Every time a patient takes a prescribed pill, they place their trust in that medicine. They believe it’s safe to use, stays stable over time, and has the full strength needed to treat their condition. Because of this trust, pharmaceutical companies have a responsibility to ensure that all of their products are safe and effective. For most oral medicines, that protection comes from blister packs, those blister packets look small, sealed plastic-and-foil packages designed to keep out air, moisture, and light.
But even this strong packaging can have hidden problems. One of the most common issues is something called a microleak which means a tiny hole or gap in foil. It’s so small that you’d never notice it just by looking. Still, that little opening can let in air, moisture, or other unwanted particles. With the course of time, they can destroy the medicine within, rendering it weaker, less efficient, or even dangerous to use.
To prevent such risks, manufacturers require reliable methods to check the quality of the seal of the blister packs. The most sensitive solution to this is the helium leak detection. In this blog, we are going to examine its major challenges, applications and benefits.
Challenges Associated with Microleaks in Blister Cavities
It only takes a tiny hole to cause big problems in a blister pack. Moist air from outside can find its way in, even if the leak is invisible to the eye. Over time, this can silently damage the medicine inside. Let’s look at the main challenges caused by microleaks in blister cavities.
Key Challenges:
- Moisture Ingress -The biggest issue is moisture entering the pack. The difference in humidity between the dry air inside and the humid air outside pushes water molecules through even the smallest openings.
- Drug Degradation -When moisture intrudes, it might begin to break down the medicine chemically in it, decreasing its stability and its overall shelf life.
- Loss of Effectiveness - As the drug degrades, it loses its potency. This implies that there is a possibility that the medicine would not act as intended, and this would be a serious threat to the well-being of the patients.
- Physical Damage - Exposure to moisture can make the pill swell, crumble, change color, or become sticky, affecting its appearance and usability.
- Hard to Detect - Traditional quality tests, like dye ingress methods, often miss these microleaks because the dye particles are too large to pass through them. This is why the pharmaceutical industry now relies on advanced methods like helium leak detection to ensure true package integrity.
Detecting Leaks with PTI’s Helium Leak Detection
To address packaging integrity issues, the pharmaceutical industry is adopting helium leak detection, a precise and scientific testing method. This technique uses helium gas, a small, inert, and stable molecule, as a tracer to identify even the tiniest leaks in sealed packages.
During the test, helium is either introduced into or around the package, and a highly sensitive mass spectrometer measures any escaping helium. Because helium atoms are extremely small, they can reveal microscopic leaks that traditional methods often fail to detect.
One of the most advanced systems in this field is PTI’s SIMS 1915+, a helium-based leak detection solution specifically engineered for pharmaceutical, medical device, and biotechnology applications. The SIMS 1915+ delivers exceptional precision, capable of detecting leaks as small as 1 × 10?¹° mbar·L/sec, and can test a wide range of packaging formats from blister packs and vials to pre-filled syringes and cartridges. It also supports testing at both room and cryogenic temperatures, making it a versatile and reliable choice for diverse manufacturing environments.
Microleaks may be invisible, but their impact on medicine safety and effectiveness is far from small. Ensuring the integrity of blister packs is crucial to maintaining drug stability, patient trust, and regulatory compliance. With advanced helium leak detection systems like PTI’s SIMS 1915+, manufacturers can confidently detect even the smallest seal defects, safeguard their products, and ensure that every dose delivered to a patient is as safe and effective as intended.
