GET TO KNOW OUR SERVICES
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LASER MARKING
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
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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.
CLEANING
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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.
PACKAGING
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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.
LABELING
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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.
VERIFICATION
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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.