Blogs CCIT

08
Feb 2022

Understanding CCIT's Seal-Scan Technology

Understanding CCIT's Seal-Scan Technology

Package integrity leak test methods offered by CCIT such as Seal-Scan utilize non-contact Airborne Ultrasonic technology for seal integrity testing and seal quality analysis of pouches and flexible packaging. The method is applicable to pharmaceutical as well as medical device packaging.

Seal Quality Testing and Seal Analysis using Seal-Scan Technology

Seal-Scan® is a non-destructive offline inspection and analysis technique for pouch seals using Airborne Ultrasonic technology (ABUS). Seal-Scan® offers advanced digital imaging software tools for process control, including in-depth seal quality inspection. Seal-Scan system uses the non-destructive ASTM Test Method F3004-13 for "Evaluation of Seal Quality and Integrity Using Airborne Ultrasound Technology." This test method was approved using PTI's ABUS technology. Seal-Scan® is a deterministic, quantitative, high-resolution technology for inspecting pouch seals for defects and ensuring seal integrity.

Seal-Scan has two scanning modes:

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

Technology Overview

The pouch seal or packaging material is scanned between two focused ultrasonic sensors. Ultrasonic waves travel through single or several layers of bonded materials. The reflection of sound waves caused by ultrasonic transmission via different materials reduces/eliminates signal intensity. The signal level that passes through the seal is a function of the seal's quality. Defects of various forms, such as leaking and non-leaking, process-related and random, can be detected. Seal-Scan® can provide Opto-Acoustic images as well as thorough statistical analysis using one of two scan modes (L-Scan and C-Scan).

An L-Scan is a single linear scan along the seal's X-axis that generates a line graph of seal integrity and replicates real-time inspection. C-Scan generates a series of scans (along the X and Y-axis of the seal region), that offers a high-resolution ultrasonic image of the seal structure. This technology, via the Seal-Sensor, can be integrated into a pouch production process for 100% online seal defect detection.

Benefits of Seal-Scan Technology

  • Deterministic inspection approach yielding quantitative results.
  • Works with any material and combination, independent of color, transparency, print, surface polish, or porosity.
  • Produces a high-resolution Opto-Acoustic seal image.
  • Characterizes the overall quality and consistency of the seal.

Seal-Scan® is a semi-automatic inspection system with an x-y drive that is used to identify seal defects, characterize seals, and analyze materials. This approach is non-invasive, non-destructive, and does not need any sample preparation. The ability of PTI to adapt this technology to diverse production restrictions and conditions makes it an effective solution for flexible packaging systems.

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seal quality inspection, airborne ultrasound, container closure integrity, cci technologies, package integrity test solutions
176
03
Feb 2022

Package Integrity Testing of Flexible Packages Using VeriPac FLEX Series

Package Integrity Testing of Flexible Packages Using VeriPac FLEX Series

The physical ability of a package to protect its contents with the necessary level of protection during a specific time is referred to as package integrity. Package integrity tests are performed to detect packaging issues that might affect the sterility of a medical device. Previously, microbial challenge or dye penetration testing was used to determine whether the product packaging has maintained its microbial barrier qualities. Due to technological advancements, VeriPac FLEX systems are currently being used for testing the package integrity of flexible packages.

VeriPac FLEX Systems to Ensure the Integrity of Flexible Packages

CCIT’s VeriPac FLEX systems are versatile non-destructive package inspection systems that are intended particularly for evaluating dry-filled pouches and flexible packaging. VeriPac FLEX systems are available in several configurations for both the leak test instrument and the test chamber capacity to accommodate various package specifications and test sensitivity requirements. VeriPac inspection systems provide a simple PASS or FAIL result, as well as quantitative test data. They offer unparalleled sensitivity, reliability, and practicality in testing a wide variety of flexible package formats and sizes, without changing settings or tools.

The ASTM technique for vacuum decay leak testing (F2338), which is specified in ISO 11607 and recognized by the FDA as a consensus standard for package integrity test solutions, is used by VeriPac FLEX Systems. As an alternative to destructive testing, they eliminate subjectivity while also reducing waste and cost. When compared to destructive techniques like water bath or blue dye leak test, vacuum decay leak testing technology has proven to provide a quick return on investment. The VeriPac test devices consistently detect significant packaging errors and provide useful packaging process information.

Technology Overview

On the basis of the package size, the VeriPac tester is initially attached to the appropriate FLEX chamber. The Integrated Flexible test Chamber (IFC) and Drawer Style test chamber (D-Series) are the two test chamber configurations available to connect with the VeriPac instrument depending on package specification and test sensitivity requirements. The Integrated Flexible test Chamber (IFC) is designed for low-headspace sachets or stick packs. Depending on the package size and requirements, the Drawer Style test chamber (D-Series) is available in 2 basic sizes: Small (D) and Large (DXL). Custom designs are possible for large packaging types and bulk products. The way the package is tested is what sets VeriPac FLEX systems apart. CCIT makes use of a flexible membrane that fits the shape and size of the package, preventing stress and damage to the film materials. In a single test cycle, several packages can be tested.

VeriPac FLEX System Advantages

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

Manufacturers are still struggling with quality standards for flexible packaging. CCIT’s VeriPac FLEX has proven to minimize manufacturing waste and costs while boosting package quality assurance and brand value. It has high test sensitivity and is capable of identifying micro leaks down to the single digit micron range.

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package integrity, package integrity test solutions, cci technologies, ccit, container closure integrity
171
27
Jan 2022

A Quick Rundown on Package Inspection Guidelines for Sterile Medical Products

A Quick Rundown on Package Inspection Guidelines for Sterile Medical Products

Class III medical devices have a unique combination of criteria and package features that necessitate a comprehensive approach to determining the best inspection procedures. For medical package inspection, there are a variety of methods that require a thorough understanding to assure quality.

Manual visual inspection has been the most common form of inspection for medical device packaging. While an ASTM standard (ASTM F1886) covers this concept, it may not be applicable for all applications and has limitations. Even though a 75-micron channel defect can be detected by manual visual inspection, the ASTM method F1886 indicates that the chance of detection ranges from 60% to 100%. This vast range of uncertainty does not give the level of assurance required for the packaging of high-risk medical devices.

Although certain offline leak detection techniques can offer a quantitative evaluation of seal quality, they miss some of the most prevalent seal problems seen in Class III medical device packaging. Testing peel strength or utilizing other destructive methods will not reveal random seal problems. For class III medical devices, online non-destructive inspection procedures are excellent since they provide quality control with comprehensive manufacturing lot data.

All Class III medical devices must be sterile, however, container materials and design differ widely. A non-porous pouch or tray demands an entirely different technique than a porous pouch or tray. Tyvek® offers a sterile barrier, and the porosity of the material limits the leak test procedures that may be used on the package body. When it comes to porous packaging, the focus of online inspection moves away from leak detection and toward seal quality evaluation.

Technology Overview

Vacuum decay and Airborne ultrasound are the two main methods used by PTI/CCIT to inspect medical device packaging. Both methods are aimed at providing quantitative and deterministic test results in order to assess package quality. In terms of function and performance, the two technologies are entirely different. Package integrity and leak path detection are the main objectives of Vacuum decay. Meanwhile, Airborne ultrasound technology focuses on package seal inspection and seal quality. Both approaches aim to meet the basic requirements of being reliable and sensitive inspection procedures for Class III medical device applications.

Vacuum Decay (ASTM F2338)

Vacuum decay is the most practical and sensitive vacuum-based leak test method of CCI. When testing pouches, a versatile adjustable test chamber may be utilized to test pouches of various sizes. The package is then placed into the vacuum-sealed test chamber. The level of vacuum, as well as the change in vacuum during a pre-defined test duration, are both monitored during the short test cycle. The change in vacuum indicates the existence of leaks and defects within the package. Vacuum decay leak testing is a go-to standard for sterile products because of its sensitivity and dependability. The approach is ideal for laboratory offline testing and production applications for quality assurance process control, since test equipment may be developed for manual or automation operation.

The ASTM Vacuum decay leak test technique (F2338), which has been accepted by the FDA as a consensus standard for package integrity testing, was developed using PTI VeriPac technology. As a deterministic test technique for package integrity test solutions, Vacuum decay is mentioned in ISO 11607 and the new USP 1207 guideline document.

Airborne Ultrasound (ASTM F3004)

Airborne Ultrasound is an ASTM Test Method F3004-13 and is one of the most effective methods for non-destructive seal quality inspection of flexible packaging. It is mentioned in ISO 11607 and the new USP 1207 guidance document. Most inspection methods are challenged by the leaking nature of porous packaging, but Airborne ultrasound, with its non-destructive measure of seal quality, effectively overcomes those challenges.

The non-contact Airborne ultrasonic testing technique is used in both Seal-Scan (Offline) and Seal-Sensor (Online). Ultrasonic waves propagate through the material as a package seal passes through the sensor head, producing sound waves to be reflected. When defects are encountered, the signal intensity is reduced or eliminated. The larger the acoustic gap between mediums, the more sound is reflected and less sound is transferred through the seal.

The variety of package forms and materials makes inspecting the integrity of class III medical device packaging a challenge. CCIT's scientists and engineers have vast industry experience and can prove a complete solution, including test method development and equipment validation for Class III medical device packaging.

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package integrity test solutions, vacuum decay leak testing, container closure integrity testing, container closure integrity, cci technologies
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