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Many industrial machines using compressed air as an energy source, use air cylinders or other pneumatic actuators to do the actual work.

Compressed air is 'explosive' as it moves from high pressu

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

re to low pressure on it's way back to atmosphere. That means when the air valve shifts and air flows to the cylinder, the cylinder piston and rod moves extremely quickly. A high speed cylinder ro

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

Examples of combination products may in

may not be best for your application, and you will want to reduce the speed and the impact.

One easy method of controlling the speed of an air cylinder is installing flow controls in the air lin

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

es between the valve to the air cylinder, in the cylinder ports themselves, or even in the exhaust ports of the air valve, though the latter is least desirable.

In the 'valve exhaust' type flow c

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

ntrol the controls themselves may be far enough away from the cylinder that the piston and rod may have traveled the full stroke before the exhaust flow control can start back-pressuring the line

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

Combination pro

o slow the cylinder. Cylinder control reaction time is always negatively affected depending on the distance from the cylinder to the flow control.

Some folks opt for needle valves to throttle the

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

flow of air into and out of the air cylinder, thereby reducing it's speed. The problem with using a needle valve to control the speed of an air cylinder is that it throttles the compressed air fl

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

w equally in both directions.

If you are using a larger cylinder, by throttling the air into the cylinder, you are actually preventing the smooth cylinder stroke desired. As air pressure builds i

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

n the cylinder it will reach the point where it overcomes the friction of the piston and rod seals and the piston will start to move. As it moves, it increases the volume of the air space inside t

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

e cylinder behind itself. The piston moves toward one end of the cylinder creating a larger area behind than in front of it. This is an area into which air has to flow quickly to ensure that the p

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

ston keeps moving. If the air inrush cannot keep up with the increasing cavity size there will be insufficient pressure to keep the piston moving, and it will stop. So too will your piston rod, an

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

Following aspects would a

d whatever tooling you have installed on the end of it.

The rule of thumb for using a flow control to reduce and smooth air cylinder piston travel is to only throttle the exhaust air from the cyl

dd to the challenges in developing combination products:

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

nder. The air flowing into the cylinder port should never be reduced.

How is this accomplished?

Use a "cylinder flow control". This is a device that may not look any different from the needle va

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

lve. Inside, however, there is a "needle bypass" which allows the air to bypass the needle which is throttling the air achieving full flow of air unidirectionally.

The "free flow" of compressed a

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

r through the cylinder flow control allows the unit, when it's installed in the correct orientation, to provide full and un-throttled inrush of air to the cylinder, yet, when the valve has shifted

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

and the double-acting air cylinder has reversed, the air that is now flowing out of the cylinder is throttled to the level necessary to achieve the cylinder speed desired.

There will be a second

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

Professional from academic institutions, pharmaceutical industries, health care indust

cylinder flow control on the other line too, and this works exactly the same way.

As a result, air flow into the cylinder ports at either end of the cylinder is totally unencumbered providing hig

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

-force piston movement. The piston is trying to go fast and at full power, but since the exhaust flow of air is impeded by the cylinder flow control, the piston moves with full power, but at a con

.

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

trolled and desired rate.

Most cylinder flow controls will have a schematic on the side showing the flow paths to ensure that they are installed correctly.

Some cylinder flow controls are equipp

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

Companies that provide selfless information through particip

d with sealant coated male threads for screwing into the cylinder port, and with an "instant" type fitting into which the cylinder air line can be quickly fitted, features that save time and money

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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