Medical device packaging plays a crucial role in maintaining product sterility, stability, and functionality. However, two of the most overlooked yet destructive environmental contaminants in medical device packaging are moisture and oxygen. While many packaging strategies focus on microbial contamination, the gradual ingress of oxygen and moisture can have severe implications for product performance and shelf-life.
For certain medical devices—such as drug-coated stents, moisture-sensitive bone cement, and oxygen-critical diagnostic kits—even minimal exposure to moisture or oxygen can result in degradation, rendering the product ineffective or unsafe. The key to mitigating these risks lies in ensuring package integrity through advanced testing methodologies like Vacuum Decay Technology
Moisture and Oxygen: Invisible Threats in Medical Device Packaging
Medical devices are often packaged in either porous or non-porous materials, each with distinct vulnerabilities:
- Porous packaging allows for equalization of partial pressures, reducing microbial contamination risks but potentially increasing exposure to environmental contaminants like moisture and oxygen.
- Non-porous packaging, on the other hand, creates a sealed environment but is susceptible to microleaks—tiny defects that permit oxygen and moisture ingress over time.
Unlike bacteria, moisture and oxygen ingress is more predictable and gradual, occurring through microleaks that might not be large enough for microbial entry. As pressure fluctuations and environmental conditions change, these contaminants steadily penetrate the packaging, compromising sterility, chemical stability, and device performance.
Medical Device Package Integrity Testing Using Vacuum Decay Technology
The VeriPac Vacuum Decay Technology, compliant with ASTM F2338 standards, is an advanced, deterministic, and non-destructive Container closure integrity test method (CCIT)for identifying microscopic leak. packaging. Designed for versatility, this technology is suitable for both rigid and flexible containers, making it an ideal solution for the pharmaceutical industry.
This innovative system follows a simple yet highly effective process. The primary packaging is placed inside a testing chamber, which is designed to accommodate various packaging formats. Once secured, a controlled vacuum is applied. A highly sensitive pressure transducer then monitors any vacuum decay, which may result from gas escaping or liquid vaporizing within the package—both clear indicators of potential leaks. Capable of detecting leaks as small as 5 microns or even smaller, this precise and reliable method ensures the highest level of package integrity.
Benefits of the VeriPac Series
- High Sensitivity: Detects microscopic leaks with precision.
- Non-Destructive: Allows manufacturers to test without damaging the product.
- Adaptability: Suitable for both rigid and flexible packaging formats.
- Efficiency: Provides fast, accurate, and quantitative results.
Moisture and oxygen pose silent but significant risks to medical device packaging. These contaminants can penetrate microleaks, degrading products and compromising patient safety. By integrating Vacuum Decay Technology into quality control processes, manufacturers can extend product shelf-life, enhance safety, and ensure the highest standards of medical device integrity.