Blogs CCIT

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
338
20
Jan 2022

MicroCurrent HVLD for Testing the Integrity of Ampoules

MicroCurrent HVLD for Testing the Integrity of Ampoules

Pharmaceutical package integrity testing has always been an important aspect of the quality control and manufacturing process. Container Closure Integrity is critical for protecting the product throughout its lifespan until it is delivered to the patient. CCIT uses non-destructive inspection technologies for ensuring container closure integrity of vials, ampoules, syringes, cartridges, and auto-injectors.

Ampoules must be properly sealed since any crack or defect might contaminate the sterile substance inside. Microbial contamination, exposure to gases, water vapor, and solvent loss can all cause product degradation if there is any breach in the package. Hence, container closure integrity is an essential stage in the lifecycle of a sterile pharmaceutical product. Patients may be at risk if the container closure integrity is compromised. Drugs that are meant to save lives might lose their effectiveness or cause fatal side effects. CCI defects can cause oxidation, which can reduce a drug's potency and shelf life.

Integrity Testing of Ampoules using MicroCurrent HVLD

MicroCurrent HVLD technology detects leaks in nonporous, rigid, or flexible packaging such as ampoules that contains liquid products. This is a non-destructive High Voltage Leak Detection Technology that is highly effective across all parenteral products (vials, syringes, ampoules and BFS). The test technique detects pinholes, microcracks, stopper/plunger leaks, non-visible leaks under crimping, and many other defects by scanning a non-conductive container sealed with electrode probes. Any crack or other defect in the container can cause a resistance difference and a change in the current flow, which would indicate a breach. It is also possible to determine the approximate position of the defect.

When compared to conventional HVLD technologies, MicroCurrent HVLD uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. At high production speeds, this HVLD method may be simply transitioned from offline to 100 percent inline testing applications. It is a cost-effective online container closure testing solution that requires only minor infrastructure changes. This method is non-invasive and does not need sample preparation. For all parenteral and biologic products, MicroCurrent HVLD is one of the most effective CCI methods.

MicroCurrent HVLD Benefits

  • Effective in all parenteral preparations, even liquids with extremely low conductivity.
  • At high production speeds, inspection can be done both offline and online.
  • Non-destructive, non-invasive, and requires no sample preparation.
  • High level of accuracy and repeatability.
  • Deterministic method for parenteral liquid package inspection.
  • A robust technique for a variety of product classes and packaging forms with an estimated 3x Signal-Noise-Ratio.

Ampoules are such little glass bottles containing a sterile pharmaceutical liquid for parenteral administration. Microbes or other harmful pollutants may enter the ampoules through capillary pores or microscopic breaks, or the contents may leak to the outside. This may result in contamination of the sterile contents as well as a deterioration of the appearance of the package. MicroCurrent HVLD technology offered by CCIT can be applied to a variety of pharmaceutical packing formats including ampoules for testing integrity.

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microcurrent hvld, package integrity, packaging integrity testing, container closure integrity, container closure integrity testing
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