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Discover why Bag-On-Valve is the optimal solution for pharmaceutical products. It's wide range of application includes 100% separation of product & propellant and 100% product emptying.

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  1. 1. PACKAGINGBag-on-Valve – Optimal Solutionfor Pharma ProductsWith the total separation ofproduct and propellant, a bag withsuperior barrier properties, andcomplete oxygen protection, Bag-on-Valve is the optimal solutionfor pharmaceutical and healthproducts. Many products can bemade in a sterile presentation.Sterility is guaranteed – even whenthe can has been opened and usedfrequently over a long period oftime. With tax-based healthcare servicesburdened by increasingly higher costsfor pharmaceuticals and the ever-more stringent regulation governingthe introduction of a new drug onthe market, there is a growing trendmoving from prescription (Rx) to non-prescription, over-the-counter (OTC)products. It has turned out that theBag-on-Valve (BoV) may in severalcases be a suitable technology forproducts to make this switch, asmarketers are looking for modern,innovative packaging that can attractconsumers. Products for which thepharmacological claims are not products using the BoV technology for the bag. When the spray button isthe primary function can often be administration. pressed, the product is squeezed outclassified and registered as medical Originating in the cosmetics industry, of the bag by the compressed air/devices utilising the BoV technology. BoV technology has entered into the nitrogen, which creates the dispensingThe physical or mechanical function pharma industry where it is expanding, as a spray, cream or gel (see graphicof a medical device spray product and now covers saline/seawater nasal for details).is suitable for this modern aerosol sprays, wound cleansing/irrigation As such, BoV is an ideal barriersystem. Being classified as a medical sprays, eyewash sprays, dermal drug pack for liquids, gels, creams anddevice, rather than pharmaceutical, a delivery products, disinfectant sprays lotions, keeping high product integrityproduct can reach the market much and veterinary products, among and protection against oxygen. Hence,faster, and in the EU, an application others. for many formulations the amountfor registration can be made once of preservatives needed is very lowinstead of the more complicated and Convenient and Environmentally- and may in some cases be excludedcostly drug application using the friendly altogether. For sterile products it iscentralised, decentralised or mutual- The Bag-on-Valve consists of a possible to arrange aseptic filling orrecognition procedures. Registering rolled-up multi-layered flexible pouch use gamma irradiation to achievean OTC-product as a medical device attached to an aerosol valve. In sterility. The propellants eliminate thecan provide a more cost-effective way the production of a BoV product, need for pumping out the content,of entering the European market. compressed air or nitrogen is charged which often is a great advantage There is therefore an increased into the can, and an aerosol valve with compared to, for example, pumpinterest in giving old products new, the bag attached is crimped onto the sprays or trigger sprays. Instead themore convenient applications as container. The formulation is forced content can be sprayed, smoothly andwell as finding niches for totally new through the aerosol valve stem to fill evenly, giving the user perfect control120 INTERNATIONAL PHARMACEUTICAL INDUSTRY Summer 2012 Volume 4 Issue 3
  2. 2. PACKAGINGover the administration of the product. Bag-on-Valve TechnologyAnother major convenience connected 1. The Valvewith BoV is the fact that it is possible Bag-on-Valve systems are available with both female and male spray from any angle without 2. The Baglosing pace or force in the spray. The FDA-approved laminated bag (three or four layers depending on product requirements). Available in a large range of of emptying is very high, up to 3. The Productnearly 100 per cent for water-based Suitable for liquid as well as viscous products, such as gels, creamssolutions. and ointments, in a number of application areas.Optimised for oxygen-sensitive and sterile products. If desired, a Bag-on-Valve aerosolcan produce a smooth and even 4. The Propellant Because of the separation between product and propellant,layer of a film-forming product or a Bag-on-Valve can be used with compressed air or nitrogen.protective barrier cream to the skin – 5. The Actuatorwithout any need for additional hand- A large range of standard actuators depending on product demands.spreading, thus resulting in advantages 6. The Canin hygiene and patient integrity. This Standard aerosol can, aluminium or tinplate. All sorts of shaped cans can be used. No limitation in marketing solutions.means that the product can be applied The Cap – Can be used with many kinds of standard overcaps.without actually touching the skin,avoiding the spread of contaminationfrom the hands, ideal for sensitiveproduct applications. For healthcareprofessionals and patients alike it isless encumbering having someone tospray rather than rub the content ontothe skin. Since a Bag-on-Valve aerosolfunctions equally well at all angles itis easy to use – even in emergency STEP 1. STEP 2. STEP 3. STEP 4. STEP 5.situations. Placing of Gassing (air/ Pressure Product filling Actuator valve and bag nitrogen) control in the bag and cap inside the can followed by followed by placementA Wide Range of Applications crimping of weight control the valveBoV can be used to upgrade the onto the canpackaging of a product, increase themarketing opportunities, and/or to addnew convenience to the formulation,for instance turning an emollientcream into an emollient spray. For aninnovative pharmaceutical companyit may be interesting how they canchallenge established brands simplyby using an alternative sprayingtechnology. With its many dispensingpossibilities, Bag-on-Valve is suitablefor direct dispensing even in suchsensitive areas as eyes or ears – evenin children. One of the most commonformulations used in BoV medicaldevices is different saline solutions.They are used in several differentapplications, such as nasal sprays,wound cleansers, ear-cleansing spraysand also eyewashes. Market leadingnasal spray brands like Simply Saline(US) and Stérimar (EU), both fromChurch & Dwight Co. Inc. are well-known examples. Nasal sprays in BoVare widely used based on saline ornatural seawater solutions. Wound care on the other hand israther “virgin soil” when it comes toBoV, even if wound cleanser with saline122 INTERNATIONAL PHARMACEUTICAL INDUSTRY
  3. 3. PACKAGINGsolutions for hospital and communitycare have been on the market for more Fact box:than 10 years in the EU and the US. Advantages of Bag-on-Valve (BoV)There is a lot of product development The Bag-on-Valve system offerscurrently in process in this segment. major advantages for a range ofOne example of an innovative approach aerosol products where safe andusing BoV is the new product Granulox contact-free dispensing is required.(SastoMed, Germany) for treatment of Bag-on-Valve gives new marketingchronic wounds. The Granulox product opportunities through improveduses haemoglobin in order to improve consumer conveniences, productoxygen supply to chronic wounds. protection, and controlled dischargeThe haemoglobin-based formulation of the product.sprayed onto the wound area is ableto penetrate the exudate and thereby Safety and environmental benefitsincrease the level of oxygen in the • No need for flammable propellants wound. The wound situation improves • Hygienic and sterilisableand wound healing is accelerated. • Used with eco-friendly Wounds stagnant due to hypoxia can air or nitrogenalso be activated. • Less need for preservatives Several companies are alsorecognising the benefits of BoV for the Consumer benefitsapplication of silicon-based products. • Up to 100% product emptyingAn example of this is the growing • Longer shelf-life with market for medical adhesive remover less preservativessprays where sophisticated silicone • Even and controlled spraying formulations are sprayed to gently and pattern for optimal resultpainlessly remove adhesive products • No pumping motion neededsuch as stoma pouches and wound • Can be used at all anglesdressings. Conventional adhesive • Reduced spray noisedressing removal is often difficult • Less-chilling product dischargefor the healthcare professional andunpleasant for the patient. Production and distribution benefits Another upcoming area currently • Longer shelf-life for oxygen- catching interest is throat spray, with product and propellant, Bag-on-Valve sensitive productsthe aim of soothing and preventing offers a more constant pressure and • Effective filling processsore throat symptoms during colds and flow rate until the last drop. • Suitable for both liquid allergies. Maybe we will see a similar Let’s not forget disinfection products and viscous productsrange of throat spray products on used in critical environments like • Can be used with standard the market as is already available for pharmaceutical industry cleanrooms. actuators and aerosol cans.nasal application. In the ENT segment Double-bagged sterile disinfectionthere are also BoV-products on the sprays for this purpose withmarket that help to prevent build-up of isopropanol alcohol or ethanol are now the ISO 13485:2003 standard.earwax. available using the BoV packaging. Some CMOs in the EU, such as Occupational safety is another area The greatest convenience of this is that Aurena Laboratories, offer medicalwhere BoV products are increasing they are easily sprayed on machinery device products, developed in-house,their market shares. A BoV first aid and surfaces in the critical areas. for companies to sell and distributeeyewash, such as is available on the under their own brands. In theseEU market, is a good complement to Integrity of Brands cases the final products are alreadythe water pipe or gravity-fed eyewashes BoV products for the pharmaceutical registered and CE-marked accordingthat are usually found at industrial market are often manufactured by to the European Medical Deviceworkplaces. Benefits include a lesser contract manufacturing organisations Directive. The brand name and artworkamount of liquid that lasts longer, (CMOs). For sterile products, some design of the new private label will beportability and the ability to be either CMOs of BoV can offer aseptic added to the technical file (dossier) ofpersonal or available in a wall station. production. A more common method the registered product and become In products such as first aid to realise sterile products is the use of a part of the registered product. Theeyewashes, the effective flushing time gamma irradiation of the final product. procedures will be different dependinghas to be as long as possible. This The manufacturers may be focusing on on the classification of the product.can be achieved with very fine spray GMP production for products classified Depending on the type of contractualactuators and a controlled discharge as drugs or on production of medical arrangement between the CMO andflow rate. Thanks to the separation of device classified products based on the brand owner it can be either the124 INTERNATIONAL PHARMACEUTICAL INDUSTRY Summer 2012 Volume 4 Issue 3
  4. 4. PACKAGINGCMO or the brand owner that is stated Leading suppliers of filling machinesas the legal manufacturer. This can are Pamasol (Switzerland) and MBC Magnusensure total integrity of the brand, as Aerosol (USA). Hedmanthe production source is not disclosed For transportation, the BoV products Mr Magnuson the packaging. are classified as aerosols (UN 1950). Hedman is the With BoV the cost per ml can often For the pharmaceutical market the cans Co-founder,be decreased, particularly regarding are most often made of aluminium, Partner,nasal sprays with a filling volume of even if tinplate BoV systems are also Marketing50ml and upwards, compared to pump available. The cans are also light to Director, Business Developmentsprays that normally contain a lesser carry and normally fit into the recycle Manager of Aurena Laboratories AB.filling volume. Available standard BoV programmes established in most He is a seasoned entrepreneur andpackaging covers a broad range from countries. business development specialist30 to 500ml. The cans also offer interesting who has been involved in the medical The components for BoV are made marketing opportunities, since they device and pharma industry for over 20by other suppliers, of which Aptar represent quite a large display area years. International Sales MarketingGroup, Lindal Group and Coster are in the store and can be designed in a Manager for Swedish respiratoryamong the leading companies. highly attractive way, giving the brand care company Aiolos Medical, 1990 Special aerosol filling machines name a high degree of exposure. to 2000. He co-founded Aurena Laboratories in the year 2000 and hasare needed to fill BoV products. developed a range of medical devices in the Bag-on-Valve packaging for the Pharma industry. He has led the dedicated work to develop Aurena into a leading international company of medical device aerosols. Email: INTERNATIONAL PHARMACEUTICAL INDUSTRY 127