Medical Device Regulation - MDR: "Prefilled syringes are generally classified as Class IIa or IIb devices, depending on the intended use and the degree of invasiveness. No classification as “Medical Device”. A judgement from authorities with statement from Notified Body is required.
Prefilled syringes: An innovation in parenteral packaging - PMC
Prefilled syringe cartridges assure that patients receive accurate dosages. This is especially advantageous for patients who need to self-inject medication, but have no medical training.
Prefillable syringe systems - BD
Whether for biologics, vaccines, anticoagulants, or small molecules and other specialties, our prefillable glass and polymer syringe systems can help effectively, reliably and consistently administer the drug therapy you provide.
BD Neopak™ Glass Prefillable Syringe platform
The BD Neopak™ Glass Prefillable Syringe platform with tailorable medication delivery solution can help support the development of your biologic drug. Getting your drug to market with a solution focused on patient safety and usability
Weighing the Pros and Cons of Prefilled Syringes
2024年8月8日 · The common options for prefilled syringes are emergency drugs that facilities like to have ready for immediate administration, such as rocuronium and ephedrine. Various ophthalmic medications that require specific dosing are also popular in prefilled form, including moxifloxacin and cefuroxime.
Advancements in silicone free prefilled syringe solutions to protect complex and sensitive biologics from silicone- induced protein aggregation and particle formation
Pre-filled Syringes for Safe and Accurate Drug Delivery
2024年4月1日 · The manufacturing of pre-filled syringes involves identifying the components and processing those materials, including filling. It must be filled aseptically in a sterile clean room with Grade A or ISO 5 laminar flow environments to prevent contamination.