Container closure integrity
We can assess the sterile seal integrity of many packaging configurations and have the most appropriate technology and capabilities for your specific application including:
from lab bench to final destination
No matter how advanced your pharmaceutical product is, it still risks being compromised if its packaging can’t endure the physical and environmental stresses of shipping. Manufacturers in highly regulated industries, such as pharmaceutical, often face uncertainty around how to replicate real-world shipping conditions in a controlled and measurable way. Ensuring packaging integrity, through each and every mile of its journey, is essential, to maintain product efficacy, achieve regulatory compliance and safeguard patient safety.
The Eurofins BioPharma Product Testing (BPT) network of laboratories offers comprehensive shipping distribution studies to meet both regulatory expectations and your product’s unique challenges. Using state-of-the-art equipment and methodologies, we can assess the durability of your packaging system under the dynamic and static stresses it will potentially encounter during distribution.
From manual drops to thermal cycling, humidity exposure, and vibration, our simulations reflect real-world transit scenarios. We will also evaluate how packaging performance is impacted by environmental extremes, which is critical for products sensitive to temperature shifts or humidity fluctuations.
Each test is designed to confirm that your packaging retains seal integrity, protects product quality, and meets regulatory requirements from agencies, including the FDA and EMA.
Our clients rely on our ability to validate the performance of labelling and secondary packaging throughout the shipping process. We assess everything from adhesive strength and legibility of printed data to abrasion resistance during transit.
Our shipping distribution studies are often integrated with container closure integrity, shelf-life, and stability testing programmes, offering you a complete view of packaging performance throughout the product lifecycle.
With decades of pharmaceutical packaging expertise, Eurofins BPT has become the trusted partner to a whole host of pharmaceutical manufacturers, who have come to rely on us to ensure their products reach their patients as intended: safe, stable, and compliant.
We can assess the sterile seal integrity of many packaging configurations and have the most appropriate technology and capabilities for your specific application including:
Eurofins BPT can perform all of the validation testing needed to meet international product submission requirements and ensure your packaging is robust enough to survive the rigours of transit, whether you are shipping individual units or pallet-loads.
Unreadable barcodes or misread text can result not only in complaints and product returns, but can also compromise patient safety. Our team can help you ensure your products meet the latest serialisation and traceability labelling requirements and that your barcodes remain readable throughout the entire distribution chain with label testing services including:
Whether you are developing a new packaging design, evaluating a new material or sterilisation technique or qualifying a new supplier, we can perform characterisation and performance evaluation studies to meet the full range of USP, ASTM, and ISO standards, as well as custom methodologies for materials testing including:
With more than 12.200m3 (430,000 ft3) of environmental chamber space worldwide, we have the capacity to carry out all levels of accelerated and real-time shelf aging studies. Our chambers are continuously monitored with validated electronic tracking systems integrated into our LIMS system. Our online portal, LabAccess.com, also allows you to track the progress of your studies via our shelf-life calendar and provides you with 24/7 visibility of your data.
We can simulate the real-world conditions a container, package, or packaging component may encounter during its life or testing cycle including: