CHALLENGES IN GOING FROM

LABORATORY TO PRODUCTION SCALE..

Posted by andriantoangkadirjo85 on August 30, 2011

Hi guys,

Hows the things? Sorry for no posting lately, merely just lack of idea. Now I got one, dealing with my situation right now. As most
of you know Im working in a small..very small.. :) cosmetics manufacturer, formulating mostly make-up kit

( compact powder-

foundation ) & perfume. Though were small, our orders have increased so much lately to a point where we need to figure outwithin a very strict budget and space-how to increase our production so we can get more product out the door fast. Right now, we
can make about 10 kg/batch and Id like to at least double that. The equipments we have are simple filler with a manual piston type
and hopper fits just about 15 kg products. I know that we need to invest in some equipments to be more productive and efficient.
Anyhow, the price of equipments is very..very frightening.

Its very crucial for cosmetics company to go from lab-batch to pilot project and last scale-up production. Scale-up from laboratory
to production is can sometimes be a little difficult. There are some factors that must be taken into consideration before even get to
the production floor. The most critical points to look at are batch size, energy requirements, equipment
capabilities, timeand temperature, among others. These must be considered along with type of product, ingredient type,
concentration, phase ratio and order of addition. One point overlooked may mean the difference between a successful batch and a
total failure. Theres nothing worse than expecting a product to turn out as a heavy cream and you wind up with a thin lotion.

Energy requirements

The total amount of energy required to produce a batch in the lab must be translated into larger production batches, no matter
what the batch size is. This is even more critical when making emulsions. Examples :

1. If it takes 10 minutes to add an oil phase to a water phase in the lab, then it must also take 10 minutes to incorporate that same
oil phase into the water phase of a 2000 kilogram size batch in production. Yes, a transfer pump must be used in production to
recreate the emulsion. The same exact speed and flow characteristics must be used for the pump.

2. Mixer speed and energy produced by a homogenizer (lab and production models shown below) if all this energy is required to
create the product.

homogenizer-lab(left) & homogenizer-production(right)

This must be duplicated in order to produce the same product with the same identical characteristics: droplet size, viscosity,
application characteristics, feel, color, etc. The energy required in production must be the same as used in the lab which means that
mixer size, rpms, energy output, sheer rate, etc. must all be calibrated to be equal. Otherwise the possibility of having a different
type of emulsion is quite real if the proper conditions are not met.

3. The grinding method used in the lab must also be used in manufacturing. This will ensure that all color particles have been
broken down to 3-5 microns to guarantee optimum color development and avoiding any color streaking or specks. The equipment
pictured below (a pigment disperser and a 3-roll mill) are not equal and will give the final product differences in feel, consistency,
color particle size, possible hardness, and above all, shade. However the lab bench top roller mill and the larger mill next to it are
definitely equivalent.

(L-to-R)-Hockmeyer-Dispenser,-Exakt-50-3-roll-Mill,-Roller-Mill
Manufacturing procedures

The formulator must be able to create manufacturing procedures that will guarantee reproducibility of a certain type of product, no
matter how large the batch may be. These include :

1. Mixing. Mixing speeds and the amount of energy introduced during processing have a direct impact on the final aesthetics,
stability and homogenity of the final product. This may be easy for small lab batch but can be more complicated in production.
Lately, I succeded in developing compact powder with simple ingredient in lab scale, about 500 g/batch. But, frankly, Im confused

how to make if the batch size is 10 kg. Also, in developing nail polish, I succeded in lab scale about 500 g/batch. The question is
how supposed to make if the batch size is 10 kg? This is exactly the same to cream.

2. Heating and Cooling. Lab batches can heat/cool to ambient temperature rather quickly, but it takes much longer for a plant to
heat/cool a production- size batch. Uneven cooling process could cause, for example, the premature solidification of waxes in the
development of an emulsion.

3. Sub-phases or Pre-mixes are smaller phases compromised of several ingredients that require pre-mixing to dissolve, wet or react
prior to their addition to the main phase. If sub-phases/pre-mixes are necessary ensure that this type of mixing is possible for
production with just a propeller mixer rather than a homogenizer.

4. Rate and Order of Addition. The rate and sequence for transferring materials into the main kettle must also be controlled and
consistent. Each phase should have adequate mixing time before the subsequent sequence is added. To maintain uniform mixing,
the order and rate of addition during scale-up may be modified. The batch may cannot withstand over-mixing during a long addition
sequence.

5. Formula Adjustments. Adjustments, whether for color, pH or viscosity, ensure consistency in aesthetics as well as micro integrity.
If in-process adjustments are necessary, determining the specific amount of adjuster added is useful so that in the future, it can be
added up front during lab batches and pilots to optimize the process for production. Making lab batches with multiple lots can
provide insight on the amount required for the pH or viscosity adjustment. It is easier to slightly adjust the pH or viscosity of a
batch near the end of the process rather than to initiate prolonged mixing with a long adjustment sequence after the batch has
been completed.

Equipments

The correct equipment available will guarantee that the batch scale up can adequately be performed. All the equipment used in the
laboratory and production is designed with documented specifications regarding pump speed, torque, rpms, horsepower rating,
heating and cooling rate, etc. Some examples lab-equipmetnts :

Some examples production equipments :

 Process Development Engineer

Product physics and energy requirements are usually beyond the capabilities of the average formulator unless they have some level
of engineering experience which is only in very rare instances. In order to meet these challenges, a process development
engineer is necessary to work very closely with the formulator. The engineer knows exactly what equipment to use to achieve the
desired energy necessary to replicate a product successfully and reproduce it no matter how big the batch is or what kettle/
equipment combination is used. If certain equipment is not available to perform a certain task on a larger scale, then the
engineer is capable of making suitable recommendations as to the design and construction of such a piece of equipment. With new
products comes new technology and the need for new equipment to successfully replicate these new products. Thats why process

engineers are usually involved very early in the product development process, advising and offering input to the formulator with
regard to equipment and energy requirements.

In a process development lab, a laboratory formula is made with the equipment the process engineer feels will adequately duplicate
the product. Larger batches of the formula are made to see if this will happen. Recommendations are made to the formulator as to
changes that may be necessary in the formula. The formulator and the process development engineer usually work very closely
together in this process. When a formulator presents the formula to the engineer, theengineer knows (based on the equipment
available in the production facility) exactly where and with what equipment the product will be made. It will be known right away
which equipment combination will be optimum for a specific product for a specific kettle/mixer combination. But not every piece of
equipment can be used for every product.

New equipment design may be necessary in order to manufacture a specific type of cosmetic or personal care product. New
equipment design will make it possible to manufacture products that were once thought to be impossible to make. Such specialized
equipment can be manufactured for laboratory or production use, making batch scaleup less of an issue because scaleup has
already been considered by the manufacturer in the equipments design. Usually an engineer has to calculate the differences in
energy output compared to horsepower rating and rpms between different pieces of equipment. This is how an engineer knows
what product can be made where and at what batch size. With new equipment, the manufacturer already knows and has calculated
these differences ahead of time making the engineers job a little bit easier. It is sometimes based on an engineers specifications
with custom designed equipment setups geared towards specific production requirements.

So, these are Im facing right now. I have copied nail polish product, compact powder and whitening cream in laboratory. And now,
time to scale up the batch size to production scale and it is not as simple as theres different problems are awaiting to be solved..

If you finish read this posting and like to comment just feel free to write below..

andriantoangkadirjo85 bottom line

There should be no guessing or question marks when it comes to recreating an approved formula that has to ship quickly. A
formulator must keep these points in the back of their mind and be aware that these conditions must be addressed in order to
create the best product.

There should be no holdup when the lab formula has to go to production. A product should be in and out of the kettle, filled and
shipped to the cosmetic counter for sale to consumers around the world.

An experienced process development engineer is really important part of this scale up process.

At last, the most important is the financial..as many problems cant be solved without investing new equipment, new
ingredient or even new environment condition.