Blogs

21
Apr 2022

Container Closure Integrity Testing using VeriPac 355 Technology

Container Closure Integrity Testing using VeriPac 355 Technology

Evaluating the ability of the container closure system to provide a sterile barrier and prevent leaks resulting from contamination is a crucial step towards maintaining the safety and suitability of primary packaging. United States Pharmacopeia (USP) and Food and Drug Administration (FDA), the driving forces behind container closure systems in the US, enforce strict regulations for Container Closure Integrity Testing (CCIT).

Traditionally, Dye Ingress and Microbial immersion were two popular methods to evaluate container closure integrity. However, they were probabilistic methods that lacked accuracy and provided subjective test results. In 2016, USP issued guidelines that they preferred deterministic test methods over probabilistic test methods. Examples of deterministic test methods include Vacuum Decay technology, Airborne Ultrasound technology, Helium Leak Detection etc. In this blog, we will discuss the role of VeriPac 355, which is a Vacuum Decay technology in testing container closure integrity.

CCI Testing Using VeriPac 355 Technology

The VeriPac 355 is a non-destructive technology based on the ASTM vacuum decay leak test method (F2338-09) and is recognized by the FDA as a consensus standard for package integrity testing. This micro leak detection system is applicable across a wide range of packaging formats and is specially designed to test containers for gas leaks for dry products (lyophilized vials, powder-filled) as well test for liquid leaks (non-protein based liquid-filled vials, prefilled syringes). The non-destructive nature of the technology allows it to be incorporated into protocols at any point in the handling process. VeriPac 355 technology's capability of detecting leak rates as low as 0.2 cc/min makes it an optimal quantitative test method for many pharmaceutical and food applications.

VeriPac 355 Working Principle

The VeriPac 355 leak tester is connected to a test chamber designed specially to hold the package being tested. Vacuum is then applied to the package inside the test chamber. Using a high-resolution absolute transducer technology, the test chamber is monitored for the level of vacuum as well as the change in vacuum over a predetermined test time. Although the test cycle takes only a few seconds, it produces accurate and non-subjective test results. 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 semi-automatic operation. This inspection method is suitable for laboratory offline testing and QA/QC statistical process control.

Inspection Criteria

  • Measures seal integrity of entire container or package
  • Tests for gas leaks for dry products (lyophilized vials, powder filled)
  • Tests for liquid leaks (liquid filled vials, prefilled syringes)

Benefits of VeriPac 355 Series

  • Non-destructive, non-subjective, no sample preparation
  • Deterministic, quantitative test method
  • Measures seal integrity of entire container or package
  • Tests for gas leaks for dry products (lyophilized vials, powder filled)
  • Tests for liquid leaks (liquid filled vials, prefilled syringes)
  • Measures and verifies container closure system integrity
  • 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
Readmore...
ccit, container closure integrity testing, veripac 355, cci technologies, package integrity testing
79
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
03
Mar 2022

VeriPac Test Systems for Powdered Dairy Products Package Testing

VeriPac Test Systems for Powdered Dairy Products Package Testing

Most powder dairy products (milk powders, infant formula, protein-based powders, etc.) require process monitoring, production control and modified atmosphere packaging (MAP) to retain their quality throughout its shelf-life or until it reaches the end-user. However, products that use MAP often have high risks of deficiencies in package quality control. Most MAP applications use Nitrogen flushing, and testing package quality involves sampling package gas content days after the product has been packaged. The protein based content of many products will allow bacteria to consume the majority of the O2 content before the increase in O2 is detected by gas testing equipment. Leaks as small as 10-20 microns will only increase the oxygen content to levels below 3%, the typical pass/fail threshold, passing defective product. Although packaging integrity testing can be conducted using traditional methods like water bath, they are only sensitive to 25-micron leaks at best. Therefore, dairy product manufacturers should use testing methods that offer highly sensitive leak testing along with the highest level of quality assurance.

Package Testing using VeriPac Test System

Vacuum Decay has been verified as the most practical and sensitive vacuum based leak test method. It is capable of creating reliable and accurate quantitative results and a pass or fail determination. The standard Vacuum Decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the Food and Drug Administration (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). VeriPac series are a practical alternative to destructive testing methods that provide subjective test results and variable test standards.

PTI brings a tradition of excellence and performance reliability to our line of VeriPac non-destructive package testing equipment. PTI's VeriPac Series has the capability to non-destructively test packages at the production line with high levels of accuracy and sensitivity. Non-destructive testing not only reduces wastage, but it also allows operators to have a greater understanding of package quality. Moreover, it can accommodate multiple package formats and requires non changeover when testing different size packages.

Technology Overview

Under this technique, the VeriPac 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.

VeriPac Inspection system:

  • 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, container closure integrity testing, ccit, dairy product package testing, veripac test systems
180
28
Feb 2022

Package Integrity Testing using VeriPac 310 Series

Package-Integrity-Testing-using-VeriPac 310

Finding the appropriate packaging for perishable foods can be quite challenging for manufacturers. Apart from considering factors such as vulnerability and freshness, a food package must ensure safety throughout its shelf life or until it reaches the end-user. To ensure that the contents are not exposed to any foreign contamination, manufacturers should conduct regular tests that can evaluate the ability of the packaging in maintaining seal integrity. Package integrity testing can pinpoint the exact location of leaks which helps operators identify the problematic area and make necessary adjustments. As a result, manufacturers can be sure of the packaging quality and ensure that the customers enjoy their products in the freshest possible state.

For inspecting package integrity of food products, PTI has developed VeriPac 310 series, a non-destructive, non-invasive Container Closure Integrity Testing (CCIT) system for highly effective leak detection. It is an ASTM approved patented vacuum decay leak test method F2338-09 recognized by the FDA as a consensus standard for package integrity testing. The VeriPac 310 provides quantitative measurements for identifying package defects before critical process issues get out of control. The tests can be performed in any sequence with real-time results.

VeriPac 310 series was developed using VeriPac leak test instruments. The next generation of VeriPac systems combines both technological innovation and practical adjustments to current technology to make it the most sensitive and versatile vacuum-based leak detection technology to date. Through the introduction of unique test cycles, pneumatic controls and processing algorithms, the VeriPac technology is establishing itself as the foremost vacuum-based leak detection technology. VeriPac systems reduce waste and provide operators with a clear understanding of package quality.

Technology Overview

Under this method, VeriPac leak testers are connected to the test chamber designed to hold the sample packages. Vacuum is then applied to the package being tested. 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. VeriPac 310 test systems are suitable for manual or automatic operation and are designed for laboratory offline testing and production applications for QA/QC statistical process control. Testing is more reliable, sensitive and efficient than destructive methods such as the water bath or burst test.

Benefits of VeriPac 310 Series

  • 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...
package integrity testing, container closure integrity testing, ccit, veripac 310 series, CCI
180
15
Feb 2022

How to Ensure Package Integrity of Medical Devices

How to Ensure Package Integrity of Medical Devices

Medical devices play a key role in the diagnosis and treatment of many conditions and life saving treatments. To insure patient safety, the effectiveness of such medical devices should be carefully evaluated. Package integrity testing of medical devices is a crucial part of the manufacturing process.

Medical device package testing methods offered by PTI

1. Airborne Ultrasound technology

PTI’s Airborne Ultrasound technology (ABUS) is a seal quality inspection test method, capable of non-destructively examining packaging seal quality for defects, primarily flexible packaging seals. Under this method, ultrasound waves are passed through the pouch seal, creating a reflection of sound waves. The signal strength variations are analyzed to identify the presence of seal defects. Airborne Ultrasound technology creates a quick analysis of the seal area without tampering with the packaging to identify many common seal defects, such as incomplete or missing seals, wrinkles, and channel defects. The technology is in high demand due to its applicability across several industries, specifically the medical device industry. “Ultrasound is the only technology capable of identifying what the quality of that physical bonded nature of the seal materials are,” comments Tyler Harris, applications engineer at PTI- Packaging Technologies & Inspection. Medical device packaging including TYVEK® pouches is a very common application for ABUS technology.

PTI's Seal Scan (Offline) and Seal-Sensor (Inline) technology have further redefined pouch seal integrity testing. Both these technologies utilize non-contact airborne ultrasonic testing technology. With these advancements, Airborne Ultrasound technology has positioned itself to be the most sensitive method for non-destructive seal quality testing, in both the laboratory and in automated 100% inline testing production lines. ABUS is an ASTM Test Method F3004, recognized by the FDA as a standard for seal quality inspection and also referenced in the USP 1207 chapter guidelines.

2. Vacuum Decay technology

For several decades, Vacuum Decay has been proven to be the most practical and sensitive leak detection method for medical device and pharmaceutical packaging. It is a Container Closure Integrity Test (CCIT) capable of evaluating a wide range of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Vacuum Decay, being a non-destructive test method, does not cause any damage to the package being tested. This reduces significant waste and allows operators to have a thorough understanding of package integrity and package quality.

PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating a wide range of high-risk package applications. To conduct this test, packages are first placed in a well-fitted evacuation test chamber, which has an internal or external vacuum source. The test operator continuously monitors the vacuum levels to identify variations from a pre-determined targeted vacuum level. In the presence of a defect, air escapes from the package into the test chamber. Packages without any defect retain the air, maintaining a constant chamber vacuum level. It is an ideal solution for medical device manufacturers to assure that the product meets regulatory standards. Based on the packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.

Readmore...
ccit, vacuum decay, airborne ultrasound, package integrity testing, medical device package testing
210
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
25
Jan 2022

How to Leak Test High Risk Medical Device Packages

How to Leak Test High Risk Medical Device Packages

Medical devices are available in a variety of forms with complex geometric attributes such as valves, tubes and others that can complicate the medical device testing process. Hence, medical device leak testing equipments are expected to provide high levels of sealing effectiveness and test result sensitivity to narrow down the complexities.

Medical Device Package testing using Seal Scan technology

Seal-Scan® is a deterministic, quantitative, high-resolution method based on is an Airborne Ultrasonic Technology (ABUS). It is highly effective in non-destructively inspecting and analyzing pouch seals for defects and seal integrity for consistency. Seal-Scan systems utilize the ASTM Test Method F3004-13, which is a non-destructive test method for evaluating seal quality and integrity using Airborne Ultrasound technology. The test procedure is simple, quick and requires no sample preparation. Additionally, Seal-Scan® provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis.

Seal-Scan features two scan modes:

  • Linear Scan (L-Scan) to simulate online defect detection (line graph)
  • C-Scan for detailed seal analysis, producing pixel by pixel evaluation of seal (Opto-Acoustic image)

Technology Overview

The test beings by scanning the pouch seal or package material between two focused ultrasonic sensors. Ultrasonic waves propagate through single or multiple layers of bonded materials. As the ultrasonic waves propagate through different mediums, it causes reflections of sound waves, which reduces/eliminates signal strength. The level of signal passing through the seal is a function of the quality of the seal. Various types of defects; leaking and non-leaking, process-related and random are detectable.

Seal scan has two scan modes (L-Scan and C-Scan) that is capable of producing Opto-Acoustic images as well as detailed statistical analysis. An L-Scan is a single linear scan along the X-axis of the seal that provides a line graph of seal integrity and simulates online inspection. C-Scan produces multiple scans (along X and Y-axis of seal area) that provide a high-resolution ultrasonic image of the seal structure. This technology can be integrated into a pouch production line via the Seal-Sensor for 100% fully automated on-line seal defect detection.

Benefits of Seal Scan Technology

  • Deterministic inspection method producing quantitative results.
  • Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity.
  • Produces high resolution Opto-Acoustic image of seal.
  • Characterizes overall quality and uniformity of the seal.
  • ASTM Test Method F3004 and FDA recognized standard for seal quality inspection.
Readmore...
container closure integrity testing, package integrity testing, ccit, airborne ultrasound technology, seal scan
225
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
21
Dec 2021

Why Manufacturers Rely on High Voltage Leak Detection Technology to Ensure Pharmaceutical Package Integrity

Why Manufacturers Rely on High Voltage Leak Detection Technology to Ensure Pharmaceutical Package Integrity

Packaging is an essential part of the pharmaceutical industry, given the sensitive nature of the contents. High-risk medications and lifesaving drugs need utmost care and protection until they reach the patient. As such, stringent industry standards apply to pharmaceutical packaging. Manufacturers give high priority to safety and quality while selecting packaging materials for a drug or healthcare product. The packaging should be able to act as a barrier against external contamination and chemical reactions. Exposure to reactive gases can alter the physical, chemical and biological attributes of the products. This makes Container Closure Integrity Testing of pharmaceutical packaging a regulatory requirement.

Role of MicroCurrent HVLD in ensuring pharmaceutical package integrity

Often referred to as the conductivity and capacitance test, High Voltage Leak Detection (HVLD) is a test method found to be highly effective in detecting the presence and location of leaks in a wide range of pharmaceutical and parenteral applications. It can be used for leak testing in nonporous, rigid or flexible packages, as well as packages containing liquid or semi-liquid products. High Voltage Leak Detection test is conducted using electrical conductivity and resistance principle. This method operates by passing high voltage micro current signals through sample packages. Under the presence of a leak, the electrical resistance of the sample declines, causing an increase in current. Compared to other leak detection methods that rely on flow of gas or liquid, HVLD technology relies on “flow” of current. This reduces challenges with defect clogging compared to flow-based analysis.

The latest evolution of HVLD, PTI’s patent pending MicroCurrent technology, aims to achieve a high level of CCI assurance across the entire range of pharmaceutical products. The MicroCurrent HVLD reduces voltage exposure to the product to less than 5% of the voltage exposure experienced when testing with comparable HVLD solutions. Reducing exposure voltage not only reduces any risk that the voltage poses to the product, but also greatly reduces the production of Ozone during operation when compared with traditional HVLD solutions. Ozone in the headspace of a container can be detrimental to the product, and in the operating environment can affect respiratory health.

Benefits:

  • Non-destructive Container Closure Integrity Test (CCIT)
  • Requires no sample preparation
  • Capability to test multiple packages in a single test cycle
  • Identifies which package is defective
  • Simplifies the inspection and validation process
  • Supports sustainable packaging initiatives
  • ASTM test method and FDA standard
  • Cost effective with rapid return on investment
  • Readmore...
    hvld, package integrity testing, ccit, container closure integrity, microcurrent hvld
    185
    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
    14
    Dec 2021

    Testing Integrity of Low Headspace Packages with VeriPac 410 Series

    Testing Integrity of Low Headspace Packages with VeriPac 410 Series

    According to USP1207, the headspace inside a sterile pharmaceutical or medical device packaging is an important part of a product. Therefore, it should comply with corresponding quality-relevant attributes. The attributes may vary depending on the product. For instance, the residual oxygen concentration is one of the attributes for oxygen-sensitive formulations. Testing low headspace packages like sachets and blister packages can be quite challenging for manufacturers. Read on to know how PTI's VeriPac 410 ensures package integrity of low headspace packages.

    Leak testing using VeriPac 410 series.

    Over the years, manufacturers of multi-cavity blister packs and low headspace packaging have been using destructive test methods to evaluate the integrity of such packages. However, such traditional test methods lacked accuracy and produced subjective, and unreliable results. In order to overcome the limitations of destructive test methods, PTI has developed VeriPac 410 inspection system - a non-destructive seal and leak detection technology for blister packs, sachets, and pouches with low headspace.

    The VeriPac 410 employs a mix of vacuum decay technology and differential force measurement to identify defects in packages. Multiple packages can be tested in a single test cycle, depending on package specifications. The non-deterministic nature of the test produces accurate and reliable results, removes subjectivity and the operators can get a definite pass/fail outcome. Additionally, being a non-destructive test method, the VeriPac 410 allows tested packages to be returned to the production line and eliminates the cost and waste associated with destructive leak test methods. This test method has a wide range of applications including low volume flexible and semi-flexible package leak testing.

    Technology Overview

    The VeriPac 410 tester is connected to a specially designed drawer-style test chamber. A custom package insert that conforms to the package shape increases test sensitivity. Certain types of packages can be tested in multiple during a single test cycle. The location of the defective package or cavity is identified. Vacuum levels are monitored during the test cycle to evaluate the package using the ASTM F2338 vacuum decay leak test method. Decay of the vacuum level indicates that air is leaking from the package into the test chamber.

    Once the vacuum testing phase is complete, a pressure plate maps the surface pressure of the flexible package lidding. The pressure plate system recognizes the pressure pattern exerted by the package when it is not defective, and the lack of pressure exerted on the pressure plate by a defect, allowing for both defect detection and location of the defective package or cavity.

    Benefits of VeriPac 410 system

  • Non-destructive, non-invasive, no sample preparation
  • Non-subjective, accurate and repeatable results
  • Capability to test multiple packages in a single test cycle
  • Identifies which package is defective
  • Simplifies the inspection and validation process
  • Supports sustainable packaging initiatives
  • ASTM test method and FDA standard
  • Cost effective with rapid return on investment
  • Readmore...
    CCIT, container closure integrity testing, package integrity testing, veripac 410
    200
    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
    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
    16
    Nov 2021

    Vacuum Decay Technology for Pharmaceutical Package Inspection

    Vacuum Decay Technology for Pharmaceutical Package Inspection

    As pharmaceutical products leave the laboratory for distribution, they may be exposed to certain conditions that put their integrity at risk. Product quality deterioration and economic losses may be caused due to extreme temperatures or shocks during transportation. Pharmaceutical package inspection is vital to identify and control materials that may alter the protective capacities of packaging. Container Closure Integrity Testing of pharmaceuticals is performed with the purpose of guaranteeing the safety of the products during its distribution and storage lifecycle until delivery to the patient. CCIT helps in determining the integrity and stability of packaging or container until the point of delivery.

    CCI testing using Vacuum decay technology

    To guarantee integrity and consistency of packages, the ability to precisely detect leaks and defects is necessary. Although destructive Container Closure Integrity Testing (CCIT) methods like water bath, dye tests, peel and burst tests can detect leaks, they are time-consuming, unreliable and produce subjective test results. Additionally, they generate significant product loss and wastage. Over the years industry has seen an increasing demand for non-destructive package integrity testing methods. One such method is Vacuum Decay technology.

    Vacuum Decay is a test method that has been proven over decades as the most practical and sensitive vacuum-based leak test method. It is a simple test method that challenges container integrity based on fundamental physical properties. Vacuum Decay technology creates reliable and accurate quantitative results with a pass or fail determination and has been established as a non-destructive deterministic alternative method to the blue dye test. 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)

    How does Vacuum Decay Technology work?

    Under this method, the leak testers are first connected to a test chamber that is specifically designed to hold the package to be tested. Vacuum is applied to the package placed inside the test chamber. Using single or dual vacuum transducer technology test chamber and level of vacuum are monitored along with a 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. This inspection method is suitable for laboratory offline testing and can be designed for manual or fully automated operation. The test cycle is non-destructive to both product and package and takes only a few seconds. It provides significant savings by not wasting products for a leak test and generates a return on investment in under six months for many products.

    Key Benefits of Vacuum Decay technology

    • Non-destructive and non-invasive
    • No sample preparation
    • ASTM approved test method
    • FDA Recognized Consensus Standard
    • Allows for increased sampling
    • Quantitative results
    • Repeatable
    • Rapid test time
    • Eliminates cost and waste of destructive testing
    • Test results can be easily validated
    • SPC laboratory testing or online applications
    Readmore...
    package integrity testing, ccit, container closure integrity testing, pharmaceutical package testing, vacuum decay leak test
    278
    28
    Sep 2021

    Medical Device Package Inspection using Seal-Scan Technology

    Medical Device Package Inspection using Seal-Scan Technology

    Medical device packaging plays a fundamental role in safeguarding the product and retaining its quality throughout its shelf life. A package containing medical devices should not only reach the hospital defect free, but it also must withstand sitting on a shelf, possibly for years, without breaking down. Therefore, medical device packaging should be in line with international regulations and quality standards. In order to ensure quality of medical device packages, manufacturers reply on package integrity and seal quality test methods. Although the market offers a complete range of inspection techniques, it is important for manufacturers to choose the appropriate one based on packaging material used and sensitivity levels required.

    The ideal solution is a non-destructive method for inspecting the physical properties of the seal and a non-subjective analysis to determine the seal quality. PTI’s Airborne Ultrasound technology (ASTM Test Method F3004-13) uses a transmission of high frequency sound waves through the pouch seal area, providing a simple pass or fail result of seal quality. A linear scan analysis of the seal area will detect channel defects, misaligned seals, incomplete and missing seals immediately after the package has been sealed. If the system detects a package defect, the product can immediately be removed from the packaging and reworked. Process related defects can be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced.

    Package inspection using Seal-Scan technology

    PTI's Seal-Scan® is a non-destructive Airborne Ultrasonic technology (ABUS) that inspects and analyzes pouch seals offline. Seal-Scan® is a semi-automatic inspection system with x-y drive, used for the detection of seal defects, seal characterization and material analysis. This technology utilizes the ASTM Test Method F3004 for seal quality and integrity evaluation. .Seal-Scan® is a deterministic, quantitative, high-resolution method that inspects pouch seals for defects and seal integrity for consistency. Testing using a Seal-Scan® is non-destructive, non-invasive, and requires no sample preparation. Seal-Scan® provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis. PTI has designed several configurations of SEAL-SCAN® for both offline inspections to accommodate various package specifications, test sensitivity and package handling requirements.

    Technology overview

    Under this method, the pouch seal or package material is scanned between two focused ultrasonic sensors. Ultrasonic waves pass through single or multiple layers of bonded materials. Ultrasonic propagation through different mediums causes reflection of sound waves and reduces/eliminates signal strength. Seal Scan technology can detect different types of defects including leaking and non-leaking, process-related and random are detectable. This technology can produce Opto-Acoustic images as well as detailed statistical analysis by either of two scan modes (L-Scan and C-Scan). An L-Scan is a single linear scan along the X-axis of the seal that provides a line graph of seal integrity and simulates online inspection. C-Scan produces multiple scans (along X and Y-axis of seal area) that provide a high-resolution ultrasonic image of the seal structure. This technology can be integrated into a pouch production line via the Seal-Sensor for 100% on-line seal defect detection.

    Benefits of Seal Scan Technology

    • Deterministic inspection method producing quantitative results
    • Works for any material and combinations, regardless of color transparency, print, surface finish and porosity
    • Produces high resolution Opto-Acoustic image of seal
    • Characterizes overall quality and uniformity of the seal
    Readmore...
    package integrity testing, ccit, container closure integrity testing, airborne ultrasound technology
    314
    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
    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
    22
    Sep 2020

    Ensuring Bottle and Container Integrity through VeriCon Technology

    Ensuring bottle and container integrity through VeriCon Technology

    What is VeriCon Technology?

    VeriCon system encompasses a complete line of leak testers for empty bottles and containers. It is a powerful leak detection system that operates round-the-clock to ensure high leak test sensitivity with the capability to measure down to 200 microns. Under this process, the container is filled with pressure to a certain level. The rate of pressure decay is analyzed and measured which corresponds to pressure within the container. The operating panel displays pass/fail results and the defective container is rejected from the line . With PTI’s VeriCon technology, users can choose from a wide range of leak tester configurations, according to different container specifications. Its applications include plastic, blow molding, food, beverage and pharmaceutical industries. VeriCon technology works well for small, medium to large size containers and has inspection rates upto150 bottles/min. range. According to Heinz Wolf, general manager, Packaging Technologies and Inspection “In addition to the basic inspection economics of identifying leaking containers and minimizing false rejects, VeriCon systems offer many additional advantages that increase overall operational efficiency. The Auto-learn feature for example, automates setup of accept/reject criteria. Real time inspection data with reject statistics and test result With reject statistics & test result trends, VeriCon technology ensures on demand analyses of container quality.”

    VeriCon technology can be implemented using pressure decay or vacuum decay technology. Plastic containers of almost all sizes use pressure decay technology. In situations where due to specific characteristics of the container, pressure decay technology is not capable of detecting leaks, Vacuum decay technology is applicable. Depending on the line speed/hole size requirement, VeriCon testers are available in one to four station configurations.

    VeriCon Configurations

    • Trimmer mount: available in single and dual station configurations, VeriCon trimmer mount systems are designed precisely for indexing systems installations.
    • Linear Leak Testers: available in single or multi-station configurations for standard online linear leak detection with inspection speeds up to 70 bottles/min.
    • Continuous Motion Testers : available in 1 to 4 station configurations with inspection speeds up to 150 bottles/min. Continuous motion inspection’s high speed testing ensures uninterrupted inspection of containers.

    Benefits of VeriCon technology:

    All VeriCon systems offer the following features and benefits:

    • VeriCon technology uses high-resolution non-drifting transducers thereby ensuring consistent leak detection.
    • Accurate leak testing with repeatable results
    • 24/7 operation
    • Capable of accommodating multiple container specifications and test sensitivity requirement

    Ensuring packaging quality is pivotal in all manufacturing. For efficient packaging, it is important for manufacturers to have complete knowledge of packaging material used and test sensitivity desired, so that appropriate package integrity tests can be undertaken.

    Readmore...
    pharmaceutical package testing, VeriCon Technology, pharmaceutical package integrity, package integrity testing, pressure decay technology
    794
    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
    1291
    04
    Sep 2020

    CCIT - A risk mitigation tool for parenteral products

    CCIT - A risk mitigation tool for parenteral products

    Today’s healthcare industry assures treatments that were unimaginable a few years ago. As pharmaceutical industry grows in importance, the techniques of primary packaging for healthcare products, especially parenteral products has taken on new prominence. Common parenteral packaging methods include Liquid-filled containers such as vials, ampoules, syringes, blow-fill-seals and auto-injectors and containers filled with lyophilized products. Since these drugs are directly administered into human bodies, high sensitivity integrity tests are required to ensure product quality throughout its shelf life. For reasons of safety, packaging material, integrity and design are regulated by Food And Drug Administration as strictly as the product itself.

    Container Closure Integrity Testing is a leak detection test conducted using a non-destructive packaging inspection system to protect the drug from any possible contamination. It is a crucial step in evaluating safety and integrity of the primary packaging so as to maintain a sterile barrier and to avoid leakage resulting in contamination of the drug. Packaging components like bottles, vials, syringes that are in direct contact with the product are called primary components while aluminum caps, cardboard boxes are secondary components as they are not in direct contact with the product. Proper packaging should be a priority for all drug products, but in case of parenteral products, these concerns amplifies several folds as they are directly injected. Hence initiating a proper container closure system is vital for product and consumer safety.

    Although Container Closure Integrity Testing can be performed in many different ways, it can be broadly classified into Probabilistic methods and Deterministic methods. Probabilistic test methods including Microbial Challenge by Immersion, Tracer Liquid Tests (e.g. Dye Ingress), Bubble Tests etc. are traditional test methods where result accuracy may be uncertain. On the other hand, Deterministic test methods like Electrical Conductivity and Capacitance Test (HVLD), Laser-based Gas Headspace Analysis, Mass Extraction, Pressure Decay provide quantitative results with high accuracy. The United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods.Packaging Technologies And Inspection (PTI’s) Microcurrent HVLD technology and vacuum decay technology are the latest inventions in package integrity testing of parenteral products.

    1. Microcurrent HVLD Technology: Microcurrent HVLD is a unique High Voltage Leak Detection Technology, highly effective across all parenteral products. Its Applications include liquid-based products ranging from extremely low conductivity sterile water for injection (WFI) to proteinaceous products with suspensions. Its ability to detect small pinholes, micro cracks and seal defect detection down to single-digit microns makes it an ideal choice for testing parenteral products.

    2. VeriPac Vacuum Decay Technology: VeriPac Vacuum Decay Technology, based on the ASTM vacuum decay leak test method (F2338-09) and accredited by the FDA for package integrity testing, is a non-destructive inspection system, capable of defect detection down to 0.002 cc/min. This system is applicable for empty and pre-filled syringes, liquid-filled and lyophilized vials and other flexible and rigid liquid-filled packaging. Depending on the package type and leak test sensitivity needed, appropriate VeriPac model can be selected.

    PTI’s next generation PERMA- VAC technology addresses vacuum decay detection at the very core of physical test measurement by controlling the test system volume and maximizing the SNR between good and defective samples. This makes PERMA-VAC the most reliable vacuum-based leak test available in the market.
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    CCIT, parenteral product leak testing, container closure integrity testing, container closure integrity, package integrity testing, ccit pharmaceutical, hvld
    1491
    01
    Sep 2020

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

    Container closure integrity testing - An ideal solution for pharmaceutical industry

    The global pharmaceutical industry has seen tremendous growth over the last few decades. The complex nature of the industry coupled with frequent breakthroughs has made it a favorite subject of scrutiny. Since any defect in the packaging of drugs can have serious consequences, assuring the quality of the packaging is of prime interest for every manufacturer. Pharmaceutical products are expected to be free from microbial contamination and safe to use right from production throughout their shelf-life. The drug’s stability can be adversely affected through contamination in the form of oxygen, humidity or microbiological ingress. In order to prevent such risks, integrity tests with high sensitivity are required.

    Previously, only sterility testing was conducted on pharmaceutical packaging. However, when it was realized that sterility testing alone is not sufficient to hold the integrity of the medical products, the US FDA published Guidance for Industry for Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. This emphasised the importance of verification of microbial barrier properties of a pharmaceutical product package (i.e., CCI). FDA defines Container Closure Integrity Testing (CCIT) “as the sum of packaging components that together contain and protect the dosage form”.

    Container Closure Integrity Testing is a method of leak detection using a non-destructive packaging inspection system to prevent possible contamination. Such a test is essential since any defect in the container can cause external particles to enter the product, thereby reducing its shelf life. Implementing right Container Closure System has been of prime importance for a manufacturer as it affects both the product and the patient. Hence, the relevance of CCI Testing in the pharmaceutical industry has steadily increased over the years. Contaminants that can enter a product include micro-organisms, reactive gases, and other substances. CCIT ensures product quality is maintained from the point of manufacture throughout its distribution and use. Container closure systems include primary packaging components and secondary packaging components. Components such as a glass vial or syringe, which come into direct contact with the product, are primary packaging components. On the other hand, components that are crucial to ensure correct package assembly, such as aluminum caps, over stoppers etc. are the secondary packaging components

    CCI Testing Methods

    Container closure integrity testing can be performed in many different ways. Each method has its own merits and demerits. A number of factors have to be considered while selecting appropriate testing methods. These factors include, but are not limited to; the reliability of the test method, material of the primary package and inline versus an offline testing requirement. CCI testing methods can also be selected depending on specific desired outcomes. Examples of desired outcome include: identifying the presence of leak paths, understanding leak path’s location, evaluating leak rate for the whole package, and measuring potential for microbial ingress. The United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test method.

    1. Probabilistic methods: Here, the testing methods are more traditional, and the accuracy of the result is uncertain. The probabilistic methods include the following:
    • Microbial Challenge by Immersion
    • Tracer Liquid Tests (e.g. Dye Ingress)
    • Bubble Tests
    • Tracer Gas (Sniffer Mode)
    2. Deterministic methods: Such methods provide quantitative results with a higher level of accuracy. The chances of errors are also minimal. The deterministic methods include the following:
    • Electrical Conductivity and Capacitance Test (HVLD)
    • Laser-based Gas Headspace Analysis
    • Mass Extraction
    • Pressure Decay
    • Tracer Gas (vacuum mode)
    • Vacuum Decay
    Readmore...
    CCIT, container closure integrity, container closure integrity testing, pharmaceutical product leak testing, pharmaceutical package testing, package integrity testing
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