Medical Packaging & Kitting Materials

A crosslinked polyethylene foam is the usual choice for a tray or instrument cavity insert. It is a firm, fine-celled closed-cell foam that holds its shape, gives a clean, precise cavity wall, and tolerates a high radiation dose if the package is gamma-sterilized.

For an economical block, corner, or void-fill cushion, an expanded polyethylene is the cost-effective option; for a softer cushion or a tray liner on a lighter device, an EVA foam works; and for a precise cradle for a delicate instrument or optic, a microcellular polyurethane such as PORON Medical gives controlled low-load cushioning with low compression set.

State the device weight, the fragility, the drop and vibration level, and the sterilization method, so the grade, the gauge, and the cavity fit match. H-O die-cuts and mills the cavities to the tray footprint. Foam cushioning is characterized per ASTM D3574; the package drop performance is the device maker's to validate.

A sterile-barrier system is the packaging that lets a terminally sterilized medical device be sterilized inside its package and then maintains its sterility until use, typically a porous lid or pouch face that the sterilant passes through, sealed to a formed tray or a film. H-O supplies the sterile-barrier materials by designation: a porous spunbond polyethylene lidding stock that is sterilant-permeable yet a microbial barrier, films, papers, and laminates, to the lid, header, or pouch geometry.

These materials are commonly used in ISO 11607-evaluated sterile-barrier systems, and H-O references them by designation. What H-O does not do is certify the sterile-barrier system, validate the seal, or run the sterilization validation, those, and the sealed-and-tested finished package, belong to the device maker. H-O converts the designated material; the device maker owns the validated system, the seal integrity, and the sterilization validation.

No, and the distinction is important. ISO 11607 applies to a sterile-barrier system, the validated, sealed, and tested package, not to a single converted material in isolation. A porous spunbond lidding stock or a film is a material commonly used in ISO 11607-evaluated sterile-barrier systems, and H-O references it by designation, but the material itself is not a certified system.

The system is validated by the device maker, who selects the materials, seals them, and runs the seal-integrity and sterilization validation against ISO 11607-1 (the system requirements) and ISO 11607-2 (the validation of the forming, sealing, and assembly process).

H-O supplies the converted sterile-barrier material to the designation you specify; it does not certify a system, validate a seal, or claim a cleanroom certification. State the sterilization method and the system the material goes into, and H-O converts the designated material to the geometry you need.

The sterilization method narrows both the cushioning foam and the sterile-barrier material. For the foam, polyethylene foams tolerate a high radiation dose, so they suit gamma and e-beam, while any grade has a method and dose limit on its maker TDS to verify. For the sterile barrier, a gas (ethylene oxide) sterilization needs a porous, sterilant-permeable lidding so the gas can get in and out and then the barrier maintains sterility, while a gamma- or e-beam-sterilized package can use a different barrier construction that does not need gas permeability.

State the sterilization method, because it sets which foam grade and which sterile-barrier material the kit is converted from and how the package is constructed. The cushioning foam must survive the method without degrading, and the sterile-barrier material must suit it; both are referenced by designation. The sterilization validation of the finished package belongs to the device maker.

Yes, where the device is static-sensitive, H-O converts an ESD-aware material to the cavity. A static-sensitive electronics module wants a static-dissipative or conductive foam grade that does not generate or hold a charge against the part, rather than a standard insulating foam that can charge and discharge against sensitive electronics. H-O names a specific conductive or static-dissipative grade only where it is catalog-verified, and otherwise frames the ESD-aware material qualitatively and selects it with you for the ESD level you need.

State that the device is static-sensitive and the ESD performance it requires, and H-O converts the ESD-aware material to the cavity and the protective construction. The ESD performance of the finished package is verified by the device maker. H-O is an ISO 9001:2015 certified converter; it supplies the converted ESD-aware material, not a certified ESD-protected device.

They are three cushioning foams at different firmness and cost points. A crosslinked polyethylene foam is firm and fine-celled, so it holds a precise cavity with a clean wall and resists crushing, which makes it the workhorse for instrument and device cavity inserts. An expanded polyethylene is an economical block stock for corner, block, and void-fill cushions where a precise cavity is not needed.

An EVA foam is softer and resilient, so it suits a soft cushion, a tray liner, or a soft-touch presentation surface for a lighter device. Choose crosslinked polyethylene for a firm, precise cavity, expanded polyethylene for economical bulk cushioning, and EVA for a softer cushion or liner; a layered, laminated stack of two of them is common where both firmness and a soft surface are wanted.

Foam cushioning and density are material properties per the maker TDS, characterized per ASTM D3574. The package protection is the device maker's to validate.

A clean, low-shed converted edge is a converting-side requirement, and H-O selects the cutting method and tooling for the foam grade to give it. Die-cutting, kiss-cutting, laser-cutting, and waterjet-cutting each give a different edge on a given foam, and H-O chooses the method that gives a clean edge that does not shed loose particles into a clean package. State the cleanliness and the edge requirement on the drawing, and for a clean device, name the cleanliness level needed.

The edge quality and the converting cleanliness are things H-O owns as the converter, under its ISO 9001:2015 quality management system; the device maker validates the finished package for particulate. H-O does not claim a cleanroom certification; cleanliness is handled as a material and converting specification, and a clean-converted or controlled-handling step is added where the package calls for it.

Yes. Beyond die-cutting the individual parts, H-O laminates layered cushions, assembles multi-part inserts, and kits the components together so they arrive ready for your line, which is the kitting side of packaging and kitting. H-O laminates a soft layer over a firm base, and mills the cavities, combines the cushion, liner, and any film into a sub-assembly, and packages the kit to your bill of materials.

State the layer order, the assembly, and how you want the kit presented and packaged, and H-O converts, laminates, and kits to your drawing and BOM, with material traceability and lot-code documentation. The converting, lamination, and kitting are H-O operations; the validated, sealed sterile-barrier system, where one is involved, is completed and validated by the device maker.

Usually only where the foam contacts the device in a way that matters, or contacts a patient or fluid. Most cushioning foam in a shipping or kit tray protects the device without a biological-contact concern, so it is referenced to its ASTM cellular-foam methods and, where it touches a device or fluid surface, an FDA composition basis.

Where the packaging material does contact a patient, a fluid path, or a device surface where extractables matter, then an ISO 10993 or USP Class VI designation applies at the material level, and a microcellular polyurethane such as PORON Medical or an FDA-grade film referenced to those designations is the choice.

State whether the part is patient-contact, device-contact, or pure protective cushioning, so H-O references the right grade, neither over-specifying a biological designation on a shipping cushion nor under-documenting a device-contact layer. The material maker evaluates the grade; the device maker owns the finished-package file.

H-O converts sheet, slab, and roll stock to your drawing across the gauges, cavities, and geometries packaging needs: die-cut tray inserts with single- or multi-level milled cavities, corner and edge blocks, soft liners, protective films, and sterile-barrier lids and pouches. The converting toolkit is rotary and flatbed die-cutting, kiss-cutting on liner, laser and CNC waterjet cutting, cavity milling, adhesive lamination, slit-to-width, and kitting, holding the gauge and cavity tolerance to the drawing and stacking to thickness for a layered cushion.

State the cavity layout, the fit (snug or clearance), the gauge and stack-to-thickness, the clean-edge requirement, and any film or lid geometry, and H-O selects the converting method that fits the material and the part. Gauge, cavity, and tolerance are held to the drawing; specific material gauge ranges are per the maker stock and the maker TDS.

No. H-O Products is a precision converter: it makes the cushioning and sterile-barrier material parts (tray inserts, cushions, protective films, porous lidding stock, films, and laminates) to your drawing from material grades commonly used in medical-device packaging, under an ISO 9001:2015 quality management system. H-O is an ISO 9001:2015 certified organization; that certification governs the converting process, not a packaging-system clearance.

H-O does not certify a sterile-barrier system, validate a seal, run a sterilization validation, or claim an ISO 13485 certification, an FDA registration, or a cleanroom certification.

Sterile-barrier materials are referenced to ISO 11607-evaluated systems by designation, and other grades to their ASTM, FDA, ISO 10993, or USP Class VI references at the material level. The validated, sealed, and tested packaging system, the seal integrity, the sterilization validation, and the regulatory file belong to the device maker. H-O supplies the converted parts, the material documentation, and lot traceability aligned to your requirements.

Send the device or tray drawing or a sample, the part, and four things: the job (kit or tray cushioning, precise instrument protection, ESD-aware electronics protection, or sterile-barrier material), the protection level or sensitivity (economy block, firm cavity, soft cushion, or delicate and static-sensitive), the sterilization method (none, ethylene oxide, gamma, e-beam, or steam), and the material basis (ASTM cushioning, FDA contact, ISO 10993 or USP Class VI where patient- or fluid-contact, or an ISO 11607 sterile-barrier designation).

Add the cavity layout and fit, the gauge or stack thickness, the clean-edge requirement, any kitting or assembly, and prototype and annual volume. With that, engineering returns a material family, a converted-part approach, prototype lead time, and the documentation that can be aligned to your requirements. The quote form below has fields for each of these. Samples typically ship in 3 to 5 business days; standard production in about 2 weeks.