We’ve got about 500 units in stock right now, and they ship within 5 business days — but if you need cold chain, that adds 2-3 days for dry ice packing. The packaging is a standdard 50-unit case, each pen individually sealed in a blister pack with a desiccant sachet (usually 2-4 weeks lead time if we run low). It’s a single-dose autoinjector pen, basically a shell that takes your prefilled syringe and does the work for you.
Most buyers go with this for diabetes or growth hormone therapy, but it’s also used for osteoporosis — you just need to check the viscosity of your drug because it only handles up to 20cP or so. What it does is let someone press the needle cover against skin, and the thing fires, gives a click and a visible plunger movement, then locks teh needle away permanently. It’s not suited for high-volume vaccines or anything over 1ml, so keep that in mind.
The dimensoins are 18×18×145mm, which is pretty compact for a device that hides a 27G or 29GTW needle — the injection depth is fixed at 6±2mm, so it’s subcutaneous only. We’ve had buyers ask about using it with 30G needles, but the spec sheet says 27G or 29G, and honestly, we’ve never tested smaller. The material is medical-grade plastic, and whole thing is one-hand operation with passive locking after use.
We don’t customize the pen body itself, but our company can tweak the injection time and depth within the 6±2mm range — that’s usually a batch-level change, not per unit. Actually, what we see is that most customers just take the standard 6mm depth, as it works for the majority of subcutaneous application. The feedback system gives you both a visual indicator and an audible click, so there’s no guessing if the dose went in.
Also, our company provide a COA for each lot, and the pens are assembled in a cleanroom — we’ve handled about 20,000 units this year alone, so we know the quirks. One thing you might not think to ask: the needle cover activation requires a firm press, about 5N of force, so it’s not suitable for very frail patients without assistance. Shipping is typically by air freight, and we can include temperature data loggers if you need them.
MOQ is typically 10,000 units for customized orders, but we can discuss smaller trial quantities if you're just getting started.
Yes, our manufacturing facility holds ISO 13485 certification, and we can provide compliance documentation for FDA registration or other regulatory filings upon request.
No, it's designed for low-viscosity fluids up to 20cP. Higher viscosities may cause inconsistent dosing or incomplete injection.
Standard packaging is 50 units per sealed tray with a Tyvek lid, then 10 trays per carton. We can also customize blister or pouch packaging if needed.
Once the design is finalized, production usually takes 30 to 45 days for a standard custom run, plus shipping time.