Clinical Polymer Technologies, known as CPT, is our sister company in the Clinipol Group. It was established in 1989 and is based in Coalville, Leicestershire, where it moulds precision silicone components for medical devices, diagnostics and life-science equipment under an ISO 13485:2016 certified quality management system.
This page is a short summary of what CPT can take on, how that work is controlled, and the sort of projects that come through the door. For anything more specific, the CPT team can talk it through with you directly.
Materials
- Liquid silicone rubber (LSR) for injection moulding, metered and mixed before it reaches a heated tool
- High-consistency rubber (HCR) for compression and transfer moulding
- Fluorosilicone where fuel, oil or hydrocarbon resistance matters
- Other specialist elastomers where a specific hardness, colour or mechanical property is the starting point
- Custom compounds where a standard grade will not meet the specification
The choice between LSR and HCR usually follows the part rather than a preference. LSR flows readily into fine features and suits automated multi-cavity production. HCR remains the practical option for larger sections, lower volumes and geometries that do not suit a cold-runner tool.
Processes
- LSR injection moulding
- Compression moulding
- Transfer moulding, useful where material has to flow around an insert without the movement of an injection cycle
- Room-temperature vulcanising (RTV) casting for prototypes, potting and low volumes
- UV-cure processing
- Insert moulding and overmoulding onto metal and polymer inserts
- Adhesive bonding where a bond line is specified
- Assembly and printed identification
- Packaging to agreed customer requirements, including controlled quantities, double bagging and batch labelling
- Coordination of sub-contract sterilisation through approved external providers
Cleanroom manufacture
CPT runs two in-house ISO 8 Class K cleanrooms, so moulding, handling, assembly and packaging stay inside a defined environment rather than depending on cleaning a component afterwards. Silicone takes a static charge and picks up dust and fibres readily, which shows up quickly on clear and light-coloured parts.
Environmental control is only part of it. Material movement, operator handling, tool condition, maintenance and inspection all have to support it, and cosmetic limits need agreeing in measurable terms before production starts. A written visual standard covering permitted flash, gate witness and particulate gives an inspector something to work to, where a drawing note saying "free from marks" gives them nothing.
ISO 13485:2016 in practice
ISO 13485 is the quality management standard for organisations involved in medical devices. It does not certify an individual component, and it does not transfer a device manufacturer's regulatory responsibilities. What it provides is a controlled system behind every job.
In day-to-day terms that means:
- Customer requirements are reviewed and translated into controlled manufacturing information before production begins
- Materials and purchased services come from approved sources, with batch identity held from goods-in through to despatch
- Equipment, processes and inspection methods are qualified and maintained
- Process, material and tooling changes go through assessment and authorisation, because a change that looks minor can alter evidence a customer relies on
- Records show what was made, from which material batch, on which approved process, and what was checked before release
- Non-conformances and complaints are investigated, with corrective action recorded and closed out
The benefit to a customer is a chain of evidence. A question about a delivered batch can be traced back to the production and material records behind it.
Projects that come through
- Silicone seals, grommets and diaphragms for diagnostic and monitoring equipment
- Tubing, connectors and fluid-path components
- Overmoulded inserts and encapsulated sensor assemblies
- Keypads, buttons and user-interface parts with printed markings
- Custom moulded housings, covers and protective caps
- Prototype and pre-production batches alongside routine production runs
- Components destined for sterilisation, where the method is settled early enough to influence material choice
Sterilisation is worth settling early. Heat, radiation and chemical sterilants affect silicone grades and printed marks differently, so the decision belongs at material-selection stage rather than after tooling. A cleanroom also does not make a part sterile; clean and sterile are separate claims, and the device manufacturer defines and validates the sterilisation requirement for the finished device.
Where Mowtec fits
Mowtec, the other company in the group, moulds precision rubber for aerospace, defence, industrial, scientific, automotive and electronics work under AS9100D. Medical silicone enquiries go to CPT because the quality system, environment and records behind that work are specific to it. The two businesses share polymer engineering, tooling and failure-analysis knowledge while keeping certification scope and project records separate.
Starting an enquiry
Useful starting information is a drawing or 3D model, intended use, type and duration of contact, sterilisation method if there is one, target hardness and properties, expected volumes, and any existing validation or regulatory requirements. With that, CPT can propose a material and process route and confirm what evidence will be provided with the parts.
