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.

1. PACKAGING
Bag-on-Valve – Optimal Solution
for Pharma Products
With the total separation of
product and propellant, a bag with
superior barrier properties, and
complete oxygen protection, Bag-
on-Valve is the optimal solution
for pharmaceutical and health
products. Many products can be
made in a sterile presentation.
Sterility is guaranteed – even when
the can has been opened and used
frequently over a long period of
time.
With tax-based healthcare services
burdened by increasingly higher costs
for pharmaceuticals and the ever-
more stringent regulation governing
the introduction of a new drug on
the market, there is a growing trend
moving from prescription (Rx) to non-
prescription, over-the-counter (OTC)
products. It has turned out that the
Bag-on-Valve (BoV) may in several
cases be a suitable technology for
products to make this switch, as
marketers are looking for modern,
innovative packaging that can attract
consumers.
Products for which the
pharmacological claims are not products using the BoV technology for the bag. When the spray button is
the primary function can often be administration. pressed, the product is squeezed out
classified 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 dispensing
The physical or mechanical function pharma industry where it is expanding, as a spray, cream or gel (see graphic
of 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 barrier
system. Being classified as a medical sprays, eyewash sprays, dermal drug pack for liquids, gels, creams and
device, rather than pharmaceutical, a delivery products, disinfectant sprays lotions, keeping high product integrity
product 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 amount
for registration can be made once of preservatives needed is very low
instead of the more complicated and Convenient and Environmentally- and may in some cases be excluded
costly drug application using the friendly altogether. For sterile products it is
centralised, decentralised or mutual- The Bag-on-Valve consists of a possible to arrange aseptic filling or
recognition procedures. Registering rolled-up multi-layered flexible pouch use gamma irradiation to achieve
an OTC-product as a medical device attached to an aerosol valve. In sterility. The propellants eliminate the
can 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, pump
interest in giving old products new, the bag attached is crimped onto the sprays or trigger sprays. Instead the
more convenient applications as container. The formulation is forced content can be sprayed, smoothly and
well as finding niches for totally new through the aerosol valve stem to fill evenly, giving the user perfect control
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over the administration of the product. Bag-on-Valve Technology
Another major convenience connected 1. The Valve
with BoV is the fact that it is possible Bag-on-Valve systems are available with both female and male valves.
to spray from any angle without 2. The Bag
losing 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 sizes.
degree of emptying is very high, up to
3. The Product
nearly 100 per cent for water-based Suitable for liquid as well as viscous products, such as gels, creams
solutions. and ointments, in a number of application areas.Optimised for
oxygen-sensitive and sterile products.
If desired, a Bag-on-Valve aerosol
can 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 Actuator
without any need for additional hand- A large range of standard actuators depending on product demands.
spreading, thus resulting in advantages 6. The Can
in 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 contamination
from the hands, ideal for sensitive
product applications. For healthcare
professionals and patients alike it is
less encumbering having someone to
spray rather than rub the content onto
the skin. Since a Bag-on-Valve aerosol
functions equally well at all angles it
is 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 placement
A Wide Range of Applications crimping of weight control
the valve
BoV can be used to upgrade the onto the can
packaging of a product, increase the
marketing opportunities, and/or to add
new convenience to the formulation,
for instance turning an emollient
cream into an emollient spray. For an
innovative pharmaceutical company
it may be interesting how they can
challenge established brands simply
by using an alternative spraying
technology. With its many dispensing
possibilities, Bag-on-Valve is suitable
for direct dispensing even in such
sensitive areas as eyes or ears – even
in children.
One of the most common
formulations used in BoV medical
devices is different saline solutions.
They are used in several different
applications, such as nasal sprays,
wound cleansers, ear-cleansing sprays
and also eyewashes. Market leading
nasal spray brands like Simply Saline
(US) and Stérimar (EU), both from
Church & Dwight Co. Inc. are well-
known examples. Nasal sprays in BoV
are widely used based on saline or
natural seawater solutions.
Wound care on the other hand is
rather “virgin soil” when it comes to
BoV, even if wound cleanser with saline
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solutions for hospital and community
care 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 offers
currently in process in this segment. major advantages for a range of
One example of an innovative approach aerosol products where safe and
using BoV is the new product Granulox contact-free dispensing is required.
(SastoMed, Germany) for treatment of Bag-on-Valve gives new marketing
chronic wounds. The Granulox product opportunities through improved
uses haemoglobin in order to improve consumer conveniences, product
oxygen supply to chronic wounds. protection, and controlled discharge
The haemoglobin-based formulation of the product.
sprayed onto the wound area is able
to penetrate the exudate and thereby Safety and environmental benefits
increase the level of oxygen in the • No need for flammable propellants
wound. The wound situation improves • Hygienic and sterilisable
and wound healing is accelerated. • Used with eco-friendly
Wounds stagnant due to hypoxia can air or nitrogen
also be activated. • Less need for preservatives
Several companies are also
recognising the benefits of BoV for the Consumer benefits
application of silicon-based products. • Up to 100% product emptying
An example of this is the growing • Longer shelf-life with
market for medical adhesive remover less preservatives
sprays where sophisticated silicone • Even and controlled spraying
formulations are sprayed to gently and pattern for optimal result
painlessly remove adhesive products • No pumping motion needed
such as stoma pouches and wound • Can be used at all angles
dressings. Conventional adhesive • Reduced spray noise
dressing removal is often difficult • Less-chilling product discharge
for the healthcare professional and
unpleasant 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 products
the aim of soothing and preventing offers a more constant pressure and • Effective filling process
sore 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 products
range 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 disinfection
there are also BoV-products on the sprays for this purpose with
market 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 medical
where 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 distribute
eyewash, such as is available on the under their own brands. In these
EU market, is a good complement to Integrity of Brands cases the final products are already
the water pipe or gravity-fed eyewashes BoV products for the pharmaceutical registered and CE-marked according
that are usually found at industrial market are often manufactured by to the European Medical Device
workplaces. Benefits include a lesser contract manufacturing organisations Directive. The brand name and artwork
amount of liquid that lasts longer, (CMOs). For sterile products, some design of the new private label will be
portability and the ability to be either CMOs of BoV can offer aseptic added to the technical file (dossier) of
personal 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. The
eyewashes, the effective flushing time gamma irradiation of the final product. procedures will be different depending
has 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 contractual
actuators and a controlled discharge as drugs or on production of medical arrangement between the CMO and
flow rate. Thanks to the separation of device classified products based on the brand owner it can be either the
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4. PACKAGING
CMO or the brand owner that is stated Leading suppliers of filling machines
as the legal manufacturer. This can are Pamasol (Switzerland) and MBC
Magnus
ensure total integrity of the brand, as Aerosol (USA). Hedman
the production source is not disclosed For transportation, the BoV products Mr Magnus
on 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 Marketing
50ml and upwards, compared to pump available. The cans are also light to Director, Business Development
sprays 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 and
packaging covers a broad range from countries. business development specialist
30 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 20
by other suppliers, of which Aptar represent quite a large display area years. International Sales Marketing
Group, Lindal Group and Coster are in the store and can be designed in a Manager for Swedish respiratory
among 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 has
are 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: magnus@aurena.se
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