Learn more about contract manufacturer Aurena Labs and what's possible for your product. Work with a trusted partner in the medical device industry to take your product to the next level of innovation.

1. What’s Possible with Aurena

2. From
product
development
to
packaging
and
cer3fica3on,
your
product
deserves
the
a9en3on
of
a
leader
in
medical
device
and
bag-­‐on-­‐valve
(BOV)
packaging.

3. Partner with Aurena for innovative and
creative solutions to your contract
development and manufacturing needs
We collaborate with you to make
the following possible…..

4. Range of Approved Medical Device Products
Private Label
• Aurena will act as the legal
manufacturer and OEM.
• The product will say
“Manufactured by Aurena”, but
will have the client’s brand name
and graphic design.
Own Brand
• The client places the product on
the market and has the full
product responsibility. The CE-
product registration will coincide
with Aurena’s.
• The product will say
“Manufactured by <the OBL
company>
Visit aurenalabs.com for more information
Market an Aurena OEM product under your brand name, with
one of these two options:

5. Product Development
• Pre-formulation development and formulation development
for liquids, gels or creams for bag-on-valve packaging
• Unique expertise in saline based formulations, sprayable
emollients, and wound and skin formulations using advanced
silicone technologies

6. Small Scale Production
• Flexible solutions to test
your product’s stability
and see it in bag-on-valve
packaging:
– Make products based on as
little as 1 liter of your
product bulk.
– Perform small scale fillings
if you only need a few
hundred or a few thousand
products.

7. CE-Marking and Regulatory Support
• All medical devices sold in Europe must bear the CE mark to
be legally sold. Aurena works with clients to support the
regulatory process, including:
– Device classification
– Evaluation and substantiation of product claims
– Preparation of the technical documentation and file
– Audit and notification process

8. Logistics
• Getting your product in
markets around the world in a
timely, safe and cost manner is
critical to the success of your
brand
• Work with Aurena for a logistic
solution that follows all
necessary aerosol regulations

9. Licensing and Partnering
• Work with Aurena to develop innovative medical device
products through in-licensing of intellectual property and
products
• Aurena may also be interested to license your IP for
commercialisation on other markets

10. Packaging Development and Graphic Design
• Catch the attention of your
consumer with high-quality
graphics designed by Aurena
on your BOV packaging:
– Enhance the aluminum
container with full body
design or sleeves
– Eliminate secondary
packaging
– Innovative self adhesive
booklet labels

11. Sterilisation
• Validate and perform the sterilisation of your products with a
trusted partner that uses an effective sterilisation process:
– Since gamma rays are able to penetrate aluminium, the most
convenient sterilization method for BOV products is gamma
irradiation.
– Gamma irradiation is normally used for products that shall be
classified as sterile.
– The most common irradiation dose is a minimum of 25kGy, even if
lower doses are also used. Minimum and maximum irradiation doses
shall be validated for each product.

12. Let’s work together.
For more information, visit aurenalabs.com