Jan 2021

How can Helium Leak Detection Technology Ensure Pharmaceutical Package Integrity?

How can Helium Leak Detection Technology Ensure Pharmaceutical Package Integrity

Over the last two decades, pharmaceutical industry has seen tremendous growth in the form of technological advancements and drug delivery system innovations. However, such innovations have increased quality assurance challenges for drug manufacturers. For this reason, drug product manufacturers give at most importance to their quality control procedure as well as package integrity tests.

Packaging plays a vital role in preserving product quality and maintaining a sterile barrier against external damaging force. Even a minute breach in the package can cause moisture, reactive gases, 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. Given the sensitive nature of pharmaceutical products, ensuring Container Closure Integrity holds high relevance.

Container Closure Integrity testing is a leak detection technique for evaluating the ability of container closure systems in maintaining sterile barrier against external contaminations. Such tests can be broadly classified into Probabilistic and Deterministic test methods. Although Probabilistic test methods like Bubble Tests and Dye Ingress were initially popular, with more technical advances, better, non-destructive methods are now the go-to solutions to insure container integrity. Manufacturers are encouraged to switch to more reliable Deterministic test methods that provide guaranteed quantitative results with precision. In this blog we will be discussing in detail Helium Leak Detection Technology.

What is Helium Leak Detection Technology?

Helium Leak Detection Technology is a Container Closure Integrity test method that is used to find leaks in different types of enclosed or sealed systems. The technique uses helium as a tracer gas and its concentration is measured as it escapes through the leaks. Under this method, the package is helium filled and subjected to vacuum. The amount of helium escaping the package is quantitatively measured and stated as a leak rate. Helium is an ideal choice for package leak testing and container closure integrity testing in particular during container closure development for pharmaceutical products, due its key qualities:

  • It is inert, non-toxic, non-condensable and non-flammable.
  • Being inert, it is safe to use as it will not react with other materials being tested.
  • The atom size of helium is really small therefore it can easily pass through leaks.
  • The instrument noise due to environmental helium is inherently low because of its limited presence in the atmosphere at less than 5ppm and thus gives incredibly accurate reports.
  • Helium is relatively inexpensive and is available in multiple cylinder sizes.

Seal Integrity Monitoring System

The Seal Integrity Monitoring System (SIMS) 1915+, is the ideal choice for your helium-based leak detection system for testing rigid containers including vials, syringes, and cartridges and blister cards. Using helium as the tracer gas, packages can be quantitatively tested to levels far exceeding the vacuum bubble and dye penetration test methods. This quantitative approach allows direct comparison across various packaging materials and forms, production line settings and stability storage conditions, supporting the entire lifecycle.

THE SIMS 1915+. features an oil-free detector and power system that is designed for the needs of the pharmaceutical and medical device industries. In addition, this system will enable you to quantitatively analyze package system at a sensitivity level as low as 1 x 10 -11 mbar-L/s and provides relevant data sets in place of a simple pass/fail criteria while enabling testing to be performed at room temperature.

Each SIMS 1915+ Helium Leak Testing instrument manufactured by Leak Detection Associates is custom built to client specific standards and package configurations.

Custom Built to Client Specification SIMS 1915+ Leak Detection System with Add -On Components

  • Helium Leak Detector Module (HLDM): Oil Free, Production version in Console Frame Assembly, with Stainless Steel working surface and Dual Test Port Manifold (allows concurrent use of VTFM & HSAM on HLDM unit).
  • Vacuum Test Fixture Model (VTFM) – custom designed for use in testing of vial container samples
  • Head Space Analyzer Module (HSAM) – Model VM-2 that includes three (3) Puncture Probes (two spares) for determination of Helium Concentration in the headspace of vial containers.
  • Integral Calibration Chamber (w/ Calibrant Gas Flow Meter/Controller) provided for HSAM Calibration and a Universal Holder to be used for various vial diameters.
  • Helium Filling Device specific for vial testing sample prep to enable vials to be filled with helium
helium leak detection technology, helium leak testing, helium leak detector, helium leak detection, pharmaceutical package integrity, helium leak detection solutions
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.

pharmaceutical package testing, VeriCon Technology, pharmaceutical package integrity, package integrity testing, pressure decay technology

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