Medical devices, food lines, EV packs, outdoor lighting, automation cells and consumer products usually fail for the same reason: a silicone part specified for the wrong media. We compound, extrude and mould in-house, so grade, tolerance and certificate all come from one factory.
CoA and migration reports ship with each batch. Third-party lab testing on request.
Hardness, cure system and post-cure decide whether a tube survives 10 000 pump cycles or swells after a week in coolant. A 50 Shore A peroxide-cured tube is the right answer for a coolant hose and the wrong one for a peristaltic pump head — same material family, opposite failure mode.
So we start from the application instead of the catalogue: media, temperature, cycle count, cleaning regime, and the certificate your end customer will audit. Then we shortlist two or three compounds and send samples, so validation happens before tooling money is spent.
Media in contact
Temperature
Cleaning
Certificate
Volume
Five answers are enough to quote. A sketched drawing is enough to sample.
Each sector below has its own failure mode, its own test standard and its own sensible compound. These are the six we build for every week.
Tubing, seals and moulded parts for the patient side and the drug path — peristaltic pump heads, catheter shafts, drainage lines and vial closures.
Transfer hose, dispensing seals and dairy-grade gaskets that hold up to daily CIP, steam and caustic wash without taste or colour transfer.
Battery thermal interfaces, connector seals and under-hood hose assemblies rated for continuous heat and long coolant exposure.
Optical-grade sleeves and weather seals for outdoor fixtures, plus keypad and gasket parts that keep IP ratings after thermal cycling.
Vacuum cups, roller sleeves and bellows that survive millions of cycles on packaging, pick-and-place and converting equipment.
Soft-touch grips, wearable bands and kitchenware seals with Pantone colour matching and skin-contact grades.
Medical projects fail on paperwork as often as on tolerance. We compound platinum-cured VMQ in-house, post-cure it to drive out volatiles, and keep the batch traceable from raw silicone to the bag you receive.
A food-grade hose is judged on two things the datasheet rarely shows: whether it changes the taste of the product, and whether it still seals after a year of caustic CIP. Both come down to cure system and post-cure, not to the word “FDA”.
EV programmes moved the hard problems from the engine bay to the battery pack: thermal interfaces that must not pump out, connector seals that survive temperature shock, and flame requirements that did not exist five years ago.
Filled and unfilled compounds are certified per part number, not per sector. This is the starting point we confirm with you before sampling.
| Application | FDA 21 CFR 177.2600 | LFGB §30 / §31 | USP Class VI | ISO 10993 | REACH / RoHS | Validation we run |
|---|---|---|---|---|---|---|
| Medical & Pharmaceutical | ● | — | ● | ● | ● | Cytotoxicity, extractables, USP VI |
| Food & Beverage | ● | ● | ○ | — | ● | Overall migration, sensory, steam cycling |
| Automotive & EV | — | — | — | — | ● | Coolant immersion, compression set, VDA 278 |
| Lighting & Electronics | — | — | — | — | ● | UV 1 000 h, IP68, thermal cycling |
| Industrial & Automation | — | — | — | — | ● | Tear, abrasion, 1 M cycle flex |
| Consumer & Lifestyle | ● | ● | ○ | ○ | ● | Phthalate screen, colour fastness |
Years compounding in-house
Since 2003, Dongguan
Industries supplied
Audited by OEM customers
mm extrusion tolerance
Held on 38 extrusion lines
Sample turnaround
From existing tooling
Media, temperature, cycle count, cleaning method and the certificate your customer audits. A sketched drawing is enough to quote.
Reply within 24 h
Two or three compounds with hardness and cure options, plus the migration data that goes with them — not a catalogue page.
Samples in 72 h
Run your own validation on the samples. Once approved we cut tooling, hold the process on the approved compound and keep the batch traceable.
Tooling 7–15 days
Send media, temperature, cycle count and annual volume. Our engineers reply with two or three compound options, pricing, tooling cost and lead time — no obligation.
sales16@yutiansilicone.com
+86 136 6281 5387
MOQ from 500 pcs · free samples from existing tooling