instruments, it is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

    Technology overview

    Vacuum Decay test method is simple in practice and challenges container integrity based on fundamental physical properties. The samples are placed in a closely fitting test chamber, equipped with external vacuum source. A pre-determined vacuum level is selected depending on test sample and level of sensitivity required. The next step involves evacuating the test chamber and test system dead space for a pre-determined period. Differential pressure transducers are used to monitor change in vacuum level for a specified period. A pressure increase beyond predetermined pass/fail limit indicates container leakage.

    Advantages of Vacuum Decay technology:

    • Non-destructive package inspection system
    • Accurate and reliable results
    • Definite pass/fail result based on quantitative test data 
    • Accommodates multiple packaging formats
    • Eliminates destructive, subjective testing methods 
    • Effective in detecting even minute leaks 

    Airborne Ultrasound technology

    Airborne Ultrasound technology is a non-destructive Container Closure Integrity test used to examine seal quality for defects. It is an ASTM Test Method F3004 and FDA recognized standard for seal quality integrity testing. These tests are primarily conducted to provide advanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection technique suitable for many materials including Tyvek, paper, foil, film, aluminum and plastic. Airborne Ultrasound technology offers a comprehensive approach to evaluate seal quality even in conditions where a seal has a defect but may not leak.

    Technology overview

    Under this method, ultrasonic waves are propagated through the package seals as they move along the sensor head. This causes reflections of sound waves. The signal strength is either eliminated or reduced in the presence of any defect/leak. Such variations in signal strength are closely monitored to identify the defects.

    Benefits of Airborne Ultrasound technology

    • Non-destructive, non-subjective, no sample preparation
    • Accurate and reliable results
    • Deterministic package inspection technique 
    • Works on multiple packaging formats and materials 
    • Economical cost-effective solution for seal integrity testing
    • Can be applied to 100% inline seal quality testing
    Readmore...
    medical device package testing, cci, ccit, airborne ultrasound technology, vacuum decay technology, pharma package inspection
    341
    11
    Jun 2021

    VeriPac Series-Elevating Standards for Package Integrity Testing

    VeriPac Series-Elevating Standards for Package Integrity Testing

    Package integrity testing may be understood as a set of techniques used to protect the contents of a package from potential physical, chemical and microbial threats. It plays a crucial role in determining and maintaining sterility and shelf life of pharmaceutical products, medical devices, and food and nutrition products. Since such products are extremely sensitive to external environmental conditions, even a minute breach in the package can cause micro-organisms, reactive gases or other harmful substances to enter the product. This can result in serious health issues to the end user and affect brand loyalty of manufacturing companies. As such, testing for leaks is an important aspect of the manufacturing process.

    Historically, manufacturers relied on destructive testing methods like Water Bath or Dye Ingress as well as other unreliable methods such as Visual Inspection to test integrity of packages. However, such tests lacked accuracy and reliability in test results. Moreover, being destructive testing methods, it caused damages to the package being tested making it unfit for use. These limitations of destructive techniques prompted manufacturers to opt for non-destructive testing methods that do not harm the product and provide reliable, repeatable and quantitative rest results. Reduction in waste coupled with material cost advantage gives non-destructive methods an practical edge over destructive test methods. Examples of non-destructive testing methods include Vacuum Decay technology, Airborne Ultrasound technology and Microcurrent HVLD technology.

    VeriPac test systems for precise and reliable package integrity testing

    PTI’s VeriPac series are non-destructive, non-invasive inspection systems for leak detection and package integrity testing. These systems reduce waste and provide operators with a clear understanding of package quality. The VeriPac test system produces real time results from precise quantitative measurements that identify packaging defects before critical process issues get out of control. Tests can be performed in any sequence and even repeatedly on a single sample. Good packages can be returned undamaged to the packaging line. Testing is more reliable, sensitive and efficient than destructive methods. VeriPac series utilizes the ASTM approved patented Vacuum Decay leak test method F2338, recognized by the FDA as a consensus standard for package integrity testing.

    Technology Overview

    PTI’s VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The absolute 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. The test cycle takes only a few seconds, results are non-subjective, and testing is non-destructive to both product and package. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or fully automated operation. This inspection method is suitable for laboratory offline testing, QA/QC statistical process control, automated batch or 100% inline testing.

    Benefits of VeriPac series

    • Non-destructive, non-subjective, no sample preparation
    • Deterministic, quantitative test method
    • Defect detection down to 0.2 ccm
    • High level of sensitivity, repeatability and accuracy
    • Short cycle time provides operator with PASS/FAIL result
    • Small footprint and modular portable design
    • ASTM test method and FDA standard
    • Referenced in USP 1207 guidance
    Readmore...
    package integrity testing, veripac series, vacuum decay technology, hvld, airborne ultrasound technology
    544
    15
    Apr 2021

    Evaluating Container Closure Integrity of High-Risk Pharmaceuticals

    Evaluating Container Closure Integrity of High-Risk Pharmaceuticals

    The pharmaceutical industry is crucial to the health care system as they assure treatments that were unimaginable a few years ago. As the industry grows in importance, the techniques of primary packaging for pharmaceutical products, especially high-risk medicines have taken on new prominence.

    Since many high-risk pharmaceutical products are filled and sealed in combination devices, it’s critical for manufacturers to ensure that the components function well together. Hence, design and distribution considerations are critical to both the drug and the container. Manufacturing inconsistencies and tolerance differences in packages containing multiple components are primary contributors to distribution issues. Often, such inconsistencies result in container closure failure, causing serious implications down the supply chain. For instance, glass vials and pre-filled syringes may not seal properly at critical fill-finish closure points. Such a failure can cause oxygen or other environmental contaminants to enter the product and compromise the efficacy of the drug in the barrel. At this point, it is critical to use the most precise leak testing method possible.

    Why Container Closure Integrity testing is important?

    As per the FDA- Food and Drug Administration, A container and closure system refers to "the entirety of packaging components that together contain and protect the product". In simple words, Container Closure Integrity testing can be understood as a leak detection test. CCI solutions include non-destructive package inspection technologies to ensure product sterility throughout the product’s lifecycle. CCIT plays a vital role in ensuring that the products are free from any possible contamination. Conventionally, probabilistic test methods like bubble tests, dye ingress and microbial challenge were extensively used in pharmaceutical package testing. Since it was found that such test results lacked accuracy and reliability, the United States Pharmacopeia (USP) released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods. With this new USP <1207> chapter guidance, manufacturers today rely on non-destructive alternatives like Vacuum Decay technology and Micro Current HVLD technology that ensure highly sensitive package integrity solutions.

    1. Vacuum Decay technology: Vacuum Decay technology is a non-destructive container closure integrity solution capable of detecting leaks in nonporous, rigid or flexible packages. Vacuum Decay leak testing is conducted by placing a sample package in a well-fitting evacuation chamber, which is provided with an external vacuum source. The vacuum levels as well as the change in vacuum over a fixed test time are closely observed using single or dual vacuum transducer technology. Changes in vacuum level beyond a predetermined pass/fail limit indicate defects within the package. VeriPac Vacuum Decay series can non-destructively test packaging down to sub-micron leak rates - making it an excellent alternative to destructive testing methods.

    PTI’s VeriPac 465, the latest addition to the vacuum decay series is a robust and reliable solution for testing pharmaceutical containers and parenteral products, achieving highly sensitive sub-micron leak detection. The VeriPac 465 is the most sensitive vacuum based technology on the market to-date.

    Benefits of Vacuum Decay Technology:

    • Non-destructive, non-subjective, no sample preparation
    • Deterministic test method that provides quantitative results
    • Multiple package testing in a single test cycle
    • Economical with rapid return on investment
    • ASTM Test Method, FDA standard and USP 1207 Guidance

    2. Microcurrent HVLD technology: Microcurrent HVLD is a unique High Voltage Leak Detection technology, highly effective across all liquid filled parenteral products. Its applications include liquid-based products ranging from extremely low conductivity sterile water for injection (WFI) to large molecule-based proteinaceous products with suspensions. Its ability to detect small pinholes, micro cracks and seal defects makes it an ideal choice for testing high risk pharmaceutical and parenteral 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 test results
    • Simplifies the inspection and validation process
    • Offline and 100% online inspection
    • Referenced in USP 1207 Guidelines
    Readmore...
    CCIT, container closure integrity testing, container closure integrity, vacuum decay technology, high risk pharmaceuticals, hvld
    988
    30
    Mar 2021

    Vacuum Decay Technology for Ophthalmic Product Package Inspection

    Vacuum Decay Technology for Ophthalmic Product Package Inspection

    Ophthalmic preparations majorly consist of sterile liquid, semi-solid or solid preparations with active pharmaceutical ingredients. More than 70% of ophthalmic drug products are supplied in plastic container closure systems, which generally contain a month or longer supply of the drug. The liquid filled package formats are often soft containers with snap on or torque screw caps, but also include foil lidded blister packs for single use contacts. Any breach, channel, or micro leak in the container closure systems can greatly increase the risk of contamination of the ophthalmic solution. Therefore, in terms of product performance and safety, ophthalmic drug product packaging is considered to be more crucial than the packaging used for solid oral drug dosage forms.

    Packaging defects are the key factors contributing to contaminated eye care solutions. For instance, the soft plastic containers and snap caps are typically blow molded plastics. The area for primary concern with both torque and snap on caps is the flange area of the bottle. Although traditional methods like visual inspection can detect many container failure modes of an uncapped container, inaccuracies or marks in the flange area can go unnoticed. However, such a defect can provide a clear path for bacteria and fungi to transfer into the product. This is both the most common and most difficult container defect to detect and remains hidden beneath the cap once it is applied. Hence, manufacturers require leak detection techniques capable of detecting even minute leaks for ensuring highly sensitive leak testing solutions.

    PTI’s Vacuum Decay technology is a non-destructive leak testing method, capable of evaluating both liquid and air-filled containers and detecting defects as small as below 1 micron. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is an ASTM test method, FDA consensus standard, eliminating false positives and subjective results associated with manual visual inspection. Vacuum Decay technology is capable of identifying leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection.

    PTI’s VeriPac 455 is a deterministic and quantitative package inspection solution for highly sensitive liquid filled containers making it ideal for ophthalmic package leak testing needs. This test method was developed using VeriPac leak test instruments. The VeriPac 455 features patented dual vacuum transducer technology, PERMA-Vac, which offers increased test sensitivity and produces repeatable, reliable results. Under this technique, the VeriPac 455 leak tester is connected to a test chamber that contains sample packages. Vacuum is applied to these packages and a dual 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. The test cycle takes only a few seconds, results are non-subjective, and testing is non-destructive to both product and package.

    Benefits of Vacuum Decay technology

    • Non-destructive, non-subjective, no sample preparation
    • Defect detection down to 0.01 cc/min
    • Results have proven superior to dye ingress
    • Deterministic, quantitative test method
    • Supports sustainable packaging and zero waste initiatives
    • ASTM test method and FDA standard
    Readmore...
    vacuum decay technology, veripac 455, ophthalmic product package inspection, package inspection technology
    872
    24
    Mar 2021

    Evaluating Quality Assurance Solutions for Coffee Packaging

    Evaluating Quality Assurance Solutions for Coffee Packaging

    Fresh coffee is the best coffee. The quality of coffee is directly linked to freshness, and maintaining freshness requires adequate packaging. In simple words, packaging is what holds coffee products and maintains its quality. However, maintaining freshness and shelf life of packaged coffee is often a challenge for manufacturers. The flavors and oils in coffee are oxygen sensitive, while flavor profile being the key differentiator for consumers. External conditions like high temperature, light, or high humidity can increase the rate of staling. Under such conditions, whole beans will lose significant amounts of flavor and develop stale fragrance in 1-2 weeks, while in case of ground coffee the process takes 1-2 days. Compromised package integrity can result in oxidation, flavor degradation, and spoilage. Leaks as small as 10 microns can draw oxygen into the package over its shelf life. If a consumer encounters a product that exhibits oxidation, the bitterness and stale flavor will likely affect the consumer’s decision to repurchase. This explains why manufacturers give prime importance to evaluating integrity of coffee packaging.

    Conventionally, water bath was the most popular technique for leak testing coffee products. Although water bath is a simple and effective leak testing method for rigid containers, it fails to meet critical needs associated with flexible coffee packages. Additionally, the cost associated with maintaining standard destructive methods is high. Subjective test results, variable test standards, and higher risks associated with the use of other methods emphasize the need for better alternatives. Hence manufacturers today opt for non-destructive testing methods that eliminate the cost associated with wasted product, and ultimately facilitate better quality control.

    Package integrity testing using Vacuum Decay technology

    PTI’s Vacuum Decay technology is an ASTM-approved, FDA recognized non-destructive Container Closure Integrity test method with proven capabilities to provide reliable, reproducible, repeatable and accurate quantitative results. It can detect oxygen critical leaks, providing a more reliable and sensitive solution for a range of packaging formats that is designed to protect oxygen sensitive products. This method involves drawing vacuum on the sample package kept in the test chamber, and analyzing the vacuum level for any defect-indicating a leak. VeriPac systems reliably detect leaks as small as 10 microns, identifying process issues before they become critical, avoiding costly quality deviations.

    For coffee sachets, stick packs or pouches, PTI’s VeriPac FLEX series offer the highest level test sensitivity, detecting micro leaks into the single digit micron range. These are versatile non-destructive package inspection systems designed specifically for flexible packages. To accommodate various package specifications, the VeriPac FLEX is available in several configurations. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics. Hence, VeriPac vacuum decay is a practical alternative and significant improvement to the destructive test methods commonly used for flexible packaging.

    Benefits of Vacuum Decay technology:

    • Reliable and sensitive leak detection of quality critical defects
    • Cost savings
    • Using a non-destructive leak test method allows an increase in the number of product samples tested
    • Rapid test cycle and minimal training required to operate tester
    • Rapid ROI due to substantial cost savings and elimination of product loss
    Readmore...
    package integrity testing, coffee packaging, ccit, quality assurance solutions, vacuum decay technology, veripac flex series
    645
    23
    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
    Readmore...
    nutrition package inspection, vacuum decay technology, cci, container closure integrity test, nutritional packaging inspection
    655
    11
    Dec 2020

    What are the Different Seal Quality Inspection Techniques Offered by PTI?

    What are the different seal quality inspection techniques offered by PTI

    Seal integrity plays a vital role in ensuring the quality of packaging products. Even a minute defect in the seal can initiate a leak, which can compromise the quality of the product and directly affect its shelf life. It can also result in huge financial losses to the manufacturer. That being said, manufacturers give considerable importance to conducting appropriate seal integrity tests to ensure package integrity at every stage of its lifecycle.

    Seal integrity testing methods can be classified into two- Destructive testing methods and Non-Destructive testing methods. Since under Destructive methods, the packages may get destroyed, its popularity has steadily declined over the past few decades due to this waste and high cost. “There is a huge shift in the industry towards deterministic and quantitative test methods,” says Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection. “This includes vacuum decay and airborne ultrasound for medical device applications. The industry is currently moving away from dye ingress and manual visual inspection because there are so many blind spots in applying them and there’s a huge false sense of assurance.”

    Seal quality inspection techniques offered by PTI:

    Vacuum Decay technology is a non-destructive Container Closure Integrity test method, used for seal quality inspection in nonporous, rigid or flexible packages. With the ability to detect leaks down to the sub-micron level, , Vacuum Decay technology is identified as one of the most practical vacuum-based leak detection methods. Its ability to provide quantitative, reliable and repetitive test results make it ideal solution for seal quality inspection in Pharmaceutical, Medical Device and Food and Nutrition industries.

    Under this method, the sample packages are first placed in a close fitting evacuation test chamber that contains an external vacuum source. The vacuum levels and changes in vacuum over a pre-determined time are closely monitored. The 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 the absolute and differential vacuum indicate the presence of leaks and defects within the package.Over the past few years, Vacuum Decay technology has seen great advancements in the form of PTI’s PERMA-VAC technology and VeriPac FLEX Series.

    The next generation PERMA-VAC technology is a single or dual vacuum transducer technology that has made the VeriPac line of test systems the most sensitive vacuum-based leak tests available in the market. It has higher test sensitivity for providing accurate and reliable results and can be applied to rigid and semi-flexible packages alike. PTI’s PERMA-VAC technology ensures the most stable test measurement ever achieved through vacuum decay.

    VeriPac FLEX series is an ideal package inspection solution for dry filled pouches and flexible packaging. To accommodate different package formats and test sensitivity requirements, VeriPac FLEX series is available in several configurations with multiple test chamber sizes.

     

    2.Airborne Ultrasound technology:

    Airborne Ultrasound technology is yet another seal quality inspection technique, which is capable of non-destructively conducting advanced seal quality inspection of pouches and flexible packaging. It is capable of accommodating multiple packaging materials like Tyvek, paper, foil, film, aluminum, plastic and poly and is also proven to provide deterministic, reliable and accurate test results.

    As the name suggests, this method utilizes ultrasound waves to detect defects in package seals. Ultrasound waves are passed through the material as the package seal moves along the sensor head. This causes reflections of sound waves. Such signal strength variations are closely monitored to identify defects if any. Its ability to evaluate seal quality even under conditions where the defect may not result in a leak, makes Airborne Ultrasound technology a practical choice for seal quality inspection across different industries.

    PTI’s Seal-Scan (Offline) and Seal-Sensor (Online) are the latest advancements to the ultrasound test series. Both these technologies make use of non-contact airborne ultrasonic testing technology and have been established as one of the most effective methods for inspection of flexible package seals. Airborne ultrasound is also an ASTM Test Method F3004 for seal quality inspection.

     

    Readmore...
    seal quality inspection, airborne ultrasound technology, vacuum decay technology, container closure integrity testing, ccit, container closure integrity
    537
    10
    Dec 2020

    Role of Vacuum Decay Technology in Medical Device Package Inspection

    Role of Vacuum Decay technology in medical device package inspection

    Apart from validating the functionality and design of medical devices, ensuring package integrity is crucial to make sure that the product reaches the end-user intact. Packaging and delivery formats available for medical devices range from porous flexible packaging to non-porous rigid containers. Each packaging format has a unique set of characteristics and requirements, which necessitates a comprehensive approach while selecting an appropriate inspection technique.

    With increasing innovations in packaging formats and materials, packaging challenges have also increased. Among other medical devices, Class III medical devices pose the highest level of risk associated with ensuring package integrity. Such devices sustain or support life and are implanted. Examples of Class III devices include pacemakers, cardiovascular stents, respiratory ventilators and breast implants. Since these devices are directly placed into human bodies, even a minute breach in the packaging can pose significant risk to patient safety. Hence testing container closure integrity (CCI) of medical devices is crucial.

    Vacuum Decay is a non-destructive Container Closure Integrity test method focused on package integrity and detection of leak paths. Compared to manual inspection and other non-deterministic test methods, Vacuum Decay offers quantitative, deterministic and reliable test results to ensure package integrity. Vacuum decay technology is capable of accommodating a wide variety of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. This test operates by placing packages in a well fitted evacuation test chamber, which has an external vacuum source. The vacuum levels are continuously monitored to identify any variations from a pre-determined targeted vacuum level. A defect in the package will cause air to escape from the package into the test chamber. On the other hand, packages without any defect hold in the air, maintaining constant chamber vacuum level. Vacuum Decay technology has been proven over years to be one of the most practical and sensitive vacuum-based leak detection solutions.

    PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating wide range of high-risk package applications. It can be efficiently incorporated into the packaging process to ensure quality, reduce waste and allow operators to have a proper understanding of package integrity. Multiple vacuum supply types along with single or dual high-resolution transducers configuration enables the VeriPac series to provide fast and reliable test results that are quantitative and deterministic. It is an ideal solution for medical device manufacturers to ensure that the product meets regulatory standards. Based on packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.

    PTI has revolutionized Vacuum Decay technology with the development of next generation PERMA-VAC technology, that offers increased test sensitivity and repeatable results. The technology is capable of detecting leaks in the MALL range for parenteral packaging and can accommodate a variety of flexible and semi-flexible package formats. The advancements in PERMA-VAC technology has made the VeriPac series the most reliable and practical vacuum-based leak test method available today.

    Benefits of Vacuum Decay technology:

    • Non-destructive, non-subjective, no sample preparation
    • Capable of detecting defects down to 0.05 ccm
    • Accurate, reliable, repeatable results
    • Supports sustainable packaging and zero waste initiatives
    • FDA recognized standard for package integrity testing
    • ASTM test method F2338
    Readmore...
    vacuum decay technology, medical device package inspection, package inspection technologies, Class III medical devices, CCIT
    624
    15
    Sep 2020

    The Importance of Seal Integrity Testing in the Food and Nutrition Industry

    Importance of Seal integrity testing

    Food and nutrition packaging are much more than attractive containers kept on a retail shelf. Packaging executes multiple functions since it conveys information about the product, educates the consumers, ensures product protection, helps market the product and much more. Therefore, manufacturers of food and nutrition products must keep package quality at the forefront.

    Innovations in packaging including the use of flexible packages and shift from plastics to more sustainable materials have accelerated packaging challenges. Hence, ensuring package quality is vital for preventing possible contamination and resultant spoilage of goods. Often, customers may or may not be aware of such contamination, which can cause serious health problems. In case of high-risk individuals such as the elderly or children under 5 years, the consequences may be fatal. Such consequences have a direct impact on company/brand image resulting in product recalls and huge financial losses.

    This stresses the importance of implementing appropriate packaging integrity testing solutions in the production line. Among many other techniques available in the market, seal integrity testing is a popular choice for most manufacturers. There are multiple methods of conducting a seal integrity test including destructive and non–destructive test methods. A method applicable in one situation may not be so in other. Manufacturers should choose the appropriate technology depending upon package type, product specifications, defect profile, and testing requirements.

    Methods of Seal Integrity Testing

    Under destructive testing methods, the sample package may get destroyed and become useless even though the seal passes the test. Demand for such tests has steadily declined due to its inability to detect non-leaking defects. Common test methods under this category include water bath/bubble testing and peel strength test.

    To overcome the shortcomings of destructive test methods, non-destructive test methods and technology advancements have been developed. Such methods cause no harm to the package or product and they can be returned to market after testing. 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”. PTI’s VeriPac Vacuum Decay Series and Airborne Ultrasound technology are non-destructive test methods having high applicability in the food and nutrition industry.

    PTI’s VeriPac Vacuum Decay technology is a non-destructive package inspection technique, applicable for rigid and flexible packages and with a capability of detecting leaks as small as 10 microns. It has the potential to test different size pouches, stick packs or sachets without any changeover in parts or system settings. VeriPac FLEX Systems, a non-destructive package inspection technique specifically for dry-filled flexible packaging (pouches, stick packs and sachets). The VeriPac FLEX Series are available in several configurations taking into account varied package specifications and test sensitivity requirements.

    Pouches are the common form of packaging for many food products like juices, snacks, nuts and coffee. Therefore, ensuring package integrity of such pouches are crucial. PTI’s Airborne Ultrasound technology is a non-destructive seal integrity test that serves as an ultimate solution for pouch seal quality testing, specifically to check that final top seal after filling and sealing the pouch contents. When high frequency sound waves are passed through the pouch seal area, reflections of sound waves are created. Defects are identified by analysing variations of reflected signal strength. It ensures 100% defect detection of pouch seals. PTI’s ultrasound technology can be applied to 100% defect detection of pouch seals as well as for in-depth seal quality testing and analysis.

    VeriPac Vacuum Decay technology (F2338) and Airborne Ultrasound technology (F3004) are both ASTM test methods and also FDA consensus standards for package integrity and seal quality inspection. According to the specific nature of the product and package, appropriate testing methods can be selected.

    Readmore...
    seal integrity testing, airborne ultrasound technology, seal quality testing, airborne ultrasound, package integrity testing, vacuum decay technology
    1292
    10
    Sep 2020

    Automated CCI technologies- Revolutionizing medical device testing

    Automated CCI technologies- Revolutionizing medical device testing

    Medical device industry is crucial to health care system as they play a vital role in the delivery of many health care services. Over the past few decades, tremendous developments in medical technologies have challenged the medical device packaging industry to ensure quality and reliability in packaging. Although testing package quality of all medical devices is critical, in case of Class III medical devices it amplifies several folds. Class III medical devices are understood as devices that sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples include pacemakers, breast implants, and respiratory ventilators. Since these devices are directly placed into human bodies, proper packaging is required to ensure the quality of the product until it reaches the patient. Any breach in the packaging can cause contaminants to enter the device, thereby making it more of a threat to the patient than a treatment. Hence appropriate CCI technologies are needed to ensure standardized packaging quality.

    Container Closure Integrity Testing is a leak detection test conducted using a non-destructive package inspection system to ensure sterility and product quality throughout its shelf life. Earlier, probabilistic test methods such as bubble test, dye ingress and manual visual inspection were used to test package quality of medical devices. However, these traditional methods lacked accuracy and provided uncertain and subjective results. In order to overcome the shortcomings of probabilistic methods, industries are now moving towards deterministic methods that assures a higher level of accuracy with quantitative results. 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 method. This includes Vacuum Decay and Airborne Ultrasound for medical device applications. The industry is currently moving away from dye ingress and manual visual inspection because there are so many blind spots in applying them and there’s a huge false sense of assurance.”

    Packaging Technologies & Inspection-PTI’s VeriPac Vacuum Decay Technology and Airborne Ultrasound Technology have revolutionized automated CCI Technologies.

    Vacuum Decay Technology is a CCI testing method that detects leaks in nonporous, rigid or flexible packages. Such tests are conducted by placing a sample in an evacuation test chamber, drawing vacuum and monitoring vacuum level for any decay, indicating a leak. Such tests are known to provide reliable and quick results. PTI’s VeriPac Vacuum Decay Technology is a non-destructive package inspection system based on the ASTM vacuum decay leak test method (F2338-09) and accredited by the FDA for package integrity testing. Its applications include empty and pre-filled syringes, liquid-filled and lyophilized vials and other flexible and rigid liquid-filled packaging. PTI’s PERMA- VAC technology, known to provide consistent and reliable results is the latest development in the VeriPac line of test systems. The VeriPac Universal Blister Verification (UBV) system designed for non-destructive blister package leak detection uses a volumetric imaging technology to measure the motion of a blister package under vacuum to detect leaks.

    PTI’s Airborne Ultrasound Technology is a non-destructive Seal Integrity Test used to examine seal quality for defects. “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. Under this method, high-frequency sound waves are passed through the pouch seal area, causing the reflection of sound waves. Variations of the reflected signal strength are used to reflect defects if any. PTI’s Airborne Ultrasound Technology for 100% Inline inspection of pouch seals has been extremely helpful in verifying final pouch seal quality. Any defect in the pouch seal including voids and delamination, foreign materials and inclusions, incomplete seals and misaligned seals can be detected using a Seal-Sensor scan and are automatically rejected from the production line.

    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.

    Both methods are established ASTM test methods: Vacuum Decay ASTM F2338 and Airborne Ultrasound ASTM F3004.These technologies are non-destructive methods and can be chosen depending on the characteristics of the product to be tested.

    Readmore...
    CCI technologies, Airborne ultrasound technology, seal integrity testing, Class III medical device package integrity, vacuum decay technology, container closure integrity testing
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