Cleanroom Injection Moulding

The required clean room classification is determined by your product’s intended use, risk profile, and regulatory requirements. High-risk, implantable, or critical-path medical components typically require an ISO Class 7 environment, while lower-risk or non-patient-contact components may be suitable for ISO Class 8.

To define the correct classification, we assess your product’s clean room injection moulding requirements, including material selection, exposure risk, downstream sterilisation, and applicable regulatory standards. This ensures the clean room environment is appropriate without introducing unnecessary complexity or cost.

An effective Injection moulding clean room design is built around contamination control and process stability. Key design features include:

• HEPA filtration systems to control airborne particulates
• Positive air pressure to prevent contaminants entering the clean room
• Controlled zoning and material flow to separate clean and non-clean areas
• Non-contaminating machinery and materials designed for medical manufacturing

These elements work together to maintain consistent environmental conditions and support reliable Injection Moulding in Clean Room operations.

Yes. We manage the full validation lifecycle for clean room moulded components. This includes comprehensive documentation of:

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

These validation activities ensure that processes are controlled, repeatable, and compliant with relevant clean room injection moulding standards, providing full traceability to support regulatory submissions and audits.

Yes. While both processes require controlled clean room environments, clean room LSR Injection Moulding involves additional technical considerations. Liquid Silicone Rubber requires specialised metering and mixing equipment, along with precise control of temperature, pressure, and curing conditions.

Because LSR components are often used as seals, membranes, or flexible medical parts, even minor contamination can compromise performance. Maintaining a clean environment is therefore critical to preserving material integrity and ensuring consistent part quality.

Yes. Achieving tight tolerances is often a key driver for clean room precision injection moulding. The controlled environment significantly reduces particulate contamination and process variability, both of which can impact dimensional accuracy.

Our clean room facilities are equipped with advanced tooling, process controls, and monitoring systems that enable the production of highly precise medical components, including parts requiring micron-level tolerances.