Sep 2022

How can Manufacturers Ensure Integrity of Combination Products Using Helium Leak Testing?

How can Manufacturers Ensure Integrity of Combination Products Using Helium Leak Testing?

Combination products, which provide effective and novel treatment options and approaches across various disease states, have made a significant influence on the healthcare landscape in recent years. The acceleration of growth in this field of science and medicine is expected to continue propelling at an increased rate. The packaging and device industry has focused its innovation specifically on combination therapeutics to fulfill the demands of both drug developers and patients. To ensure that the best results may be obtained, these therapeutic products need to be tested for integrity and quality using a very sophisticated approach.

Challenges Faced by Combination Products

Patient safety can be improved by addressing these three challenges.

  • Device Robustness and Reliability
  • If a pharmaceutical or biologic is not administered safely, properly, and consistently, it cannot benefit the patient. The delivery method for this is a sturdy, dependable device, and the technique to make sure that the device performs as intended is through the design control process. Verification testing is an important stage that ensures the device has been developed appropriately and operates dependably in accordance with established patient needs and drug specifications. Additionally, it assesses how well the product will withstand in the most adverse circumstances, which may include drops, climatic extremes, and moisture exposure.

  • Drug - device integration
  • When developing combination products, it's crucial to take the interaction between the device and the drug into consideration. The FDA categorizes combination products into nine separate categories, which include pre-filled drug devices or delivery systems as well as devices that have been coated, impregnated, or mixed with drugs or biologics. The development process can be considerably influenced by the precise combination of components as well as the crucial interfaces.

  • Accommodating various volumes
  • Large drug volumes have been difficult for patients to self-administer using devices like autoinjectors, pens, or pre-filled syringes. But the development of wearable devices is changing the game by enabling greater volumes to be administered subcutaneously over a longer period. This increases the potential for patient-centered healthcare but poses a number of manufacturing and packaging challenges.

Here, we will discuss how helium leak testing helps in testing the combination products.

Testing Integrity of Combination Products Using Helium Leak Testing

Helium leak detection is a highly sensitive technology for identifying leaks in any closed or sealed system using helium gas and monitoring the concentration of the gas as it escapes due to a leak. The integrity of a variety of complicated pharmaceutical and parenteral products may be evaluated using helium leak detection. Combination products, cold form blister packs, foil pouches, pre-filled syringes, and many more drug packages can be tested using helium leak testing. This technique is the best option for verifying the integrity of pharmaceutical products since it can accurately determine integrity between certain major container closure system components.

Helium leak detection works as follows: The package is initially vacuumed and helium filled. The quantity of helium leaving the package is then measured quantitatively and expressed as a leak rate using a helium leak detector. Helium leak testing is used in product design, product quality evaluations, failure analyses, and validation in addition to examining the integrity of container closures. It is possible to test "in-leakage" or "out-leakage" as well as the location of leaks using helium leak testing, which may be employed with or without a test chamber.

Helium Leak Testing Applications

  • Seal integrity monitoring during stability studies.
  • Useful in the early stages of developing a drug product packaging system.
  • Selecting closure formulation and configuration.
  • Ensuring container closure integrity.
  • Verify and predict shelf-life seal integrity.

The need for complex drug delivery systems and combination products continues to fuel the development of new products and innovation within the medical device industry. At LDA (a PTI Company), we understand that the combination of medical devices and pharmaceuticals opens a world of promising new opportunities. LDA has the experience and expertise necessary to seize these opportunities and assist clients in testing combination products.

helium leak testing, helium leak detection, helium mass spectrometry, pharmaceutical package leak detection, helium CCIT
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