Service
Product design
- Contract development of ready-to-use – medical devices
- Development of components and sub-assemblies
- Sterile products for single use / multiple use
- Short-term implementation
Manufacturing
- Classroom class ISO 7
- Injection moulding in classroom class ISO 7, 25-100 t
- Insert moulding / Plastic-metal-assemblies < 1g weight per cavity
- Processing of medical tubing: Tip forming / Printing / Punching / Boarding
- Ultra-Sonic-Welding / Thermoforming
- In-process quality control
- Blister packaging up to 250 μm foil thickness
- Set packaging
Sterilization
- Moist heat (in house) DIN EN ISO 17665-1
- Ethylene Oxide DIN EN ISO 11135-1
- Radiation (Co-60) DIN EN ISO 11137-1
Registration
CE-Certification
- Validation: Packaging / Cleaning / Sterilization (Moist heat, EO, Radiation) / Transport / Durability (accelerated / real-time aging and control of sterile barriers)
- Planning and implementation of validations
- Validation plans
- Validation reports