Mar 2022

Understanding Combination Products Leak Detection Using SIMS 1915+

Understanding Combination Products Leak Detection Using SIMS 1915+

Food and Drug Administration (FDA) requirements for drug testing of combination products are strict. Companies seeking FDA clearance for such products must fully understand the requirements for FDA approval in order to prevent costly and time-consuming errors. Combination products are made up of two or more regulated components, such as pharmaceuticals, devices, or biologicals, that have been physically, chemically, or otherwise combined and formed as a single entity to achieve a therapeutic effect. A combination product can combine at least two of these product categories, and sometimes all three. Traditional drug-device combination products, such as a syringe pre-filled with a drug, auto-injectors containing a filled cartridge and needle, and co-packaged or kitted products, are some of the most common types of combination products.

The constantly increasing demand for combination pharmaceutical products continues to fuel innovation and creates numerous interesting opportunities that will provide the medical community with promising new alternatives for improving patient care and results. However, bringing bio/pharmaceuticals and medical devices together to form a combination product necessitates extensive testing of all product ingredients.

Why Use SIM 1915+ for Leak Testing Combination Products?

A Helium-based leak detection system-Seal Integrity Monitoring System (SIMS) 1915+ is an excellent solution for detecting leaks in combination products. Packages may be quantitatively evaluated using helium as the tracer gas, which assures better levels of accuracy when compared to traditional vacuum bubble and dye penetration test procedures. SIMS 1915+, which has been proven to be an effective leak detection approach, may also be utilized for package design, tooling certification, manufacturing line setup, and ongoing product quality monitoring. LDA custom builds each SIMS 1915+ Helium Leak Testing device to customer specifications. Cold form blister cards, foil pouches, parenteral vials, syringes, pre-filled syringes, and unique medical devices can also be tested using SIMS 1915+.

Technology Overview

SIMS Model 1915+ helium-based leak testing system offered by LDA ( a PTI company ) is specifically designed for medical and pharmaceutical package leak detection. The SIMS 1915+ enables quantitative analysis of package systems at sensitivity levels as low as 1 x 10 -10 cc/s at room temperature. The Helium Leak Detector Module (HLDM), the most crucial component, is built within a Console Frame Assembly with a Stainless Steel working surface and an optional Dual Test Port Manifold. The consoles have a locking wheel and an articulating arm system for attaching the computer and peripherals, making the independent device simple to operate and maneuver.

The SIMS 1915+ Leak Detection System specs and add-on components are shown below.

  • Helium Leak Detector Module (HLDM): Oil-Free, Production Version in Console Frame Assembly with Stainless Steel Working Surface and Dual Test Port Manifold.
  • Vacuum Test Fixture Model (VTFM): a custom-made fixture for testing vial container samples.
  • Head Space Analyzer Module (HSAM): Model VM-2 that includes three (3) Puncture Probes (two spares) for determining the concentration of helium in the headspace of vial containers.
  • Integral Calibration Chamber (with Calibrant Gas Flow Meter/Controller) for HSAM Calibration and a Universal Holder for various vial diameters are offered.
  • Helium Filling Device designed specifically for vial testing sample prep that allows vials to be filled with helium.
  • Low Temperature (LT) Add-on devices created particularly for evaluating products in ultra-cold storage temperatures as low as –140 °C.

SIMS 1915+ Applications

Common applications of SIMS 1915+ include:

  • Pre-filled syringes
  • Vials
  • Bottles
  • Combination products
  • Foil pouches
  • Blister packs

Combination products provide a safe, effective, and convenient method of administering the drug or biologic therapies. The purpose of testing combination products is to obtain information to support the claim that all use-related hazards connected with the product have been reduced to the greatest extent possible. LDA is well-versed in the extensive testing requirements and regulatory criteria for bio/pharmaceutical products and medical devices, and provides complete testing services for these components, both individually and in combination.

helium-based leak detection systems, helium leak testing, pharmaceutical leak detection, helium leak detection, pharmaceutical package leak detection, sims 1915+
Jan 2022

How Helium Mass Spectrometry Ensures Quality and Integrity of Bottles?


Maintaining the integrity of products from the time it is manufactured to the time it is distributed to the patient is a great challenge. Liquid pharmaceuticals, capsules, and formed tablets are typically packaged in bottles. To assure the quality of these items, leak testing is carried out on each bottle to ensure that it does not leak. Testing pharmaceutical bottles or pharmaceutical package leak detection before filling is a critical step in ensuring the integrity of the container.

Helium leak testing is one of the most sensitive Container Closure Integrity (CCI) testing techniques that can be applied to pharmaceutical bottles for testing quality. Helium is used as a tracer gas, and the quantity of helium leaving through the package is measured and stated as leak rate. Since it is non-toxic, non-flammable, and non-condensable, helium is an ideal tracer gas for finding leaks. Its atmospheric presence is restricted to 5ppm. Due to its tiny atomic size, helium can easily pass-through leaks. Helium is also safe to use since it does not react with the materials of the components under test.

Significance of Helium Mass Spectrometry in Leak Testing Pharmaceutical Bottles

Helium mass spectrometry is a leak detection standard for pharmaceutical containers including bottles. Helium mass spectrometer, a commonly used instrument detects and locates tiny leaks. It usually works with a vacuum chamber and a sealed container filled with helium. A mass spectrometer detects the rate at which helium is leaking out of the container. This method uses tracer gas - helium to fill the product attached to the detector. The tested product leaks helium into the detector, where its partial pressure is measured and displayed.

The leak detector's principle is based on a sector field mass spectrometer. In vacuum, entering helium gases are ionized. The helium ions are then accelerated by adding voltage and then separated in a magnetic field. The ion current is converted to an electric current by using a particular detector. This current is accelerated using leak detection units and displayed on the screen. The current measured will be directly proportional to the concentration of helium and therefore equal to the leak measured.

Applications of Helium Leak Detection

  • Ensure container closure integrity.
  • Seal integrity monitoring during stability studies.
  • Verify and predict shelf-life seal integrity.
  • Useful in the early stages of the development of a pharmaceutical product packaging system.
  • Closure formulation and configuration selection.

Bottles are useful in the healthcare industry, hence evaluating them is a challenging task nowadays. These containers are extremely difficult to test, however, helium leak detection can be used to qualify them prior to use or as a proof of concept. LDA provides professional engineering solutions for the Active Pharmaceutical Ingredient (API) sterile container testing.

helium mass spectrometry, pharmaceutical package leak detection, pharmaceutical leak detection, mass spectrometer, mass spectrometry

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