5 Costly Mistakes of Research & Development… and how to avoid them!

There are certain steps of production and product evaluation that go beyond initial formulation development that still fall into the scope of R&D. All too often, these steps may be skipped or not carried out effectively, 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 most importantly, tells you how to avoid them!
 

Costly R&D Mistake #1: Incorrect preservative selection

The preservatives used in your cosmetic formulas are often 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

You can’t just swap out one cosmetic preservative for another, watch why here.

For an overview of preservatives used in cosmetics, watch this video.  

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 or cosmetic formulation.

Formulators are responsible to ensure theoretical efficacy of the preservatives they use in cosmetic formulas 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.
 

Costly R&D 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 R&D 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. Learn the common formulation mistakes to avoid in this video.

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!
 

Costly R&D 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 cosmetic 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

Watch how to perform scale up steps easily and accurately with the right equipment in this video.

Learn the essential steps to cosmetic manufacture here.  
Learn how to calculate larger batch sizes with this video.

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 R&D 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 the shelf life of a cosmetic formula is to run longer term accelerated and real time stability studies. If you want to sell product in the UK and Europe, stability programs are essential!

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/medicinal goods
• get an overview of stability and shelf life testing, watch our video here.
• learn professionally with our Certificate in Cosmetic Quality & Stability.

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 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.
 

Costly R&D mistakes can be avoided!

In a tight economy, it’s natural for organisations to try to save time and costs where they can; unfortunately, R&D is not an area that should be skimped because the costs of failed batches and product recalls are far more costly to brand reputations and hip pockets than setting aside an appropriate R&D budget to begin with.

Avoid issues, make sure your brand avoids the 5 costly R&D mistakes listed here for more successful formulation developments, and avoid unnecessary stress when your cosmetic product reaches the market.
 

Happy formulating!