With a massive investment of over one million euros, in early 2014, Marle established a workflow in clean rooms, which covers both the coating and packaging of orthopedic implants: the guarantee of maximum safety.
This is how Marle complements its production "turnkey," and demonstrates its capacity to anticipate regulatory changes in food contamination and food safety.
Coating and packaging: the cleanroom advantage
Marle teams have chosen to provide maximum safety for coating operations, and have developed a process carried out in clean room setting to minimize the risk of bacterial contamination:
- Masking takes place in clean room on cleaned products whose level of contamination is perfectly controlled.
- Clean products are then brought on an automatic sandblasting machine which gives the necessary roughness to the substrate for the coating application
- Waiting phases of products after coating in non-controlled environments are completely removed. The masks are removed and mask residues are cleaned with alcohol directly in the clean room by qualified personnel.
To complete the cycle, the products can then be packaged in a second clean room. They enter the clean room packaging by a washer-disinfector, followed by an assembly station (trays, equipment grip, etc...). Only the products have access between two clean rooms, excluding all human movement.
A controlled and validated process
Clean room packaging is classified ISO 7 in activity, and ISO 6 at rest. Clean room masking/unmasking is classified ISO 8 in activity, and ISO 7 at rest.
Our teams perform, directly and monthly, particle sampling and counts (air sampling and surface agar sampling). Analyses of samples assigned to a laboratory (placing in oven, germ count, etc.).
This equipment provides a flow of clean production; the level of contamination is perfectly controlled. This clean flow is assured even in case of a subcontracted coating: products are vacuum sealed in a clean room, right out of the cleaning phase. The production flow is completely linear and ensures zero crossing, therefore, no contact with other products. The overall plant layout has been redesigned to achieve this result.
This type of equipment provides Marle with rapidly deployable options for domestic production to compensate for the unexpected and ensure unchanged deadlines and full compliance with the level of contamination.
The coating process has been fully validated; this allows significant time savings in the quality validation of specific production programs.