Over the past decades, there has been steady stream of advances over combination products and a deepening trend towards self-care. This is because combination products offer a safe and convenient method of operating drug or biologic therapies. Medical devices that can be self-administered are increasingly being used to shorten procedure time and reduce the chance for practitioner errors.A combination product is a mixture of a drug and device that includes pre-filled syringes, insulin injector pens, transdermal patches, and catheters with antimicrobial coatings. These are often termed as high-risk devices in the life science industry. As such, devices they require in-depth testing and evaluation.
The risk associated with combination products depend on the likelihood of interaction between the package and the drug, as well as the level of risk associated with the administration route. For many drug-device combination products, inhalations and injections are specified as high-risk routes of administration. Hence, evaluating seal integrity of combination products is extremely critical. Due to inadequate sealing, there is a chance for water vapor or oxygen to enter the package through a permeable surface. In such cases, surfaces and seals may need to be tested depending on the nature of the products. Also, there is a need to evaluate the packaging components and dosage, ignoring which, could cause serious health risk to the patient.
Importance of Helium Mass Spectrometer Leak Detector in Combination Products
The Mass Spectrometer Leak Detector is a system used for localization and measuring leaks inside or outside a product. This method uses tracer gas – helium, which is used to fill up the product connected to a detector. It is well documented that helium mass spectrometry is most suited for non-porous packaging such as vials and syringes. The same methodology can also be applied to cartridge-based delivery systems. In most cases, the key to success is developing a text fixture device, designed and manufactured to cater to the needs of specific cartridge system being tested.
Applications of helium leak testing.
Following are the applications of helium leak testing:
- Ensuring Container Closure Integrity
- Closure formulation and configuration
- Seal integrity monitoring during stability studies
- Extremely valuable in early-stage pharmaceutical product package system development
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