Plastic Injection Moulding for Medical & Regulated Manufacturing
Medical and regulated manufacturing environments demand structured validation, traceability and controlled production processes. Tooling strategy, material selection and inspection discipline must align with documented quality systems and compliance frameworks.
Regulated Manufacturing Challenges
SGH supports organisations operating in regulated supply chains through integrated tool engineering, ISO-aligned quality governance and controlled assembly capability within a UK manufacturing platform.
- Documented validation and PPAP requirements
- Batch traceability and inspection control
- Material compliance and specification integrity
- Tool modification control and revalidation
- Controlled assembly and packaging environments
Consistency and documentation are as critical as dimensional accuracy.
Validation & Quality Governance
SGH operates under ISO 9001 and ISO 14001 frameworks, with ISO 13485 alignment supporting regulated sector expectations.
Our validation processes include:
- Structured tool trials
- Dimensional verification
- Cosmetic and functional review
- Controlled documentation and approval workflows
Where required, we support formal PPAP submissions and documented process capability reporting.
ISO Class 8 Cleanroom Assembly
While injection moulding is conducted in controlled production environments, SGH provides ISO Class 8 cleanroom capability for secondary assembly and packaging operations where required.
This supports:
- Controlled assembly processes
- Reduced contamination risk
- Regulated product handling
Tooling Control & Lifecycle Discipline
Regulated environments require clear tool ownership, modification control and documented servicing.
Our integrated toolroom provides:
- Preventative maintenance scheduling
- Controlled repair and cavity modification
- Post-modification validation
- Transparent tooling records
Established Regulated Sector Supply
SGH has supported Oxylitre for over 22 years, supplying components integral to medical product programmes serving the NHS.
During the COVID-19 pandemic, SGH implemented dedicated supply cells and transitioned to twin-shift operations to meet urgent demand increases, maintaining uninterrupted component supply during a period of exceptional national pressure.
Long-term regulated supply demands operational agility combined with disciplined governance.
Established Medical Device Supply Experience
SGH has supported DePuy, a Johnson & Johnson company, for over a decade, supplying injection mould tools used within orthopaedic device manufacturing programmes.
Medical device supply demands structured tool control, dimensional precision and disciplined lifecycle servicing. Our integrated toolroom and regulated production governance framework supports long-term tooling performance within compliance-driven environments.
This experience reinforces our ability to operate within high-accountability supply chains requiring documented control and repeatable performance.
UK Manufacturing Stability for Regulated Supply Chains
For regulated and healthcare-related supply chains, UK-based production provides:
- Audit accessibility
- Structured compliance oversight
- Controlled material sourcing
- Reduced geopolitical exposure
SGH’s Greater Manchester manufacturing footprint supports transparent collaboration and controlled supply continuity.