What does it contact?
Nothing, intact skin, fluids, or tissue.
Silicone manufacturing guide
Choosing silicone for medical device components.
Medical-grade is a phrase that gets used loosely. For device makers, what matters is the right grade for the contact, a documentation trail you can rely on, and a supplier who won't change anything without telling you.
The first questions
Contact type and duration drive the grade choice.
The first thing to establish is how the part contacts the body — or doesn't. A seal inside a device that never touches a patient has very different needs from a pad worn on skin for hours, or a component in a fluid path.
Silicone suppliers offer grades with different levels of testing and documentation behind them. Choosing between them is part of your device's risk assessment. We can share options and supplier data, but the decision sits with the device maker.
Once the grade is chosen, our job is to use it consistently, record every batch and never substitute. See our medical-grade manufacturing page.
Before you choose
Four questions that narrow the options.
For how long?
Minutes, hours, days or longer.
How is it sterilised?
Some methods suit some grades better than others.
What documentation do you need?
Supplier data, batch certificates and change notifications.
Material form
Both families have medical grades.
LSR
Consistent, clean release and suited to high-volume small parts. The usual choice for seals, valves and micro parts.
HCR
Suits compression moulding at lower volumes and larger parts. See medical compression.
Switching later
Moving from HCR to LSR is possible but is a material change that needs formal review.
Over the programme
How grade control works in practice.
The grade decision is made once. Keeping it is a daily discipline.
Record the grade
Supplier, grade, data sheets.
Record every batch
Material batch against production batch.
Notify changes
Supplier changes flagged to you immediately.
Formal change approval
No change without your written sign-off.
Keep reading
More guides from the workshop.
Scaling a silicone part to volume
Your part is selling. Demand is climbing. The tool and process that worked for early batches start to strain. Here's how to scale…
Read the guideWhen to switch from HCR to LSR
Many silicone parts start life in HCR, compression or injection moulded. As volumes grow, LSR starts to look attractive. Here's…
Read the guideCompression, injection or LSR — which route fits your part?
Three routes, one part, one honest answer. This is the conversation we have with almost every OEM customer on the first call.…
Read the guideDesigned and developed in the UK. UK moulding capability, with some higher-volume production placed with trusted partners where that's the right commercial answer.
Get in touch
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.
Real people, a real workshop
You deal with the people who make it.
No call centre and no middlemen. When you contact TCI Products, you speak to the team who design, build and check your mould.
- A real Warwickshire workshopUnit 15, Waterloo Park, Bidford-on-Avon, Alcester B50 4JG.
- Real people on the phoneCall the team on 01789 224228, Monday to Friday.
- The same team on every jobDesign, production and aftercare come from the people you see here.
- Part of TCI GroupFive specialist brands, one engineering team. Visit TCI Group.
Thomas LaneManaging Director
George PrestonDesign & Project Manager
Kelly BallingerHead of Partnerships
Jim AndertonProduction Manager
TheodoreEmployee Welfare