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Project record · Medical device · LSR

A medical device OEM's LSR gasket in volume.

A sealing gasket for a housing on a device that gets held all day. Compression-moulded worked, but every part needed a hand-trim on the sealing face. At volume, that stopped scaling.

Medical deviceSector
LSRRoute chosen
Cold runnerTool type
2019Established

The brief

A seal that had to be perfect on the sealing face, batch after batch.

Silicone gaskets showing sealing lip edge quality on inspection bench
Sealing lip quality on silicone gaskets

A medical device OEM produces a hand-held diagnostic device. It has a sealed enclosure with a silicone gasket around the perimeter — the gasket keeps dust and moisture out during clinical use and cleaning.

The gasket had been running on compression tooling for two years. It worked, but every part needed hand-trimming on the sealing lip because the parting line landed just at the edge of the sealing face. A skilled operator could produce good parts, but the process wasn't scaling — annual volumes had doubled, and hand-trim was becoming the bottleneck.

Cosmetic acceptance was tightening too. The device had been through a design revision that made the gasket more visible in use. What had been acceptable in year one wasn't acceptable in year three.

The problem

The parting line was in the wrong place, and hand-trim was reaching capacity.

The compression tool had been designed with the parting line at the widest point of the gasket cross-section — the easiest place to machine. Unfortunately, that was also the sealing face. Every part came off the tool with a fine witness line on the seal, and hand-trim brought back the problem the trim was supposed to solve.

Compound the design issue with rising volume, and hand-trim capacity was the constraint on the entire programme. Adding operators was expensive and slow to train. The right answer wasn't more people — it was a tool that didn't need trim.

We proposed migrating to LSR with a cold-runner tool. The parting line would be relocated onto the hidden underside of the gasket; cold-runner design would eliminate the sprue witness; the cavity finish would be specified to leave the sealing face untouched.

Opened LSR tool holding pale silicone gaskets with clean hidden parting line

What we changed

We moved the parting line, went to LSR, and eliminated hand-trim.

The design change was one geometry decision. The manufacturing route change did the rest.

  1. Relocated the parting line

    The parting line now runs across the underside of the gasket, where it seats into the enclosure housing. Any witness is hidden by the assembly.

  2. Migrated the material to LSR

    Same silicone family, LSR grade documented for medical device applications. Material batch traceability built into the run record.

  3. Cut a cold-runner tool

    Cold-runner design meant essentially no sprue on the finished part. What little witness remained landed on the underside.

  4. Locked cavity finish for the sealing face

    The cavity was polished specifically on the sealing face to leave a defined finish. First-off inspection focused on the sealing lip, not on the whole part.

  5. Ran validation batches

    Three validation batches produced, dimensional and cosmetic inspection at full spec. Sign-off achieved without any hand-trim on any part.

  6. Transitioned supply

    Old supply on compression continued for two batches while the LSR tool proved itself. Then the customer switched entirely.

Cold runner LSR tool and finished pale gaskets with underside parting line
LSR gasket moulding with hidden parting line

The commercial shape

The tool cost more. The unit cost dropped. The bottleneck went away.

LSR tooling investment was several times the compression tool cost. Per-part cost dropped once the trim operation was eliminated. The bottleneck — hand-trim capacity — went away entirely, freeing capacity for other programmes.

The medical documentation shifted: LSR batch traceability was simpler to record than the compression-plus-trim process, because the operator step disappeared. The device history file benefits went beyond just the trim savings.

For this customer, LSR was the right answer once annual volumes had grown past their earlier threshold. Two years earlier, compression had been correct. Neither decision was wrong for its time.

“The compression tool was right for year one. The LSR tool was right for year three. Nobody made a mistake — the volumes moved.”
— Quality manager, medical device OEM

Services used

How this programme was actually delivered.

LSR injection moulding

Two-part liquid silicone metered, mixed, injected cold and cured hot. The cleanest route we have for medical, wearable and electronics parts at…

See the service

Medical-grade manufacturing

Silicone moulding for medical device makers using medical-grade materials to a documented specification, with batch traceability from drum to…

See the service

Gasket and seal manufacture

Silicone and rubber gaskets moulded to your drawing, in the grade and hardness your sealing job actually needs. Enclosure gaskets, static fluid…

See the service

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Next step

If your project rhymes with this one, get in touch.

The commercial shapes described in our project records are examples of what's worked, not prices we're quoting today. Every programme sizes differently based on part geometry, annual volume, material family and paperwork requirements.

For a first conversation about whether we'd be the right supplier for your part, send a drawing or a sample with your rough annual volume. That's enough to know if the fit is real.

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At a glance

The idea in a picture.

Which route suits your quantity

PrototypesHundredsThousandsTens of thousandsPrototype toolingCompression mouldingTransfer mouldingSolid silicone injectionLSR injection

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A general picture. Shape, material and detail also decide the route, and we talk it through with you.

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Tell us the part, the volume, and the timeline.

Rough annual volume, target unit price, and any deadlines. That's enough to work out whether compression, LSR injection or something else is the right tool.

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A stack of TCI silicone moulds.
A stack of TCI silicone moulds.
The TCI design and project office.
The TCI design and project office.
The TCI workshop, with moulds on the bench mid-build.
The TCI workshop, with moulds on the bench mid-build.
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