Checking Packaging Integrity: Various Testing Methods
Checking Packaging Integrity: Various Testing Methods
For decades, the pharmaceutical industry has relied on advanced machinery to ensure the integrity of drug packaging. These machines are designed to deliver high performance and seamlessly integrate into existing production processes. They incorporate innovative control systems to meet the stringent quality standards demanded by the pharmaceutical sector and comply with international regulatory requirements.
To meet these objectives, the market offers equipment capable of employing various methods to inspect packaging integrity, including:
Headspace Gas Analysis: This non-destructive technique detects the presence of specific gas molecules in a container’s headspace (the area not occupied by the product itself). The quantity of gas is determined by analyzing how target gas molecules absorb laser light, allowing the detection of unexpected values. For example, if an inspection reveals more oxygen than expected, the container may be damaged or improperly sealed, posing a risk of product oxidation. Such non-conforming containers are automatically removed from the production line.
Automatic Visual Inspection: This technique uses high-resolution cameras to capture images of the product, which are then analyzed by a cluster PC. Bonfiglioli Engineering’s proprietary software employs neural networks (artificial intelligence) to process these images and identify non-conformities. The software can detect cosmetic defects, such as flaws in the container or incorrect fill levels, as well as contamination issues, such as particulates or foreign objects, which pose GMP risks.
Vacuum Decay Method: This technology detects leaks in sealed containers by creating a vacuum outside the packaging. The products are placed in a test chamber where a vacuum is generated. If an abnormal increase in pressure is detected—caused by air escaping from the packaging—the product is identified as non-conforming and removed from the production line.
Lid Deflection: This method leverages the concept of a bulging lid in hermetically sealed products placed in a vacuum chamber. Sensors analyze lid deformation, which must remain within a specific range. Abnormal or unexpected lid movement may indicate improper sealing or leakage, necessitating the removal of the sample from the line.
Why Are Pharmaceutical Packaging Quality and Safety Controls So Important?
Each of these methods examines a distinct aspect of packaging integrity. While the goal is always the same—removing non-conforming products from the production line—selecting the most appropriate testing method is critical to achieving optimal speed and reliability in analysis.
When deciding which testing method is best suited for a specific product, several factors must be considered, including:
- The packaging material
- The packaging shape and color
- The required performance and speed of the production line analysis
- International regulatory requirements
- The characteristics of the production line and facility
While the relative importance of these factors may vary between customers, certain general principles can help guide the decision-making process.
Citations
This article is inspired by information from Bonfiglioli Engineering.
- Bonfiglioli Engineering. “The best methods to quickly, safely and efficiently inspect different types of drug packaging” – Bonfiglioli Engineering, BONFIGLIOLI ENGINEERING S.r.l
