Our
Our technical teams specialise in high-end technical injection moulding; and in the research, development, manufacturing and commercialisation of innovative technologies and solutions for human and animal health.
Our
Capabilities
Our technical teams specialise in high-end technical injection moulding; and in the research, development, manufacturing and commercialisation of innovative technologies and solutions for human and animal health.
Product Development
- ISO 13485 compliant design
- Prototyping (3D printing, casting, moulding)
- Lab-scale silicone, thermoplastic injection, and compression moulding
- Small-medium volume manufacture for clinical trials
- Process development (GMP/ISO 13485 compliance)
- Analytical development (GMP/ISO 13485 compliance)
Product Manufacture
- Thermoplastic and silicone moulding
- Extrusion systems (gravimetric feed for precision polymer/drug/excipient ratio control)
- Co-extrusion
- Compression moulding
- Moulding and extrusion tool management
- Pilot-scale encapsulation
- Formulation/composite mixing and processing
- Medical device assembly (ISO 13485 compliance)
- Packaging
- Labelling
- Large, GMP warehouse
Analytics
- R&D (flexible) and GLP (controlled) Quality teams, (raw material, in-process, and release testing)
- Image-based, automated measurement (Micro-Vu)
- HPLC, UPLC, UV-Vis, FTIR, (chromatography/spectral analysis)
- DSC (thermal analysis)
- Polarised microscopy (materials and crystallisation analysis)
- Dissolution with autosampling (drug release)
- Sonication or soxhlet (content analysis)
- Mechanical testing
- Stability chambers (intermediate and accelerated protocols)
Quality
- GMP (pharmaceutical)
- FDA audited
- ISO 13485 compliance (medical device manufacture)
- ISO 9001 compliant (low cost plastic moulded components)
- Quality by Design (QbD)
- Quality Control team (~25 staff)
- Quality Assurance team (~15 staff)
- Installation Qualification (IQ, OQ, PQ)
- Process validation (process studies, gauge R&R, method validation)
- Tool inspections and refurbishment
- Root cause analysis (RCA, FMEA)