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Blister packs are widely used across various industries, including pharmaceuticals, to protect products from external contamination and environmental factors such as moisture, air, and light. Maintaining the integrity of these packages is paramount for ensuring product quality and adhering to regulatory standards. Among the available leak testing methods, helium leak testing has proven to be a highly reliable and precise technique for verifying the integrity of blister packs. This method not only ensures compliance with stringent industry regulations but also enhances product reliability by identifying potential packaging failures before they reach the end-user. Therefore, helium leak testing offers a significant advantage in maintaining the quality and safety of goods packaged in blister packs.

Key Standards for Blister Package Leak Detection 

• USP 1207: Guidance for container integrity testing principles and methods.
• ASTM Standards: Standards for packaging materials and testing methods.
• FDA Regulations: Regulations for packaging and labelling, including leak prevention.

Factors influencing the sensitivity and accuracy of helium leak detection 

• Exceptional Sensitivity: Detects even the smallest leaks that could compromise product quality.
• High Throughput: Ideal for high-volume production environments, ensuring efficient testing.
• Product Safety: Helium is non-reactive and inert, guaranteeing no product contamination.
• Precise Leak Identification: Accurately pinpoints the location and size of leaks
• Cost-Effective: Reduces product loss and enhances packaging integrity, resulting in long-term cost savings.
• Regulatory Compliance: Meets stringent industry standards for product safety and quality assurance.

Why is Helium Leak Detection Ideal for Blister Pack Testing? 

Helium is considered an ideal choice of tracer gas because of multiple reasons. Helium is non-toxic, non-flammable, non-condensable and its presence in the atmosphere is not more than 5ppm. The small atomic size of helium makes it easier to pass through leaks. Since helium does not react with other materials, it is relatively safe to use. Additionally, compared to other tracer gases helium is less expensive and is available in multiple cylinder sizes. Under this method, a helium leak detector otherwise known as Mass Spectrometer Leak Detector (MSLD) is used to identify and calculate size of the leak. The test part is first connected to a leak detector and then the tracer gas, helium is introduced. In the presence of a leak, helium escapes from the test parts and this partial pressure is measured and results are displayed on the meter.

In conclusion,helium leak detection is indispensable for ensuring the integrity of blister packs in the pharmaceutical and medical device industries. Its high sensitivity guarantees the detection of even minute leaks, safeguarding product safety and ensuring regulatory compliance. PTI's expertise and customized solutions empower manufacturers to seamlessly integrate this vital testing method into their quality assurance processes, thereby protecting both product integrity and patient health.