Blogs

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
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    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
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    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
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    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
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