A home-care distributor in Lyon sent a brief that read like a packing puzzle: two insulin pens, a glucose meter, lancets, a sharps box and a gel pack, all in one case that has to hold a working day of temperature without being carried like a suitcase. The first sample kept the cold for six hours. The buyer needed ten. That gap changed the lining spec, the wall build and the closure, and it is a fair picture of how most medical case projects at our factory actually start.
Insulation is a build-up, not a material
Cold retention comes from layers, not from one clever foam. The working build is a 3 to 4 mm EVA shell, a 6 to 8 mm closed-cell PE foam insulation layer, and a reflective facing, with a pre-frozen gel pack sitting in its own pocket so condensation never touches the pens. In our in-house checks at 25 degrees Celsius ambient, a 400 g pack in that build holds 2 to 8 degrees Celsius for roughly 8 to 10 hours. Those are bench numbers from our workshop, not a certified figure, and we hand over the raw log so your regulatory team can read it. Storage cavities come from the actual pens and vials, because a loop cut 2 mm loose lets a vial rattle against the case wall for eight hours.
Cleaning and documentation
Clinical users wipe cases down between visits, so the surfaces get specified for that. PU leather grain and a laminated Oxford shell both survive repeated 70 percent isopropyl wipes without going tacky; bare EVA marks less but scuffs more. Seams are kept off the wipe path where the layout allows. Customers whose own quality system runs to ISO 13485 normally ask us for documented incoming inspection, lot traceability on sheet stock and a retained first article, all of which we issue under our ISO 9001 system. We do not claim ISO 13485 certification for the factory itself.
- Insulin and injectables: insulated wall build, gel-pack pocket, elastic vial loops with a finger cut-out
- First aid and response: high-visibility shell, internal elastic organisers, a clear sleeve for a contents checklist
- Diagnostic kits: die-cut cavity for the meter or monitor, cable channel in the lid, moulded recess for a desiccant sachet
Materials are declared against RoHS and REACH with CTI test reports tied to the batch, and SGS factory audit records are available for review. Medical builds sit in the medical case range, minimum 500 pieces, samples in about three days for a simple layout. Send the device list and target temperature window to lucy@lianpingbag.com or start from the company profile if you need our audit file first. The Lyon sample is now at a 10-hour build with a second gel-pack pocket, and it goes back out on Tuesday.