Aug 2021

How to Evaluate Sterility of Pharmaceutical Packages?

How to Evaluate Sterility of Pharmaceutical Packages

Sterility testing of pharmaceutical products is crucial to ensure that drugs and other biopharmaceutical therapeutics are actually sterile and safe for human use. No pharmaceutical drug can be released into the market without appropriate sterility testing. Pharmaceutical drug products often contain complex active ingredients that stress the importance of sterility and CCI testing. Even a minute breach in the package can cause moisture, air, or other harmful substances to enter the product- thus compromising its healing properties. Moreover, a contaminated drug product can cause serious health issues to the user, making it more of a threat than treatment. Hence, ensuring container closure integrity holds high relevance.

Ensuring Package Sterility with Vacuum Decay Technology

Vacuum Decay is a non-destructive CCI test method that has been proven over decades and improved with new technology innovations. The test method is simple in principle and challenges container integrity based on fundamental physical properties. Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. Single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package.

Being a non-destructive test method, it provides significant savings by not wasting product for a leak test and generates return on investment in under six months for many products. Vacuum Decay technology has established itself as a non-destructive alternative to the blue dye leak 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).

Overview of PTI’s VeriPac Vacuum Decay Technology

PTI's improvements in the form of VeriPac test systems have raised a bar for excellence and performance reliability in terms of non-destructive package testing equipment. Its ability to detect leaks down to the sub- micron level and identify process issues before they become critical has made it an ideal choice for pharmaceutical package integrity. 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.

Benefits of Vacuum Deacy Technology

  • Non-destructive technology
  • ASTM Test Method F2338, FDA Consensus Standard and referenced in USP 1207 Guidelines
  • Accurate, repeatable results
  • Pass/fail results backed by quantitative test data
  • Completely tool-less with no changeover to test different packaging formats
  • Identifies which cavity is defective
  • Eliminates destructive, subjective testing methods
pharma package testing, pharmaceutical package testing, container closure integrity of pharmaceuticals, CCIT, veripac test system, package integrity testings
Aug 2021

How to Ensure CCI of Combination Products

How to Ensure CCI of Combination Products

The rapidly increasing preference towards combination pharmaceutical products continues to fuel innovation, while presenting unique challenges in implementing a container closure integrity (CCI) testing strategy. Common examples of combination products include prefilled syringes, pen injectors, inhalers, and drug-eluting stents, orthopedic products, infusion pumps and more. The packaging for combination products can be just as complex as the products themselves. Hence, container closure integrity testing in line with current USP <1207> guidance and regulation is critical to ensure package integrity.

Techniques to ensure CCI: Helium leak testing & Microcurrent HVLD technology

1. Helium leak testing

Helium leak testing refers to the process of finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas and measuring its concentration as it escapes due to leakage. Apart from being an ideal solution for ensuring Container Closure Integrity, the technology is also applicable in package design, monitoring product quality, failure analysis and line set up and validation.

Under this method, a helium leak detector otherwise known as Mass Spectrometer Leak Detector (MSLD) is used to identify and calculate size of the leak. The test part is first connected to a leak detector and then the tracer gas, helium is introduced. In the presence of a leak, helium escapes from the test parts and this partial pressure is measured and results are displayed on the meter. Helium Leak Detection per ASTM F2391, has long been recognized by the FDA as a consensus standard for package integrity evaluation. The test method is also referenced in the United States Pharmacopeia (USP) Chapter on Container Closure Integrity (CCI) – USP <1207>.

2. Microcurrent HVLD technology

PTI’s MicroCurrent HVLD technology is a non-destructive, non-invasive container closure integrity test method that is found to be highly effective across applications such as pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. This technique 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. Under this method, the sealed container is scanned using electrode probes to detect the presence of any leak. Defects in the container as well as its approximate location can be identified by analyzing a change in the current flow. MicroCurrent HVLD technology utilizes about 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. It is one of the most effective CCI technologies for all parenteral and biologic products.

Benefits of PTI’s MicroCurrent HVLD technology

  • Non-destructive, non-invasive, no sample preparation
  • Highly effective across all parenteral products, including extremely low conductivity liquids (WFI)
  • Ensure higher levels of accuracy and reliability in results
  • Offline and 100% online inspection at high production speeds
  • Simplifies the inspection and validation process
  • Referenced in USP 1207 Guideline
cci, pre filled syringes, helium leak testing, microcurrent hvld technology, container closure integrity testing
Aug 2021

VeriPac LPX for Automated Inspection of Parenteral Products

VeriPac LPX for Automated Inspection of Parenteral Products

Parenteral product package systems are expected to provide barriers against drug contamination and ensure stability and sterility throughout the entire shelf life. Any defect in packaging can cause microbial contamination, exposure to gases and water vapor, resulting in product deterioration. Furthermore, the industry has seen a spike in demand for combination products and patient-centered drug delivery systems, that present a high level of technical risk for maintaining container closure integrity (CCI). Therefore, container closure integrity testing is an important stage in the sterile drug product lifecycle.

Automated package inspection with VeriPac LPX

As the pharmaceutical industry continues to grow, manufacturers require capable, consistent automated solutions for container closure integrity testing. Automated inspection systems improve package reliability, reduce chances of product recalls and packaging failure.

PTI's VeriPac LPX series are a line of fully automated package quality inspection systems for 100% inline testing. The LPX enables enhanced automated testing that provides a high level of confidence in packaging line performance. Veripac LPX is a practical and reliable solution for the problems associated with performing infrequent testing as well as for recognizing and correcting process-related quality issues.

Sensitivity and reliability go hand in hand with CCI testing. The VeriPac LPX 430.8S is the next generation automated inspection system for container closure integrity testing of parenteral products. Automated for 100% testing or batch release, the VeriPac PLX 430.8S is an eight-station dual chamber design, with robotic testing platform for pre-filled syringes and vials, products filled with lyophilized product, small molecule liquids and Water for Injection (WFI).

The VeriPac LPX features a dynamic robotic design, tailored to fit varied production requirements. LPX Series are scalable, modular solutions to meet production line demands. This adaptable platform provides reliable automated handling of a variety of packaging formats. Applications for LPX automation range from flexible packaging to rigid containers, and parenteral products. Additionally, VeriPac LPX allows easy changeover for testing different size packages on the same system.

Benefits of VeriPac LPX test systems

  • Automated testing enables the highest level of container quality assurance
  • Self-teach software
  • Non-drift transducers for consistent leak detection
  • Low false rejects
  • Operator friendly
  • Reject statistics & test result trends
  • 24/7 operation
  • Increased productivity
  • Reduced downtime
  • Low maintenance
veripac LPX, parenteral product leak testing, container closure integrity, ccit, automated inspection systems

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