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MPP/PE Thermoforming Film — Medical Care Package F4538 (80μm)
F4538 is an 80μm MPP/PE vacuum thermoforming base film purpose-built for medical device packaging — injection syringes, gauze, cotton pads, suction tubes, and other disposable medical supplies — with suitability for E.O. (ethylene oxide) sterilization.
A Vacuum Thermoforming Base Film Built for Medical Device Packaging
F4538 is the 80μm entry gauge in Intlpak's MPP/PE series, running as the forming (base) film at a shallow 10–15mm draw. It is produced by computer-controlled co-extrusion with automatic foreign-object detection and thickness control under clean-room standards, and combines high formability and strong pinhole resistance with the transparency and gloss needed to inspect a device clearly through the sealed pack.
Where F4538 Is Used
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Vacuum Thermoforming Base Film
Vacuum thermoforming base film for disposable medical supplies and medical equipment. F4538 is the 80μm grade in Intlpak's MPP/PE series, an all-polyolefin alternative to nylon (PA)-based medical forming film at a 10–15mm forming depth.
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Syringe and Gauze Packaging
Injection syringes, gauze, cotton pads, and sputum suction tubes. Haze is 3.5% — the clearest medical forming film Intlpak makes — so contents and any pack indicator remain readable without breaking the seal.
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Shallow-Draw Single-Use Devices
Other single-use medical devices requiring shallow vacuum-formed packaging. Elongation 770/820% is high for a forming web, letting the film follow tooling detail closely, while tensile modulus 3600/3600 kg/cm² keeps the formed cavity from slumping.
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E.O. Sterilization Compatibility
Packaging lines requiring E.O. (ethylene oxide) sterilization compatibility. MPP/PE is specified for the E.O. route; where a gamma option is needed, the NE nylon (PA)/PE series is the sibling to look at. Sterile barrier validation belongs to the device maker.
Full Specifications — MPP/PE Thermoforming Film Series
F4538 is the 80μm shallow-draw grade in Intlpak's MPP/PE medical thermoforming film family — an 80 micron medical thermoforming film for a 10–15mm forming depth, with 3.5% haze, the clearest grade in the series, and suitability for E.O. sterilization. The table below shows F4538 alongside the deeper-draw 120μm F4539 grade in the same series.
| Property | Standard | Unit | F4538 (80μm) | F4539 (120μm) |
|---|---|---|---|---|
| Thickness | — | μm | 80 | 120 |
| Yield Point (MD) | ASTM D882 | kg/cm² | 180 | 180 |
| Yield Point (TD) | ASTM D882 | kg/cm² | 180 | 170 |
| Break Point (MD) | ASTM D882 | kg/cm² | 410 | 350 |
| Break Point (TD) | ASTM D882 | kg/cm² | 360 | 360 |
| Elongation (MD) | ASTM D882 | % | 770 | 800 |
| Elongation (TD) | ASTM D882 | % | 820 | 770 |
| Tensile Modulus 2% (MD) | ASTM D882 | kg/cm² | 3600 | 3500 |
| Tensile Modulus 2% (TD) | ASTM D882 | kg/cm² | 3600 | 3300 |
| Static C.O.F. (treated) | ASTM D1894 | kg/200g | 0.28 | 0.20 |
| Static C.O.F. (untreated) | ASTM D1894 | kg/200g | 0.08 | 0.12 |
| Kinetic C.O.F. (treated) | ASTM D1894 | kg/200g | 0.20 | 0.20 |
| Kinetic C.O.F. (untreated) | ASTM D1894 | kg/200g | 0.07 | 0.10 |
| Haze | ASTM D1003 | % | 3.5 | 5.3 |
| Suggested Forming Depth | — | mm | 10–15 | 10–30 |
| Formability / Pinhole Resistance | — | — | Best-in-class | |
| Optical Properties | — | — | High transparency, high gloss | |
| Sterilization Compatibility | — | — | Suitable for E.O. (ethylene oxide) sterilization | |
| Typical Application | — | — | Injection syringes, gauze, cotton pads, suction tubes, and other medical equipment | |
| Width | — | — | Customized | |
| Length | — | — | Customized | |
Reviewed by: Intlpak R&D Team.
Why F4538 Performs
Storage Notice
Avoid exposure to direct light, wind, and rain — store under appropriate conditions. Prevent products from slipping from high places, being polluted, or being impacted during handling.
Quality & Certification
Manufactured under ISO 9001 quality management and GMP clean-room production standards suited to medical-grade packaging, with ISO 22000 & HACCP certification. All products undergo annual safety checks.
Questions About F4538
F4538 and F4539 are both medical forming base films — 80 or 120 μm?
Die depth decides. F4538 at 80 μm is rated for 10–15 mm forming depth, suited to flat devices — catheters, syringes, dressings. F4539 at 120 μm reaches 30 mm for more three-dimensional instrument sets. Depth is the hard constraint: measure the tooling, then choose gauge.
Which sterilization methods is F4538 compatible with?
Ethylene oxide (E.O.). The MPP/PE structure is built for E.O. processing, allowing sterilant exchange through a breathable top web while the film retains integrity and seal strength. If your process uses gamma irradiation, move to the nylon grades F2624-M or F2703 , which are compatible with both E.O. and gamma.
Which side of the pack is F4538, and what pairs with it?
The bottom web, thermoformed into the cavity that carries the device. The top web is typically a breathable medical-grade paper or Tyvek to permit sterilant exchange; sealed together they form the sterile barrier system. Top-web selection and seal parameters should be settled alongside your sterilization validation.
Is 80 μm enough to survive sterilization and distribution?
For 10–15 mm shallow cavities it is — that is the range the gauge is designed for. But sterile barrier integrity never rests on film thickness alone: seal parameters, cavity geometry, shipping configuration and ISO 11607-related validation all contribute, so run accelerated ageing and distribution simulation on the actual pack.
How does F4538 meet cleanliness expectations for medical packaging?
It is produced in a GMP clean-room environment under an ISO 9001 quality management system with raw-material traceability. Where you need specific cleanliness class statements, particulate counts or bioburden data to support sterilization validation files, raise it with our engineering team and we will supply documentation aligned to your regulatory pathway.
Which medical forming film gives the clearest view of the contents?
In Intlpak's medical range it is F4538, at 3.5% haze — clearer than any of the nylon/PE medical grades, which run 5.7% to 12.5%. It is the 80 μm MPP/PE grade rated for a 10–15 mm forming depth, used for syringes, gauze, cotton pads and suction tubes. Note that MPP/PE grades are stated for E.O. sterilization only.
We need gamma sterilization — can we still use this film?
Not this one. Intlpak states MPP/PE grades, F4538 included, for E.O. sterilization only. If your process uses gamma (r-ray), move to the nylon/PE medical series — F2624-M (80 μm, 10–15 mm), F2703 (110 μm, 20–40 mm), F2615-M (120 μm, 10–30 mm) or F2606-M (150 μm, 40–50 mm) — which are stated for E.O. or gamma. Confirm compatibility against your validated cycle.