The ISO 11040 Pre-Filled 1ml Glass Syringe with Staked Needle is the gold standard for the delivery of sensitive parenteral drugs, including vaccines, biologics, and high-potency active pharmaceuticals (HPAPIs). It combines the inert properties of glass with the safety of an integrated needle system.
Technical Specifications & Material Science: The syringe body is manufactured from borosilicate glass (Type I), renowned for its exceptional chemical inertness, thermal shock resistance, and low leachability. This ensures drug stability and compatibility over the product’s shelf life. The needle is staked (crimped) directly onto the glass barrel, creating a monolithic, leak-proof system that eliminates the dead space found in detachable needle assemblies. The needle is typically thin-wall, siliconized, and ranges from 25G to 27G for patient comfort. A tamper-evident tip cap and plunger stopper complete the system.
Industry Standards & Compliance: This product is explicitly designed to meet the rigorous ISO 11040 series standards for pre-filled syringes. It also complies with FDA, EMA, and PMDA regulatory expectations for combination products (drug + device). The manufacturing environment is ISO Class 7/8 cleanroom.
Application Scenarios: Primarily used by pharmaceutical companies for OEM drug filling. It is ideal for:
- Auto-injectors for emergency therapies (e.g., epinephrine, rheumatoid arthritis drugs).
- Vaccines requiring precise, single-dose delivery.
- Biologic drugs (e.g., monoclonal antibodies, hormones) that are sensitive to interaction with plastics.
Usage Guidelines: (For the end-user) Remove the tip cap, administer via subcutaneous or intramuscular route as directed, and dispose of safely. (For the pharmaceutical partner) We provide comprehensive OEM services, including custom printing (track-and-trace serialization, brand colors), siliconization level adjustment, and assembly into secondary packaging like blister packs or folding cartons.
Market Value Proposition: For pharmaceutical partners, this syringe reduces development time and regulatory risk by utilizing a pre-qualified, standard platform. The staked needle design enhances patient safety by preventing needlestick injuries post-use and ensures dose accuracy. It offers a premium, patient-friendly presentation that can support higher drug pricing and improve patient compliance, representing a critical value-add in competitive therapeutic markets.