PACKAGING
MedicalGroup performs cleaning and final packaging for all types of medical devices
Cleaning is fully automated, on a line equipped with baths allowing great technical flexibility. Products can be cleaned with detergents (removal of machining residues), passivated (nitric acid treatment), rinsed with demineralized water and alcohol, then dried in an oven. Pre-recorded and validated programs guarantee the reliability and repeatability of these operations essential for the cleanliness and quality of implants.
Medical device packaging
Packaging is carried out in an ISO 7 clean room equipped with ISO 5 laminar flow. Environmental control and monitoring guarantee a minimum bioburden level before the final sterilization step performed by a specialized service provider.
The various available sealers allow product packaging in single, double or triple packaging according to our clients’ constraints and requirements. The possibilities are extensive and allow combining different types of packaging to adapt to geometries, weights and any other particularities of implants.
The choice of packaging is made in collaboration with our customers after production of prototypes, in particular:
- vacuum sealed PA/PE pouches
- TYVEK® pouches
- PETG blister packs with TYVEK® opercululm
This range of solutions makes it possible to package all types of medical devices from the smallest parts (a few mm) to the largest (several tens of cm).
It is also possible to add more specific packaging such as tubes with screw caps, particularly for the dental sector, or any other accessory essential for the intended use.
All these steps are carried out with complete control of the traceability of operations and component batches, guaranteeing sealing in compliance with the requirements of applicable standards with regular controls performed by the MedicalGroup laboratory.
Once products are packaged in the clean room, MedicalGroup performs labeling and boxing according to client specifications.
A label layout mockup is developed to allow the client to verify that all transmitted requirements have been properly taken into account and comply with current regulations.
Very strict controls at different production stages (printing, labeling and shipping), and a secure flow throughout the process guarantee the accuracy of variable information in accordance with the client’s order.