aurena laboratories | product information

AURENA Laboratories ABFjärrviksvägen 22, S-653 50 Karlstad, Swedenwww.aurena.se, www.bagonvalve.comemail: [email protected]: +46 54 53 11 99

MedicalDevices

AURENA Laboratories AB is a pioneer in the �eld of sterile packed aerosol products, based on the Bag-on-Valve technology. Since the year 2000, we have speciali-zed in the development of a new generation of spray products. AURENA o�ers a unique combination of production and �lling in clean rooms and aerosols using the Bag on Valve barrier system. The company has also developed and registered several successful medical device products based on this combination.

Our operations are carried out in our facility in Karlstad, Sweden. The aerosol production line uses state-of-art �llers/crimpers and typically the �lled products are alu-cans using Bag-on-Valve. AURENA has a production laboratory which is used for various raw material and product analyses.The production at AURENA also meets ESD and EX-standards. This means that we also o�er �lling of �ammable products in Bag-on-Valves.

Contract ManufacturingAURENA Laboratories o�ers services as a contract manufacturer or contract �ller. 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.

Contract manufacturing

As additional services we can also provide:• Development or modifications of your product formulations• Test productions• Stability tests / validation• Regulatory support

QualityAURENA is dedicated to provide quality services that meet the requirements and expectations of regula-tions and customers.The products for private labeling AURENA o�ers are approved and CE-marked in accordance with the EU’s medical technology Directive, MDD, a statutory mark for medical devices in Europe. AURENA Laboratories is registered by the FDA as a Drug Establishment and has a FDA Labeler Code number.


MedicalDevices Product list

Ce marked medical devices available from Aurena, October 2012

Product Market StatusSaline Solution Nasal Sprays OTC Medical Device II a

Natural Seawater Nasal Sprays OTC Medical Device II a

Saline /Seawater Nasal Spray w Aloe, Chamomille

OTC Medical Device II a

Saline + Xylitol Nasal Spray OTC Available Q1, 2013, MD II a

Wound Cleansing/Irrigation Spray Healthcare Institutions, Community Care, OTC

Medical Device II b

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 institutions

Biocidal Product

70% Ethanol Sterile Alcohol Spray Pharma Industry, Healthcare institutions

Biocidal Product


MedicalDevices

Bag on ValveThe Technology


MedicalDevices

This new medical device safely cleans and removes ear wax buildup. The device helps maintain healthy clean ears, using a naturally-sourced solution.

Wax in the ear canal is produced in the outer part of the ear. Wax tends to build up and eventually work its way into the ear canal. Ear Spray is a safe, simple easy way to remove wax.

MarketOTC

Composition• Sterile Isotonic Seawater Solution• Sterile Isotonic Saline Solution

Shelf life3 years from production date

Product approvalsCE marked according to MDD (Medical Device Direc-tive, 93/42/EEC, Class IIa)

PresentationsBoth 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.

Brand ownerProducts are available in:• Aurena brand name.• OEM version, Brand-holders brand, Aurena as legal manufacturer and brand-holder are stated as distributor• OBL version brand-holders brand and brand-holder stated as legal manufacturer, (requires certi�cation according ISO 13485)

Ear Spray


MedicalDevices Emollient Spray

A spray product for apply White Soft Para�n, Liquid Para�n onto the skin. The spray contains no preservatives or other additives. The para�n’s are dissolved in a volatile silicone which quickly evaporates leaving only the pure emollient onto the skin.• Protects skin from minor irritation and soreness.• Creates a barrier that protects irritated and intact skin from damage causedby urine and feces.• Barrier effect soothes and protects sensitive skin and soothes and protectschapped and cracked skin from further damage.• Package makes it easy to apply product to skin without risks for cross-contamination

MarketSkin care

CompositionHexamethyldisiloxan, Petrolatum, Liquid Para�n

Batch sizes 850 and/or 1700 kg.


Product approvalsCE marked according to MDD (Medical Device Directive, 93/42/EEC,Class IIa)

PresentationsBoth 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


Brand ownerProducts are available in:• Aurena brand name.• OEM version, Brand-holders brand, Aurena as legal manufacturer and brand-holder are stated as distributor• OBL version brand-holders brand and brand-holder stated as legal manufacturer, (requires certification according ISO 13485)


MedicalDevices Eye Wash Spray

The Saline Eye Wash is a hand-held emergency eye wash used for occupational safety. The Bag-on-Valve portable package makes it the perfect choice when a piped eye wash station is not possible. Several con�gurations and product sizes are available to meet di�erent requirements. Flushing of eye can be given constantly for more than 15 min with just one 250 ml can. It’s very important to rinse the eye in the �rst seconds after an eye accident. AURENA Eye Wash Sprays provide immediate �ushing of eyes when a plumbed eye wash is not readily available. The spray gives a gentle and soft rinsing directly to the eyes, avoiding unnecessary spillsOther advantages:Maintain sterility for 3 years.• Can be used in all direction.• No preservative.• A tamper seal provides highly visible notification if product has been used or not.• Triple or single can Wall Stations available that holds bottles �rmly in place with easy access to bottles in an emergency.

MarketOTC, 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 approvalsCE marked according to MDD (Medical Device Directive,93/42/EEC, Class IIa).

Accessories• Wall station (for 3 cans)• One Can Holder


Individual carton boxes with or without lea�ets are also available for can sizes up to 125 ml.



MedicalDevices

Medical Adhesive Remover Spray

Medical Adhesive Remover spray (sometimes called SMARs), for pain free removal of adhesive products such as stoma pouch, external sheath catheter, wound dressing etc. Medical Adhesive Remover sprays make adhesive removal quick and painless. Just spray around the edge of the adhesive and wait a few seconds• no-sting silicone medical adhesive remover• stoma pouch, wound dressings and other medical adhesives• quick and pain free removal of adhesive products• dries quickly and can be sprayed at any angle• Available in sterile and non-sterile versions

MarketHeath 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)

PresentationsBoth 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




MedicalDevices

The Saline Nasal Spray helps to restore moisture to dry, irritated nasal passages. It soothes and relieves stu�y noses and sinus pressure. It is safe for everyone, no matter how long or how often it is used.The Saline Nasal Spray restores moisture to nasal passages irritated by:• Colds or allergies.• Dry air from cold weather or airplane flights.• Pollution.• Overuse of nasal decongestants.

The spray contains no preservative and works in any direc-tion.

MarketOTC

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


Product approvalsCE marked according to MDD (Medical Device Directive, 93/42/EEC, Class IIa)

PresentationsBoth 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



Saline Nasal Spray


MedicalDevices

The Seawater Nasal Spray soothes and relieves stu�y noses and sinus pressure. It is safe for everyone, no matter how long or how often it is used. The Seawater Nasal Spray restores moisture to nasal passages irritated by:• Colds or allergies.• Dry air from cold weather or airplane flights.• Pollution.• Overuse of nasal decongestants.The Seawater Nasal spray is a non-medicated deeply penetra-ting nasal irrigation spray and can be used on baby's children and adults. It works by thinning mucus, helping normalise the acidic environment and washing away foreign particles such as dust pollen and allergens. This helps relieve conges-tion and restore normal respiratory function. Seawater Nasal Spray is non-habit forming and can be used together with other medications. Frequent sufferers of rhinitis and sinusitis may �nd that regular use of Seawater Nasal Spray nasal spray may help decrease the use of medicated products.The spray contains no preservative and works in any direc-tion.

MarketOTC

Composition• Natural sea water solution (isotonic or hypertonic)• Natural sea water solution (hypertonic) with addition of Aloe and Chamomille

Shelf life3 years from production date.





Natural Sea Water Nasal Spray


MedicalDevices

Throat Spray is a sterile non medicated spray, that contains no preservatives and works in any angle.

• Alleviate and prevent sore throat symptoms during colds and allergies• Washing off excess mucus formed during colds and allergies from the mouth and throat• Alleviate feeling of dryness and irritation

MarketOTC

Composition• Sterile hypertonic Seawater with Aloe and Chamomille• Sterile hypertonic Saline with Aloe and Chamomille


Product approvalsCE marked according to MDD (Medical Device Direc-tive, 93/42/EEC, Class IIa)




Throat Spray

MedicalDevices


Wound & EyeWash Spray

The Wound & Eye Wash Spray for rinsing and cleansing away dust and dirt from wounds and eyes. The spray provides an e�ective �ow of sterile 0.9% saline solution that enables continuous treament/cleansing for several minutes.

Contents remain sterile after each application. The can may be angled in any direction during application, even if held upside down, with the same performance. Perfect for Fist Aid applications or as a family OTC-product.

MarketFirst Aid, OTC

Composition• Sterile Isotonic Saline solution• Sterile Buffered Isotonic Saline solution







MedicalDevices

Wound & EyeWash

The wound Cleansing/Irrigation spray is a sterile saline solution designed for cleansing of wounds. It is used for: • removal of foreign bodies• reduction of pathogen numbers• removal of blood, clot and dead tissue• moistening of tissue• Support wound healingThe spray is very economical, convenient and easy to use. Perfect to clean cuts, scrapes and burns. The spray works in any angle and the solution remains sterile during the shelf-life.

MarketHealth care institutions, community care, OTC

Composition• Sterile 0,9% NaCl solution• Sterile Ringer solution


Product approvalsCE marked according to MDD (Medical Device Directive, 93/42/EEC, Class IIb)





MedicalDevices

Available Q1 - 2013

Xylitol Nasal SprayThe product is a sterile isotonic seawater or saline nasal spray with an additive of 2 %Xylitol.

Use of xylitol in the prophylaxis of AOM (acute otitis media)w is based on the e�ect of the 5-carbon sugaron bacteria on the mucosa of the rear nasal cavity, i.e. the mucosa in close vicinity of the opening of the eustachian tube. Xylitol have been shown to a�ect the cell capsule, the cell wall, the adherence to epithelial cells by Streptococcus pneumoniae These e�ects result in a lower virulence of the Streptococci, in particular S. pneumonia. Hemophilus in�uencae is also a�ected to some degree.

Product claims:• Help inhibit/guard against bacteria frequently associated with sinus and ear infections• ”Supports inner ear health”.• To enable washing out of secretions during colds and 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, �ights, or other mild irritation of the nose.

Hypertonic nebulizer saline solutionThe product is a sterile Hypertonic (3%) saline solution for use with nebulizer.

The Hypertonic Saline Nebulizer Solution has been developed to act by exerting an osmotic e�ect in the lower respiratory tract and to in�uence mucus directly. These actions will result in a higher clea-rance of the mucus by lowering viscosity, increase mucociliary clearance and thereby trigger expecto-ration of the mucus.

Product Claims• Mobilises secretions in the lower respiratory tract after inhalation from a nebulizer• The spray works in any angle.• preservative free• The can can be stored in a horizontal position without leakage.• Can be used until last drop.


Sterile Alcohol Sprays

Sterile Alcohol SpraysGeneral purpose disinfection of surfaces and equipment in cleanrooms and other critical environments.

Sterile, alcohol based ready-to-use solution for surface disinfection in cleanrooms.

• 0.2 μm filtered • Gamma irradiated • Double bagged to preserve product integrity • Closed System, sterile to the last drop

MarketPharma 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


Product approvalsBiocidal product

PresentationsBoth 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 200, 250 and 300 ml

aurena laboratories | product information

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