Cormica® Medical Device & Pharmaceutical Testing

What does your E&L testing plan need to account for before work begins? A pre-filled syringe brings together the drug formulation, container materials and manufacturing processes. If the study design misses a relevant interaction, the resulting data may leave important questions unanswered when your team needs to make a decision. Planning E&L studies around your specific syringe and drug product helps you understand potential chemical risks earlier and make more confident decisions. Cormica’s expert scientists bring analytical chemistry, pre-filled syringe testing and toxicological assessment together to help you build a clearer picture of product safety with fewer handoffs. Contact us [email protected] #ExtractablesAndLeachables #PrefilledSyringes #PharmaceuticalTesting

An air bubble inside a prefilled syringe can influence how its stopper behaves during transport. When external atmospheric pressure drops, the gaseous headspace can expand and exert additional force on the stopper. That makes headspace a relevant factor when assessing unintended movement, alongside the syringe configuration and expected transportation conditions. Controlled low-pressure testing allows stopper position to be measured at defined intervals, helping manufacturers understand the response. Our article explores the mechanism and the considerations behind an appropriate study. Read the article: https://lnkd.in/eXWHJd9n #PrefilledSyringes #CombinationProducts #DeviceDevelopment

Build evidence for how your prefilled syringe behaves during transportation. Assessing plunger stopper movement under relevant low-pressure conditions can help you understand potential risks to syringe performance and sterile barrier integrity. It can also inform reassessment following changes to fill volume, stopper configuration, components or distribution routes. The starting point is a study that reflects your product and its risks, including reduced temperatures where cold-chain transportation is relevant. Read our technical article which includes a practical checklist to help you identify what to consider: https://lnkd.in/eXhCij64 #PrefilledSyringes #ProductDevelopment #DrugDelivery

Regulators scrutinise pre-filled syringes as true drug–device combinations. Our specialists help you stay ahead by aligning testing with key international standards for PFS and needle-based injection systems. We generate robust data packages covering performance, container closure integrity, sterility, and injection forcesso you can move into submissions and audits with confidence.

When you’re developing a pre-filled syringe, you can’t afford late surprises. At Cormica, we integrate analytical chemistry, microbiology, functional testing, and biocompatibility to give you a clear view of performance, sterility, and stability from early R&D through to batch release. Partner with us to de‑risk development and move toward approval with regulator‑ready data.

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