OVERVIEW - add'n solutions

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Laser marking is the core competency of add’n solutions. With modern and highly professional equipment we can mark your products precisely utilizing validated processes. We are equipped with fully-automated FOBA fiber lasers. Your products are marked according to your specifications. At the same time, we can verify and validate the marking performed. If desired, we can confirm this to you by means of a protocol. We can bring on standard marking but also every type of barcode (i.e. data matrix code acc. to GS1 or HIBC standard). Especially for the implementation of the UDI-requirements for reusable medical products we have established a process which guarantees marking in accordance with all requirements of the FDA as well as the European Directive.

Passivation acc. to ASTM 380 and A967 takes place in our fully automated and validated cleaning and passivation machine. Passivation using citric acid is an indispensable component of our process, especially for laser marked stainless steel products. Combining the add’n laser marking with subsequent passivation will guarantee optimal corrosion protection. By means of passivation the free iron surface particles are removed; a chromic-oxide layer develops even thicker than the natural passive layer. As such corrosion resistance and lifetime of the instruments are increased. After the laser marking, the passivation in combination with a thorough cleaning of the products offers an optimal value-added package for your products.

The final cleaning in accordance with ASTM A380 takes place in our fully automated and validated cleaning and passivation machine. In various cleaning and flushing chambers – with and without ultrasound – both larger dirt residues, like polishing and abrasive agent residues, as well as fine debris or grease and oil residues are fully removed. Furthermore, sulfur as well as excess carbon particles are removed from the surface. After the cleaning, passivation and flushing processes the instruments are dried in an air blower. This validated approach promises optimal cleaning results of your instruments. After the cleaning process, we treat all movable parts of the instruments with the appropriate lubricant.

Given the vast variety of instruments it is not always easy to find the right packaging. We can support you both in finding the right packaging for your instruments as well as properly packaging them for you. You can choose from almost all unsterile packaging materials such as PE-bags, plastic cases, boxes, packaging tubes or individual packaging materials. We can either purchase the packaging on your behalf or use the packaging materials provided by you. We will treat and protect your products with the highest care and precision.

Labelling is not only the attaching of a label to the packaging of a medical device, but a critical process for the commercialization of surgical instruments. Apart from the physical attachment of the label according to your specifications we offer a thorough documentation both with regards to the validation of our machines and processes and also the verification of the label attached by us. We not only offer traditional labelling but also direct label printing onto a PE bag which can be specifically useful for larger quantities. Here, we can import your specifications according to your requirements from various file formats or develop the label together with you.
The verification according to ISO15415 and AIM/DPM verifies, that the marked barcodes are conform with the current barcode standards. Therefore we use the latest scanning technology that allows us to read and verify 2D Data Matrix Codes. Our system guarantees standardizes and stable parameters to verify. The inspection report of the verification can be sent to you upon request.
© 2018 Copyright add'n solutions GmbH & Co. KG

add'n solutions GmbH & Co. KG
Föhrenstrasse 7
78532 Tuttlingen


Phone: 07461 171541-0
Fax: 07461-171541-1

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