Pharmaceutical Packaging Testing Services

Microbial barrier testing is essential for sterile and non-sterile pharmaceutical products alike. The primary goal is to assess whether a packaging system can effectively prevent microbial ingress during storage and handling. We employ validated methods such as aerosol challenge testing and immersion techniques to simulate real-world contamination risks. Our testing protocols are aligned with industry standards and regulatory expectations, ensuring that results are both scientifically robust and audit-ready. By identifying potential vulnerabilities early, we help clients mitigate risks before commercialization.

Packaging shelf life studies are designed to determine how well a packaging system preserves the quality of a pharmaceutical product over time. These studies evaluate the interaction between the drug product, packaging materials, and environmental conditions. We conduct both real-time and accelerated aging studies in accordance with ICH guidelines. Parameters such as temperature, humidity, and light exposure are carefully controlled to simulate various storage conditions. Our analytical assessments include physical, chemical, and microbiological evaluations of the product, as well as integrity checks of the packaging system.

Container closure integrity is a critical quality attribute for pharmaceutical packaging, particularly for sterile products. The testing ensures that the packaging system maintains a complete seal, preventing the ingress of contaminants and the loss of product. Our container closure integrity analysis employs state-of-the-art technologies, including helium leak detection, vacuum decay, high-voltage leak detection, and dye ingress testing. We tailor our approach based on the specific packaging format, such as vials, syringes, blister packs, or flexible containers. By combining deterministic methods with regulatory-compliant validation protocols, we provide highly sensitive and reliable results.

Pharmaceutical products often travel long distances through complex distribution networks before reaching patients. Transportation and Distribution Testing evaluates how packaging systems perform under mechanical and environmental stresses encountered during shipping and handling. We simulate real-world distribution conditions, including vibration, shock, compression, temperature fluctuations, and humidity variations. Our testing protocols are aligned with international standards such as ISTA and ASTM. This service helps identify potential risks such as package deformation, seal failure, or product damage. By understanding how packaging behaves during transit, clients can make informed decisions about packaging design, materials, and logistics strategies.