Aurena Laboratories AB is a pioneer in sterile packed aerosol medical devices based on Bag-on-Valve technology. They offer contract manufacturing of medical devices like saline nasal sprays, eye washes, and adhesive removers. Their facility in Karlstad, Sweden meets quality standards like GMP, ISO 13485, and MDD to ensure regulatory compliance of their CE marked products.

1. Medical Contract
Devices manufacturing
AURENA Laboratories AB is a pioneer in the field of As additional services we can also provide:
sterile packed aerosol products, based on the Bag-on- • Development or modifications of your product
Valve technology. Since the year 2000, we have speciali- formulations
zed in the development of a new generation of spray • Test productions
products. AURENA offers a unique combination of • Stability tests / validation
production and filling in clean rooms and aerosols using • Regulatory support
the Bag on Valve barrier system. The company has also
developed and registered several successful medical Quality
device products based on this combination. AURENA is dedicated to provide quality services that
meet the requirements and expectations of regula-
Our operations are carried out in our facility in Karlstad, tions and customers.
Sweden. The aerosol production line uses state-of-art The products for private labeling AURENA offers are
fillers/crimpers and typically the filled products are approved and CE-marked in accordance with the EU’s
alu-cans using Bag-on-Valve. AURENA has a production medical technology Directive, MDD, a statutory mark
laboratory which is used for various raw material and for medical devices in Europe. AURENA Laboratories is
product analyses. registered by the FDA as a Drug Establishment and has
The production at AURENA also meets ESD and a FDA Labeler Code number.
EX-standards. This means that we also offer filling of
flammable products in Bag-on-Valves.
Contract Manufacturing
AURENA Laboratories offers services as a contract
manufacturer or contract filler. The contract manufac-
turing services are focused on medical device products
using Bag-on-Valves. Typical examples of such products
are Saline products for wound irrigation, eye washes,
nasal sprays. Skin care products, Aerosol disinfectants
for contamination control, Burn gels and antiseptic
sprays are other examples of medical devices that can
be produced by AURENA.
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

2. Medical Product list
Devices
Ce marked medical devices available from Aurena, October 2012
Product Market Status
Saline Solution Nasal Sprays OTC Medical Device II a
Natural Seawater Nasal Sprays OTC Medical Device II a
Saline /Seawater Nasal Spray w Aloe, OTC Medical Device II a
Chamomille
Saline + Xylitol Nasal Spray OTC Available Q1, 2013, MD II a
Wound Cleansing/Irrigation Spray Healthcare Institutions, Community Medical Device II b
Care, OTC
Eye Wash Spray OTC, Occupational Safety, First Aid Medical Device II a
Wound & Eye Wash Spray OTC, Occupational Safety, First Aid Medical Device II a
Medical Adhesive Remover Spray, non-sterile Healthcare institutions, Stoma care Medical Device II a
Medical Adhesive Remover Spray, sterile Healthcare institutions, Stoma care Medical Device II a
Emollient Spray Skin care Medical Device II a
Throat Spray OTC Medical Device II a
Wax Prevention Ear Spray OTC Medical Device II a
Saline Nebuliser Solution, 3 % Respiratory care Available Q1, 2013, MD II a
70% Isopropanol Sterile Alcohol Spray Pharma Industry, Healthcare Biocidal Product
institutions
70% Ethanol Sterile Alcohol Spray Pharma Industry, Healthcare Biocidal Product
institutions
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

3. Medical Bag on Valve
Devices The Technology
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

4. Medical Ear Spray
Devices
This new medical device safely cleans and removes Brand owner
ear wax buildup. The device helps maintain healthy Products are available in:
clean ears, using a naturally-sourced solution. • Aurena brand name.
• OEM version, Brand-holders brand, Aurena as legal
Wax in the ear canal is produced in the outer part of manufacturer and brand-holder are stated as distributor
the ear. Wax tends to build up and eventually work its • OBL version brand-holders brand and brand-holder
way into the ear canal. Ear Spray is a safe, simple easy stated as legal manufacturer, (requires certification
way to remove wax. according ISO 13485)
Market
OTC
Composition
• Sterile Isotonic Seawater Solution
• Sterile Isotonic Saline Solution
Shelf life
3 years from production date
Product approvals
CE marked according to MDD (Medical Device Direc-
tive, 93/42/EEC, Class IIa)
Presentations
Both sticker-labels and preprinted cans can be used.
AURENA may assist during artwork providing templa-
tes etc for all can sizes. Labels can be provided with a
tamper seal. Preprinted cans are recommended for
quantities over 25000+ per order.
Standard cans sizes are 50, 100, 125, 200 and 250 ml
Individual carton boxes with or without leaflets are
also available for can sizes up to 125 ml.
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

5. Medical Emollient Spray
Devices
A spray product for apply White Soft Paraffin, Liquid Paraffin Preprinted cans are recommended for quantities over
onto the skin. The spray contains no preservatives or other 25000+ per order.
additives. The paraffin’s are dissolved in a volatile silicone Standard cans sizes are 50, 100, 125, 200 and 250 ml
which quickly evaporates leaving only the pure emollient
onto the skin. Individual carton boxes with or without leaflets are also
• Protects skin from minor irritation and soreness. available for can sizes up to 125 ml.
• Creates a barrier that protects irritated and intact skin
from damage causedby urine and feces. Brand owner
• Barrier effect soothes and protects sensitive skin and Products are available in:
soothes and protectschapped and cracked skin from • Aurena brand name.
further damage. • OEM version, Brand-holders brand, Aurena as legal
• Package makes it easy to apply product to skin without manufacturer and brand-holder are stated as distributor
risks for cross-contamination • OBL version brand-holders brand and brand-holder
stated as legal manufacturer, (requires certification
Market according ISO 13485)
Skin care
Composition
Hexamethyldisiloxan, Petrolatum, Liquid Paraffin
Batch sizes
850 and/or 1700 kg.
Shelf life
3 years from production date
Product approvals
CE marked according to MDD (Medical Device Directive,
93/42/EEC,Class IIa)
Presentations
Both sticker-labels and preprinted cans can be used.
AURENA may assist during artwork providing templates etc
for all can sizes. Labels can be provided with a tamper seal.
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

6. Medical Eye Wash Spray
Devices
The Saline Eye Wash is a hand-held emergency eye wash
used for occupational safety. The Bag-on-Valve portable Presentations
package makes it the perfect choice when a piped eye wash Both sticker-labels and preprinted cans can be used.
station is not possible. Several configurations and product AURENA may assist during artwork providing templa-
sizes are available to meet different requirements. Flushing of tes etc for all can sizes. Labels can be provided with a
eye can be given constantly for more than 15 min with just tamper seal. Preprinted cans are recommended for
one 250 ml can. It’s very important to rinse the eye in the first quantities over 25000+ per order.
seconds after an eye accident. AURENA Eye Wash Sprays Standard cans sizes are 50, 100, 125, 200 and 250 ml
provide immediate flushing of eyes when a plumbed eye
wash is not readily available. The spray gives a gentle and soft Individual carton boxes with or without leaflets are
rinsing directly to the eyes, avoiding unnecessary spills also available for can sizes up to 125 ml.
Other advantages:
Maintain sterility for 3 years. Brand owner
• Can be used in all direction. Products are available in:
• No preservative. • Aurena brand name.
• A tamper seal provides highly visible notification if product • OEM version, Brand-holders brand, Aurena as legal
has been used or not. manufacturer and brand-holder are stated as
• Triple or single can Wall Stations available that holds bottles distributor
firmly in place with easy access to bottles in an emergency. • OBL version brand-holders brand and brand-holder
stated as legal manufacturer, (requires certification
Market according ISO 13485)
OTC, occupational safety
Composition
Sterile Saline Solution 0,9%
• Sterile Saline Solution 0,9% Phosphate buffered solution
• Actuators for different flow rates and impact pressures are
available.
Shelf life:
3 years from production date
Product approvals
CE marked according to MDD (Medical Device
Directive,93/42/EEC, Class IIa).
Accessories
• Wall station (for 3 cans)
• One Can Holder
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

7. Medical Medical Adhesive
Devices Remover Spray
Medical Adhesive Remover spray (sometimes called quantities over 25000+ per order.
SMARs), for pain free removal of adhesive products Standard cans sizes are 50, 100, 125, 200 and 250 ml
such as stoma pouch, external sheath catheter, wound
dressing etc. Individual carton boxes with or without leaflets are also
Medical Adhesive Remover sprays make adhesive available for can sizes up to 125 ml.
removal quick and painless. Just spray around the
edge of the adhesive and wait a few seconds Brand owner
• no-sting silicone medical adhesive remover Products are available in:
• stoma pouch, wound dressings and other medical • Aurena brand name.
adhesives • OEM version, Brand-holders brand, Aurena as legal
• quick and pain free removal of adhesive manufacturer and brand-holder are stated as
products distributor
• dries quickly and can be sprayed at any angle • OBL version brand-holders brand and brand-holder
• Available in sterile and non-sterile versions stated as legal manufacturer, (requires certification
according ISO 13485)
Market
Heath care institutions, stoma care
Composition:
100% siloxanes
Shelf life:
3 years from production date
Product approvals:
• Sterile version CE marked according to MDD (Medical
Device Directive, 93/42/EEC, Class IIa)
• Non sterile version CE marked according to MDD
(Medical Device Directive, 93/42/EEC, Class I)
Presentations
Both sticker-labels and preprinted cans can be used.
AURENA may assist during artwork providing templa-
tes etc for all can sizes. Labels can be provided with a
tamper seal. Preprinted cans are recommended for
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

8. Medical Saline Nasal Spray
Devices
The Saline Nasal Spray helps to restore moisture to dry, Individual carton boxes with or without leaflets are also
irritated nasal passages. It soothes and relieves stuffy noses available for can sizes up to 125 ml.
and sinus pressure. It is safe for everyone, no matter how
long or how often it is used. Brand owner
The Saline Nasal Spray restores moisture to nasal passages Products are available in:
irritated by: • Aurena brand name.
• Colds or allergies. • OEM version, Brand-holders brand, Aurena as legal
• Dry air from cold weather or airplane flights. manufacturer and brand-holder are stated as distributor
• Pollution. • OBL version brand-holders brand and brand-holder
• Overuse of nasal decongestants. stated as legal manufacturer, (requires certification
according ISO 13485)
The spray contains no preservative and works in any direc-
tion.
Market
OTC
Composition
• Sterile Saline Solution (isotonic and hypertonic versions)
• Sterile Sea Salt Solution (isotonic and hypertonic versions)
• Saline nasal spray with Aloe and Chamomille
• Saline Nasal spray with Xylitol available in Q1 2013
Shelf life
3 years from production date
Product approvals
CE marked according to MDD (Medical Device Directive,
93/42/EEC, Class IIa)
Presentations
Both sticker-labels and preprinted cans can be used. AURENA
may assist during artwork providing templates etc for all can
sizes. Labels can be provided with a tamper seal. Preprinted
cans are recommended for quantities over 25000+ per order.
Standard cans sizes are 50, 100, 125, 200 and 250 ml
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

9. Medical Natural Sea Water
Devices Nasal Spray
The Seawater Nasal Spray soothes and relieves stuffy noses Presentations
and sinus pressure. It is safe for everyone, no matter how Both sticker-labels and preprinted cans can be used.
long or how often it is used. The Seawater Nasal Spray AURENA may assist during artwork providing templates
restores moisture to nasal passages irritated by: etc for all can sizes. Labels can be provided with a tamper
• Colds or allergies. seal. Preprinted cans are recommended for quantities over
• Dry air from cold weather or airplane flights. 25000+ per order.
• Pollution. Standard cans sizes are 50, 100, 125, 200 and 250 ml
• Overuse of nasal decongestants.
The Seawater Nasal spray is a non-medicated deeply penetra- Individual carton boxes with or without leaflets are also
ting nasal irrigation spray and can be used on baby's children available for can sizes up to 125 ml.
and adults. It works by thinning mucus, helping normalise
the acidic environment and washing away foreign particles Brand owner
such as dust pollen and allergens. This helps relieve conges- Products are available in:
tion and restore normal respiratory function. Seawater Nasal • Aurena brand name.
Spray is non-habit forming and can be used together with • OEM version, Brand-holders brand, Aurena as legal
other medications. Frequent sufferers of rhinitis and sinusitis manufacturer and brand-holder are stated as distributor
may find that regular use of Seawater Nasal Spray nasal spray • OBL version brand-holders brand and brand-holder
may help decrease the use of medicated products. stated as legal manufacturer, (requires certification
The spray contains no preservative and works in any direc- according ISO 13485)
tion.
Market
OTC
Composition
• Natural sea water solution (isotonic or hypertonic)
• Natural sea water solution (hypertonic) with addition of
Aloe and Chamomille
Shelf life
3 years from production date.
Product approvals
CE marked according to MDD (Medical Device Directive,
93/42/EEC, Class IIa)
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

10. Medical Throat Spray
Devices
Throat Spray is a sterile non medicated spray, that Brand owner
contains no preservatives and works in any angle. Products are available in:
• Aurena brand name.
• Alleviate and prevent sore throat symptoms during • OEM version, Brand-holders brand, Aurena as legal
colds and allergies manufacturer and brand-holder are stated as distributor
• Washing off excess mucus formed during colds and • OBL version brand-holders brand and brand-holder
allergies from the mouth and throat stated as legal manufacturer, (requires certification
• Alleviate feeling of dryness and irritation according ISO 13485)
Market
OTC
Composition
• Sterile hypertonic Seawater with Aloe and
Chamomille
• Sterile hypertonic Saline with Aloe and Chamomille
Shelf life
3 years from production date
Product approvals
CE marked according to MDD (Medical Device Direc-
tive, 93/42/EEC, Class IIa)
Presentations
Both sticker-labels and preprinted cans can be used.
AURENA may assist during artwork providing templa-
tes etc for all can sizes. Labels can be provided with a
tamper seal. Preprinted cans are recommended for
quantities over 25000+ per order.
Standard cans sizes are 50, 100, 125, 200 and 250 ml
Individual carton boxes with or without leaflets are
also available for can sizes up to 125 ml.
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

11. Medical Wound & Eye
Devices Wash Spray
The Wound & Eye Wash Spray for rinsing and cleansing away Brand owner
dust and dirt from wounds and eyes. The spray provides an Products are available in:
effective flow of sterile 0.9% saline solution that enables • Aurena brand name.
continuous treament/cleansing for several minutes. • OEM version, Brand-holders brand, Aurena as legal
manufacturer and brand-holder are stated as
Contents remain sterile after each application. The can may distributor
be angled in any direction during application, even if held • OBL version brand-holders brand and brand-holder
upside down, with the same performance. Perfect for Fist stated as legal manufacturer, (requires certification
Aid applications or as a family OTC-product. according ISO 13485)
Market
First Aid, OTC
Composition
• Sterile Isotonic Saline solution
• Sterile Buffered Isotonic Saline solution
Shelf life
3 years from production date
Product approvals
CE marked according to MDD (Medical Device Directive,
93/42/EEC, Class IIa)
Presentations
Both sticker-labels and preprinted cans can be used.
AURENA may assist during artwork providing templates etc
for all can sizes. Labels can be provided with a tamper seal.
Preprinted cans are recommended for quantities over
25000+ per order.
Standard cans sizes are 50, 100, 125, 200 and 250 ml
Individual carton boxes with or without leaflets are also
available for can sizes up to 125 ml.
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

12. Medical Wound & Eye
Devices Wash
The wound Cleansing/Irrigation spray is a sterile saline Brand owner
solution designed for cleansing of wounds. It is used for: Products are available in:
• removal of foreign bodies • Aurena brand name.
• reduction of pathogen numbers • OEM version, Brand-holders brand, Aurena as legal
• removal of blood, clot and dead tissue manufacturer and brand-holder are stated as
• moistening of tissue distributor
• Support wound healing • OBL version brand-holders brand and brand-holder
The spray is very economical, convenient and easy to use. stated as legal manufacturer, (requires certification
Perfect to clean cuts, scrapes and burns. The spray works in according ISO 13485)
any angle and the solution remains sterile during the
shelf-life.
Market
Health care institutions, community care, OTC
Composition
• Sterile 0,9% NaCl solution
• Sterile Ringer solution
Shelf life
3 years from production date
Product approvals
CE marked according to MDD (Medical Device Directive,
93/42/EEC, Class IIb)
Presentations
Both sticker-labels and preprinted cans can be used.
AURENA may assist during artwork providing templates etc
for all can sizes. Labels can be provided with a tamper seal.
Preprinted cans are recommended for quantities over
25000+ per order.
Standard cans sizes are 50, 100, 125, 200 and 250 ml
Individual carton boxes with or without leaflets are also
available for can sizes up to 125 ml.
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

13. Medical Available
Devices Q1 - 2013
Xylitol Nasal Spray Hypertonic nebulizer saline solution
The product is a sterile isotonic seawater or saline nasal The product is a sterile Hypertonic (3%) saline
spray with an additive of 2 %Xylitol. solution for use with nebulizer.
Use of xylitol in the prophylaxis of AOM (acute otitis The Hypertonic Saline Nebulizer Solution has been
media)w is based on the effect of the 5-carbon sugaron developed to act by exerting an osmotic effect in
bacteria on the mucosa of the rear nasal cavity, i.e. the the lower respiratory tract and to influence mucus
mucosa in close vicinity of the opening of the directly. These actions will result in a higher clea-
eustachian tube. Xylitol have been shown to affect the rance of the mucus by lowering viscosity, increase
cell capsule, the cell wall, the adherence to epithelial mucociliary clearance and thereby trigger expecto-
cells by Streptococcus pneumoniae These effects result ration of the mucus.
in a lower virulence of the Streptococci, in particular S.
pneumonia. Hemophilus influencae is also affected to Product Claims
some degree. • Mobilises secretions in the lower respiratory tract
after inhalation from a nebulizer
Product claims: • The spray works in any angle.
• Help inhibit/guard against bacteria frequently • preservative free
associated with sinus and ear infections • The can can be stored in a horizontal position
• ”Supports inner ear health”. without leakage.
• To enable washing out of secretions during colds and • Can be used until last drop.
allergies.
• Facilitate cleaning of the nasal cavity from particles,
as dust and air pollutions.
• Moisten the nasal cavity when dry or irritated as a
consequence of low air humidity, e.g. when staying in
heated/air conditioned rooms, at higher altitudes,
flights, or other mild irritation of the nose.
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99

14. Sterile Alcohol
Sprays
Sterile Alcohol Sprays Product approvals
General purpose disinfection of surfaces and equipment in Biocidal product
cleanrooms and other critical environments.
Presentations
Sterile, alcohol based ready-to-use solution for surface Both sticker-labels and preprinted cans can be used.
disinfection in cleanrooms. AURENA may assist during artwork providing templates
etc for all can sizes. Labels can be provided with a
• 0.2 μm filtered tamper seal. Preprinted cans are recommended for
• Gamma irradiated quantities over 25000+ per order.
• Double bagged to preserve product integrity Standard cans sizes are 200, 250 and 300 ml
• Closed System, sterile to the last drop
Market
Pharma industry, Healthcare institutions
Composition
• 70% Isopropyl Alcohol and 30% water for injection (USP).
Propellant: Nitrogen
• 70% Ethanol and 30% water for injection (USP).
Propellant: Nitrogen
•70% Denatured Ethanol and 30% water for injection (USP).
Propellant: Nitrogen
Shelf life
3 years from production date
AURENA Laboratories AB
Fjärrviksvägen 22, S-653 50 Karlstad, Sweden
www.aurena.se, www.bagonvalve.com
email: contact@aurena.se
Phone: +46 54 53 11 99