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TeroLab Surface SAS possesses its own equipment for its tests and its Research and Development

Master Files

TeroLab Surface SAS will have Master Files filed with the American Food and Drug Administration (FDA) to validate the special processes of implant coatings.

Implant manufacturers may complete their technical dossiers with our Master Files.

This will make things easier and faster, simply by giving the reference to the TeroLab Surface SAS Master File registered with the FDA.

Robotised equipment ensures perfect reproducibility of coatings.

Continuous monitoring of the different manufacturing phases ensures high product quality and eliminates the risk of bacterial contamination.

1- Acceptance and verification of implants

2- Masking implants

Protection of zones not to be coated

3- Corundum blasting of implants

Corundum blasting roughens the surface to be coated so as to ensure adhesion of the coating on validated installations

4- Plasma spraying on validated installations

TeroLab Surface SAS has 4 air plasma sprays (APS) and one vacuum plasma spray (VPS). The latter prevents all risk of oxidation when titanium is sprayed.

5- Finishing, deburring in ISO7 rooms

Since June 2010, all finishing work has been performed in ISO7 compliant clean rooms. HA and TI coatings will be deburred in different rooms.

6- 100% quality control of implants

 

7- TEROCLEAN® (optional), cold plasma decontamination in an ISO7 room

TeroLab Surface SAS owns the TEROCLEAN® process for low temperature plasma treatment enabling implants to be decontaminated without the use of liquids (solvents, acids or detergents).

Advantages:

  • no modification or alteration of the surface
  • no organic or inorganic residues on the implant after treatment
  • reduction of bioburden and of endotoxin levels present on the surface of the coated implant

 

8- Packaging of implants (on request) in an ISO7 clean room with or without vacuum

 

9- Delivery

  • deadline adjusted to the client’s needs
  • 24/48-hour processing is possible for urgent deliveries (on request)

Research and Development

Terolab Surface SAS possesses its own equipment for its tests and its Research and Development

Vacuum plasma spray torch

4- Vacuum plasma spray torch

Finitions
Finitions

5 – Finishing

quality control
quality control

6 – Implant quality control in a clean room

TEROCLEAN

7 – TEROCLEAN®

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