So, what is a stability test and why

do we need them?
A stability test is  a way to fi nd out over a period of 1 to 3 months whether a
product will hold up during its intended lifetime.  These are called accelerated
tests that put the product under extreme conditions and are supposed to
indicate how long the product would last under real life conditions.  So, if we
want to give a shelf life to a product and we also want to get that product to
market in 6 months then we will need to check that nothing will change to it
over time.  We need to know that it will smell and look the same, it's viscosity is
unchanged, it's pH is the same (will indicate chemical changes which we don't
want.)   We will also need to know if the packaging is right for the product (it
doesn't leak) or that it is generally compatible with the ingredients.  We might
also need to know whether it will stand up to ongoing insult from the consumer.

There is also  preservative effi cacy testing (PET) or challenge tests which will
determine whether the product is microbiologically sound - but that is a whole
diff erent post.

When to do a test.

Normally, we should do stability tests on all new products.  We should also do
stability tests if we need to change an ingredient or packaging. We would need
to do one if we are making scale up batches or if we have a change of machinery
or processes.

So how does this happen?

According to some sources there is little published research into how to

conduct a stability test, this is because of the great variation between diff erent
products.  It is generally up to the manufacturer to agree their own protocols on
determining when it is appropriate to do a stability test and how that test
should be conducted, depending on the type of product they are testing.  A
salve or balm which has no water in it and is expected to melt at high
temperatures and will have diff erent parameters than an emulsion which is
inherently unstable.  That said there are some guidelines off ered by the
pharmaceutical industry which have informed the cosmetic industry and there
are some useful guides by the FDA and COLIPA.

What to do Generally speaking, it involves making a batch of product and

separating it into a number of diff erent containers and storing it at diff erent
temperatures and conditions.  You need to keep one which is your control.  You
test and record the control sample for viscosity, pH, scent profi le and keep it in
the cupboard to test against the ones you put under stress. Colipa advises that
the product is put in an oven at 37c, 40c and 45c.  Depending on who you ask, or
what protocol you are following, a product at a diff erent temperature over a
certain period will indicate a diff erent shelf life, there is actually no prescription
(of a few diff erent ones.)  So we can say that one month at 40-45c will indicate
1 year at room temperature - or thereabouts.  As a little side note, in the EU, in
order to get a period after opening sign on the product we need to know that
the product will be durable for 30 months minimum, so it would need to pass the
3 months in the oven with no signifi cant changes. There are also tests like the
freeze thaw cycle