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OEM/ODM EVA Insulin Cooling Case Manufacturer — Dongguan, China

Keep Insulin Viable, Anywhere. Custom EVA Cooling Cases Built for Medical Brands.

Pengtour engineers OEM insulin cooling cases with integrated electronic thermometers and reusable ice pack systems — keeping insulin within the critical 2–8°C window for 8–12 hours in typical travel conditions. Designed for diabetes management brands, pharmacy chains, and medical device OEM buyers.

8–12 Hr Cooling at 25°C
Electronic Thermometer Built-In
CE Support
Years Team Experience
Start Your Custom Project
Keep Insulin Viable, Anywhere. Custom EVA Cooling Cases Built for Medical Brands.
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Why an Integrated Thermometer Changes Everything for Insulin Safety

Insulin is a biological product. Temperature deviation — even brief exposure above 25°C — accelerates degradation and reduces potency. The challenge: a cooler box with ice packs tells you nothing about the actual interior temperature. Your patient (or your brand's end user) is flying blind. Pengtour's insulin case solves this with an integrated electronic thermometer that provides real-time interior temperature readings — visible through the lid or on an external display panel. Users know immediately if the thermal envelope has been breached. Medical brands know their product arrived safe.

FeatureStandard Cooler CasePengtour Insulin Case
Interior temperature visibilityNoneReal-time electronic display
Temperature range maintainedUnknown2–8°C (tested)
Duration at 25°C ambientVaries, unverified8–12 hours (in-house validated)
Duration at 35°C ambientVaries, unverified4–6 hours (in-house validated)
Ice pack systemBasicReusable, custom-fit to cavity
Compartment layoutGenericOEM custom per device SKU
CE registration supportVariesCE documentation support available

Insulin Case Configurations Available for OEM Development

Every configuration below is available as an OEM/ODM starting point. Compartment layout, ice pack size, thermometer display style, logo, color, and medical packaging are all customizable.

Insulin Pen Travel Case

Insulin Pen Travel Case

The everyday carry solution. Holds 1–3 insulin pens, 1 lancet device, needle pack and alcohol wipe roll. Clam-shell EVA shell with custom-fit microfiber lining. Electronic thermometer integrated in lid.

  • Capacity: 1–3 insulin pens + accessories
  • Thermometer: Digital display, ±0.5°C accuracy
  • Ice pack: 1× reusable gel pack, custom cavity fit
  • Cooling duration: 8–12 hrs at 25°C / 4–6 hrs at 35°C (in-house test method)
  • Shell: EVA cold-pressed, exterior finish customizable (matte / glossy / fabric-wrap)
  • Opening: Clamshell with dual zipper or magnetic snap
Full Diabetes Management Kit Case

Full Diabetes Management Kit Case

The comprehensive solution. Pen tray + blood glucose monitor bay + test strip pod + lancet port + alcohol swab dispenser + emergency card sleeve. Two-tier EVA interior. Ideal for pharmacy chain branded kits.

  • Tiers: 2-tier EVA die-cut interior
  • Pen capacity: Up to 3 pens
  • BGM bay: Fits FreeStyle Libre / Accu-Chek / OneTouch (custom fit available)
  • Ice pack: 2× reusable gel pack
  • Cooling duration: 8–12 hrs at 25°C / 4–6 hrs at 35°C (in-house test method)
  • Thermometer: External panel LCD, IP54 splash-resistant probe
Insulin Pump Carrier Case

Insulin Pump Carrier Case

Engineered for tubeless and tubed insulin pump users. Secure pump bay with anti-vibration foam lining, reservoir/cartridge storage slot, infusion set coil tray, and rapid-access top pocket.

  • Compatible: Medtronic / Omnipod / Tandem T:Slim / custom fit
  • Anti-vibration lining: 10mm closed-cell EVA foam + microfiber surface
  • Infusion set tray: Adjustable coil diameter 5–25cm
  • Ice pack: 1× slim-profile gel pack, side-panel insertion
  • Thermometer: Compact NTC probe, side-wall display
  • Attachment: Belt clip + shoulder strap loop + bag-clip D-ring
Clinical Insulin Transport Case

Clinical Insulin Transport Case

For hospital pharmacies, clinical trial logistics, and cold-chain medical supply brands. Multi-pen capacity (up to 10 pens or 5 vials), dual ice pack system, tamper-evident zipper, lot number label panel.

  • Capacity: 10 insulin pens or 5 × 10ml vials (customizable)
  • Ice pack: 2× dual-phase gel pack with individual bay
  • Tamper-evident: Tamper-evident zipper slider + security label panel
  • Thermometer: Dual-probe (interior + ambient), USB data logging port (optional)
  • Label panel: Embossed lot number field + QR patch area
  • Regulatory: ISO 13485-compatible quality records available; CE registration documentation support for OEM buyers

Don't see your configuration?

We engineer custom solutions from your product dimensions and clinical requirements.

Thermal Engineering: How Pengtour Maintains the 2–8°C Insulin Storage Window

WHO insulin storage guidelines specify that unopened insulin should be kept at 2–8°C. Once in use, pens may be stored at 15–25°C for up to 4 weeks — but the safest approach for travel and transport is to maintain cold chain throughout. Every Pengtour insulin case is engineered around this requirement. Reference: WHO Insulin Storage Guidance — iris.who.int

PENGTOUR IN-HOUSE METHOD

EVA shell insulation layer

The outer EVA shell is cold-pressed to a uniform wall thickness of 18–22mm with a closed-cell foam density of 38–42 kg/m³. Closed-cell structure prevents moisture ingress and convective heat transfer. Inner cavity surface is lined with 3mm microfiber for secondary insulation and product protection.

PENGTOUR IN-HOUSE METHOD

Reusable ice pack system

Each case ships with a custom-cavity-fit reusable gel pack. The gel formulation maintains phase-change temperature at 0–4°C, releasing cold energy gradually as ambient heat penetrates the shell. Gel pack is non-toxic, TSA-compliant (frozen solid, not liquid), and rated for 500+ freeze-thaw cycles.

PENGTOUR IN-HOUSE METHOD

Integrated electronic thermometer

The integrated NTC thermistor probe measures interior case temperature with ±0.5°C accuracy across the 0–40°C operating range. Display: LCD panel (lid-integrated or external side panel, OEM selectable). Low-battery alert function. Optional: dual-probe model with USB data logging for clinical/logistics applications.

PENGTOUR IN-HOUSE METHOD — Controlled internal testing, not a published standard

Thermal performance validation data

The above data represents results from Pengtour's in-house thermal performance tests under controlled laboratory conditions. Actual duration may vary. Third-party laboratory validation (SGS / Intertek) is available on request.

Test ConditionInitial TempMaintained RangeDuration
25°C ambient4°C2–8°C8–12 hours
35°C ambient4°C2–8°C4–6 hours

The above data represents results from Pengtour's in-house thermal performance tests under controlled laboratory conditions. Actual duration may vary. Third-party laboratory validation (SGS / Intertek) is available on request.

What You Can Customize on Every Pengtour Insulin Case

OEM and ODM EVA camera case customization service
ComponentSpecification
Shell Shape & SizeClamshell, top-zip, or dual-compartment shell engineered to your device SKU.
Interior LayoutPen slots, vial bays, BGM cavity, lancet port, test strip pod, and infusion set tray are configurable.
Thermometer StyleLid-integrated LCD, side-panel LCD, or external clip-on probe; single or dual probe.
Ice pack systemSingle gel pack / dual gel pack / slim-profile side-panel pack; custom cavity fit
Exterior FinishMatte EVA / glossy EVA / fabric-wrap (neoprene / microfiber) / medical-grade polymer coating
Logo & BrandingDebossed / embossed on shell, woven label, printed insert card, medical device labelling panel
Medical PackagingIFU insert, CE marking label, UDI barcode panel, retail blister, or folding carton.
Regulatory SupportCE registration documentation support (technical file, test data, DoC for buyer's CE application); ISO 13485-compatible QMS records; REACH/RoHS material declaration

Regulatory Compliance & Certifications for Medical Brand OEM

Medical device buyers require more than a well-made box — they need a manufacturing partner who can deliver documentation. Pengtour's insulin cases are produced under a quality management system aligned with ISO 13485 requirements, ensuring traceability from raw material to finished product. We provide the full technical file and test data required to support your brand's own CE registration under EU MDR 2017/745.

Certification / StandardStatusReference / Governing Document
CE Marking (EU)CE registration supportPengtour provides technical file, thermal test data, and manufacturing documentation to support your brand's CE application under EU MDR 2017/745 (EU Medical Device Regulation — eur-lex.europa.eu). Your EU Authorized Representative handles submission. Pengtour does not hold CE certification in its own name.
ISO 13485:2016QMS aligned — production records availableMedical devices — Quality management systems — Requirements for regulatory purposes, published by ISO (iso.org/iso-13485-medical-devices.html). Third-party certification audit available via SGS or Bureau Veritas on request.
REACH — Regulation (EC) No 1907/2006CompliantEU chemical registration and restriction regulation (echa.europa.eu). Material declaration available on request.
RoHS — Directive 2011/65/EUCompliantRestriction of hazardous substances in electrical and electronic equipment.
WHO Insulin Storage GuidelinePerformance alignedManufacturers' specifications: unopened insulin 2–8°C; in-use at 15–25°C up to 4 weeks (iris.who.int).
TSA / IATA (ice pack)CompliantFrozen solid gel packs exempt from TSA 3-1-1 liquid restrictions (US routes). IATA LAGs-compliant for international routes (tsa.gov / iata.org).

Our production is organized around the ISO 13485 quality management framework. Third-party ISO 13485 system audit by SGS or Bureau Veritas can be arranged at the buyer's request and cost.

From Prescription Requirements to Production: How We Develop Custom Insulin Cases

STEP01

Design

Maps device dimensions to cavity layout. Thermometer placement, ice pack bay, compartment architecture modeled in 2D/3D. Regulatory labelling positions proposed.

Timeline:
1-3 working days
Your Input Required:
Device dimensions / CAD + branding artwork + regulatory requirements
STEP02

Sampling

EVA shell cold-pressed, interior die-cut, thermometer integrated, ice pack fitted. Thermal hold validated at 25°C and 35°C. Fit check with actual device.

Timeline:
7 days
Your Input Required:
Review & approve sample + thermal test report
STEP03

Sign-Off

Pre-production sample shipped to you. Test with actual insulin pens / pump. Final specs, branding, packaging locked. Golden reference established.

Timeline:
3-5 days (shipping dependent)
Your Input Required:
Sign sample approval; confirm regulatory documentation requirements
STEP04

Mass Production

Bulk manufacturing under 5-gate QC. Performance batch test on every lot (thermal hold at 25°C ≥ 8 hrs). Batch QC records and material COA issued per lot.

Timeline:
30–45 days after sample approval
Your Input Required:
None — we handle everything
STEP05

Pack & Ship

Packed per your spec: retail blister, folding carton, or FBA carton. IFU insert, UDI barcode panel applied. Pre-shipment inspection report issued. FOB / CIF / EXW.

Timeline:
As per shipping terms
Your Input Required:
Confirm packaging spec and shipping destination

Mold Fee Policy

  • Stock mold: free (existing cavity shapes)
  • Semi-custom mold (existing shell + adjusted interior): 400
  • Full custom mold (new EVA shell shape + new interior): 1,500
  • Mold fee 100% refundable against first bulk order ≥ 2,000 pcs

Pengtour's 5-Gate QC Process for Insulin Case Production

GateWhat We CheckStandard / Equipment
IQC — Incoming MaterialEVA sheet density & uniformity; thermometer probe accuracy batch test; gel pack phase-change temperature; zipper pull-forceDensity tester; NTC calibration bath; DSC phase-change analyzer; zipper pull gauge
IPQC — In-ProcessShell wall thickness at 8 sampling points; cavity dimensional accuracy ±0.3mm vs. CAD; thermometer integration sealing; label position and adhesionDigital caliper; CMM gauge; water ingress probe; peel test
FQC — Finished ProductFull fit check with actual device (pen/pump/BGM); thermometer display accuracy ±0.5°C at 4°C reference; ice pack cavity fit; zipper 50-cycle checkReference thermometer; AQL 2.5 sampling per ISO 2859-1:1999 (iso.org/standard/1141.html)
Performance TestThermal hold: 2–8°C for minimum 8 hrs at 25°C (in-house method); 1.5m drop test on 6 faces; IP54 splash resistance; tamper-evident zipper functionInsulated thermal chamber; drop tester; IPX test chamber; torque meter
OQC — Pre-ShipmentCosmetic inspection (shell finish, logo alignment, label completeness); packaging completeness (IFU, UDI panel)Visual inspection jig; carton compression per ISTA 1A (ista.org)

QC Documentation Per Shipment:

  • Signed QC report (IQC + IPQC + FQC + OQC summary)
  • Material COA (EVA, thermometer probe, gel pack, zipper)
  • CE technical file documentation (if buyer CE registration is in progress)
  • REACH / RoHS declaration
  • Third-party test report (if commissioned)
  • Packing list with batch traceability code

Custom Insulin Cooling Case FAQs — What Medical Brands Ask Pengtour

Yes. Pengtour provides the full product technical file, thermal performance test data, Bill of Materials, and manufacturing documentation required to support your brand's CE registration under EU MDR 2017/745 (eur-lex.europa.eu). Your EU Authorized Representative (EU AR) handles submission. Pengtour does not hold CE certification in its own name — the CE is applied for and held by your brand entity. This is standard practice for OEM medical device branding and gives your brand full regulatory ownership of the product.
In Pengtour's in-house thermal tests: at 25°C ambient (typical temperate indoor or aircraft cabin), the case maintains 2–8°C for 8–12 hours. At 35°C ambient (tropical outdoor or summer conditions), 4–6 hours. Validated with pre-cooled ice pack (frozen to -18°C, thawed 10 minutes before sealing). Third-party thermal validation by SGS or Intertek available on request.
Yes. OEM CE registration requires a Technical File and Declaration of Conformity specific to your brand's product configuration. We supply the product technical file, test data, and manufacturing documentation; your EU AR handles submission. We have experience supporting this process for medical device brand clients.
Standard MOQ is 100 pcs per configuration for custom designs. Mixing configurations in one order is possible — we'll advise on how to structure production batches to optimize unit cost and lead time.
Every thermometer probe batch is calibrated against a NIST-traceable reference thermometer in IQC, with acceptance criterion ±0.5°C across 0–40°C. At FQC, each finished case is tested at 4°C reference temperature. Calibration records maintained per batch. Third-party calibration certificates available on request.
Yes. The reusable gel pack, when frozen solid, is exempt from TSA 3-1-1 liquid restrictions on US routes (tsa.gov). For international routes, frozen gel packs fall outside IATA LAGs restrictions (iata.org). We recommend your IFU insert include a note advising users to ensure the pack is fully frozen before travel.

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Insulin is a lifeline. The case that carries it should meet the same standard as the therapy it protects. Send us your device specifications, brand requirements, and target market — Pengtour will have a design direction back to you within 24 hours.

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