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How to Spec a Medical Packaging or Kitting Part: What to Send H-O for a Quote
A medical packaging or kitting part quotes fastest when the request states the track, the geometry and the role up front. A converter cannot select a tray foam, a dunnage cushion or a barrier stock from a part name alone, because cushioning and barrier are two different material problems with different properties.
This guide is the eight-item checklist that turns a packaging RFQ into a same-direction quote and a sample on your geometry, with barrier material treated as an input to your validated system, ISO 11607 referenced by designation, and no sterility claim.
What does H-O need to quote a medical packaging or kitting part?
A packaging or kitting part quotes fastest when the request states the track, the geometry and the role up front. A converter cannot select a tray foam, a dunnage cushion or a barrier stock from a part name alone, because cushioning and barrier are two different material problems with different properties. The checklist below turns a packaging RFQ into a same-direction quote and a sample on your geometry, with the barrier material treated as an input to your validated system and no sterility claim.
The eight things to send
- The track and the role. Name what you need quoted: kit or tray cushioning, dunnage or light cushion, sterile-barrier stock, or surface-protection film. List each part; each is a separate selection.
- The geometry and cavities. A die line, a DXF, a tray layout, or a marked-up sketch, including cavity positions, depths and the parts they hold.
- The contents and weights. What the tray holds and roughly how heavy, so the cushioning grade and cavity firmness can be matched.
- Gauge and thickness. The foam thickness or insert depth, or the barrier stock and film gauge.
- The protection level. The shipping and handling environment and the protection needed, so the cushioning grade can be selected.
- The barrier role (for barrier stock). Whether the material is a porous web, a film web or a component, and the sealability or porosity your process needs; the validated system stays with you.
- Cleanliness and documentation. The cleanliness requirement and any material-level documentation you need; H-O references ISO 11607 by designation and does not validate or certify the package.
- Quantities and dates. Prototype count plus annual volume, and your sample and production dates.
What you get back
With the checklist in hand, H-O returns a cautiously framed grade direction for each track, a converting plan (die-cut, waterjet, routed and milled for cavities; die-cut and slit for barrier stock and films; kitted), and samples on your geometry for common configurations.
Grade-specific values are confirmed against the manufacturer's current technical data sheet; the validated sterile barrier system, its seal validation and its sterility assurance remain with you. We name a family only where it is catalog-verified, and we make no sterility or certification claim. For example, kit and tray cushioning commonly maps to crosslinked polyethylene foam, confirmed to your grade on the data sheet.
What H-O does not decide for you
- The sterile barrier system. H-O supplies barrier materials as inputs; you design and validate the system against ISO 11607 by designation.
- The seal validation. Seal strength and seal-defect verification are yours, on the system, by ASTM F88 and ASTM F1929 as test-method designations.
- Sterility assurance and certification. H-O claims only ISO 9001:2015 for the converting process; it certifies nothing as sterile.
- Grade-level numbers. Density, force-deflection and sealability are read on the maker's current data sheet, not invented in the quote.
A model RFQ
"We need a crosslinked polyethylene tray insert with milled cavities for a five-piece instrument kit (weights listed), plus porous spunbond lidding stock as an input to our sterile barrier system. Tray layout attached as DXF with cavity depths; insert about 25 mm thick. The lidding is a porous web for our sealing process; we own the ISO 11607 validation and will run seal strength to ASTM F88 and dye penetration to ASTM F1929.
We need the foam cleanliness stated and the spunbond grade data sheet. Quantities 40 prototype plus 12,000 per year; samples in three weeks." That request can be directioned and sampled without a clarifying round, with the barrier stock treated as an input and no sterility claim.
Ready to spec a medical packaging or kitting part?
Send the track and role, the tray layout and cavities, the contents and weights, and any barrier stock need as an input to your validated system. We will return a grade direction for each track and convert samples on your geometry.
Samples typically ship in 3 to 5 business days for common die-cut configurations; standard production runs about two weeks; special orders are quoted to the job.
Family-owned in Winsted, Connecticut since 1971 · ISO 9001:2015 certified · OEMs worldwide send us a drawing — and get back their part.
Related reading
ApplicationMedical Packaging & Kitting Materials (application page)Read →
GuideCushion or Barrier? Choosing Materials for Medical Packaging and KittingRead →
GuideSeal Integrity and ISO 11607 by Designation: Reading Sterile-Barrier MaterialsRead →
IndustryMedical & clean components overview (industry hub)Read →
Frequently asked questions
What do I need to send H-O to quote a medical packaging part?
State the track and role (kit or tray cushioning, dunnage, sterile-barrier stock, or surface-protection film), send the geometry and cavity layout with depths and the parts held, the contents and weights, the gauge or insert depth, the protection level and shipping environment, the barrier role and sealability for any barrier stock, the cleanliness requirement, and your quantities and dates. With that, H-O returns a grade direction per track and samples on your geometry. The validated sterile barrier system stays with you.
Do I have to choose the material before I ask for a quote?
No. Describe the track, the cavity layout and the protection level, and H-O recommends a cautiously framed grade direction. We name a material family only where it is catalog-verified, and we confirm grade-specific values against the manufacturer's current technical data sheet. For barrier stock we supply the material as an input to your system; we reference ISO 11607 by designation and do not validate or certify the package.
Can H-O certify my package as a sterile barrier?
No. H-O Products is a die-cut converter that supplies barrier materials and tray cushioning as inputs; it does not design, validate or certify sterile barrier systems and never represents a converted material as a sterile or certified barrier. The validated sterile barrier system, its seal validation by ASTM F88 and ASTM F1929 as test-method designations, and its sterility assurance against ISO 11607 by designation are owned by you as the packaging maker. H-O claims only ISO 9001:2015 for the converting process.
Request a quote for your medical packaging or kitting part
Send H-O your tray layout and barrier need—engineering reviews every RFQ, recommends a grade per track, and converts samples on your geometry.
Last updated · Reviewed by H-O Products engineering (ISO 9001:2015 certified converter, Winsted, CT).
References
- ISO 11607, Packaging for Terminally Sterilized Medical Devices. International Organization for Standardization (referenced by designation).
- ASTM F88, Standard Test Method for Seal Strength of Flexible Barrier Materials. ASTM International.
- ASTM F1929, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. ASTM International.
- ASTM D3574, Standard Test Methods for Flexible Cellular Materials: Slab, Bonded, and Molded Urethane Foams. ASTM International.
- Manufacturer technical data sheets for the named material families; grade-specific values are confirmed on the maker's current TDS.
This article describes material families H-O Products converts and references published standards by designation (ISO 11607 as the designation for terminally sterilized medical device packaging, ASTM F88 for seal strength and ASTM F1929 for seal-defect dye penetration as test-method designations, ASTM D3574 for urethane cellular materials, ASTM D1056 for cellular rubber). It describes kit-cushioning and sterile-barrier packaging materials only, and makes no patient, clinical, therapeutic or sterility-assurance claim.
A sterile barrier system is designed, validated and released by the device or packaging maker against ISO 11607 by designation; selecting and converting a material is not a sterility, sterilization or certification claim, and nothing here certifies a package as sterile. H-O Products is a precision die-cut converter, not a raw-material producer and not a medical-device or packaging-system manufacturer; this is not, and does not imply, an ISO 13485 certification, an FDA device registration, a cleanroom certification or a sterile-barrier certification.
The only certification claimed is ISO 9001:2015, which governs the converting process. Grade-specific values are confirmed against the manufacturer's current technical data sheet and an engineering drawing review. All parts are custom manufactured to order and minimum production run quantities apply.