STATICE is able to supply all adapted tools required for a specific production together with a rigorous logistics team.
Two manufacturing plants offer all necessary services to adapt the production to our customers needs: France and Mauritius.
Production management with ERP Enterprise Resource Planning ensure traceability of all production lots:
- Labelling of finished products (GTIN 14) or other codes
- Lot approval with a DHR Device History Record
- Management of any changes or modifications (Change Control).
All manufacturing processes are controlled in a 1,000 m² facility classed ISO 5 and ISO 7; production quantities vary between 100 to 500,000 units per year depending on the item and the project.
Our industrialisation and methods team of 4 can setup and prepare the required tools to produce your devices under the applicable Standards for the industry with a DMR Device Master Record:
- Design, manufacture, and production of series of tools
- Optimisation of the production flow (setting-up workplaces and storage)
- Producing instructions for manufacturing, controls and checks, cleaning, conditioning, maintenance, etc...
- Training courses for personnel
- Validation of special processes for specific requirements such as moulding, gluing, or assembling, under the VMP Validation Master Plan and IQ/OQ/PQ Installation Qualification, Operational Qualification, Performance Qualification logistics
- Validation for cleaning and conditioning
- Follow-up until the sterilisation validation