5 costly mistakes of R&D report

Institute of
Personal Care Science
PO Box 995, Coolum Beach, QLD Australia 4573
Ph: (07) 5446 4680 www.personalcarescience.com.au
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5 Costly Mistakes of Research &
Development
AND HOW TO AVOID THEM!
You’ve got this fantastic sample of product, have approved the formula and are now ready to get
it mass produced. It should turn out fine, right? WRONG!!! Liking the feel or look of that sample is
only one aspect of Research & Development (R&D) – the tip of the iceberg really – because lying
beneath the surface of that product is a multitude of errors that can be made, and come back to
haunt you at a later date.
If something does go wrong, it’s the fault of the formula, right? NOT NECESSARILY!!! There are
certain steps of production and product evaluation that go beyond initial formulation development
that still fall into the scope of ‘R&D’ – but all too often, aren’t carried out effectively, if at all,
because of ‘cost’ - such as extended stability testing and appropriate scale up. Just remember
though, there is nothing cheap about a failed production batch or product recall!
This report looks at 5 Costly Mistakes of R&D that all too commonly occur and tells you how to
avoid them!
Costly Mistake #1: Incorrect preservative selection
The preservatives used in your products would invariably be the most controversial part of the
development – with so much misinformation on the internet about their safety (or potential harm),
and avoidance of certain preservatives by consumers, preservative selection is something your
brand needs to think carefully about. However, incorrect preservative selection is the most
harmful of all!
For example, did you know that different preservatives have different selection criteria based on:
 form of the finished product
 pH of the finished product, and likely pH drift over time
 application of the finished product, i.e. the age of the user, how often they will be using it,
where they will be using it, whether it will be left on or washed off
 certification requirements of the finished product
 required smell, feel and look of the finished product
 the country or countries the products will be sold in
Despite common internet misconceptions, the preservatives that are permitted by regulatory
authorities in personal care products, when selected and used correctly, are SAFE when used
within the stated limits – but this doesn’t necessarily mean they will suit your company
philosophy!
Formulators are responsible to ensure theoretical efficacy of the preservatives they use in your
products after taking into consideration all required selection criteria. True guarantees of
effectiveness, however, can only be confirmed by Preservative Efficacy Testing (PET or
Challenge Testing). Even then, things can and do go wrong during scale up or bulk production
that may cause a preservative to fail – but when product is adequately tested before being
released for sale, preventing contaminated product from entering the market place is largely
avoidable, and prevents one of the most common costly mistakes that occurs in the personal care
industry.

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Costly Mistake #2: Ingredient incompatibilities
Not all ingredients are compatible with other ingredients, and this goes far beyond the standard
water hates oil concept! For example, did you know:
 certain active ingredients are only compatible within very specific pH limits, and this
varies depending on the type of preparation it is?
 various gums and thickeners are not compatible with certain pH levels, in the presence of
charged compounds and have very specific processing requirements to be effective?
 the pH required by your preservative can inactivate the performance of other ingredients,
and vice versa?
 some emulsifiers have charge, form and ingredient incompatibilities depending on how
they are used and what they are used in conjunction with?
 the polarity of lipids can affect product stability, particularly when certain combinations of
lipid soluble actives, performance enhancers or aesthetic agents are used?
Not checking (and double checking) ingredient compatibilities can lead to rapid instability of the
finished product and greatly reduce or negate product performance and aesthetic aspects.
Knowing how to check for ingredient incompatibilities and formulate around these issues is the
only way to ensure theoretical best formulation practice.
Even when the best theoretical development has been conducted, there is nothing like extended
stability testing to confirm suitability.
Costly Mistake #3: Inefficient development time
Investing in R&D is an investment in your brands future – but this doesn’t mean you need to
throw good money after bad in your quest for the next big thing! Have you:
 set a realistic budget for formulation development?
 considered the costs of additional testing that should be conducted e.g. stability and
PET?
 budgeted for the costs of appropriate regulatory checks?
 allowed for the costs of pilot and up-scale batches?
 worked with your development team to ensure cost- and time-saving efficiencies?
All too often, realistic budgets are not set or adhered to, leading to unrealistic expectations or
unexpected costs! Good formulation principles result in more efficient development time and far
better sample outcomes. Knowing how to formulate correctly and completely leads to faster turn-
around times on samples – saving your company time and money!
Essential elements such as stability, regulatory and scale up steps are commonly not budgeted
for or left out because inefficient development has already broken the budget – but not confirming
stability, not ensuring compliance and not completing necessary scale up steps can lead to failed
batches and product recalls – the costs of which far, FAR exceed having completed these steps
in the first place.
Save on inefficient development time using good formulation principles and invest those savings
into other areas of R&D that often get left out. The result – cost savings AND thorough R&D
which potentially prevents costly mistakes from happening!

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Costly Mistake #4: Inadequate scale up procedures
Scale up is the process of taking a formulation from the lab bench to production equipment and
checking it at various sizes of production to ensure its suitability for larger scale equipment. If a
formula fails on larger equipment, it is usually a manufacturing problem, not a formulation
problem – so prevent the problem by performing appropriate scale up.
It is foolish to think that a sample produced in a lab in a 200g or even 1kg sample will turn out the
same if you go straight to producing 100kg. Instead, 10 – 20x increments of scale up is the MOST
that should be used at a time to limit or potentially prevent things from going wrong. For example,
this means:
 preparing a 1 – 4kg ‘lab batch’ after a 200g lab sample/formula has been approved – in
many cases, you can use this larger lab batch to start your stability study, so it is never
wasted
 preparing a 10 – 20kg ‘pilot batch’ using similar equipment to that which will be used to
produce the full production batch to confirm its suitability when scaling up from the lab
into production equipment – this batch can normally be sold albeit will cost more per kilo
than the full production batch
 proceeding to the full 100 – 200kg production batch once the pilot has passed quality
checks and been signed off as suitable
 scaling up again if 1000kg or more is required
Not performing appropriate scale up is one of the most preventable costly mistakes of R&D –
don’t fall victim to a failed batch simply because you tried to save time and money by skipping
good scale up procedures!
Costly Mistake #5: Insufficient stability testing
Your formulator is responsible for ensuring good ingredient selection, formulation development
and theoretical stability – but the ONLY way to confirm this is to run longer term accelerated and
real time stability studies. If you want to sell product in Europe, stability programs are essential!
The ONLY way you can confirm the true shelf life of a product is to store it at the temperature
stated on the pack for the duration of the shelf life e.g. 30 months at 25°C. But you don’t want to
have to wait 30 months before you start selling product, so accelerated programs provide relative
confidence as to the product achieving the required shelf life without having to wait too long to
start production.
An effective stability program should include:
 preliminary accelerated testing of at least 3 - 6 months on large lab batches before
proceeding to pilot (these results can also be extended to 9-12 months accelerated and
30-36 months real time and be used to support full scale production batch shelf life)
 full accelerated and real time stability on the pilot and full production batch
 ongoing accelerated and real time stability is also required for therapeutic goods
Brands releasing personal care and cosmetic products all too often think PET is the same as
stability testing or that a 2 week indication of how a product performs under different temperature
conditions is sufficient to proceed to full scale production… but it’s not! If that product separates,
develops off notes over time or otherwise becomes unsuitable to sell due to aesthetics or safety
reasons, a recall will be necessary. There is only one way to be sure your product is suitable to
sell over a 1, 2 or 3 year period and comply with EU requirements. Remove the risk, comply with
the requirements, and know what to expect by conducting appropriate stability testing or have
experts do it for you.

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WANT TO LEARN HOW TO GET IT RIGHT?
Want to improve your skills and knowledge as a:
 Cosmetic Formulator,
 Brand Manager, or
 Regulatory Affairs Associate?
Study with the Institute of Personal Care Science – we have a range of Formulating, Brand
Management and Regulatory Diplomas, Certificates, short courses and workshops that can see
you comprehensively trained and/or rapidly up-skilled in key areas, all from the convenience of
a time and place that suits you with:
 All distance (on-line) study
 1-on-1 tutorial support via skype or phone with our trainers
 Flexible study options – study full time, part time or very part time – from as
little as 5-6 hours per week!
 Instalment payment options – monthly instalments to help make study
affordable
ALL STUDY IS ON-LINE VIA DISTANCE EDUCATION – study at a time and place that suits you,
anywhere in the world!
With 1-on-1 tutorial support throughout the study period if required and flexible study and
payment options, there has never been a better time to upgrade your skills and knowledge!
Take a look at our YouTube videos on various courses to see what you get when studying with
IPCS:
Formulation courses:
• Diploma of Personal Care Formulation: https://youtu.be/gSyt6wnVVAQ
• Certificate in Advanced Cosmetic Science: https://youtu.be/KpENGIw6bFc
• Certificate in Beginners Cosmetic Science: https://youtu.be/_RPITpWG3PI
• Certificate in Organic Formulations: https://youtu.be/YKBKcD1Wyjg
• Certificate in Colour Cosmetics Formulation: https://youtu.be/8qRAk3obwMc
Brand Management courses:
• Diploma of Personal Care Development & Promotion: https://youtu.be/5flTooGcuR8
• Certificate in Cosmetic Brand Management: https://youtu.be/wVsYcl0Og6Q
Regulatory compliance courses:
• Diploma of Regulatory Compliance: https://youtu.be/iZKetrE8hrA
• Certificate in Cosmetic Regulatory Essentials:
http://personalcarescience.com.au/certificate-cosmetic-regulatory-essentials/
• Certificate in EU compliance: http://personalcarescience.com.au/certificate-eu-
compliance/
Contact us for more information to get the learning and answers you are
searching for no matter where you are located in the world!
info@personalcarescience.com.au
or visit www.personalcarescience.com.au

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