Account
Inquiry
base on your RFQ, the 159.2×22×22 mm footprint for the 2.25ml model fits most standdard storage trays, and we've run it with viscosities up to 20 cP without issues — anything thicker and the spring rates start feeling sluggish.
You'll get a needle cover that triggers the injection, and it's pretty much foolproof for patient handling, though the 6±2 mm depth setting means it's not suited for intramuscular dilevery at all.
The audible click is loud enough to hear in a clinical setting, and the visual window lets you see plunger travel, so it's actually better than most older designs we've tested.
We typically stock both 27G and 29G needle configurations, but lead time for a custom injection time (say 5–10 seconds) can stretch to 8 weeks or so depending on your batch size, so confirm that early.
One detail that catches buyers off guard is the gamma sterilization compatibilty — we've had no delamination with standard prefilled syringes, but the polymer mix does require a dry cycle or you risk surface crazing.
MOQ is usually 5000 units, and our company can ship within 20 days or so once the COA clears form our HPLC runs for the 1ml version, though the 2.25ml model adds 2 weeks to that.
We typically start at 10,000 units for new customers, but we can discuss lower volumes for pilot runs or trials. Just reach out with your estimated annual usage.
Yes, we can share a full regulatory package including design history files and risk management docs that demonstrate compliance with ISO 11608. Just let us know what specific documentation your team needs for submissions.
Absolutely, the injection time is adjustable to suit your drug's viscosity, which must stay at or below 20 cP. We'll work with your formulation to dial in the optimal time for consistent delivery.
Units are packaged in nested trays inside sealed pouches, with 50 to 100 injectors per carton. They should be stored in a clean, dry environment between 15-30°C, and we can provide accelerated aging data upon request.
Yes, the device is designed for both gamma and e-beam sterilization without degradation of the medical-grade polymers. We'll validate the process with your chosen method during the development phase.
