The quality of the product and the maintenance of the sterile barrier against outside forces are both critically dependent on the packaging. Even a tiny hole in the packaging might allow moisture, reactive gases, or other dangerous elements to enter the product, limiting its ability to heal. Additionally, a contaminated pharmaceutical product can cause serious health issues to the user, making it more of a threat than a treatment. Maintaining Container Closure Integrity is extremely important due to the sensitive nature of pharmaceutical products.
Container Closure Integrity testing is a leak detection technique for determining how well sterile barriers are maintained against external contamination. These tests may be roughly divided into probabilistic and deterministic test methods. Manufacturers choose deterministic test procedures since they provide precise, guaranteed quantitative results. One such test method is helium leak detection technology.
Helium Leak Detection Technology Overview
Helium leak testing is the method of identifying leaks in various enclosed or sealed systems by utilizing helium as a "tracer" gas and measuring the concentration of the gas as it leaves due result of a leak. A vial is a good example of package system. A pre-filled syringe, a foil pouch, and a cold form blister card are some other examples. Each of these package types is intended to keep the pharmaceutical product contained while preventing the entry of potentially dangerous environmental contaminants like dust, bacteria, or even gases. Helium leak testing method can evaluate these package types. It is a highly efficient approach for finding leaks that provide quantitative leak rate data considerably beyond the capabilities of existing leak testing techniques.
The following describes how helium leak detection works: The package is initially vacuumed and helium-filled. The amount of helium escaping the package is then measured quantitatively and expressed as a leak rate using a helium leak detector. The technique is also ideally suited for packaging line setup and validation, failure analysis, tool qualification, monitoring product quality, and package design.
Why Use Helium as a Tracer Gas?
There are several reasons why helium is considered an ideal test gas for finding leaks.
- Deterministic seal quality inspection method that produces quantitative outcomes.
- Regardless of color, transparency, print, surface polish, or porosity, this method works for all material types and combinations.
- Non-destructive and non-subjective test technique that does not require any sample preparation.
- Technology may be used for 100% online final pouch seal defect detection.
- Seal quality inspection results are repeatable, reproducible and reliable.
- Cost-effective solution for testing seal integrity and seal analysis that characterizes the overall quality and uniformity of the seal.
Helium Leak Detection Merits
- Practical and sensitive flow-based leak test method.
- Enables the discovery of extremely small microleaks.
- Detects leaks with sensitivity levels as low as 1x10-10 mbar L/sec.
- Helium is a non-explosive, non-toxic and non-destructive tracer gas.
- Applicable across package design, failure analysis, packaging line setup and validation.
- Faster test cycle reduces cost and total processing time.
Applications of Helium Leak Detection
- Pre-filled syringes
- Blister packs
- Combination products
- Foil pouches
Helium leak detection is the best option for evaluating the inherent integrity of specific primary container closure systems of pharmaceutical and parenteral products. It is a commonly used technology in early stage pharmaceutical package development and component compatibility evaluation. In comparison to other leak test techniques, helium leak testing has the highest level of sensitivity, making it the most used CCI test method. In accordance with ASTM F2391, helium leak detection is a widely used method in the pharmaceutical industry.
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