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The power is in the air! Well, I am not talking about aero planes or the military but on something we have taken for granted. It's about the air we

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

breathe. Invisible to the naked eye, you can get a lot of power from it if you know how.

Do you know that the air compressor is a very important pi

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

Examples of combination products may in

ece of machinery on board a diesel operated ship? It is the heart of the starting air system for the diesel electrical generators and the main diese

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

engine. Without these engines, everything comes to a standstill.

The compressed air that is stored at 25 to 35 bars in air reservoirs has the capa

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

city to start the main engines for at least 13 times before it becomes too weak. The pressure in the compressed air is sufficient to push huge pisto

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

Combination pro

ns and turn the crankshafts of engines so that enough momentum is created for the engine to start.

Below are some practices that engineers should o

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

serve when they are operating and maintaining air compressors:

Grit or dirt must be prevented from entering any part of the unit. As with any machi

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

nes, these will give rise to numerous problems later. When opening any pipes, the ends need to be covered up to prevent dirt from entering the syste

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

m. Any oil pipes need to be blown through with air. All air passages must be examined and cleaned, and blown through with high pressure air to remov

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

loose material.

If crankcase oil is changed, clean the crankcase. Do not use waste that may leave lint because they can get trapped in the system.

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

Never use any inflammable liquid to clean the crankcase.

Valves must be cleaned and examined for cracks, marks, or scratches. If found, the valves

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

Following aspects would a

must be replaced, because if any small pieces from the valve were to break they can cause severe damage to the compressor.

The amount of oil must

dd to the challenges in developing combination products:

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

e checked at intervals. Too little of it will cause wear down of the parts. If too much, carbonizing of valves can occur, resulting in loss of compr

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

essor efficiency, and loss of cooler efficiency. Check on the oil condition. If unsuitable oil is used, it may emulsify with the water vapor contain

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

ed in the air, resulting in loss of lubricating quality and wear down of parts. Unsuitable oil may also evaporate, condense and deposit at the coole

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

tubes resulting in poor heat transfer, which can lead to carbonizing of valves.

Keep records of the number of working hours so that oil can be cha

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

Professional from academic institutions, pharmaceutical industries, health care indust

nged at the correct intervals.

Engineers must take care of the compressors diligently, especially the cooling system. If the compressor becomes ove

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

rheated, usually many other problems will occur.

Because of the overheating, carbonization of the valves and even tubes can take place. The latter

.

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

ill result in poor heat transfer and more overheating. The compressed air might become so overheated that even the valve springs may lose their elas

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

Companies that provide selfless information through particip

ticity and fail. In the worst case, the compressor may even explode due to heat, air and fuel present together.

Well folks, bring up your air power

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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