Nuvisan offers mechanical testing services to evaluate the performance and integrity of pharmaceutical packaging and delivery systems. Tests include both destructive and non-destructive methods.
Material testing of syringes, vials and other disposables
Disposable medical syringes support various medical applications that require high precision and sterility, such as injection of drugs and vaccines into the body as well as blood sampling. For this reason, the assembly of syringe components, such as the barrel, the plunger rod, the needle and the cap, needs to fulfill the highest standards in safety and robustness, which can be verified by tests such as functionality and breakage.
An even more advantageous system for medical applications is the pre-filled syringe, in which the syringe’s barrel is both the sterile primary packaging container as well as the delivery tool of the drug. This device helps to greatly reduce risks of contamination, inefficient or incorrect drug dosing, and a number of handling steps compared to traditional vial-syringe systems.
However, these advantages of pre-filled syringes come at the cost of a much more complex manufacturing process and the requirement of even more extensive functional testing, which must cover the interplay between the assembled syringe and drug product.
Nuvisan provides customized ISO-compliant functional testing programs for syringes and pre-filled syringes encompassing break loose and glide force, closure system leakage, extractable volume, force -distance/time profiles, glass vial breakage, and tear-off force studies for blister packs.
Non-destructive CCIT (laser headspace, HVLD)
Unrestricted container closure integrity of primary packaging material is a mandatory prerequisite for any medicinal product’s effectiveness. High voltage leakage detection (HVLD) and laser headspace CCIT are both non-destructive techniques, leaving the tested container unharmed. This is a significant advantage over classical, destructive CCIT, allowing for repetition of tests or additional examination of individual containers to better identify the sources of abnormal test results. We offer HVLD and laser headspace CCIT to specifically meet our clients’ needs.
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