Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Intertek experts will present during ACI’s European Prefilled Syringes Summit on silicone determination in prefilled syringes
Prefilled syringes are expected to become important to an expanding patient demographic including patients with chronic conditions who need to self-administer their medication. Across the biopharmaceutical sector, a move towards prefilled syringes is expected considering factors such as smaller product batches, fully enclosed manufacturing and automated systems and a continual drive to minimise risks of contamination.These products do face challenges from risks posed by leachables and the potential risk of interaction between prefilled syringe components and drug formulations.
Intertek's scientists are experts in safety studies for all types of pharmaceutical packaging materials including glass and plastic. With expertise in extractables and leachables and glass delamination studies, we also provide sensitive and specific analytical investigations into other potential packaging-related contaminants such as silicones or silicone emulsions which are often used to lubricate the inner wall of glass prefilled syringes. The presence of silicones can impact patient safety through the unintended injection of silicone impurities and there may also be risks from the toxicity of smaller silicone fragments, such as octamethylcyclotetrasiloxane, which may also be present. Other risks may arise from the formation of silicone droplets (sub-visible particles) which could contribute to protein aggregation. Proteins could also adsorb onto siliconized surfaces.
Intertek's packaging expert Ruckstuhl, Laboratory Manager, Intertek (Schweiz) AG will present during ACI’s European Prefilled Syringes Summit on the Silicone determination in prefilled syringes:
“qNMR AS A POWERFUL TOOL FOR RESIDUAL SILICONE DETERMINATION IN PFS AT TRACE LEVELS”
Request a copy of the presentation
About the European Prefilled Syringes Summit
ACI’s European Prefilled Syringes Summit will explore the advancements in regulatory guidelines, product development, manufacturing processes, risk mitigation, portfolio management and answer some infinite industry questions such as; how the industry is responding to disruptive technology, connectivity, speed to market, and next generation syringes.
Need help or have a question?