By Aurena Laboratories
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Aurena Laboratories’ mission is to supply medical device and pharmaceutical products to the global market. To this end, Aurena operates as a contract manufacturer as well as a manufacturer of a private label program of CE-marked medical devices. Aurena manufactured products are brought to market under private labels, store brands, or as contract-manufactured products.
With twenty years of experience in medical device, Aurena has built up a reputation as a leader in manufacturing of final products in bag-on-valve packaging.
Aurena focus its resources close to market, in late clinical or registration phases. The focus is on well-known active ingredients or improving the characteristics of an existing product. This approach reduces time to market, development cost and risks compared with traditional drug development.
Ear, Nose and Throat
Aurena produces a wide range of trusted saline and seawater sprays for ear, nose and throat applications; available in both hypertonic and isotonic spray formulae.
Aurena offers a range of seawater nasal sprays for all the family, from infants to adults. The range includes a choice of additives as Aloe Vera & Chamomile and Xylitol.
Together with our partner Clover Hill Healthcare we now offer the next generation drug-free nasal sprays combining saline with carbon dioxide. The carbonation of saline solutions gives a unique sensory effect unlike other nasal sprays. Users experience a deeper and cleaner feeling in their nose
The many ENT uses for saline solutions include ear sprays that effectively combat wax build up and throat sprays to alleviate irritation and soreness caused by colds and allergies.
Wound & Skin Care
Aurena has developed a wide range of innovative wound and skin care products that include sterile wound wash and irrigation sprays, silicone-based barrier films and increasingly popular medical adhesive remover sprays. Aurena’s unique emollient sprays provide barrier protection to skin irritation and soreness, while burn gel spray offers rapid pain relief. Aurena has also developed a first-in-class diabetic foot wound healing spray forming an emollient barrier to protect feet in diabetic patients.
Aurena meets rising demand for innovative first aid sprays in market segments such as occupational safety, law enforcement and rescue services, as well as for family use and the sporting industry with a range of convenient and effective private label products using BoV technology. These include CE-marked eyewash, burn gel and combined wound and eyewash sprays available as OEM products.
Together with our partner Lipidor AB we offer the AKVANO formulation technology. AKVANO is a novel proprietary lipid-based technology for topical medication, skin care, disinfection, and wound care. Combined with BoV, it forms a powerful combination of topical medication and product delivery that can be used to innovate a new or existing product.
Supplier of Natural Seawater. We offer 100% natural-source seawater from Gullmarsfjorden on the west coast of Sweden. The collection of water is located 32 meters below sea level.
Aurena Laboratories has developed a wide range of registered CE-marked products ready for marketing under customer’s own brand, with Aurena acting as legal OEM manufacturer, assuming full responsibilities towards Notified Body and Competent Authorities.
Aurena can label these products to conform to customer’s own branding, adding relevant artwork, etc., to the existing product list and technical file.
As a Contract Manufacturing Organization (CMO) and Contract Development and Manufacturing Organization (CDMO), Aurena is committed to innovation and creative solutions, with a proven manufacturing process that can transform customer formulations into modern spray delivery systems.
Operations are carried out in Karlstad, Sweden with quality services that exceed the requirements and expectations of regulatory agencies and customers:
Product Development and Small Scale Production
Bag-on-valve (BoV) packaging is applicable to a huge range of liquid, ointment, gel, cream or lipid-based formulations. Aurena’s experienced team can conduct pre-formulation development and formulation development. These include:
- Unique sprayable petrolatum-based emollients
- Saline solutions for ENT, eye care and wound management
- Natural seawater-based products for ENT applications
- Silicone based wound/skin formulations
Aurena can test product stability for BoV delivery by performing small-scale fillings based on as little as one liter of original product bulk. Small-scale fillings are also applicable to trial or niche products with production runs limited to a few hundred or thousand units.
CE-marking and Regulatory Support
Aurena can work with clients to obtain all the regulatory approvals and CE-markings needed to market products. Aurena’s regulatory team will work with clients to assemble relevant technical documentation and prepare the audit and notification processes needed to bring product to market. The service can include:
- Device classification
- Evaluation and substantiation of product claims
- Preparation of the technical documentation and file
- Audit and notification process
Structure and history:
Brothers Lars and Magnus Hedman founded Aurena Laboratories in the year 2000, with a guiding vision of creating a successful international business that was a strong, creative, positive, and innovative force in the medical device and pharma industries.
From the start, Aurena’s business has been anchored in four core values:
- Collaboration: working closely with our employees, partners and customers, adopting a consultative approach to embrace challenges
- Innovation: taking a leadership position in BoV production and medical devices, dedicated to constant improvement in product development, manufacturing methodology, equipment, materials, technology, research, IT, customer service and communication
- Creative Solutions: Dedication to solving problems creatively while striving to understand customer needs by finding customized product, packaging and production solutions
- Humble & Caring Culture: following a friendly and flexible approach in all things, embracing the concepts of partnership and mutual trust at all levels
A key ingredient of Aurena’s success is that all its activities are located under one roof, including manufacturing facilities, research laboratories, product formulation (including purpose-built area for handling natural seawater), regulatory expertise, sales and marketing. This allows the company to be ultra-responsive and tailor truly integrated solutions.
Bag-on-valve technology (BOV) aerosol is a superior spray dispensing system, with modern packaging that improves products in a range of industries, including pharmaceutical, occupational safety, cosmetic, or food. Compared to traditional aerosol spray technology (and other alternative packaging), BOV has several benefits, for manufacturers, consumers and the environment: Up to 100% product emptying, Longer shelf life with less preservatives, Even and controlled spraying pattern at any angle, No pumping motion needed, Fully recyclable, Suitable for both liquid and viscous products, No need for flammable propellants, Hygienic and sterilisable, Used with eco-friendly air or nitrogen.
The technology is applied across a wide range of products that are highly relevant in today’s OTC and ethical healthcare markets.
Quality and Regulatory
Aurena’s operations are certified in accordance with SS-EN ISO 13485:2012, with products approved and CE-marked in accordance with Medical Devices Directive (MDD). Aurena Laboratories is registered and inspected by FDA as a Drug Establishment and also FDA registered as a Medical Device Establishment.
All filling is performed in ISO class 7/8 clean rooms.
The Aurena Quality Management System (QMS) includes a full quality system documentation structure. The company also embraces a full QRM (Quality risk management) regime in which the scope is to continuously identify and reduce risks connected to Aurena’s products, processes and methods that can affect the company and/or end user. All risks and corrective actions are fully documented.