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Process Optimization

Manufacturing processes can easily be optimized . . . Now that is a bold statement which I can back up. Lets assume you need to maximize the performance of your product by

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

such things as:

●Minimizing material cost or

●Minimizing process time or

●Maximizing product appearance to minimize rejects or

●Maximizing product taste

Notice that the

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

claim is not just reducing or improving. That implies 'just' an improvement but not necessarily optimized to the maximum. Maximizing and minimizing results are easily achieve provided that the pro

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

uct is manufactured by machines such as plastic molding machines, die presses, and processes using a recipe such as baking bread. Essentially any process that can be repeated and has a minimum of h

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

uman involvement can be driven to peak performance of the process.

The method is extremely simple to use as a computer program guides you:

1.The computer asks a few simple questions about the pro

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

cess. The questions asked are that the baker, technician, or setup operator can answer. This is not rocket science stuff. The mathematics of it certainly are but that’s the computers job.

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

.The computer details eight experiments to run. Each experiment involves changing different specific setting of the process.

3.The success of each experiment is judged on a scale of 1(failure) to

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

10(excellent) and reported to the computer.

4.The computer then gives the best setting for each of the controls.

You must admit that this is simplicity itself.

For the non-technical person, th

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e point is to insist the technical group investigate the process known as Design of Experiments. There are oceans of information on the net about Design of Experiments. Someone in your organization

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

will have to take a short course to obtain the software and how to use it. It is not difficult to learn. I took a two day course and never looked back.

What are the questions to be answered?

`

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

79;List all the controls the process has. For a molding machine it would be various pressures, temperatures, speeds, and timings.

●For each control estimate the highest and lowest value you

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

think may work. You do not have to be accurate. Just what you estimate the highest and lowest are. It is best that the process actually works, even if not well. I once had a process we could not ru

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

at all. We guessed all the values and had wonderful success.

Given this information the computer details eight specific production runs using its specific settings. There is only one proviso: The

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

tests must be run in the order specified for rearranging the order of tests offers a high risk of failure.

Make enough samples for the process to settle down. How good are the parts? Evaluate the

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

results. Place a rating from one(failure) to ten(excellent) for each experiment and report them to the computer.

The computer responds with the best setting possible for the process, as the mach

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ne and controls currently exists. Remember, additional controls reduce the uncontrolled variables reducing the range of product variations. Lacking key controls means a grater variability of the pr

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

oduction results.

As a bonus feature, the computer reports what settings are critical, which ones are critically interrelated, and which are not particularly critical. Further refinements for othe

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

r features can also be done.

Probably the most famous story about Design of Experiments was about a Japanese ceramic manufacture that had a wonderful product but was running a ten percent scrap ra

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

e. What to do? Purchase a better oven? Would that work? So he ran a Design of Experiment and reduced rejects to one percent with the existing oven. One surprising result: For hundreds of years it w

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

as known that one specific chemical was a “must have” in the formula to make excellent ceramics but it turned out it was not necessary.

So that is the basics. I have used it with wonderful success

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Management is a totally different function from leadership but just as important. Managers deliver quality results at the right price and time. Leadership is only required to promote change. Management gets things done.

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